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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically confirmed, American Joint Committee on Cancer (AJCC) stage II or III breast cancer High risk of breast cancer recurrence, defined as documented evidence of one or more of the following i) Biopsy evidence of breast cancer in regional lymph node(s) (LN) (node-positive disease); Nodal micrometastases only are not considered node positive ii) Tumor size > 5 cm (T3) or locally advanced disease (T4) Documented pathological evaluation of the breast cancer for hormone receptor (estrogen receptor [ER] and progesterone receptor [PR]) status and HER-2 status Subjects must be receiving or be scheduled to receive standard of care systemic adjuvant or neoadjuvant chemotherapy and/or endocrine therapy and/or HER-2 targeted therapy For subjects receiving adjuvant therapy only subjects must have undergone complete resection of the primary tumor with clean surgical margins, or subjects must have undergone resection of the primary tumor and be scheduled for further treatment of the primary tumor with curative intent. Definitive treatment must be planned to be completed within approximately 9 months of randomization Time between definitive surgery and randomization must be ≤ 12 weeks. Definitive surgery may secondary interventions (e.g. to clear inadequate surgical margins) Subjects with node positive disease must have undergone treatment of axillary LN with curative intent, or subjects must be scheduled for further treatment of regional lymph nodes with curative intent. Definitive treatment must be planned to be completed within approximately 9 months of randomization Subjects must not have received prior neoadjuvant treatment. Endocrine treatment for less than 30 days prior to surgery is not considered prior neoadjuvant treatment For subjects receiving neoadjuvant therapy only Prior or current evidence of any metastatic involvement of any distant site History of breast cancer (other than ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS]) prior to the current diagnosis Osteoporosis requiring treatment at the time of randomization or treatment considered likely to become necessary within the subsequent six months Any prior or synchronous malignancy (other than breast cancer), except i) Malignancy treated with curative intent and with no evidence of disease for ≥ 5 years prior to enrollment and considered to be at low risk for recurrence by the treating physician ii) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Active infection with Hepatitis B virus or Hepatitis C virus Known infection with human immunodeficiency virus (HIV) Prior history or current evidence of osteomyelitis/osteonecrosis of the jaw Active dental or jaw condition which requires oral surgery Planned invasive dental procedure for the course of the study Non-healed dental or oral surgery
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-120.0, Breast Cancer Histologically confirmed locally recurrent breast carcinoma consistent with the following cell types Invasive ductal breast carcinoma Medullary ductal breast carcinoma Tubular ductal breast carcinoma Mucinous ductal breast carcinoma Lobular breast carcinoma Ductal carcinoma in situ (DCIS) No Paget disease of the nipple Target lumpectomy cavity must be clearly defined and the target lumpectomy cavity/ whole-breast reference volume must be < 30% based on a post-operative, pre-treatment CT scan Tumor size ≤ 3 cm in greatest dimension on pathologic specimen
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Phyllodes Tumor Histologic proof of phyllodes tumor of borderline or malignant grade, as first defined by Pietruszka and modified by Azzopardi and adopted by the World Health Organization (1,2,17) Borderline malignant: 5-9 mitoses/10 HPF, pushing or infiltrating margins, 2+ (moderate) stromal cellularity and atypia Malignant: 10 or more mitoses / 10 HPF, predominantly infiltrating margins, usually 3+ (severe) stromal cellularity and atypia but occasionally 2+ The tumor has been excised with a breast-conserving resection and there is no tumor seen at any of the margins of the resection No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast. Patients with a local recurrence of a previously excised phyllodes tumor are eligible if the recurrence is in the area of the previous excision No history of irradiation of the ipsilateral breast No evidence of other areas worrisome for cancer on physical examination and mammography of the ipsilateral breast Age >18 years Informed consent Documentation that either: 1. the patient's medical insurance company has certified that they will pay for the cost of radiation therapy treatments, or 2. a letter from the patient indicating that they explicitly understand the costs of radiation therapy and that the sponsor (Principal Investigator) of this study will not be held responsible for these costs Histologically positive margins Breast carcinoma or ductal carcinoma in situ in the ipsilateral breast A history of irradiation to the ipsilateral breast Pregnancy. A urine pregnancy test will be performed on each fertile premenopausal female prior to entry into the study. Patients with childbearing potential must employ effective contraception during the radiation therapy A radiation planning CT scan which demonstrates a target lumpectomy cavity that is not clearly delineated or a target lumpectomy cavity/whole breast reference volume > 30% Unacceptable radiation therapy quality assurance parameters, as defined in Section 5 of the protocol
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Subjects must be 18 years of age or older 2. Diagnosis of breast cancer requiring axillary nodal dissection 3. Negative urine pregnancy test within 72 hours prior to study drug administration, if female of childbearing potential 4. Females of childbearing potential who agree to use a medically accepted method of contraception for a period of one month following the study. Medically acceptable contraceptives (i) hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot) if such use is approved by the subject's Oncologist; (ii) barrier methods (such as a condom or diaphragm) used with a spermicide, or (iii) an intrauterine device (IUD). 5. Continuation of #4: Non-childbearing potential is defined as physiologically incapable of becoming pregnant, including any female who is post-menopausal; postmenopausal is defined as the time after which a woman has experienced 12 consecutive months of amenorrhea (lack of menstruation). 6. Patients with a positive fine needle aspirate or core biopsy of their axillary nodes Women who are pregnant or breast-feeding 2. Persons who are allergic to iodine 3. A female of child-bearing potential who does not agree to use an approved contraceptive for one month after study participation 4. History of ipsilateral axillary surgery including sentinel node biopsy 5. Any patient who does not meet for study
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Ductal Breast Carcinoma in Situ Estrogen Receptor-negative Breast Cancer Estrogen Receptor-positive Breast Cancer HER2-negative Breast Cancer HER2-positive Breast Cancer Invasive Ductal Breast Carcinoma Invasive Lobular Breast Carcinoma Male Breast Cancer Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate Mucinous Ductal Breast Carcinoma Papillary Ductal Breast Carcinoma Progesterone Receptor-negative Breast Cancer Progesterone Receptor-positive Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Tubular Ductal Breast Carcinoma Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm) All radiographically suspicious lesions must be biopsied and have histologically confirmed ductal carcinoma in-situ, invasive ductal, invasive lobular, medullary, papillary, colloid (mucinous), or tubular histologies A maximum of two radiographically detected malignant lesions Clinical Stage I-II breast carcinoma, with lesion size =< 5 cm for the dominant mass and the second lesion detected only on MRI, treated with lumpectomies; the MRI detected lesion must be pathologically =< 1 cm Axillary lymph node evaluation, either sentinel lymph node biopsy or axillary dissection as deemed appropriate by the treating surgeon for all patients with invasive cancer; no axillary lymph node sampling is needed for patients with DCIS Negative resection margins with at least a 2 mm margin from invasive and in-situ cancer or a negative re-excision A posterior margin =< 2 mm from DCIS is permissible provided fascia was taken Patients are eligible regardless of estrogen receptor, progesterone receptor, or Her-2/neu amplification Hormonal therapy is allowed; if adjuvant chemotherapy is planned, the chemotherapy should be delivered first and radiation must begin no earlier than three weeks and no later than eight weeks following completion of chemotherapy Signed study-specific informed consent prior to study entry
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-74.0, Breast Cancer Subjects must have histologically confirmed invasive breast cancer and be enrolled in the trial within 12 months after the first histologic diagnosis of invasive breast cancer. A core biopsy interpreted as invasive cancer meets this criterion; otherwise, the date of first histologic diagnosis will be the date of first surgical procedure that identifies invasive cancer (biopsy, lumpectomy or mastectomy). Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery. Bilateral breast carcinoma is allowed provided diagnoses are synchronous - that is, within 3 months of one another and at least one of the two breast carcinomas meet the and neither violates the criteria All subjects (both adjuvant and neo-adjuvant) must have sentinel lymph node biopsy and/or axillary lymph node dissection. Sentinel lymph node biopsy alone is allowed in the following instances: 1. sentinel lymph node biopsy is negative: pN0 2. sentinel lymph node biopsy is positive for isolated tumour cells only: pN0 (i+) 3. * clinically node negative, T1-2 tumours with sentinel lymph node biopsy positive in ≤ 2 lymph nodes without extra-capsular extension or matted nodes and undergoing breast conserving surgery and tangential whole breast irradiation (* excludes subjects treated with neo-adjuvant systemic therapy) Definitive surgery and/or chemotherapy have been completed at least 4 weeks prior to randomization. Surgical margins must be clear of invasive carcinoma. If there is microscopic residual ductal in situ disease present at lumpectomy or total mastectomy margins, further excision is highly recommended. If further excision is not undertaken, the subject may still be entered on study, provided that in addition to breast or chest wall irradiation, a boost to the tumour bed is delivered. In situ lobular disease at the margin is acceptable. Adjuvant subjects with the following pT pN combinations are eligible pT1c, pN0 AND negative estrogen and progesterone receptors AND HER2 negative OR pT2N0 and at least one of the following tumour characteristics: histologic grade 3, lymphovascular invasion, negative estrogen and progesterone receptors, HER2 positive, Oncotype Dx recurrence score ≥ 25 (or if Oncotype Dx recurrence score is not available, Ki67 > 14%) OR Subjects with pT3, pN0 OR Subjects with pT1-3, pN1-3 The of neo-adjuvant subjects is assessed on the basis of cTNM. The same eligible TNM combinations apply HER2 status must be known. (Positive = 3+ over-expression by IHC in > 30% of invasive tumour cells OR HER2 gene amplification by FISH/CISH > 6 HER2 gene copies per nucleus, OR a FISH/CISH ratio: HER2 gene copies to chromosome 17 signals of ≥ 2.2. All other results will be considered negative) Patients must have had a bilateral mammogram within 12 months prior to randomization, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required. (Subjects with bilateral total mastectomies and no mammogram within 12 months prior to randomization must, instead, have a physical examination of the chest wall to ensure there is no residual or recurrent disease at the time of randomization. The date of this examination is used in place of the mammogram date on the checklist.) Investigations, including chest X-ray or CT chest, bone scan (with radiographs of suspicious areas) and abdominal ultrasound or liver scan or CT abdomen have been performed between the first histologic diagnosis and the time of randomization Subjects with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years Subjects with locally recurrent or metastatic breast carcinoma. (Subjects with prior invasive breast cancer at any time are not eligible. Subjects with prior DCIS only in either breast are eligible provided the DCIS has been curatively treated including surgery, radiotherapy and/or Tamoxifen) Subjects whose axillary node status is unknown Known diabetes (type 1 or 2) or baseline fasting glucose > 7.0 mmol/L (126 mg/dL). (Sampled and assayed according to local institution's procedures.) Known hypersensitivity or intolerance to metformin Any condition associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heart failure defined as New York Heart Association {NYHA} Class III or IV functional status [see Appendix IX], history of acidosis of any type; habitual * Currently taking metformin, sulfonylureas, thiazolidinediones or insulin for any reason Current or planned pregnancy or lactation in women of child-bearing potential. Men should not father a child. (An effective method of birth control should be used while on study treatment which could abstinence, IUD, condoms or other barrier methods of birth control because the safety of metformin in pregnancy or in male fertility has not been established) Concurrent or planned participation in randomized trials of weight loss or exercise interventions or trials targeting insulin, IGF-1 or their receptors, or involving P13K inhibitors (at the time of randomization)* These interventions would interfere with the primary endpoint. (Also, in general, double randomizations in breast cancer trials for MA.32 patients are permitted only if the patient meets all the for MA.32 and the sponsor of the previous trial has no objection to the patient also being enrolled in MA.32)
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-75.0, Cholelithiasis age: 18-75 BMI: <30 ASA: I-III absence of non-correctable coagulopathy (international normalized ratio >1,5, or platelet count <90 × 109/l) diagnosis: cholelithiasis (gallstones < 2 cm in diameter) gallbladder dyskinesia cholecystitis suspected presence of common duct stones suspected presence of biliary cancer Previous abdominal surgery Previous umbilical surgery
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 50.0-999.0, Breast Neoplasms A confirmed histological diagnosis of invasive breast carcinoma Treated by breast conserving surgery with axillary node dissection (with a minimum of 6 nodes sampled) or sentinel lymph node biopsy Surgical margins clear over or equal to 2 mm A maximum tumor size of 3 cm Age >= 50 years old ECOG performance status of 0 or 1 Informed consent signed Previous history of cancer other than curable skin SCC or Tis or T1 cervix Patient receiving anti-coagulant that cannot be stopped two weeks prior PBSI Autoimmune disorder Diabetes insulin-dependant Pregnancy Breast implants Psychiatric or addictive disorder that would preclude attending follow-up Post-operative breast infection Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign) Lobular features on histology (pure or mixed) or sarcoma histology
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1
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 35.0-999.0, Breast Cancer Group I Females at least 35 years of age of any ethnicity Had a mammogram, read as BI-RADS® 1 or 2 Will undergo study imaging no later than four weeks from date of mammogram Is able to undergo informed consent. Group II Females at least 35 years of age of any ethnicity Require diagnostic imaging Will undergo study imaging no later than four weeks from date of diagnostic mammogram Is able to undergo informed consent Group I and Group II Pregnancy Lactation Subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker Subjects who are unable to tolerate study constraints Subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) Treatment for enlarged thymus gland as an infant Irradiation for benign breast conditions, including breast inflammation after giving birth Treatment for Hodgkins disease Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer All patients who are considered candidates to receive Herceptin for this indication Patients for whom Herceptin is contraindicated
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Sentinel Node treatment with BCT with SNB and/or ALND for primary breast cancer previous primary breast cancer located in the upper-outer quadrant of one breast Primary breast cancer treatment at least 3 years before the analysis, with or without adjuvant chemo or hormonal therapy breast surgery for other reasons than breast cancer recurrent breast cancer former allergic reaction to 99mTc-colloidal albumin
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically or cytologically confirmed invasive breast carcinoma Early stage breast cancer (Stage I (tumor size ≥ 1cm), II and IIIA) Invasive breast cancer must be estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, human epidermal growth factor receptor 2 (Her2)-negative. If breast cancer is Her2 2+ by immunohistochemistry (IHC), then fluorescence in situ hybridization (FISH) must be negative for Her2 gene amplification No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes Patients must have measurable disease as defined by palpable lesion with both diameters ≥ 1cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension ≥ 1cm. Screening mammogram of the contralateral breast must be performed within past 12 months per standard practice guidelines. Clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements on clinical exam must have been made within 14 days if the mass is palpable. If the mass is not palpable, a mammogram or MRI must be done within 14 days. If the mass is palpable, a diagnostic mammogram of the affected breast or MRI must be done within 2 months prior to study entry Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 14 days of study entry Normal (greater than 50%) left ventricular ejection fraction (LVEF) by multigated acquisition (MUGA) scan or echocardiography Signed informed consent Adequate organ function within 2 weeks of study entry Absolute neutrophil count ≥ 1000/mm³, Hgb ≥ 9.0 g/dl and platelet count ≥ 100,000/mm³ Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer Metastatic disease on baseline staging scans Medical, psychological or surgical condition which the investigator feels might compromise study participation History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible Evidence of grade 2 or greater sensory and/or peripheral neuropathy Serious, uncontrolled, concurrent infection(s) Major surgery within 4 weeks of the start of study treatment, without complete recovery Pregnant or lactating women are not eligible. Women or men of childbearing potential not using a reliable and appropriate contraceptive method are not eligible. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) Use of St. John's Wort or rifampin (rifampicin) Known or suspected allergy to sorafenib or any agent given in the course of this trial
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 20.0-50.0, IVF Poor Responders Antral follicle count < 8 Antimullerian hormone (AMH) <1.3 Follicle stimulating hormone (FSH)>10 History of follicular dysynchrony or poor response Menopause FSH >40 Age > 50 Contraindication to estradiol or COCP (including pre-existing cardiovascular disease, familial thrombophilia (factor V Leiden), severe hypercholesterolemia, smoker over age 35) Ovulation induction during month of estradiol treatment
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Female Age ≥ 18 years Unicentric Stage I (T1N0M0) invasive ductal breast cancer or Grade 1 or II DCIS measuring <2 cm on pathology and/or mammogram that is histologically confirmed at MSKCC Histologically negative tumor margin 2 mm or more from any inked edges or no tumor in a re-excision specimen or final shaved specimen ECOG Performance Status of 0 or 1 Granulocytes ≥1,500/μl and platelet count must be ≥100,000/μl at the beginning of therapy for patients treated with adjuvant chemotherapy Women >70 years or older with T1 invasive ductal carcinoma who are estrogen-receptor positive (ER+) with clinically negative axillary nodes and do not undergo surgical lymph node evaluation are eligible if patient will take hormonal therapy Patients with T1N0(i+) tumors on sentinel lymph node mapping or dissection (i.e., if tumor deposit is 0.2 mm or less, regardless of whether the deposit is detected by immunohistochemistry or hematoxylin and eosin staining) will also be eligible Clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery Patients with distant metastasis Patients who are pregnant or breastfeeding Patients with diffuse (>1 quadrant or >5 cm) suspicious microcalcifications Prior radiation therapy to the ipsilateral or contralateral breast or thorax Histological evidence of lymphovascular invasion (LVI). Cases termed focally suspicious for LVI but where no definitive LVI is found are eligible Histologic evidence of EIC, defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumor area) and intraductal carcinoma present clearly beyond the edges of the invasive tumor, or as a predominantly intraductal tumor with one or more areas of focal invasion Patients are not required to undergo BRCA1 and BRCA2 or other genetic mutation tests in order to enroll on the study. However, in the event a patient is tested and is found to be a mutation carrier, she would be excluded from the study. It would be an extremely rare/unlikely scenario for patients to be discovered BRCA positive after the completion of PBI, as all patients with risk factors for BRCA mutations (positive family history, Ashkenazi Jewish descent, ER-/PR-/her2-neu negative receptor status) are usually tested prior to radiation. Should such a situation exist, these patients will not receive additional RT and the patient will be replaced in the trial History of cosmetic or reconstructive breast surgery Psychiatric illness that would prevent the patient from giving informed consent Patients for whom the delivery of PBI is not feasible
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Bacterial Resistance Infection Resistant to Multiple Drugs Staph Aureus Methicillin Resistant Colonization Infection Due to ESBL Bacteria All hospitalized non ICU patients at hospital admission/discharge Age >18 years old All patients starting intravenous and/or oral antibiotic treatments during hospitalization Pregnancy Recent nose surgery (for nasal swabs)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically proven primary invasive breast carcinoma. 2. Tumor pathologically determined <= 5cm in diameter. 3. Single, discrete, well-defined primary tumor. 4. Any micro-calcifications must be focal. A specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications. 5. Pathologically negative surgical margins. 6. Axillary lymph node status can be determined by level I and II lymph node dissection or sentinel lymph node sampling. 7. ECOG performance status 0-2. Contraindications: 1. Multicentric disease and/or diffuse malignant appearing microcalcifications. 2. Evidence of metastatic breast cancer. 3. Axillary lymph node involvement. 4. Pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy. 5. Prior irradiation to the ara of planned radiation field. 6. Pregnant or lactating women
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Adenocarcinoma Ductal Breast Carcinoma In Situ Invasive Breast Carcinoma Stage 0 Breast Cancer AJCC v6 and v7 Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage II Breast Cancer AJCC v6 and v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines The patient must have stage 0, I, or II breast cancer; if stage II, the tumor size must be 3 cm or less On histological examination, the tumor must be ductal carcinoma in situ (DCIS) or invasive adenocarcinoma of the breast Surgical treatment of the breast must have been lumpectomy; the margins of the resected specimen must be histologically free of tumor (DCIS and invasive); reexcision of surgical margins is permitted Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less; (patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3 cm or less) Patients with invasive breast cancer are required to have axillary staging which can sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes); axillary staging is not required for patients with DCIS The target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity/whole breast reference volume must be less than or equal to 30% based on the postoperative/pre-enrollment computed tomography (CT) scan Patients are eligible if, based on the postoperative CT scan, partial breast irradiation (PBI) is judged to be technically deliverable Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to enrollment and are deemed by their physician to be at low risk for recurrence; patients with the following cancers are eligible if diagnosed and treated within the past 5 years; carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin Men are not eligible for this study T2 (> 3.0 cm), T3, stage III, or stage IV breast cancer More than 3 histologically positive axillary nodes Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes at time of enrollment unless there is histologic confirmation that these nodes are negative for tumor Suspicious microcalcifications, or densities (in the ipsilateral or contralateral breast as documented on mammogram or breast ultrasound) unless biopsied and found to be benign Non-epithelial breast malignancies such as sarcoma or lymphoma Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters Paget's disease of the nipple Synchronous bilateral invasive or non-invasive breast cancer
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Women with pathologically demonstrated breast cancer Patients must be candidates for neoadjuvant paclitaxel chemotherapy by their treating oncologist. Generally this would Women with node-positive breast cancer based on ultrasound-guided axillary node biopsy, regardless of hormone or HER2 receptor status Women with greater than 1 cm breast cancer on imaging (mammogram, ultrasound, breast MRI) who are HER2+ or triple negative (ER-PR-HER2-) Women who are candidates for standard paclitaxel chemotherapy from treating oncologist for any other reason Patients must not have metastatic disease on staging work-up with chest imaging, CBC, and liver function studies A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from a prior biopsy of the primary tumor. A minimum of 5 unstained slides must be available The primary tumor must be readily able to be biopsied by palpation The primary tumor must be measurable by an imaging modality prior to treatment. This imaging modality is to be repeated after completion of 4 cycles of paclitaxel and prior to surgery. Such imaging modalities may ultrasound, CT, mammography, or MRI. MRI will be the preferred imaging modality Subjects may not have had prior systemic chemotherapy or targeted therapy regimens administered for treatment of their current breast cancer Patients who have had systemic chemotherapies, targeted therapies or radiotherapy for any cancer within 5 years prior to entering the study History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel including to other drugs formulated in Cremophor(R) EL (polyoxyethylated castor oil) Patients with known HIV due to concern that chemotherapy may cause further immunosuppression and potential infectious complications Patients on non-aspirin anti-coagulation (Coumadin, heparins, or clopidogrel) or with documented bleeding disorders will be excluded due to risk of bleeding with biopsy Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, other malignancies requiring therapy or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study because paclitaxel is a pregnancy category D drug and may cause deleterious effects to the fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with paclitaxel, breastfeeding should be discontinued if the mother is enrolled in the trial
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 40.0-999.0, Breast Cancer Pathologically confirmed ductal carcinoma in situ of the breast or early invasive breast cancer defined as pathologic stage Tis, T1, or T2, N0, N1mic, or N1a (pathologic staging of the axilla is required for all patients with invasive disease but is not required for patients with DCIS only). (Upfront pathologic stage cannot be assigned to patients treated with neoadjuvant chemotherapy. For such patients, the for pathologic stage shall be applied to the initial clinical stage) 2. Treatment with breast conserving surgery. 3. Final surgical margins must be negative, defined as no evidence for ductal carcinoma in situ or invasive breast cancer touching the inked surgical margin. If the invasive or in situ breast cancer approaches within less than 1 mm of the final surgical margin, then a reexcision is strongly encouraged. Lobular carcinoma in situ at the final surgical margin will be disregarded. 4. Age 40 years or older. This age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences. 5. Female sex. 6. Attending radiation oncologist declares intention to treat the whole breast only and that a third radiation field to treat regional lymph nodes is not planned (radiation of the undissected level I/II axilla with high tangents is allowed). 7. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer. 8. Patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast conserving surgical procedure or administration of the last cycle of cytotoxic chemotherapy Pathologic or clinical evidence for a stage T3 or T4 breast cancer. 2. Pathologic evidence for involvement of 4 or more axillary lymph nodes, or imaging evidence of involvement of infraclavicular, supraclavicular, or internal mammary lymph nodes. 3. Clinical or pathologic evidence for distant metastases. 4. Any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either breast. 5. Current diagnosis of bilateral breast cancer. 6. History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast. 7. Patients not fluent in English or Spanish. (The Informed Consent will be available in these two languages) 8. Patient is pregnant
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-69.0, Nasopharyngeal Carcinoma Histologic diagnosis of nasopharyngeal carcinoma Range from 18～69 years old T3-4，N0-2，M0 (AJCC 2009) KPS ≥ 80 Nonmetastatic diseases WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L ALT or AST < 1.5×ULN、bilirubin < 1.5×ULN erum creatinine < 1.5×ULN Distance metastases Previously treated (surgery，chemotherapy, radiation therapy，EGFR targeted therapy or immunotherapy) Second malignancy within 5 years Precious therapy with an investigational agent Uncontrolled seizure disorder or other serious neurologic disease ≥ Grade Ш allergic reaction to any drug including in this study Clinically significant cardiac or respiratory disease Creatinine clearance < 30ml/min Drug or alcohol addition Do not have full capacity for civil acts
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, HER2/Neu Positive Progesterone Receptor Positive Recurrent Breast Carcinoma Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer; (comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer) Women of reproductive potential must agree to use an effective non-hormonal method of contraception (for example condoms, some intrauterine devices, diaphragms, tubal ligation, vasectomized partner, or abstinence) during therapy and for at least 6 months (Arm 1 patients) and for at least 7 months (Arm 2 patients) after the last dose of study therapy (chemotherapy or trastuzumab) Submission of tumor samples from the breast surgery is required for all patients; therefore, the local pathology department policy regarding release of tumor samples must be considered in the screening process; patients whose tumor samples are located in a pathology department that by policy will not submit any samples for research purposes should not be approached for participation in the B-47 trial The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines Eastern Cooperation Oncology Group (ECOG) performance status of 0 or 1 The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination All of the following staging (according to the 7th edition of the American Joint Committee on Cancer [AJCC] Cancer Staging Manual) must be met By pathologic evaluation, primary tumor must be pT1-3 By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b If pN0, one of the following must be met Primary tumor with any of the following HER2 testing results IHC staining intensity on all evaluations of specimens on evaluation of any specimen ISH with a ratio of HER2 to CEP17 >= 2.0 on evaluation of any specimen ISH result indicating HER2 gene copy number >= 4 per nucleus on evaluation of any specimen T4 tumors including inflammatory breast cancer Definitive clinical or radiologic evidence of metastatic disease NOTE: Chest imaging (mandatory for all patients) and other imaging (if required) must have been performed within 90 days prior to randomization Synchronous or previous contralateral invasive breast cancer (patients with synchronous and/or previous contralateral DCIS or LCIS are eligible)
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 21.0-999.0, Breast Cancer Only women who satisfy all of the following conditions will be eligible for this study. 1. must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines 2. must be at least 21 years old 3. must have stage 0, I, or II breast cancer 4. On histological examination, the tumor must be ductal carcinoma in situ (DCIS) or invasive adenocarcinoma of the breast. 5. Surgical treatment of the breast must have been breast conserving surgery (BCS). The margins of the resected specimen must be histologically free of tumor (including DCIS component). Reexcision of surgical margins is permitted. 6. Gross disease may be unifocal or multifocal with pathologic (invasive and/or DCIS) tumor size excised with negative margins. 7. Patients with invasive breast cancer are required to have axillary staging which can sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is not required for patients with DCIS. 8. must begin adjuvant therapy (chemotherapy or radiotherapy) within 9 weeks following the last surgery for breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure) 9. Patients must have all usual and customary hormone receptor (ER/PR) and estrogen receptor (ER) analysis performed on the primary tumor prior to enrollment. Patients with invasive disease must have HER2 receptor status determined (positive or negative) with immuno-histochemistry (IHC) and/or fluorescent in-situ hybridization (FISH). 10. At the time of study enrollment, patients must have had a history & physical exam within 4 months and a bilateral mammogram within 6 months. 11. Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to enrollment and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin. 12. Patients must live in a county that is designated as Appalachian and/or rural by Kentucky Cancer Registry (see list below) and/or must hold their primary residence at least 10 miles from the nearest radiation facility. Patients who do not fit these may still be considered eligible if they are determined to suffer significant financial and/or transportation hardship during a typical course of CF-RT or HF-RT (in the judgment of any of their treating physicians). Patients who live outside the Commonwealth of Kentucky are eligible if they fit any of these aforementioned conditions Appalachian counties in KY Adair, Bath, Bell, Boyd, Breathitt, Carter, Casey, Clark, Clay, Clinton, Cumberland, Edmonson, Elliott, Estill, Fleming, Floyd, Garrard, Green, Greenup, Harlan, Hart, Jackson, Johnson, Knott, Knox, Laurel, Lawrence, Lee, Leslie, Letcher, Lewis, Lincoln, Madison, Magoffin, Martin, McCreary, Menifee, Metcalfe, Monroe, Montgomery, Morgan, Nicholas, Owsley, Perry, Pike, Powell, Pulaski, Robertson, Rockcastle, Rowan, Russell, Wayne, Whitley, Wolfe Men are not eligible for this study. Women with one or more of the following conditions are ineligible for this study. 1. T3, stage III, or stage IV breast cancer 2. More than 3 histologically positive axillary nodes 3. Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension 4. One or more positive non-axillary sentinel node(s) (Note that intramammary nodes are staged as axillary nodes.) 5. Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor 6. Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign 7. Non-epithelial breast malignancies such as sarcoma or lymphoma 8. Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters 9. Paget's disease of the nipple 10. Synchronous bilateral invasive or non-invasive breast cancer 11. History of invasive breast cancer or DCIS (Patients with a history of lobular carcinoma in situ (LCIS) treated by surgery alone are eligible.) 12. Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation (If surgical margins are rendered free of disease by reexcision, the patient is eligible.) 13. Treatment plan that includes regional nodal irradiation 14. Current therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention (Patients are eligible only if these medications are discontinued prior to enrollment.) 15. Cosmetic breast implants (Patients who have had implants removed are eligible.) 16. Prior breast or thoracic RT for any condition 17. Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma 18. Pregnancy or lactation at the time of proposed randomization. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy. 19. Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-95.0, Suspicious Breast Lesion for Which Biopsy is Scheduled - Patients referred for a mammogram, ultrasound or breast MRI study at Mayo Clinic Rochester will be considered for the study if they meet the following Have a lesion on mammogram, ultrasound or breast MRI that measured < 2 cm and is considered suspicious or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas (BI-RADS 4 or 5). (Note: while 2 cm is larger than the desired lesion size that we wish to study, this limit was recommended by our radiology colleagues as estimates of lesion size from mammography, ultrasound and MRI are not exact) Are scheduled for biopsy (needle and/or surgical biopsy) of the suspicious lesion Are > 18 years of age Had a negative pregnancy test or must be postmenopausal or surgically sterilized
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Ductal Breast Carcinoma in Situ Lobular Breast Carcinoma in Situ Stage II Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer The treating surgeon must determine that breast conservation therapy (BCT) would be made more feasible by reducing tumor size using neoadjuvant systemic therapy The patient must have signed and dated an institutional review board (IRB) approved consent form that conforms to federal and institutional guidelines The patient must be female The patient must be greater than or equal to 18 years old The patient must have an Eastern Cooperative Oncology Group Score (ECOG) performance status of 0 or 1 The diagnosis of invasive carcinoma of the breast must have been made by core needle biopsy The primary breast tumor must be >= 2 cm by physical exam or imaging Ipsilateral axillary lymph nodes must be evaluated by imaging (MRI or ultrasound) within 6 weeks prior to randomization; If indicated for abnormal lymph nodes, fine needle aspirate (FNA) or core biopsy must be performed The tumor must have been determined to be HER2-negative as follows Fluorescent in situ hybridization (FISH)-negative (defined by ratio of HER2 to Chromosome 17 centromere (CEP17) must be < 2.2) or, if a ratio was not performed, the HER2 gene copy number must be < 4 per nucleus; or FNA alone to diagnose the primary tumor Excisional biopsy or lumpectomy performed prior to randomization Surgical axillary staging procedure or sentinel node (SN) biopsy performed prior to registration Tumors clinically staged as including inflammatory breast cancer Ipsilateral cN2b or cN3 disease (patients with cN1 or cN2a disease are eligible) Definitive clinical or radiologic evidence of metastatic disease (Note: chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 6 weeks prior to randomization) Synchronous or metachronous contralateral invasive breast cancer; (patients with synchronous and/or metachronous contralateral ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) are eligible) HER2 test result of IHC 3+, regardless of FISH results, if performed Any history of ipsilateral invasive breast cancer or ipsilateral DCIS if treated with radiation therapy (RT); (patients with synchronous or metachronous ipsilateral LCIS are eligible) History of non-breast malignancies, except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin, within 5 years prior to randomization
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 40.0-80.0, Breast Cancer Breast carcinoma DCIS Age 40 years or higher Primary tumor 3 cm or less Lumpectomy with clip placement Axillary node sampling Negative margins Distant metastasis Multicentric disease Prior radiation or chemotherapy Active collagen vascular disease Pregnant or lactating BRCA mutation Lymph nodes with more than microscopic tumor involvement
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 40.0-999.0, Female Breast Cancer Female Diagnosis of breast cancer Age 40 or younger at diagnosis for study group and older women for control group Informed consent obtained from patient Absence of informed consent
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Epilepsy, Partial Outpatients Diagnosis of partial epilepsy, defined as active, drug-resistant in accordance to the 2010 ILAE (International League Against Epilepsy) definition and actually taking an add-on therapeutic regimen Able and willing to give the written informed consent (to be obtained before any study assessment) For each drug-resistant patient, will be enrolled a patient with the same diagnosis and actually taking an add-on therapy but with controlled epilepsy according to the 2010 ILAE definition Patient currently included in a clinical trial for an AED (Anti-Epileptic Drug) Hospital record data on epilepsy not available in the Investigator's files Patient unable to fill in self-questionnaires (quality of life instrument) Patient currently hospitalized Patient who, according to the Investigator's judgment, is not able to follow the study procedures
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 Estrogen Receptor Positive HER2/Neu Negative Invasive Breast Carcinoma Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage IV Breast Cancer AJCC v8 The patient can undergo biopsy or surgery of a primary tumor site for suspected or proven invasive breast cancer of clinical stage I to III; stage IV patients will be allowed and included in the feasibility assessment, but will not be included in outcomes analysis for secondary objectives The clinical or radiologic primary tumor size is at least 1 cm diameter The patient has proven HER2-positive breast cancer, defined as a pathology report of amplification of the gene or 3+ score for immunohistochemical staining The patient has received prior systemic therapy or radiation therapy for breast cancer The patient has a prior history of invasive or metastatic cancer within 5 years of diagnosis of breast cancer, excluding squamous cell or basal cell carcinoma of the skin The patient had prior excisional biopsy of the primary invasive breast cancer There is hematoma or biopsy site changes that obscure the primary tumor Patients deemed medically ineligible for any adjuvant or neoadjuvant therapy. Patients with ER-positive (+) tumors deemed medically eligible for hormonal therapy, but not chemotherapy will be considered eligible for this protocol. Patients with ER-negative (-) tumors who are not candidates for adjuvant anthracycline based chemotherapy will be considered ineligible for this protocol. Patients who undergo biopsy and are later found to be ineligible for adjuvant therapy will be assessed for the primary objective, but will be excluded from the secondary objectives
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Pathologically proven diagnosis of breast cancer resected by lumpectomy and whole-breast irradiation (WBI) with boost without regional nodal irradiation planned Must meet one of the following three pStage I or II breast cancer AND at least one of the following Age < 50 years or Positive axillary nodes or Lymphovascular space invasion (LVI) or At least 2 close resection margins (> 0 mm to ≤ 2 mm) or One close resection margin and extensive in-situ component (EIC) or Focally positive resection margins or Non-hormone-sensitive breast cancer (estrogen and progesterone receptor negative (ER
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Locally Advanced Unresectable Breast Carcinoma Metastatic Breast Carcinoma Recurrent Breast Carcinoma Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Stage IV Breast Cancer AJCC v6 and v7 Phase I: Patients must have histologically confirmed breast cancer (metastatic breast cancer [MBC]) that is human epidermal growth factor receptor 2 (HER2/neu) negative (as determined by local pathology or reference laboratory), and have disease that is metastatic (stage IV [TxNxM1]) or locally advanced and not amenable to potentially curative surgical resection (eg, clinical stage IIIB-C) HER2/neu negative disease (performed on primary tumor and/or metastatic lesion using commercially available/approved assay in local institutional or reference laboratory), according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines National Comprehensive Cancer Network (NCCN) guidelines recommend for metastatic breast cancer "…biopsy documentation of first recurrence, if possible, and determination of hormone receptor status (estrogen receptor [ER] and progesterone receptor [PR]) and HER2 status…."; therefore, histologic and/or cytologic confirmation of metastatic disease is encouraged whenever feasible, but not required; in some circumstances, histologic confirmation may not be feasible (eg, bone metastases not amenable to biopsy and elevated cancer antigen [CA]27-29 tumor marker); for patients who have had histologic confirmation of metastatic disease, it is required that the biopsy confirm that the metastatic tumor is ER and/or PR positive, and HER2/neu negative; for patients in whom biopsy confirmation of metastatic disease is not feasible, it is required that the primary tumor be ER and/or PR-positive and HER2/neu negative Measurable disease (Response Evaluation in Solid Tumors [RECIST] 1.1) or non-measurable disease, with measurement obtained within 4 weeks of registration Phase I: Patients must have received at least one prior chemotherapy regimen for metastatic disease; patients with deleterious germ line mutations in breast cancer (BRCA)1 or BRCA2 are not required to have received prior chemotherapy for metastatic disease Patients must have had progressive disease after at least one line of endocrine therapy for metastatic disease (includes relapse while receiving endocrine therapy); there should be at least 1 week interval between the last endocrine treatment for an aromatase inhibitor and at least 2 weeks for tamoxifen or fulvestrant Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Karnofsky >= 60%) Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1,500/mcL Platelets >= 100,000/mcL Patients who have radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to systemic agents administered more than 3 weeks earlier Patients may not be receiving any other investigational agents Patients with known brain metastases with active symptoms or requiring anticonvulsive medications, or steroids should be excluded from this clinical trial History of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib (ABT-888) or cyclophosphamide used in the study Evidence of complete or partial bowel obstruction or other unable to take oral medications Patients with malabsorption syndrome or other condition that would interfere with intestinal absorption Patients unable to swallow whole capsules Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant (positive pregnancy test) or lactating women will be excluded from the study; also, unwillingness to use effective means of contraception in subjects with child-bearing potential will be excluded from the study; women of child-bearing potential must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least 4 weeks prior to study entry, for the duration of study participation Patients with active severe infection; known infection with human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, or severe concurrent illness will be excluded from the study; HIV-positive patients on combination antiretroviral therapy are ineligible
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer All patients must have signed and dated an informed consent form 2. Patients must be female 3. Primary invasive breast cancer pathologically approved by core needle or open biopsy 4. Ipsilateral axillary or internal mammary nodes positive, or tumor size is equal to or larger than 4cm. Definition of nodes positive is according to the staging system of AJCC 6th edition (American Joint Cancer Commission) for breast carcinoma. The micrometastasis must be at least 0.2mm 5. Patients must have undergone standard surgery for primary breast cancer as shown in the following a standard radical mastectomy or modified mastectomy standard breast conservation surgery (BCS), which is lumpectomy or qaudrantectomy accompany with axillary dissection, and the surgical margins of the resected specimen must be negative. BCS must be followed by standardized adjuvant radiotherapy to the partial conserved breast (delivered after adjuvant chemotherapy completed) Treatment for confirmed breast cancer including the surgery modality listed above, loco-regional radiotherapy after lumpectomy, adjuvant radiotherapy to the chest wall and/or internal mammary nodes and/or supraclavicular lymph nodes, adjuvant chemotherapy 6. adjuvant endocrine therapy of TAM or Fareston must be started within 6 weeks when adjuvant chemotherapy or radiotherapy was finished 7. The date of randomization must be processed after taking TAM or Fareston for 2 or more than 2 years, but not more than 3 years of time 8. Patients taking neo-chemotherapy are eligible, and lymph node status could be identified during surgery before neo-adjuvant chemotherapy or after neo-adjuvant chemotherapy. The definition of lymph node positive is evaluation of lymph node status before neo-adjuvant chemotherapy must pathological axillary nodes, internal mammary nodes (pN2b option) or supraclavicular nodes (pN3c option) involved. Micro-metastasis (i.e.≥0.2mm, pN1-pN3c) can be identified by the following method: fine needle aspiration (FNA) or sentinel node biopsy (SNB) or sampling/ total procedure of axillary dissection patients with no nodes positive after neo-adjuvant chemotherapy, lymph node positive must be evaluated during surgery. Its definition was the either of following According the clinical practice guidelines of the local cancer center, it is acceptable when positive nodes was identified by SNB or axillary dissection There is pathological evidence in lymph nodes positive (pN1-pN3c) during breast surgery after neo-adjuvant chemotherapy 9. Patients diagnosed as occult breast cancer clinically are found to pathologically have primary invasive carcinoma or DCIS with micro-invasive lesion in ipsilateral breast, and primary lesion or axillary node metastasis express ER and/or PR positive 10. Patients with synchronous bilateral cancers are eligible on the condition that If one side is IDC and the other side is DCIS, the IDC side should be of the ER and/or PR positive phenotype and IF two sides are both IDC, they must be ER and/or PR positive phenotype at the same time 11. Hormone receptor positive (≥＋) is defined as detecting ER or PR expression at any time is eligible. The situation of only PR positive and ER negative is eligible, too 12. According to the standard operation principles for clinical practice of local cancer center, patients must be randomized within 4 weeks after definitive physical examination, imaging examination and laboratory testing show no evidence of recurrence or metastasis 13. Based on the study objective, all patients are required to be premenopausal as defined by menstruating actively less than 6 months since last menstrual period (LMP), or patients younger than 40 years of age who became amenorrheic not more than 1 year if the serum free E2、FSH and LH level was premenopausal (according to the reference value of local center) patients with metastatic malignant tumor 2. previous history of asynchronous bilateral breast cancer 3. any previous malignancy in the past 5 years, except for those treated with curative intent, such as carcinoma in situ of the cervix, squamous carcinoma of the skin or basal cell carcinoma of the skin 4. any non-malignant systemic disease which interfere long time follow up 5. history of medical ovarian ablation therapy 6. history of AI therapy 7. severe live dysfunction, Child-Pugh is grade C 8. Occult breast cancer is found pathologically no IDC lesion or only DCIS without micro-invasive lesion in the ipsilateral breast 9. patients with Her-2 overexpression had used, or is using, or intending to use adjuvant trastuzumab 10. severe heart dysfunction, heart functional classification is above Class III Table 2 Child-Pugh score of hepatic cirrhosis
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Urothelial Carcinoma Histopathologic evidence of urothelial carcinoma, based on local pathology report High risk urothelial carcinoma, in subjects with or without prior neoadjuvant chemotherapy, defined as positive lymph node status (N+), or pathological stage ≥ pathological tumor (pT2) in patients who either have negative lymph node status (N0) or have no evaluable lymph nodes (Nx) Radical surgical resection was performed ≤ 84 days (12 weeks) prior to registration No evidence of residual disease or metastasis following surgical resection which includes: absence of invasive cancer at the margins in the surgical specimens and confirmation by CT scan of chest, abdomen and pelvis obtained at least 28 days following surgical resection and ≤ 28 days prior to registration HER2/neu tissue expression ≥ 1+ by immunohistochemistry (IHC). Available biopsy specimens from the primary tumor and involved lymph nodes are be submitted to the central pathology laboratory prior to registration for confirmation of HER2/neu tissue expression Last neoadjuvant chemotherapy treatment administered at least 60 days prior to registration Left ventricular ejection fraction ≥ 50% on multigated acquisition (MUGA) scan or echocardiogram obtained at least 28 days following surgery and ≤ 28 days prior to registration Women of child-bearing potential have a negative serum pregnancy test result ≤ 28 days prior to registration and agree not to breastfeed during investigational treatment with DN24-02 and for 28 days following the final infusion of DN24-02 All males and premenopausal females who have not been surgically sterilized have agreed to practice a method of birth control considered by the Investigator to be effective and medically acceptable for at least 14 days prior to registration, throughout treatment, and for 28 days following the final infusion of DN24-02 Adequate hematologic, renal, and liver function A history of stage III or greater non-urothelial cancer. Exceptions Subject with basal or squamous cell skin cancers that has been adequately treated who are disease-free at the time of registration. Subjects who have been disease-free and off treatment for ≥ 10 years at the time of registration A history of stage I or II non-urothelial cancer. Exceptions Subjects who have been disease-free and off treatment for ≥ 3 years at the time of registration. Subjects with incidental prostate cancer diagnosed at the time of cystoprostatectomy. Subjects with basal or squamous cell skin cancer Partial cystectomy in the setting of bladder cancer primary tumor Partial nephrectomy in the setting of renal pelvis primary tumor Adjuvant systemic therapy for urothelial or prostatic carcinoma following surgical resection Adjuvant radiation therapy for urothelial or prostatic carcinoma following surgical resection Incidental prostate cancer with detectable post-operative (radical cystoprostatectomy) prostate specific antigen (PSA) levels ≤ 28 days prior to registration Any major surgery (e.g., surgery requiring general anesthesia) ≤ 28 days prior to registration Systemic treatment on any investigational clinical trial ≤ 28 days prior to registration Systemic glucocorticoid or immunosuppressive therapy use ≤ 28 days prior to registration
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Estrogen Receptor-positive Breast Cancer HER2-negative Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Patient must have histological or cytological confirmed invasive breast cancer Patient must be premenopausal confirmed by serum estradiol level in the premenopausal range (> 25 pg/ml) at the beginning of the study; for women on oral contraceptives, these agents must be held for two weeks before the estradiol assessment is made Patient must have a negative serum pregnancy test within 7 days of registration Patient's tumor must be ER+ with or without concomitant progesterone receptor-positive (PR+) with an Allred score of 6, 7 or 8; patients with > 66.6% of cells staining positive by conventional immunohistochemistry (IHC) have a minimum Allred score of 6 and are eligible Patient's tumors must be HER2 negative by local laboratory assessment: HER2 IHC 0, 1+, or 2+ with subsequent negative fluorescent in situ hybridization (FISH) (ratio < 1.8); negative FISH alone in absence of IHC is acceptable Patient must have T2-T4c, any N, M0 breast cancer, by clinical staging (physical examination) Patient's primary tumor must be palpable and measure > 2 cm by tape, ruler or caliper measurements in at least one dimension Patient must have mammogram and ultrasound of the breast within 42 days prior to registration; if a patient has clinically palpable or suspicious nodes, then an ultrasound of the axilla is also required Patient, as documented by the treating physician, must be clinically staged as one of the following T4 a-c for which modified radical mastectomy with negative margins is the goal Patient must not have inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema) Patient must not have had prior treatment for invasive breast cancer, including radiation, endocrine therapy, chemotherapy, or investigational agent; patients whose diagnosis was established by incision biopsy are not eligible Patient must not have had prior DCIS in the ipsilateral breast Patient must not have used tamoxifen for prior contralateral DCIS Patient must not have any evidence of distant metastasis (M1) on imaging; staging scans are not mandatory but any exams performed as standard of care throughout the study period will be collected for correlation as needed If patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant therapy, she is ineligible for this study Patient must not be receiving other investigational agents or be enrolled in another neoadjuvant clinical trial for treatment of the existing breast cancer Pregnant and/or breastfeeding women are excluded from this study Patient must not have any concurrent life threatening illnesses Patient must not have undergone prior sentinel lymph node surgery; cores or FNA of lymph node are acceptable
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 21.0-999.0, Ductal Carcinoma in Situ Must sign informed consent, witnessed, and dated prior to entry The participant has breast biopsy consistent with Ductal Carcinoma in situ (DCIS) Performance Status: ECOG 0-1 unless mobility is limited from chronic physical handicap No clinical evidence of other malignancies (except Basal Cell carcinoma) Complete blood count, differential and platelet count must be WNL or verified by the study chair to be related to conditions not interfering with normal health status Adequate hepatic and renal function (these must be WNL or verified by study chair to be related to conditions not interfering with normal health status) Normal fasting glucose No history of diabetes Medically and Psychologically able to comply with all study requirements Accessible for Follow up Less than 21 years of age Known invasive breast cancer of any type Bilateral prophylactic mastectomy Prior malignancy of any type that occurred less than 5 years previously, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix Existing non-malignant disease that would preclude the administration of pasireotide Pregnancy: All subjects will have a beta-hCG serum pregnancy test to rule out pregnancy, a history will also be taken to make certain that recent sexual exposure does not put them at risk for pregnancy. If so a second serum pregnancy test will be done. Volunteers will be asked to use barrier contraception during study Tamoxifen or other preventive measures within 6 months Serious Psychiatric condition or addictive disorder Diabetes or elevated fasting blood sugar either by history or by HgbA1c greater than 6.5% or fasting serum glucose greater than 100mg/dL on screening labs. If fasting serum glucose is greater than 100mg/dL on screening labs, this test will be repeated to confirm the results Inability to inject medication or test for finger stick glucose
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. NOTE: Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or ductal carcinoma in situ (DCIS) with microinvasion are NOT eligible. Patients with contralateral disease will remain eligible. 2. Neoadjuvant chemotherapy or hormonal therapy for the index tumor is required. 3. Residual tumor size </= 2.0 cm in greatest diameter. Specifically, the tumor must measure </= 2.0 cm in the axis parallel to the treatment probe and </= 1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by mammogram, ultrasound or MRI will be used to determine eligibility. 4. Tumor enhancement on pre-registration MRI. 5. Tumor with <25% intraductal components in the aggregate. 6. Adequate breast size for safe cryoablation. Male breast cancer patients and female breast cancer patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation. 7. Patients with prior in-situ or invasive breast carcinomas are eligible if the prior carcinomas occurred in the contralateral breast. Patients with prior in-situ or invasive carcinomas of the ipsilateral breast are not eligible History of open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer. Note: Prior rotational and/or vacuum-assisted core biopsies are permitted if no significant distortion is seen on imaging that could obscure visualization and detection of residual disease on MRI, or visualization of cancer on ultrasound for cryoablation procedure. 2. Pregnant and/or lactating. Patients of childbearing potential must have a negative serum or urine pregnancy test. NOTE: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential. 3. Patient has contra-indication to an MRI examination, such as clips/prostheses/implants that are not MRI compatible, or compromised renal function, with a measured or calculated glomerular filtration rate of 60ml/min/1.73m^2 4. Patients less than 18 years of age will not be included in this study
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 35.0-75.0, Breast Cancer Patients ≥ 35 years and ≤ 75 years Indication for breast-conserving surgery according to recommended by the Norwegian Breast Cancer Group Tumor < 4 cm and acceptable tumor:breast ratio Tumor not infiltrating skin or pectoral fascia No multifocality (that is 2 foci or more, > 1 cm apart) Patient choose mastectomy Technical problems with the MR machine Pacemaker Anxiety/claustrophobia
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-70.0, Breast Cancer Eastern Cooperative Oncology Group performance score﹤2 All patients aged >18 years and < 70 years after breast conserving surgery On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast Negative nodal status determined by sentinel node biopsy, or axillary dissection. Axillary staging is not required for patients with DCIS No evidence of distant metastasis Gross disease may be unifocal or multifocal with pathologic (invasive and/or DCIS) tumor size excised with negative margins（>2mm） Surgical treatment of the breast must have been lumpectomy. Re-excision of surgical margins is permitted The patient must consent to be in the study and must have signed an approved consent form Eastern Cooperative Oncology Group performance score≧2 Presence of extensive intraductal component (ductal carcinoma in situ occupying > 25% of the primary invasive tumour and present adjacent to the primary tumour).Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant of separated Metastatic disease (M1) Pregnancy or lactating Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma Prior breast or thoracic RT for any condition Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or endometrium treated five years prior to study entry
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Estrogen Receptor-positive Breast Cancer Invasive Ductal Breast Carcinoma Progesterone Receptor-positive Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Postmenopausal women Diagnosis of early stage, invasive ductal carcinoma (for which a lumpectomy or mastectomy is planned prior to systemic therapy) Estrogen receptor (ER)/progesterone receptor (PR) positive tumor (as confirmed by City of Hope Pathology Department if done on the outside) or Biopsy proven ER/PR positive tumor Ability to provide informed consent Tumor that lacks both estrogen and progesterone receptors Patients who will receive neoadjuvant therapy prior to definitive surgery Bisphosphonate therapy currently or within the past 12 months Regular use of anti-inflammatory agents, with the exception of a baby aspirin regimen per principal investigator's (PI's) discretion Renal impairment as determined by a creatinine clearance < 60 ml/min as calculated by the Cockcroft-Gault formula using the patient's actual weight Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-60.0, Hypogonadotropic Hypogonadism Healthy Postmenopausal Women Agonadism A. Healthy Subjects All healthy subjects will meet the following normal puberty with respect to onset and pace no difficulty with blood draws no prescription medications for at least 2 months with the exception of asthma medication (albuterol only), hypercholesterolemia medication and psychiatric medication no illicit drug use or excessive alcohol consumption (>10 drinks/week) no history of a medication reaction requiring emergency medical care normal physical exam and laboratory studies within protocol reference ranges. Additional based on subject population: 1. Healthy Men between 21 and 40 years old normal erectile and ejaculatory function, no history of reproductive disorders testicular volume >15 ml. 2. Healthy women
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologic documentation: Pathologic confirmation of ductal carcinoma in situ (DCIS) of the female breast without invasive cancer, with diagnosis rendered on core biopsy only, completed within 60 days before registration. Patients diagnosed with DCIS on the basis of surgical biopsy are not eligible for this study. 1. Patients with microinvasion on diagnostic core biopsy, defined as tumor ≤ 1 mm in greatest dimension, will be allowed to participate. 2. All patients must have a clip placed, either at the time of the diagnostic biopsy or at the time of the baseline MRI prior to the start of treatment. 2. Tissue samples: Patient has diagnostic tissue available for correlative studies. 3. Clinical stage: Tis or T1mi N0, M0 4. Hormone receptor status: DCIS must express estrogen and/or progesterone receptor, as determined by immunohistochemical methods on the diagnostic pathology sample, according to the local institution's standard protocol. Greater than or equal to 1% cells will be considered to be positive. 5. Menopausal status: Patients must be postmenopausal defined as: 1. Age ≥ 55 years and one year or more of amenorrhea 2. Age < 55 years and one year or more amenorrhea, with an estradiol assay < 20pg/ml 3. Surgical menopause with bilateral oophorectomy (at least 28 days must elapse from surgery to time of study registration) The use of GnRH analogs to achieve post menopausal status is not allowed. 6. Prior treatment: 1. No prior surgical excision in the index breast for current DCIS diagnosis of DCIS 2. Any exogenous hormone therapy must be completed 4 weeks prior to registration 3. Any patients with a history of tamoxifen or raloxifene use within two years of current DCIS diagnosis are not eligible 4. No prior neoadjuvant/adjuvant therapy for current DCIS diagnosis 7. Contraindication to MRI: No contraindications to breast MRI 8. Measurable disease: Mammographic extent of calcifications must be accurately measurable in at least one dimension with each lesion ≥ 1 cm and ≤ 7 cm 1. DCIS must be visible on MRI based on central review. 2. Patients with palpable DCIS or adenopathy are not eligible to participate. 3. Patients with multifocal or bilateral disease are eligible. 9. History of osteoporosis: Women diagnosed with osteoporosis may participate in this trial provided they are receiving appropriate therapy or if they have declined therapy. 10. Age: Patients ≥ 18 years of age 11. Performance Status: ECOG performance status 0 or 1 12. Pregnancy/nursing status: Not pregnant or nursing 13. Required Initial Laboratory Values: 1. ANC ≥ 1,000/μL 2. Platelet count ≥ 100,000/μL 3. Serum creatinine ≤ 1.7 mg/dL 4. Bilirubin ≤ 2.0 mg/dL 5. AST/ALT ≤ 2.5 times upper limit of normal 6. Serum estradiol level assay < 20 pg/mL *Required for patients < 55 years of age and one year or more of amenorrhea
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 50.0-999.0, Breast Cancer A confirmed histological diagnosis of invasive breast carcinoma or DCIS 2. Age greater or equal to 50 years old 3. Life expectancy > 6 months 4. Treated by breast conserving surgery with axillary node dissection or sentinel lymph node biopsy 5. Pathologic tumor size less than or equal to 2 cm 6. Invasive ductal, mucinous, tubular or colloid histology 7. Estrogen receptor positive for invasive carcinoma. 8. Unifocal/unicentric disease 9. Negative surgical margins greater than or equal to 2 mm 10. Pathologic lymph node negative 11. No evidence of lymphovascular invasion 12. ECOG performance status of 0 or 1 (Appendix 1) 13. Informed consent signed Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required) 2. Autoimmune disorder 3. Pregnancy 4. Breast implants 5. Psychiatric or addictive disorder that would preclude attending follow-up 6. Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted) 7. Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign) 8. Lobular features on histology (pure or mixed) or sarcoma histology 9. Node positive on axillary dissection or in the sentinel lymph node biopsy; 10. Extensive in situ carcinoma (EIC) 11. Multicentric or multifocal disease 12. Paget's disease of the nipple 13. Distant metastases 14. Lumpectomy cavity not well visualized on AccuBoost imaging 15. Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator (PTV > 6cm) 16. Breast separation with compression > 7cm. 17. Overlap of skin between orthogonal treatment axes
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1
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically or cytologically confirmed breast cancer No previous interventional therapy for breast cancer Ability to provide written informed consent as per GCP and local regulations Participation in other clinical study where the diagnosis and treatment protocol is stated prior to enrolment Inability to assess and follow up patient outcomes, for example quality of life due to psychiatric illness or WHO/ECOG performance status IV or worse
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 30.0-80.0, Diabetes Patients followed in the diabetes units of the project area and doing regular consultations Patients with type 2 diabetes or treated or not with insulin Poorly controlled diabetes with HbA1c ≥ 8% Patients who accepted to undergo the whole process of peer education Patients who agreed to perform all biological measures included in the protocol Patients aged from 30 to 80 years old Diabetic patients not carrying out their monitoring in diabetes units of the intervention area Patients followed in the diabetes units of the intervention area but not realizing their consultations regularly Patients with type 1 diabetes Severe complications within the preceding 3 months: infection, coronary complications, severe renal failure Concomitant illnesses threatening the functional or vital prognosis
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Be a female diagnosed by x-ray mammography (performed within 90 days prior to the study procedure) as having a solid breast mass or abnormal area without a mass Be scheduled for a biopsy (core / excisional / lumpectomy) of the mass or region of abnormality or for mastectomy within 30 days after this study procedure Be at least 18 years of age Be medically stable If a female of child-bearing potential, must have a negative pregnancy test Have signed Informed Consent to participate in the study Males Females who are pregnant or nursing Patients whose breast lesion is unequivocally a cyst by unenhanced US Patients currently on chemotherapy or with other primary cancers requiring systemic treatment Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example Patients on life support or in a critical care unit Patients with unstable occlusive disease (eg, crescendo angina) Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia Patients with uncontrolled congestive heart failure (NYHA Class IV) Patients with recent cerebral hemorrhage
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Infiltrating Bladder Urothelial Carcinoma Muscle invasive urothelial cancer (front line or following the progression of a superficial tumor), pT2-pT3 stage without lymphatic impairment (N0) and without detectable metastases (M0). An optimal macroscopic resection (TURB) have to be performed The proof of invasive tumor to the muscle should be brought by a transurethral resection under anaesthesia less than 8 weeks before or, in the absence, by superficial biopsies and formal imaging. Multiples biopsies in the bladder must also be performed Age ≥ 18 years Life expectancy ≥ 6 months Kanorfsky index ≥ 70 % (WHO 0, 1, 2) Biological neutrophils ≥ 1500/mm3, Platelets ≥ 100 000/mm3, haemoglobin ≥ 10 g/dl, creatinine clearance > 60 ml/mn No distant metastases (Thorax, abdomen, and pelvic CT-scan, bone scan) Efficient contraception for premenopausal women, maintained during the whole treatment and up to two months after the completion of radiotherapy No radiotherapy or chemotherapy history except for in situ bladder lesions No carcinological history except for non melanoma skin tumours, in situ uterine cervix cancer Bladder tumors without any muscle infiltration Epidermoid carcinoma or adenocarcinoma Distance metastases or extrapelvic node positivity Severe digestive history (ulcerative colitis, complicated diverticulitis) Pregnancy and breast feeding
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Women with histologically proven invasive breast cancer and no distant metastases and Lymphnode negative and a clinical tumor classification of T2 (≥3.5cm)-T4 or with 1-3 positive lymph nodes and a clinical tumor classification of T2-T4 DCIS or LCIS are allowed in addition to invasive cancer at T2 or T3 level Age ≥ 18 years At least one lesion that can be accurately measured in two dimensions utilizing mammogram, ultrasound, or MRI images to define specific size and validate complete pathologic response Adequate bone marrow reserves (neutrophil count >1.5 x109 /l and platelet count >100 x109/l), adequate renal function (serum creatinine ≤ 1.5 x upper limit of normal) and hepatic function (ALAT, ASAT ≤ 2.5 x upper limit of normal, alkaline phosphatase ≤ 2.5 x upper limit of normal and total bilirubin ≤ 2.0 x upper limit of normal) Signed informed consent of the patient Any patient with confirmed metastatic disease. Patients with inflammatory breast cancer Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails Quality Assurance or Quality Control criteria Patients who have had any prior chemotherapy, radiotherapy, or endocrine therapy for the treatment of breast cancer Any serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Vitamin D Deficiency Healthy women without major medical problem delivered at term and planning breastfeeding for next six months delivering term, single, infants with birth weight appropriate for gestational age without major health problem Maternal endocrine disorders, disturbed calcium phosphorus homeostasis, anticonvulsant treatment Infants renal, hepatic insufficiency, endocrine disorders, congenital malformations, anticonvulsant treatment
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Women 18 years of age or older 2. Signed ICF 3. Women who have been histologically diagnosed with invasive ductal carcinoma or invasive lobular carcinoma of the breast prior to surgery 4. Planning breast preservation 5. Patients undergoing lumpectomy (partial mastectomy) procedure Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast) 2. Neoadjuvant systemic therapy 3. All T4 tumors 4. Previous radiation in the operated breast 5. Prior surgical procedure in the same quadrant 6. Implants in the operated breast 7. Pregnancy 8. Lactation 9. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Hepatocellular Carcinoma Patients with histologically/cytologically confirmed HCC or radiographically diagnosed as per AASLD who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made Patients must have signed the informed consent form Patients must have a life expectancy of at least 8 weeks must follow the approved local product information Prior treatment with sorafenib Concomitant participation in other clinical studies must follow the approved local product information
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-80.0, Conditions or Focus of Study: *FDAAA (Enter 1 to 5 Items) Male or Female > 18 years, 2. Newly diagnosed stage I-IV breast cancer which is defined to meets any one of the following clinical or pathological staging (version 6.0 AJCC classification17) in Appendix B. 3. No prior therapy (other than surgery) for current disease, 4. Written informed consent (if required by local regulations) Unable to receive definitive treatment 2. Unable to attend regular follow-up visit
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 40.0-999.0, Breast Cancer Registration 1. Age ≥ 40 years per National Comprehensive Cancer Network (NCCN) recommendations for breast conservation. 2. Life Expectancy of at least 5 years, excluding diagnosis of breast cancer (Comorbid conditions should be taken into consideration, but breast cancer diagnosis is not a consideration) 3. Female Gender Men are excluded from this study. Male breast cancer is a rare event. Men are rarely candidates for breast conservation surgery due to small breast size. Men are less likely to be candidates for breast conservation surgery if found to have MIBC. Men are rarely candidates for breast conservation surgery due to small breast size. Men are less likely to be candidates for breast conservation surgery if found to have MIBC. 4. Foci of Breast Cancer 4.1 Upon clinical exam and pre-operative imaging by mammogram +/ MRI, two or three foci of biopsy proven breast cancer separated by > 2 cm of normal breast tissue. 4.2 Foci must at least one focus of invasive breast carcinoma with another focus of either invasive breast carcinoma or ductal carcinoma in situ (DCIS). No more than 2 quadrants with biopsy proven breast cancer. 4.3 Note: The shortest distance between lesions must be reported on mammogram +/ MRI and must be met on both, if both are obtained. 4.4 Note: Patient is eligible for study if lesion is not visualized on all imaging modalities (i.e., any of the lesion(s) is/are visualized on MRI but not on mammogram OR visualized on mammogram but not on MRI). 4.5 Ultrasound cannot be used to determine patient eligibility; to be determined by bilateral mammogram +/ MRI only. 4.6 Fine needle aspirate of the second or third lesion to document malignancy is allowed if the first focus is shown to be invasive by core needle biopsy. 4.7 Patient may remain on study if, upon pathological assessment, two or three lesions identified on pre-operative imaging represent one contiguous lesion. 5. Patients may be registered AFTER surgery and PRIOR TO radiation therapy if either of the is met: 5.1 An area of atypia > 2cm from the index lesion excised at the time of cancer operation is upgraded to DCIS or invasive carcinoma thereby identifying MIBC. OR 5.2 Patient underwent resection of two or three foci of malignancy by breast conservation surgery with a minimum of one invasive focus of breast cancer and a minimum of 2 cm of normal breast tissue between the lesions on final pathology. 6. Mammogram Imaging Bilateral mammogram ≤ 90 days prior to date of surgery. 6.1 Note: For patients undergoing more than 1 breast operation, this is the date of the first breast surgery for breast cancer treatment. 7. Staging of Cancer cN0 or cN1 disease 8. ECOG Performance Status (PS) 1, or 2. 9. Ability to Complete Questionnaires Ability to complete questionnaire(s) by themselves or with assistance 10. Ability to Provide Written Informed Consent 11. Willing to Return to Enrolling Institution Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (the active treatment and observation portions) of the study. Patients are encouraged to return to the enrolling institution; however, patients may receive radiation therapy at a different institution other than the enrolling institution. Registration Pregnancy, Nursing and Requirement for Contraception Pregnant women, nursing women and women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician) are excluded from participation. This study involves radiation therapy (WBI) that has known genotoxic, mutagenic and teratogenic effects. 2. Size of Single Focus of Disease on Preoperative Imaging Largest single focus of disease > 5 centimeters by either mammogram or MRI or both. Note: Measurement of the largest single focus should any satellite lesions within 1 centimeter of the index lesion. 3. Prior Staging Procedure Surgical axillary staging procedure prior to first definitive breast operation. Note: FNA or core needle biopsy of axillary node is permitted. 4. Evidence of Metastatic Disease Clinical or radiographic evidence of metastatic disease 5. Prior History of Breast Cancer Prior history of ipsilateral breast cancer [DCIS, LCIS (lobular cancer in situ) or invasive] 6. Staging of Cancer cNX, cN2, or cN3 disease 7. Breast Implants Breast implants at time of diagnosis. Note: Patients who have had implants previously removed prior to diagnosis are eligible. 8. Systemic Illnesses or Concurrent Disease Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would interfere significantly with whole breast irradiation (such as connective tissue disorders, lupus, scleroderma). 9. Uncontrolled Intercurrent Illness Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 10. Bilateral Breast Cancer
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-75.0, Breast Cancer Breast Cancer Stage II-III Informed consent form signed by the patient to accept study enrollment Female with pathologically confirmed diagnosis of primary invasive operable breast cancer, stage IIa-IIIc (6th edition of the AJCC Cancer Staging Manual), with tumors ≥ 2cm. Triple negative phenotype patients (RE and PR of less than 1% of stained cells by IHQ, IHC for HER2 of 0-1+ or ISH negative if 2/3+), according to local laboratory Age 18-75 years Adequate performance status (ECOG <2) Adequate renal and liver function and bone marrow reserve Clinical or radiologic evidence of Metastatic disease Prior or concurrent anti-cancer therapy for current disease (hormone therapy, chemotherapy, radiotherapy, immunotherapy) Prior therapy with taxanes, anthracyclines or carboplatin for any malignancy Contraindication for study drugs (docetaxel or carboplatin) Serious concomitant systemic disorder that in the opinion of the investigator would compromise the patient's ability to complete the study, or have any other disease that could be worsened by chemotherapy or other potential support therapies
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-80.0, Rhinitis Sinusitis Nasal Polyps above age 18 under age 80 patients with chronic rhinitis, sinusitis and nasal polyps patients candidates for surgery or medical therapy Patients that had nasal surgery before smokers Diabetes, chemotherapy or radiation therapy Allergy to yeasts or pomegranate
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-70.0, Locally Advanced Malignant Neoplasm Women older than 18 years old and younger than 70 years old Invasive breast cancer confirmed by core biopsy, any histology Tumor ≥2 cm and/or lymph node positive (proven by FNA)(T2-4b, N0-3, M0) Must have ER/PR positive and HER2 negative Must have full staging and extent disease and clinically and radiographically tumor measure Without previous treatment for breast cancer (including surgery, hormonotherapy or chemotherapy) Normal liver, kidney and blood tests Performance Status ECOG 0-2 o Karnofsky ≥70% Fasten glucose levels <125 mg/dl Signed consent Previous use of metformin for any indication Presence of Diabetes Mellitus
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-80.0, Breast Cancer Biopsy proven invasive ductal carcinoma of the breast Unifocal disease Patient proceeding to mastectomy Multifocal disease Previous surgery to ipsilateral breast Neoadjuvant chemotherapy Ferromagnetic implants Claustrophobia Cup size DD or greater
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Lymphedema Breast Cancer Stage II Early Disease Onset Gender: female Patients operated with lumpectomy or mastectomy, Sentinel node, axillary lymphnode dissection and/or chemotherapy and/or radiotherapy Controls: operated for colon-rectal carcinoma with colectomy and adjuvant chemotherapy Patients 18 years or older No pre-existing clinical or volumetric signs of lymphoedema (CBO guideline: >10% difference with contra-lateral side Allergy against one of the used materials Patients who have a pacemaker or other inbuilt stimulator Women who are pregnant Patients with renal failure or heart failure Lymphoedema
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Female patient Ability to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines Between 18 and 90 years of age Have been diagnosed with invasive adenocarcinoma, or high-grade ductal carcinoma in-situ. If a core or open biopsy is done, it must demonstrate invasive adenocarcinoma. If only a FNA is done, it must be positive and accompanied by a positive clinical breast examination and ultrasound or mammography. The tumor must be operable Clinically negative lymph nodes Must have had a bilateral mammogram within a year of enrollment The interval between the initial cytologic or histologic diagnosis of breast cancer and enrollment must be no more than 60 days ECOG performance status 0-1 Patients in whom the diagnosis of breast cancer has been obtained utilizing fine needle aspiration cytology or core needle biopsy are preferred. However, patients who are diagnosed by open biopsy procedures are eligible Patients with prior excisional biopsy or lumpectomy are eligible for entry Male patient Ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude. (Tethering or dimpling of the skin or nipple inversion should not be interpreted as skin infiltration. Patients with these latter to conditions are eligible.) One or more ipsilateral axillary lymph nodes that are positive for tumor on clinical examination Bilateral malignancy or a mass in the opposite breast that is suspicious for malignancy, unless a biopsy proves that the mass is not malignant Previous removal of any ipsilateral axillary lymph node Diffuse tumors or multiple malignant tumors in different quadrants of the breast Suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes. Patients with these conditions are considered ineligible unless there is biopsy evidence that these are not involved with tumor Patients with any prior breast malignancy other than LCIS Prior treatment for this breast cancer including irradiation, chemotherapy, immunotherapy, and/or hormonal therapy Allergy to radiocolloid or fluorescein
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Infiltrating Bladder Urothelial Carcinoma Age ≥18 years Histologically confirmed primary transitional cell carcinoma (TCC) of the urinary bladder T2 to T4 disease, N0 M0 determined by computerised tomography (CT) imaging and biopsy or transurethral resection Eastern Co-operative Oncology Group (ECOG) Performance status 0 or 1 Glomerular filtration rate (GFR) ≥60ml/min Written, informed consent ECOG Performance Status ≥ 2 Lymph node involvement or metastatic disease Prior surgery (except transurethral resection of bladder tumour), radiation, che-motherapy, or other anti-cancer therapy within 4 weeks prior to enrolment Active Grade ≥2 peripheral neuropathy Active secondary cancers History of severe hypersensitivity reaction (≥Grade 3) to polysorbate 80 containing drugs Other concurrent serious illness or medical conditions Inadequate organ function as evidenced by peripheral blood counts at enrolment Electrocardiogram (ECG) evidence of uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension, history of congestive heart failure, or myocardial infarction within last 6 months Uncontrolled diabetes mellitus
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Infiltrating Ductal Carcinoma Invasive non-lobular breast cancer, histologically proven by biopsy Tumour T2 T3 regardless of nodal status, stemming from a primary surgery, in whom FDG-PET is performed for staging Age greater than or equal to 18 years Good condition: WHO lower 2 Women receiving effective contraception throughout the duration of treatment and 3 months after cessation of treatment Patient has signed informed consent Carcinoma other than breast ductal carcinoma Patients for whom no target tumor is assessable Patients for whom surgery first of their breast cancer is not indicated (tumor spread, metastasis, general health, co-morbidities) Pregnant women, or likely to be during breastfeeding Major protected (under supervision and under guardianship) Failure to submit to medical supervision of the study for reasons of geography, social or psychological Incomplete tumor resection
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 20.0-999.0, Breast Cancer Histologically proven primary invasive breast cancer which is thought to be suitable for neo-adjuvant treatment 2. Pathologically proven lymph node positive tumor(FNAB or Core biopsy) 3. Tumor must be ER positive(eligible patients Allred score 5 and more, Modified Allred 4 and more) and HER-2 negative(IHC score is 0-1+; If IHC score is 2+, the result of FISH or SISH is negative) 4. Premenopausal women Premenopausal status as defined by Last menses within 6 month of randomization or For patients who have had a unilateral oophorectomy, E2 ≥ 20PG/mL and FSH < 30mIU/Ml within 4 weeks of randomization 5. over 20 years old 6. Pre-treatment haematology and biochemistry values within acceptable limits ANC ≥ 1.5 × 109/l Hb > 9g/dl Platelets ≥ 100 × 109/l AST/ALT ≤ 1.5 × ULN(Upper Limit of Normal) ALP ≤ 1.5 × ULN Serum bilirubin ≤ 1.5 × ULN Serum creatinine ≤ 1.5 × ULN 7. ECOG PS of 0 or 1 8. No concomitant medical, psychiatric or geographic problems that might prevent completion of treatment or follow-up 9. Before any study-specific procedures, the appropriate written informed consent must be obtained Inflammatory breast cancer 2. Inoperable disease that is judged very unlikely to be rendered operable by neo-adjuvant treatment 3. Known severe hypersensitivity to GnRHa treatment 4. Bilateral invasive breast cancer 5. Other serious illness or medical condition congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent active uncontrolled infection 6. HRT within 4 weeks of starting treatment 7. Definite contra-indications for the use of corticosteroids. 8. Last 10 years with a history of other malignant tumor (except in the case of basal cell carcinoma or cervical carcinoma in situ, and where treatment consisted solely of resection) 9. Systemic metastatic (Tests for the diagnosis of systemic metastatic comply with the guideline in each institution) 10. Pregnant or breastfeeding women 11. Chronic oral treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (≤ 20 mg methylprednisolone or equivalent)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Infiltrating Duct and Lobular Carcinoma In Situ Invasive Lobular Breast Carcinoma Inflammatory Breast Carcinoma Previously untreated (no chemotherapy, hormonal or radiation therapy)invasive breast cancer Diagnosis of invasive ductal or lobular breast cancer plus or minus DCIS. Inflammatory carcinoma will also be elegible Age≥ 18 years Only female patients are eligible Tumor≥ 1.0cm by MRI and/or sonographic or clinical exam measurements. If the tumor is <1.0 but the patient has biopsy proven lymph node metastasis, she will also be considered eligible.Although only tumors≥2cm are consideredmeasurable by we will nevertheless tumors≥1cm since the primary endpoint is pathological CR rate Performance status ECOG≤2 or Karnofsky≥ 50% Peripheral neuropathy≤ grade 1 Hematologic (minimal values):Absolute Neutrophil count≥1,500/mm³; Hemoglobin≥8.0g/dl; Paltelet count≥100,000/mm³ Hepatic; Total bilirubin≤ULN AST and ALT and ALP do not have to be within the range. In determining the more abnormal of the two values(AST or ALT) should be use as per protocol table on p.24of 69 Women of childbearing potential must have a negative pregnancy test Pregnant or breast feeding patients are excluded Patients with second malignancies with expected survival<5 years Previous chemotherapy with Taxanes,Anthracyclines or Cyclophosphamide Patientes with history of severe hypersensitivity reaction to Taxotere(Docetaxel)or other drugs formulated with polysorbate 80 Pure DCIS diagnoses are not elegible Special histologies with favorable prognosis such as mucinous, tubular are not elegible Patients with reduced ejection fraction<50% are not eligible Patients with tumors<1.0cm unless biopsy proven axillary node metastasis present Cardiac thrombotic events in the past 12 months Stroke or transient ischemic attacks (TIA) within 12 months
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 50.0-999.0, Breast Cancer The patient must consent to be in the study and must have a signed an approved consent form conforming with institutional guidelines Patient must be > 50 years old The patient should have a life expectancy of at least two years with a karnofsky performance status > 70 The patient must have stage 0 or I breast cancer On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (>2mm, DCIS and invasive). Re-excision of surgical margins is permitted Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 2 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 2 cm or less.) Patients with invasive breast cancer are required to have axillary staging which can sentinel node biopsy alone (if negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is NOT required for patients with DCIS The patient must have simulation within 8 weeks/56 days of the final surgery for their breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure) Patients with a history of non-ipsilateral breast malignancies are eligible if they have been disease-free for 2 or more years prior to enrollment. Patients with the following cancers are eligible even if diagnosed and treated within the past 2 years: carcinoma in situ of the cervix, colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin Men are not eligible for this study as men are not breast conservation candidates T0, T2 (> 2.0 cm), T3, node positive, stage III or IV breast cancer Any positive axillary nodes Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor Suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign Non-epithelial breast malignancies such as sarcoma or lymphoma Proven multicentric carcinoma in more than one quadrant or separated by more than 2 centimeters Paget's disease of the nipple History of invasive breast cancer or DCIS in the same breast Surgical margins that cannot be microscopically assessed or are less then 2 mm
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1
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Breast Cancer Karnofsky ≥ 70 2. Provision of informed consent 3. Pathological confirmation of invasive ductal carcinoma and estrogen receptor is positive 4. Tumor stage(TNM):T2-4bN0-3M0 5. Premenopausal woman 6. Not previously received treatment with bisphosphonate 7. Laboratory PLT ≥ 100*109/L WBC ≥ 4000/mm3 HGB ≥ 10g/dl GOT,GPT,ALP ≤ 2*ULN TBIL,DBIL,CCr ≤ 1.5*ULN Pregnant or lactation woman 2. History of organ transplantation 3. With mental disease 4. With severe infection or active gastrointestinal ulcers 5. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes 6. Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ) 7. With heart disease 8. Experimental drug allergy
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 40.0-999.0, Breast Cancer Subgroup 1, Patients with breast lesions: -At least one breast lesion detected by mammogram, ultrasound or breast MRI that measures < 20 mm in greatest dimension, presents as a mass, is considered suspicious or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas (BIRADS 4 or 5), and is scheduled for core-needle biopsy or surgical biopsy. OR -At least one breast lesion that measures between > 10 mm but < 20 mm in greatest dimension, presents as a mass, is biopsy-proven as malignant, and is scheduled for surgical resection. AND Age > 40 years Negative pregnancy test, postmenopausal, or surgically sterilized Subgroup 2, Patients without known breast lesions Negative screening mammogram performed at Mayo Clinic Rochester within 15 months prior to performance of study MBI No signs or symptoms of breast disease Age > 40 years Negative pregnancy test, postmenopausal, or surgically sterilized Vacuum-assisted or excisional biopsy has been performed prior to the study MBI. Reason: these types of biopsies are more likely to remove all of the tumor MBI is performed after biopsy and neo-adjuvant chemotherapy is planned prior to surgery. Reason: true tumor size will not be able to be ascertained from the final pathology findings Breast implants. Reason: cases with breast implants will be easily identifiable on blinded interpretation to take place at the study end Suspected that breasts will not fit in the MBI field of view. Reason: cases that require tiled views or additional views will be easily identifiable on blinded interpretation to take place at the study end Only one breast remaining. Reason: unilateral cases will be easily identifiable on blinded interpretation to take place at the study end; injection timing is designed for bilateral views Pregnancy test (if necessary) is not negative, or the patient is unable to complete the pregnancy test Physically unable to sit upright and still remain still during two consecutive MBI studies over the course of a 2-hour period
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-80.0, Hepatocellular Carcinoma hepatocellular patients diagnosed through biopsy;or either dynamic imagine with a diagnosis of hepatocellular carcinoma and alphafetoprotein>400μg/L；or two or more dynamic imagine with a diagnosis of hepatocellular carcinoma Child-Pugh A or B well preserved renal and hematopoietic Function receive ablation therapy through percutaneous radiofrequency ablation or microwave ablation or ethanol injection ablation or any kind of combination of them achieve complete ablation accessed by contrast-enhanced CT incomplete ablation remote metastasis Child-Pugh C general infection autoimmune diseases suffer from other tumors concurrently or in last five years patients with immune deficit or infected by HIV receiving glucocorticoid or other medicine inhibiting immune system
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Breast Carcinoma Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. Patients with contralateral disease will remain eligible. Note: Results of ER, PR, HER-2/neu must be obtained on pre-registration needle core biopsy material Tumor size ≤ 2.0 cm in greatest diameter as measured by breast ultrasound, MRI and mammogram. The largest dimension measured will be used to determine eligibility Tumor enhancement on MRI Tumor with <25% intraductal components in the aggregate Non-pregnant and non-lactating patients. Patients of childbearing potential must have a negative serum or urine pregnancy test. NOTE: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential Adequate breast size for safe cryoablation. Patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation. NOTE: The minimal distance of tumor margins from the breast skin should be analogous to the surgical margins of a lumpectomy Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or evidence of excessive DCIS History of rotational vacuum assisted core biopsies, en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer Prior or planned neoadjuvant chemotherapy for breast cancer Patients with thrombocytopenia and or any other coagulation abnormality
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 4.0-999.0, Juvenile Idiopathic Arthritis Patients who completed visit 33 (week 104) of WA19977 study and who may benefit from study drug treatment according to the investigator's assessment Patients have to receive the first RoActemra/Actemra infusion in this study at the Week 8 visit at the latest Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol Patients with, according to investigator judgment, not satisfactory benefit from RoActemra/Actemra therapy within WA19977 Treatment with any investigational agent since the last administration of study drug in the core study WA19977 Patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course Juvenile Idiopathic Arthritis (JIA) subsets: rheumatoid factor positive or negative JIA or extended oligoarticular JIA Patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug Any significant concomitant disease or medical or surgical condition History of significant allergic or infusion reactions to prior biologic therapy Currently active primary or secondary immunodeficiency Any infections with contraindications to RoActemra/Actemra therapy according to investigator judgment Inadequate hepatic, renal or bone marrow function
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen (ER) and/or progesterone-receptor (PR) status, and negative human epidermal growth factor receptor (HER)2, for whom standard adjuvant endocrine therapy is planned ER and PR positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as either ER or PR ≥ 1% positive nuclear staining HER2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using IHC, ISH or both. HER2 is negative if a single test (or all tests) performed in a tumor specimen show: 1. IHC negative (0 or 1+) 2. ISH negative using single probe or dual probe. If IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+. HER2 equivocal is not eligible Patients must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral, and primary inflammatory breast cancers are allowed Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant Multicentric disease is defined as more than one invasive cancer ≥ 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other Patients must be high risk by belonging to one of the following risk groups Completion of adjuvant chemotherapy and pathologically negative axillary nodes, and a tumor measuring ≥ 2 cm in greatest diameter, and an Oncotype DX® recurrence score (RS) > 25 (completed as standard of care). Patients with micrometastases as the only nodal involvement (pN1mi) are eligible, and will be categorized as node-negative
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer HER-2 Positive Breast Cancer Triple Negative Breast Cancer ER/Progressive Response (PR) + Refractory to Prior Hormonal Treatment Pathologically confirmed diagnosis of invasive breast cancer Stage IV disease Documented HER2 and hormonal receptor status per protocol, ER/PR+ patients must be refractory to at least one prior hormonal treatment ECOG Performance status 0-1 Measurable disease per (1.1) Adequate hematological function per protocol Adequate hepatic function per protocol Adequate renal function per protocol Negative serum pregnancy test at study entry for patients of childbearing potential Ability to understand and sign written consent and to comply with the study protocol Presence of active or untreated CNS metastases as determined by MRI/CT scan performed during screening Active malignancies other than MBC within the last 5 years except adequately treated in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin Bone as the only site of metastatic disease from breast cancer Prior radiotherapy to the only area of measurable disease. NOTE: Radiotherapy to a limited area other than the sole site of measurable disease is allowed, if received prior to initiation of ganetespib treatment. Patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of first dose of ganetespib Pregnancy or lactation Known serious cardiac illness Uncontrolled intercurrent illness per protocol Other severe acute or chronic medical condition or abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or that in the judgment of the investigator would make the patient inappropriate for entry into the study
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Abnormalities years of age or older Women who have indeterminate mammographic or sonographic findings who are recommended and for biopsy Known contraindication to mammographic imaging women who are pregnant women who are lactating women who have significant existing breast trauma women who have breast implants Women under 18 years of age women who had previous benign breast surgery within 1 year Males and children Women who are unable to understand or execute written informed consent Women who refuse to have a biopsy
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Written informed consent Patients with first relapsed or refractory multiple myeloma (including patients with relapse after high dose chemotherapy followed by autologous stem cell transplantation) who have received no more than one prior line of anti-myeloma treatment Treatment with a lenalidomide/ dexamethasone-based 2nd-line regimen is indicated and intended Measurable disease as defined by at least one of the following 3 measurements serum monoclonal protein level ≥ 1 g/dl (≥ 10 g/l) or urine M-protein level ≥ 200 mg/24hours or serum FLC assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/l) provided serum FLC ratio is abnormal ECOG performance status 0, 1, or 2 Age ≥ 18 years All previous cancer therapy (except corticosteroid therapy), including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study Pregnant or breast feeding females Any prior use of bendamustine Patients who are unable or unwillingly to undergo antithrombotic therapy Any serious underlying medical condition (at the judgment of the investigator) which impairs the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric disorder) Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she would participate in the study or any condition significantly confounding the ability to interpret data from the study, based on the local investigator's judgement Severe cardiovascular disease, including myocardial infarction within 6 months before study entry, New York Heart Association Class III or IV heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias (≥ Lown 3) Use of any other experimental drug or therapy/ treatment in a clinical trial within 30 days prior to trial entry Known hypersensitivity to study drug(s) or hypersensitivity to any other component of the study drugs Any concurrent antineoplastic therapy with chemotherapeutic agents or biologic agents or radiation therapy Any major surgical procedure within 30 days prior to study therapy
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-45.0, Breast Cancer female 2. Primary invasive breast cancer pathologically approved by core needle or open biopsy 3. Patients must have undergone standard surgery for primary breast cancer as shown in the following mastectomy breast conservation surgery followed by whole breast radiation axillary dissection or sentinel node biopsy 4. Need adjuvant chemotherapy after surgery 5. Patients taking neo-chemotherapy are eligible 6. Patients with synchronous bilateral cancers are eligible on the condition that If one side is IDC and the other side is DCIS, the IDC side should be of the ER and/or PR positive phenotype and IF two sides are both IDC, they must be ER and/or PR positive phenotype at the same time 7. Hormone receptor positive (≥＋) is defined as detecting ER or PR expression at any time is eligible. The situation of only PR positive and ER negative is eligible, too 8. Based on the study objective, all patients are required to be premenopausal as defined by menstruating actively less than 6 months since last menstrual period (LMP), or patients younger than 40 years of age who became amenorrheic not more than 1 year if the serum free E2、FSH and LH level was premenopausal (according to the reference value of local center) had previous hysterectomy with one or both ovaries left intact are eligible if the serum free E2、FSH and LH level are premenopausal (according to the reference value of local center). 9. patients must have an ECOG performance status of 0 or 1 (0-fully active, able to carry on all pre-disease performance without restriction, 1-restricted in physical strenuous actively but ambulatory) 10. leucocyte count must be ≥ 3.0*10^9/L and platelet count must be ≥ 100*10^9/L 11. AST/SGOT or ALT/AGPT must be < 3 times the ULN 12. serum creatinine must be < 2 times the ULN 13. pregnancy testing is negative and are willing to do contraception during the treatment period patients with metastatic malignant tumor 2. previous history of asynchronous bilateral breast cancer 3. any previous malignancy in the past 5 years, except for those treated with curative intent, such as carcinoma in situ of the cervix, squamous carcinoma of the skin or basal cell carcinoma of the skin 4. any non-malignant systemic disease which interfere long time follow up 5. history of medical ovarian ablation therapy 6. severe live dysfunction, Child-Pugh is grade C 7. Severe renal dysfunction 8. Occult breast cancer 9. severe heart dysfunction, heart functional classification is above Class III
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 40.0-80.0, Breast Cancer Past prior screening mammogram within the previous 11-24 months interpreted as heterogeneously dense or extremely dense and negative or benign [Breast Imaging Reporting and Data System (BI-RADS) Category 1 or 2] Subjects will be excluded if they Are unable to understand and sign the consent form Are pregnant or lactating Are physically unable to sit upright and still for 40 minutes Have self-reported signs or symptoms that may suggest breast cancer (palpable mass, bloody nipple discharge, axillary mass, etc.) Have had needle biopsy within 3 months, or breast surgery or radiation within 1 year prior to the study Are currently receiving chemotherapy or tamoxifen, raloxifene, or an aromatase inhibitor for adjuvant therapy or chemoprevention Have undergone bilateral mastectomy Have had a prior MBI within 20 months of scheduled study MBI
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Neoplasms Pre-Registration Diagnosis of pathologic stage II or III ER, PR, and HER2 negative primary invasive ductal or invasive lobular breast carcinoma. ER negative is defined as an Allred score of 0-2. PR negative is defined as an Allred score of 0-4. HER2 negative is defined as an IHC score of 0-1 and/or not-amplified by FISH testing All surgery for breast cancer (as defined by surgical excision of the cancer with a negative margin or mastectomy) must be complete Undergone axillary lymph node surgery (either sentinel lymph node biopsy or axillary lymph node dissection) per institutional standard Completed all (neo) adjuvant chemotherapy and radiation therapy as recommended by the treating physicians Completed the most recent cancer therapy (surgery, radiation, or chemotherapy) no less than 3 and no more than 24 weeks prior to registration. Note: patients who received experimental neoadjuvant or adjuvant therapy or surgical therapy (with the exception of Hh inhibitors) through participation in clinical trial are NOT excluded from this study as long as the other trial does not patients from enrolling into an additional adjuvant clinical trial and enrolling into this trial will not compromise the endpoints (primary and secondary) of the primary clinical trial. In addition, patients must have completed the experimental therapy no less than 4 weeks or 5 half lives (whichever is longer) and no more than 24 weeks prior to registration. For those patients who have enrolled into a neoadjuvant / adjuvant / surgical trial, all endpoints of these trials will be reviewed prior to consenting the patient for the sonidegib trial At least 18 years of age ECOG performance status ≤ 1 Patient (or legally authorized representative if applicable) must be able to understand and willing to sign an IRB approved written informed consent document. Pre-Registration Concurrent treatment with any other standard therapy (e.g. chemotherapy, targeted therapy or radiotherapy) or within 3 weeks of starting sonidegib Treatment with investigational anti-cancer agent within 4 weeks or 5 half-lives whichever is longer, of initializing treatments with sonidegib Previous treatment with systemic sonidegib or with other Hh pathway inhibitors Diagnosis of a neuromuscular disorder (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy) or on concomitant treatment with drugs that are recognized to cause rhabdomyolysis (such as HMG CoA inhibitors (statins), clofibrate and gemfibrozil) and that cannot be discontinued at least 2 weeks prior to starting sonidegib treatment. If it is essential that the patient stays on a statin to control hyperlipidemia, only pravastatin may be used with extra caution Known to be HIV-positive on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with sonidegib. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. Registration Presence of bone marrow DTCs after the completion of all intended breast cancer therapy including surgery, (neo) adjuvant chemotherapy therapy, and radiation as indicated. Note: Bone marrow aspiration will be performed in consented patients to evaluate DTCs provided patients meet all as described in this section ECOG performance status ≤ 1 Normal bone marrow and organ function as defined below Leukocytes ≥ 3,000/mcL Absolute neutrophil count ≥ 1,500/mcL
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 50.0-999.0, Breast Cancer Breast Neoplasm Breast Tumor Cancer of the Breast Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial Must be female Must be > = 50 years of age Must have a life expectancy of at least 5 years based on age and co-morbidities Must have pathology proven invasive ductal carcinoma (lobular is not allowed) and/or ductal carcinoma in situ (DCIS) One of the following must be met: (a) Tumors that are microscopically multifocal must be 3.0 cm or less in total aggregate size and encompassed within a single scar (b) Patient does not have microscopically multifocal tumor For tumors that are invasive, if in the presence of extensive intraductal component (EIC), the entire pathologic tumor size (including both the intraductal and invasive component) must be 3.0 cm or less Must be Stage 0, I, II (Tis, T1, or T2, N0, M0 per AJCC 7th and/or 8th Ed.). If stage II, the tumor size must be < = 3.0 cm. A patient with invasive histology must have nodal stage pN0 by H&E stains on sentinel node biopsy or axillary lymph node dissection Must have ER positive disease with ER/PR report available For tumors that are invasive, HER2 must be performed (positive or negative is acceptable) Previous history of ipsilateral invasive breast cancer or DCIS Any clinical or radiographically suspicious nodes, unless biopsy proven benign Non-epithelial malignancies such as sarcoma or lymphoma Suspicious residual microcalcifications on mammography of either breast, unless negative for malignancy on pathology Multicentric or bilateral disease unless biopsy of the clinical abnormalities are performed and result is negative Lymphovascular space invasion (LVSI) on pathology specimen Any previously treated breast carcinoma or synchronous breast carcinoma in ipsilateral breast Prior radiation therapy to the ipsilateral breast or thorax Paget's disease of the nipple Histologic examination showing invasive lobular histology
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1
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-60.0, HIV The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements ≥ 18 years Male or female subjects A female may be eligible to enter and participate in the study if she Is of non-child-bearing potential defined as ether post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age)or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or Is of child-bearing potential with a negative pregnancy test at screening and agrees to use one of the following methods of contraception to avoid pregnancy Complete abstinence from intercourse from 2 weeks prior to administration of IP, throughout the study and for at least 4 weeks after discontinuation of all study medication Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide) Any intrauterine device (IUD) with published data showing that the expected failure rate is < 1 % per year Any other method with published data showing that the expected failure rate is < 1 % per year Any significant acute or chronic medical condition Pregnant or lactating women Women of childbearing age unless using non hormonal contraception Evidence of organ dysfunction or any clinically significant deviation from normal during screening including laboratory determinations Abnormal LFTs (ALT > 2.5 x ULN, bilirubin > 1.5 x ULN) Positive blood screen for HIV-1 and 2 antibodies Positive blood screen for hepatitis B or C antibodies Current or recent (within 3 months) gastrointestinal disease Clinically relevant alcohol or drug use or history of alcohol or drug use that will hinder compliance with treatment, follow up procedures or evaluation of adverse effects Use of proton pump inhibitors
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-80.0, Carcinoma Breast Stage I HER2 Positive Breast Cancer Criteria:a. 1. Female subjects aged 18 years or older. 2. Histologically and/or cytologically confirmed diagnosis of breast cancer. Clinical stages breast cancer: HER2 positive, T1 or T2 or T3, N0 or N1, resectable T4, or resectable N2, (all M0) 3. Documentation of erbB-2 gene amplification by FISH (as defined by a ratio >2.2) or chromogenic in situ hybridization (CISH, as defined by the manufacturer's kit instruction) or documentation of erbB-2-overexpression by IHC (defined as IHC3+, or IHC2+ with FISH or CISH confirmation) based on local laboratory. 4. LVEF within institutional range of normal as measured by MUGA or ECHO. 5. Screening laboratory values within the following parameters: 1. Absolute neutrophil count (ANC) ≥1.5 x 109 /L (1500/mm3) 2. Platelet count ≥100 x 109/L (100,000/mm3) 3. Hemoglobin ≥9.0 g/dL (90 g/L) 4. Serum creatinine ≤1.5 x upper limit of normal (ULN) 5. Total bilirubin ≤1.5 x ULN (<3 ULN if Gilbert's disease) 6Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) 5 x ULN Bilateral breast cancer 2. Active uncontrolled cardiac disease, including cardiomyopathy, CHF (New York Heart Association [NYHA] functional classification of ≥3), unstable angina, and myocardial infarction (within 12 months of study entry). 3. Inadequately controlled hypertension (ie, systolic blood pressure [BP] > 180 mm Hg or diastolic BP > 100 mm Hg). 4. Family history of congenital long or short QT syndrome, Brugada syndrome or QT/QTc interval > 0.45 second or known history of QT/QTc prolongation or torsade de pointe (TdP). 5. Significant chronic gastrointestinal disorder with diarrhea as a major symptom (eg, Crohn's disease, malabsorption, or grade ≥2 diarrhea of any etiology at baseline). 6. Women who are pregnant, breast-feeding
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Invasive Ductal Carcinoma Invasive Lobular Carcinoma Ductal Carcinoma Adult patients over 18 years of age 2. Women with newly diagnosed, operable invasive ductal carcinoma, invasive lobular carcinoma or ductal carcinoma who are deemed breast conservation surgery candidates (i.e. lumpectomy +/ sentinel node biopsy). 3. Breast cancer needs to be unifocal as determined by clinical parameters, e.g. by palpation or by breast imaging findings including mammogram, US and/or breast MRI. Multifocal disease, i.e. cancer confined to one quadrant, is eligible if patients are deemed breast conservation candidates. 4. Subject capable of giving informed consent and participating in the process of consent Newly diagnosed breast cancer patients who are not breast conservation candidates and those with multicentric breast cancer (breast cancer documented in multiple quadrants by breast imaging or exam) 2. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery 3. Subjects with a history of iodide allergies 4. At-risk patient populations 1. Homeless patients 2. Patients with drug or alcohol dependence 3. Patients unable to participate in the consent process
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-70.0, Breast Cancer Female Patient aged 18 years and above Patient with histological proven invasive breast cancer Clinical T1-T2 disease with no distant metastasis Patient with clinical N0 status Patient for whom conservative surgery with sentinel lymph node (SLN) technique is feasible from the start in terms of carcinologic Patient with positive SLNs 1~2 Signed consent to participate History of neoadjuvant chemotherapy or hormone therapy History of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast) History of any other invasive cancer Initial metastatic disease known Pregnant women or lactating women Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Infiltration IV Infiltration years or older signed consent health form approved by professional practitioner abnormal bleeding or hemophilia absence of sensation in arms anemia cardiopulmonary disorders clotting disorders dehydration dizziness or fainting hepatitis high blood pressure (>160 systolic or > 115 diastolic) HIV / AIDS
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II Patients must be greater than or equal to 18 years of age Patients must have a newly diagnosed invasive ductal breast carcinoma, Stage I-II Patients who have completed their surgical and radiation therapy Patients must have SWOG performance status of 0, 1 or 2 Patients must have adequate organ function as defined by Hgb > 8.0 gm/dl, WBC > 3,500, platelet count > 100,000 Bilirubin < 2.0 mg/dl, SGOT < 4x upper limit of normal Creatinine < 2.0 mg/dl or calculated creatinine clearance > 50 ml/min Patients must have a serum calcium phosphate product that is less than 70 Patients with histology of lobular carcinoma Patients with metastatic disease Pregnant or lactating women Male gender Patients with a history of sarcoidosis Patients with any history of idiopathic urinary calcium stone disease, chronic hypercalcemia, or gastrointestinal malabsorptive conditions Patients who have received any of the following treatments within the last 14 days prior to study registration will be excluded Lithium Digitalis Thiazide diuretics
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-85.0, Endometrial Cancer The patient must be willing and able to provide informed consent The patient is willing and able to comply with the study protocol The patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy The patient agrees to follow-up examinations out to 5-years post-treatment The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy The patient has known or suspected allergies to iodine, indocyanine green (ICG) or isosulfan blue (ISB) The patient has hepatic dysfunction confirmed by bilirubin > 2 x normal (based on reference values from the laboratory used by the patient)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-90.0, Common Bile Duct Stones Gallbladder in Situ Choleretics Biliary Complications Complete clearance of CBD stones No definite GB stones Agree with the study protocol < 18 years of age Concomitant IHD stones Combined malignancy with a limted life span Prior cholecystectomy state refusal to agree to the study protocol
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy The breast cancer must be HER2-positive based on current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer The patient must have a mass in the breast measuring greater than or equal to 2.0 cm by physical exam and/or ultrasound that is accessible and safe for repeat biopsy. Patients with a diagnosis of inflammatory breast cancer are eligible if there is a palpable or detectable breast mass that is accessible and safe for repeat biopsy Planned initial treatment with a combination of paclitaxel and trastuzumab or a trastuzumab/pertuzumab-based combination. Schedule for paclitaxel/trastuzumab or trastuzumab/pertuzumab administration is per the investigator Excisional biopsy or lumpectomy performed prior to registration Previous therapy with chemotherapy or targeted therapy for any malignancy Treatment, including radiation therapy (RT), chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to registration Other nonmalignant systemic disease that would preclude the patient from receiving chemotherapy and targeted therapy
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer HER2-positive Stage I histologically confirmed invasive carcinoma of the breast ER/PR determination is required HER2 positive, confirmed by central testing: IHC 3+, FISH HER2/CEP17 <2.0 with an average HER2 copy number >/=6.0, or FISH HER2/CEP17 >/= 2.0 Bilateral breast cancers that individually meet are allowed Subjects with multifocal or multicentric disease are eligible as long as each tumor individually meets Subjects with a history of ipsilateral DCIS are eligible if they were treated with wide-excision alone, without radiation therapy; Patients with a history of contralateral DCIS are not eligible Should have tumor tissue available and a tissue block of sufficient size to make 15 slides, which must be sent to a DFCI site for testing Less than or equal to 90 days since most recent breast surgery for this breast cancer All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy) with either a sentinel node biopsy or axillary dissection All margins should be clear of invasive cancer or DCIS Pregnant or breastfeeding Use of potent CYP3A4 inhibitors during the study treatment period Excessive alcohol intake (more than 3 alcoholic beverages per day) Locally advanced tumors at diagnosis History of previous invasive breast cancer History of prior chemotherapy in the past 5 years History of prior trastuzumab or prior paclitaxel therapy Active, unresolved infection Active liver disease History of a different malignancy except for the following: disease free for at least 5 years and at low risk for recurrence; cervical cancer in situ, basal or squamous cell carcinoma of the skin
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1
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Malignant Neoplasm of Female Breast Written informed consent The diagnosis of breast cancer can be made by fine-needle aspiration (FNA), core, or tru-cut biopsy. Biopsy must demonstrate invasive adenocarcinoma Patients must have a life expectancy of at least 1 year, excluding their diagnosis of cancer Patients must have a mass on clinical or radiological examination of >1 cm and must be confined to either the breast or to the breast and ipsilateral axilla. Multiple masses permitted, provided one of them is >1cm Patients may enter prior to ER or Her2 status being known, however if Her2 is positive, then the patient is withdrawn from the treatment phase of the trial Patients with palpable mass with distant metastasis and/or palpable supraclavicular lymphadenopathy allowed if definitive local treatment is judged to be necessary Patients may have inflammatory breast cancer Prior to time of entry, patients must have had the following history and physical exam blood tests Patients with Her2 positive breast cancer Pregnancy or breast feeding at the time of proposed randomization. Women of childbearing potential with either a positive or no pregnancy test at baseline. Woman of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients will agree to continue contraception for 30 days from the date of the last study drug administration Participation in any investigational drug study within 4 weeks preceding the start of study treatment Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil Prior therapy for this breast cancer Prior chemotherapy for a different breast cancer. Patients who have received prior anthracycline therapy for any malignancy are not eligible Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient from being subjected to any of the treatment options or surgery or would prevent prolonged follow-up Active cardiac disease that would preclude the use of epirubicin. This includes Any documented myocardial infarction or unstable angina Any history of documented congestive heart failure
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Stage IB Breast Cancer Stage II Breast Cancer The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy); clinical axillary nodal involvement can be assessed by palpation, ultrasound, CT scan, magnetic resonance imaging (MRI), positron emission tomography (PET) scan, or PET/CT scan Patient must have had pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on either a positive fine needle aspirate (FNA) (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma); the FNA or core needle biopsy can be performed either by palpation or by image guidance; documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy) is not permitted Patients must have had estrogen receptor (ER) analysis performed on the primary breast tumor before neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP guideline recommendations for hormone receptor testing (http://www.asco.org) Patients must have had HER2 testing performed on the primary breast tumor before neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations for human epidermal growth factor receptor 2 testing in Breast Cancer (http://www.asco.org); patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen For patients who receive adjuvant chemotherapy after surgery, a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization; (if treatment delays occur, chemotherapy must be completed within 14 weeks); the dose and schedule of the adjuvant chemotherapy are at the investigator's discretion; Note: It is preferred that all intended chemotherapy be administered in the neoadjuvant setting Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer; acceptable procedures for assessment of axillary nodal status at the time of surgery Definitive clinical or radiologic evidence of metastatic disease T4 tumors including inflammatory breast cancer Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone N2 or N3 disease detected clinically or by imaging Patients with histologically positive axillary nodes post neoadjuvant therapy Patients with microscopic positive margins after definitive surgery Synchronous or previous contralateral invasive breast cancer or DCIS; (patients with synchronous and/or previous contralateral LCIS are eligible) Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy; (patients with synchronous or previous ipsilateral LCIS are eligible) History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization Any radiation therapy for the currently diagnosed breast cancer prior to randomization
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 40.0-999.0, Breast Imaging Breast Cancer Normal Group Are at least 40 years of age of any ethnicity Had a routine mammogram, read as BI-RADS® 0, 1, 2 or 3 Will undergo study imaging no later than six months from date of routine mammogram Is able to undergo informed consent Pregnancy Lactation Patients with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker Patients who are unable to tolerate study constraints Patients who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) Treatment for enlarged thymus gland as an infant Irradiation for benign breast conditions, including breast inflammation after giving birth Treatment for Hodgkin's disease Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram Patients who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-65.0, Healthy Healthy males and females, non-vegetarians, non-smokers, age 18-65 with BMI 18-35 kg m-2, taking no medication Diabetes Severe gastrointestinal disorders Kidney disease Thromboembolic or coagulation disease Hepatic disease Alcohol or any other substance abuse Gout Eating disorders Allergy Unregulated thyroid disease Asthma Eczema Hay fever Gluten/wheat intolerance Psychiatric disorder resulting in a perceived inability to give informed consent (including severe depression, lithium treatment, schizophrenia, severe behavioral disorders) Medication (Confirmed with GP) Orlistat (Xenical) Oral antidiabetics, insulin Digoxin, anti-arrhythmics Anti-inflammatories/anti-pyretics Tricyclic antidepressants, neuroleptics Antihistamines
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Stage II Breast Cancer Stage IIIA Breast Cancer Pre-Registration Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition No inflammatory breast cancer No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix All patients must have had an axillary ultrasound with fine needle aspiration (FNA) or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to or at most 14 days after starting neoadjuvant chemotherapy * Note: Biopsy of intramammary nodes does not fulfill Patients must have had estrogen receptor, progesterone receptor and HER2 status (by immunohistochemistry [IHC] and/or in situ hybridization [ISH]) evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy * Note: If HER2 status has not been clearly determined (i.e. equivocal/indeterminate), then patients should not be enrolled Patients must have completed all planned neoadjuvant chemotherapy prior to surgery; sandwich chemotherapy is not allowed (i.e. anthracycline/cytoxan or taxane chemotherapy planned to be given after surgery); patients must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen without evidence of disease progression in the breast or the lymph nodes * Note: Delays/dose modifications due to toxicities/adverse events are allowed as long as a minimum of 4 cycles of neoadjuvant chemotherapy is administered; more than 4 cycles of neoadjuvant chemotherapy (NAC) may be administered at the discretion of the treating medical oncologist Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab, or trastuzumab + pertuzumab, or other approved anti-HER-2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen); therapy must be Food and Drug Administration (FDA)-approved targeted anti-HER2 therapy, but additional therapies are allowed as are non-trastuzumab regimens if administered in the context of an Institutional Review Board (IRB)-approved clinical trial All patients must have a clinically negative axilla (no bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy * Note: an ultrasound of the axilla is not required at completion of neoadjuvant chemotherapy; if performed, its findings do NOT impact No more than 8 weeks of neoadjuvant endocrine therapy prior to the start of neoadjuvant chemotherapy
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Carcinoma in Situ Patients with nonpalpable breast lesions, carcinoma in situ or invasive carcinoma, where preoperative lesion localization is necessary All age groups, minimum 18 years Patients with benign nonpalpable breast lesions Patients who are unable to comprehend the information Patients who are pregnant, breastfeeding or have children < 3 years Patients who have lesions, which requires more than two wires or seeds for localization
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Focus: Breast Cancer With Axillary Node Metastasis Women with breast cancer and abnormal ipsilateral axillary nodes visible on sonography Inability to understand consent form Emotionally unprepared to discuss possibility of axillary metastasis Node not amenable to core biopsy
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-100.0, Breast Cancer Adenocarcinoma of the Breast Age ≥ 18 years. Patient must have histologically confirmed (by routine H&E staining) invasive adenocarcinoma of the breast. Primary tumor ≤ 4cm and 0-3 positive axillary lymph nodes (T1-2, N0-1, M0). Margin negative surgery. For subjects with two breasts, they must have had a bilateral mammogram prior to surgery. Patient must have a Medical Oncology consult with the recommendation of chemotherapy. Recommended regimens are as follows: Cyclophosphamide and Doxorubicin (AC); Taxotere, Doxorubicin and Cyclophosphamide (TAC); Taxotere and Cyclophosphamide (TC); or Taxotere, Carboplatin withTrastuzamab (TCH) prior to registration; or Paclitaxel and Trastuzumab. The use of additional chemotherapy, hormonal therapy or Trastuzumab after the initial regimen is at the discretion of the Medical Oncologist. Other primary regimens are possible but the PI must be notified prior to enrollment. Partial breast irradiation must be scheduled to begin less than 71 days from the last breast surgical procedure. ECOG performance status ≤ 1. Women of child-bearing potential must have a negative (urine or blood) pregnancy test within 6 weeks prior to start of protocol therapy. Women of childbearing potential must also use effective non-hormonal contraception while undergoing radiation treatment and chemotherapy. Ability to understand and the willingness to sign a written informed consent document Patients who have received neoadjuvant chemotherapy or neoadjuvant hormonal therapy for the current cancer. Patients with squamous or sarcomas of the breast. Patients who have active local-regional disease prior to registration. Patient has other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in sity cervical cancer, or any other cancer from which the patient has been disease-free for less than 5 years. Patient is pregnant. Patient has a serious medical or physciatric illness which prevents informed consent or adherence with treatment Study team (PI, Co-I, and or research nurse) may deny enrollment if in the study team's opinion, the candidate may not be adherent to the treatment protocol including scheduled follow-ups
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Phase 1 1. Age greater than/equal to 18 years 2. Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ 3. Patient desire to undergo breast surgery 3. Patients will have provided informed consent to participate, documented by their signature on the study consent form 4. The cancer enhances on breast MRI imaging. Phase 2 1. Age greater than/equal to 18 years 2. Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ 3. The tumor is visible and enhances on prone MRI and is >1 cm in greatest diameter. 4. . Determination by the surgeon that the neoplasm is non-palpable.A patient with a palpable hematoma from core biopsy, but a non-palpable neoplasm, will be eligible for study 5. Patient desire to undergo breast conserving surgery 6. Patients will have provided informed consent to participate, documented by their signature on the study consent form.The process of informed consent will be documented in the medical record and a copy of the signed consent form will be given to the patient (Phases 1 and 2) 1. Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip or metallic foreign body in or near eyes 2. Severe claustrophobia 3. Contraindication to use of gadolinium based intravenous contrast, including life threatening allergy or compromised renal function (creatinine > 2.0) 4. History of median sternotomy 5. Pregnancy (Patient attestation that they are not pregnant will be acceptable, as per standard, as per standard policy for MRIs at DHMC). 6. Multicentric breast cancer, defined as two or more tumors in different quadrants of the breast. An worksheet will be completed for each patient prior to enrollment and will be signed and dated by the surgeon investigator
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Estrogen Receptor-positive Breast Cancer HER2-negative Breast Cancer Invasive Ductal Breast Carcinoma Invasive Lobular Breast Carcinoma Recurrent Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Female ≥18 years of age 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 3. Postmenopausal, verified by post bilateral surgical oophorectomy or no spontaneous menses ≥ 1 year or no menses for < 1 year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards 4. Pathologic confirmation of invasive breast cancer diagnosed by core needle biopsy 5. Clinical T2-T4c, any N, M0 invasive breast cancer, by AJCC 7th edition clinical staging, with the goal being surgery to complete excision of the tumor in the breast and the lymph node. Primary tumor must be palpable its largest diameters is at least 2.0 cm by physical examination or by radiological assessment Note Patients with contralateral ductal carcinoma in situ and/or invasive breast cancer are not eligible Patients with multi-centric breast cancer (defined as more than one lesion is invasive breast cancer in the same breast separated by ≥ 2 cm of normal breast tissue are not eligible. 6. Invasive breast cancer is estrogen receptor positive with an Allred score of 6, 7 or 8 by local institution standard protocol. If an Allred Score is not reported on the diagnostic pathology report, ER positivity in > 66% cells is eligible. If ER positivity is ≤ 66%, the staining intensity (weak, intermediate, strong) is needed to calculate the Allred Score to determine eligibility. 7. Invasive breast cancer is Human Epidermal Growth Factor Receptor 2 (HER2) A patient is considered to have HER2 negative breast cancer if one of the following applies or 1+ by immunohistochemistry (IHC) and ISH not done Premenopausal status 2. Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d' orange without erythema). 3. An excisional biopsy of this breast cancer. 4. Hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration. 5. Tumor estrogen receptor (ER) Allred score between 0-5 or HER2 positive by IHC (3+) or amplified by FISH > 2.0. 6. Surgical axillary staging procedure prior to study entry. Note: Fine needle aspiration (FNA) or core needle biopsy of axillary node is permitted. 7. Clinical or radiographic evidence of metastatic disease. Metastatic workup is not required, but is recommended for patients with clinical stage III disease. Note: Isolated ipsilateral supraclavicular node involvement is permitted. 8. Breast implants are contraindicated only if the implant precludes the required research biopsies or interferes with palpating the breast lesion. 9. Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy or investigational agent prior to study entry. 10. History of invasive breast cancer or contralateral DCIS
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 50.0-95.0, Invasive Ductal Breast Cancer Carcinoma Breast Stage I Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer Patient agrees to evaluation of the axilla with sentinel lymph node biopsy Peri or post-menopausal women age > 50, defined as women who have experienced no menstrual period in the past 6 months or more BRCA1 and 2 gene mutation negative, if tested. [genetic testing is NOT required based upon personal or family history] Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) < 2.0 cm in diameter, primary T-stage of Tis or T1 (AJCC criteria) Grade 1, 2, or 3 acceptable Associated LCIS is allowed Pure DCIS allowed if <2.5 cm, low to intermediate nuclear grade and resected margins negative at > 3 mm (per ASTRO criteria) Estrogen receptor (ER) status of positive Patient has clear margins >2 mm on gross pathologic examination Prior breast malignancy or other malignancy if metastatic, or with expected survival of < 5 years Immunocompromised status Pregnancy Women with an active connective tissue disorder (i.e. scleroderma, lupus and others) Breast cancer that involves the skin or chest wall, locally advanced breast cancer Invasive lobular carcinoma Evidence of lymphovascular invasion (LVI) Invasive carcinoma with extensive intraductal component (EIC) Neoadjuvant chemotherapy Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-70.0, Breast - Female Identify 1. Histologically confirmed invasive and/or in situ carcinoma of the breast 2. Any race and ethnicity 3. Females 18-70 years of age 4. Willing and able to provide informed consent 5. Subject will have a CE-MRI exam within one month (31 days) of enrolling or has had a CE-MRI exam within one month (31 days) prior to enrolling with no interval treatment or procedure between the CEDM and CE-MRI Identify Unwilling or unable to undergo informed consent 2. Planned to undergo neoadjuvant chemotherapy 3. Breast implants 4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be performed for confirmation.) 5. Breast-feeding 6. Surgical excision of the biopsy proven malignancy 7. Known allergy to gadolinium contrast agents 8. Contraindication for MRI (ex: pacemaker, ferromagnetic aneurysm clips or other ferromagnetic surgical implant or severe claustrophobia) 9. Suspected to be at risk to complications from the contrast agent. These the standard iodinated contrast agent contraindications: 1. Subject has renal insufficiency as determined by an elevated serum creatinine and is not being treated with dialysis. 2. Documentation of a normal eGFR (MDRD) within the previous 2 months will be required for any subject with any of the following risk factors for renal insufficiency: i. Age > 70 ii. Diabetes iii. Personal history of renal disease iv. Family history of renal disease (e.g., polycystic kidney disease) v. Known solitary kidney vi. Other medical conditions that may affect the kidney (e.g., Lupus, multiple myeloma) c. Subject has taken metformin (Glucophage) within 48 hours of procedure d. Subject has had a prior reaction to iodinated contrast e. Subject has multiple allergies and/ or severe asthma regularly treated with medication f. Subject has had an episode of serious allergic reaction (anaphylaxis) to any substance
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Triple Negative Breast Cancer Participants must meet the following on screening examination to be eligible to participate in the study Pathologic documentation of invasive breast cancer by biopsy (FNA alone is not adequate) AJCC clinical stage I with T1 > 1.5 cm, stage II or III invasive breast cancer Participants with multicentric or bilateral disease are eligible if at least one lesion meets stage for the study and no tumor is HER2-positive. In this circumstance, the investigator must determine which will represent the target lesion to be assessed for response. This should remain consistent throughout the study. The target lesion should be selected on the basis of its size (lesion with the longest diameter) and suitability for accurate repetitive measurements Tumors must be HER2 negative defined as HER2 0 or 1+ by immunohistochemistry (IHC) assays and /or lack of gene amplification by FISH defined as a ratio < 2 on invasive tumor by local review ER and PgR status by IHC must be known. Tumor must be ER and PR negative (≤5% staining) by local review Known BRCA1/2 status is not required for study entry. However patients known to have a germline deleterious BRCA1/2 mutation should be encouraged to consider a preoperative trial specifically designed for BRCA1/2 carriers, if available Breast imaging should imaging of the ipsilateral axilla. For subjects with a clinically positive axilla, a needle aspiration, core biopsy or SLN procedure will be performed to confirm the presence of metastatic disease in the lymph nodes. For patients with a clinically negative axilla, baseline assessment of the axilla will be performed at the discretion of the treating investigator. For patients with pathologically positive axillary lymph nodes prior to preoperative therapy, a level I and II lymph node dissection at the time of definitive surgery is recommended Participants with axillary adenopathy only are not eligible for this study Patients with a prior history of contra-lateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer within the last 5 years Prior chemotherapy: Prior non-taxane or platinum containing chemotherapy will be allowed if the prior exposure was at least 5 years ago and the exposure is thought not to potentially interact with the primary outcome of the trial or put the patient at undue risk, and should be reviewed with study PI on a case by case basis Any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation or experimental therapy Ipsilateral breast recurrence, unless prior treatment consisted of excision alone for DCIS or breast conserving treatment and hormonal therapy for DCIS or invasive breast cancer Ongoing use of any other investigational or study agents Peripheral neuropathy of any etiology > grade 1 (NCI CTCAE Version 4.0 Appendix B) Significant hearing loss that would prevent cisplatin administration Renal dysfunction for which exposure to cisplatin would be unsafe or require cisplatin dose modification (i.e., Cre > 1.5 mg/dl or GFR < 60 cc/min)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-75.0, Triple Negative, HER2+, Luminal B Breast Tumors (Stages II-III)in Female Patients Informed consent Form signed Adequate Performance status (ECOG 0-1) Female patients with unifocal breast tumors (stages II-III, TN, HER2+ or Luminal B) very sensitive to neoadjuvant medical treatment (5 to 6 months in accordance with the current standard) Patients who submit clinical-radiologic greater response to the treatment administered (equal to or less than 1.5 cm in NMR residual tumor) Ki67<14% Excisional biopsy Contraindications
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed
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0
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