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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, Disorders of Breast Breast Lesions Subjects with a breast lesion requiring image-guided localization prior to excision Subjects aged 18 years or more at the time of consent The subject is pregnant or lactating Subject has pacemaker or other implantable device in the chest wall Subject has current active infection at the implantation site in the breast (per investigatordiscretion)
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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): 50.0-100.0, Breast Cancer Female sex Age > or = to 50 years of age Invasive ductal carcinoma Clinically and radiographically T1 tumor Clinically node negative Clearly demarcated tumor on magnetic resonance imaging (MRI), as determined by treating physician (MRI may be done after enrollment if not done prior) Planning breast conserving surgery including sentinel node biopsy ≥10% expression of ER and/or PR HER2 using the current College of American Pathologists guidelines Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma Pure DCIS without invasive cancer Patients who have received or will be receiving neoadjuvant systemic therapy, endocrine therapy, or targeted agents Breast implant in the involved breast unless the implant will be removed prior to initiation of study treatment Positive pregnancy test Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement Unable to meet dosimetric constraints due to tumor location and/or patient anatomy Planning mastectomy Unable to tolerate prone positioning
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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): 25.0-99.0, Ultrasonography Breast Women referred to hand-held screening ultrasound examination (BI-RADS=1/2). Women scheduled to undergo ultrasound-guided needle biopsy due to suspicious breast mass detected during hand-held ultrasound (BI-RADS>2) Women under 25 years
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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 Participants will be ≥ 18 years of age Known or suspected (BIRADS 5 on imaging) primary breast cancer At least one breast lesion one breast lesion that is 1 cm or greater in size by standard imaging (e.g. mammography, ultrasound or breast MRI). Only one type of imaging is required to show a lesion of 1 cm or greater in order for the patient to be eligible to participate in this study. Patients that have a prior diagnosis of primary breast cancer in the opposite breast can be included Willing to allow use orcollection of pathology tissue for the purposes of research from either clinical biopsy or surgical procedure (if adequate tissue is available) or research only biopsy Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening Inability to tolerate imaging procedures in the opinion of an investigator or treating physician Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in 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): 18.0-80.0, HER2-positive Breast Cancer the first diagnosis of invasive breast cancer, confirmed by histology or cytology, and surgical resection of the primary lesions before receiving any anti breast cancer treatment; 2. female patients, aged 18 years and less than 80 years of age; 3. surgical resection of the primary tumor pathological examination, showed HER2 positive (defined as immunohistochemistry [IHC] 3+ or fluorescence in situ hybridization (FISH) positive); 4. hormone receptor status is known, lymph node positive or sentinel lymph node negative but high risk factors 5. the eastern oncology cooperative group (ECOG) patients with physical status score was 0 -2; 6. baseline LVEF >50% 7. the relevant institutional review board (IRB) or independent ethics committee (IEC) written informed consent the subjects in pregnancy or lactation; 2. pregnant women may be within the first 7 days before pregnancy test positive (urine or serum). 3. received chemotherapy, endocrine or anti HER2 anti-tumor therapy; 4. congestive heart failure, unstable angina, heart failure or myocardial infarction and other diseases; 5. other invasive tumors (including the second primary breast cancer), may affect the outcome of the evaluation and program compliance; but the treatment of patients with disease free survival at least more than 5 years can be selected; 6. with chronic liver disease in patients with liver dysfunction and / or with clinical manifestations: the serum total bilirubin > 2.5 * ULN; or INR = 1.5 but no bilirubin. serum ALT or AST> * 3 * ULN; alkaline phosphatase >2.5 * ULN; ALT or AST can be gradually increased, but with gradually increasing fatigue, nausea and vomiting, fever, right upper quadrant pain or tenderness 7. hematopoietic dysfunction, defined as follows: neutrophil count (ANC) <1.5 * 109/L; platelet <100 * 109/L; hemoglobin <9 g/dL; 8. other serious diseases, including: congestive heart failure (heart function NYHA grade II, III, IV) or occurred within 6 months of congestive heart failure, unstable angina, arrhythmia, myocardial infarction patients can't control or other severe cardiovascular disease; breathing at rest or need oxygen therapy; serious infection; uncontrolled diabetes; 9. there is a serious psychological or mental abnormalities, estimated that the participants to participate in this study is not strong; 10. known to study drug allergy; 11. the past 30 days participated in the study of other drug clinical trials. 1, failed to complete the clinical trial of at least 1 cycles according to the program, can not carry out safety and efficacy evaluation 2, a serious violation of this research program, not in accordance with the prescribed dose, method and course of medication. Patients will receive lapatinib treatment, until a predetermined end end point, or development of unacceptable toxicity, or withdrawal of consent, or illness or death, to appear before the subject
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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): 18.0-80.0, Breast Cancer Histologically confirmed diagnosis of in situ ductal carcinoma (pTis) or invasive breast carcinoma (pT1 and pT2), submitted to NAC sparing mastectomy with prosthetic-based breast reconstruction (expander or prosthesis) and Group A) Negative sentinel node dissection or axillary clearance (pN0) and all the following risk factors Close (less than 1 mm) or positive (ink on tumor margin) surgical margin in a single breast quadrant Tumor diameter >2 cm Age ≤50 years Grade 3 histology Group B) Positive sentinel dissection (pN1a) followed by axillary clearance (or primary axillary clearance) with only 1 positive node and any of the following risk factors Close (less than 1 mm) or positive (ink on tumor margin) surgical margins in a single breast quadrant Age ≤50 years Tumor diameter >2 cm Stages IIIB, IIIC and IV (any T4, any N3 or M1) Pathological metastasis in ≥2 axillary lymph nodes, clinically apparent metastasis in internal mammary and/or supraclavicular lymph nodes Close (less than 1 mm) or positive (ink on tumor margin) surgical margin in multiple breast quadrants Patients submitted to neoadjuvant chemotherapy Recurrence of breast cancer following mastectomy and/or adjuvant chemotherapy Concomitant primary cancer in the contralateral breast History of other malignancy except carcinoma in situ of the cervix or non-melanoma skin cancer Pregnant or breast-feeding Other severe concomitant disease that could impact upon the ability to deliver treatment or increase the risk of toxicity (such as uncompensated congestive heart failure, unstable coronary heart disease, uncompensated chronic obstructive pulmonary disease, collagen vascular diseases including systemic lupus erythematosus, systemic sclerosis, dermatomyositis, and ataxia telangiectasia) Contraindications to radiation therapy (such as previous irradiation of the breast or chest wall)
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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 Breast Cancer Ductal Carcinoma in Situ of the Breast women diagnosed with invasive breast cancer or ductal carcinoma in situ receiving the following treatment: 1. mastectomy and sentinel lymph node biopsy 2. breast conserving surgery or mastectomy and axillary lymph node dissection 3. completion axillary lymph node dissection after positive sentinel lymph node biopsy 4. cases receiving neo-adjuvant therapy (chemotherapy or hormonal therapy) who are having axillary lymph node dissection as part of their surgical treatment - males with breast cancer 2. women less than 18 years of age 3. known allergic reaction to patent blue dye 4. pregnant 5. previous radiation therapy to affected side 6. clinical N2/N3 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): 18.0-999.0, Breast Cancer Post menopausal women with histologically confirmed hormonal positive (ER and/or PR) invasive breast cancer stages I III with no evidence of metastatic disease (M0) Patient must have completed local treatment (surgery /radiation) and recovered from all side effects of chemotherapy and surgery Patient must be on one of AI (steroidal or non-steroidal) Patient must be able to complete a demographic and the MMAS questionnaires in English or Spanish < 18 years old
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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 be female, at least 18 years of age Patients or their legally authorized representative must have signed and dated an informed consent form Patients must have at minimum, adequate samples of breast tissue available for use in this study Patients with a tissue diagnosis of low, intermediate or high grade ductal carcinoma in situ or ductal carcinoma in situ with microinvasion Patients with a diagnosis of atypical ductal hyperplasia, lobular cancer in situ or any preinvasive breast lesion Patients with ductal carcinoma in situ undergoing either lumpectomy and radiation or mastectomy Patients with a diagnosis of invasive ductal cancer Male Patients under the age of 18 or over the age of 89 Patient desires not to participate in the study Inability to consent
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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, Obesity Pregnancy Active labor according to the Swedish definition; two out of three of the following must be present: painful contractions (two to three contractions in every ten minutes), cervix shortened and dilated > one centimeter (cm) and/or rupture of membranes The maximum cervix dilatation was of seven centimeters The participant had to be aged ≥18 years The participant had to be proficient in the Swedish language Not in active labor Cervix dilatation of more than seven centimeters Age <19 Not speaking Swedish
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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 all patients undergoing breast MRI general contraindication to MRI -
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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 Written informed consent prior to beginning specific protocol procedures. 2. Female or male patients ≥ 18 years of age. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Histologically proven invasive breast cancer. 5. Operable breast cancer (cT1-3 and/or cN0-2 tumors) (breast cancer TNM classification) 6. Tumor size larger than or equal to 1.5 centimeter (cm) in diameter by magnetic resonance imaging (MRI) or ultrasound with a significant 18F-FDG uptake defined as maximum standarized uptake value (SUVmax: maximum standarized uptake value) ≥1.5 x SUVmean (mean standarized uptake value) liver + 2 SD (standard deviation. Multicentric/multifocal tumors will be allowed only if: 1. Histological confirmation of at least two lesions. 2. All tumors must be HER2-positive. 3. Largest lesion must be larger than or equal to 1.5 cm in diameter by MRI or ultrasound. 7)Centrally confirmed HER2-positive disease according to the 2018 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) criteria. 8)Patient must have known estrogen receptor (ER) and progesterone receptor (PR) status locally determined prior to study entry. Patient has adequate bone marrow, liver, and renal function: 9)Hematological: White blood cell (WBC) count > 3.0 x 109/L, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100.0 x109/L, and hemoglobin ≥ 10.0 g/dL (≥ 6.2 mmol/L). 10)Hepatic: total bilirubin ≤ institutional upper limit of normal (ULN) (except for Gilbert's syndrome); alkaline phosphatase (ALP) ≤ 2.5 times ULN; aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 times ULN. 11)Renal: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. 12)Patient must be accessible for treatment and follow-up Previous treatment with chemotherapy, anti-HER2 therapy, radiation therapy, or endocrine therapy for invasive breast cancer. 2. cT4 and/or cN3 tumors (TNM breast cancer classification) 3. Bilateral breast cancer. 4. Evidence of metastatic disease by routine clinical assessment chest x-ray, liver ultrasound, and bone scan; or computed tomography (CT) scan of thorax and abdomen and bone scan, except patients with subclinic M1 (metastases) at baseline only according to 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) that will be allowed to be included into cohort C. 5. Known hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances. 6. History of other malignancy within the last five years prior to first dose of study drug administration, except for curatively treated basal and squamous cell carcinoma of the skin and/or in situ cervical carcinoma. 7. Left ventricular ejection fraction (LVEF) below 55% as determined by multiple-gated acquisition (MUGA) scan or echocardiography (ECHO). 8. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) despite adequate antihypertensive treatment. 9. Clinically significant cardiovascular disease [stroke, unstable angina pectoris, or documented myocardial infarction within six months prior to study entry; history of documented congestive heart failure (CHF) (New York Heart Association II-III-IV); symptomatic pericarditis; documented cardiomyopathy; ventricular arrythmias with the exception of benign premature ventricular contractions; conduction abnormality requiring a pacemaker; other arrhythmias not controlled with medication]. 10. Active uncontrolled infection at the time of enrollment. 11. Current known infection with HIV, hepatitis B virus, or hepatitis C virus. 12. Patients with pulmonary disease requiring continuous oxygen therapy. 13. Previous history of bleeding diathesis. 14. Patient is currently receiving anti-coagulant therapy, chronic treatment with corticosteroids, or another immunosuppressive agent (standard premedication for chemotherapy and local applications are allowed). 15. Major surgical procedure or significant traumatic injury within 14 days prior to randomization or anticipation of need for major surgery within the course of the study treatment. 16. Patient has other concurrent severe and/or uncontrolled medical conditions that would, in the investigator´s judgment, contraindicate her participation in the clinical study. 17. Concurrent participation in other clinical trial, except other translational studies. 18. History of receiving any investigational treatment within 28 days prior to randomization. 19. Pregnant or breast-feeding women or patients not willing to apply highly effective contraception as defined in the protocol. LINGain sub-study: The project intends to a total of 126 blood samples from PHERGain trial, as follows: 105 from patients treated with trastuzumab and pertuzumab ± endocrine therapy (according to HR status); 21 from patients treated with trastuzumab and pertuzumab + carboplatin and docetaxel
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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): 18.0-99.0, Metastatic Breast Cancer Age ≥ 18 years of age Female gender Biopsy proven diagnosis of breast cancer Stage IV disease diagnosed either by radiographic studies or biopsy ER+ by immunohistochemistry on primary and/or metastatic tissue biopsy (>10%) HER2 non-amplified (1+ or below by immunohistochemistry, and/or Her2 FISH <2 HER2-to-CEP17 ratio) Progressed on at least one prior line of endocrine therapy for metastatic disease Three or fewer prior endocrine-containing therapies for recurrent/metastatic disease Two or fewer prior lines of cytotoxic chemotherapy for recurrent/metastatic disease Plans to initiate 2nd, 3rd, or 4th line endocrine therapy for metastatic disease < 18 years of age Tissue biopsies that support the presence of both ER+ and ER metastatic breast cancer in the same patient Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent 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): 18.0-85.0, Breast Cancer Female Thyroid Gland Female patients with histologically or cytologically proven primary breast cancer; 2. Age >18 years; 3. ECOG Performance Status: 0-2; 4. Life Expectancy: 3 months or more; 5. No previous anti-cancer therapy; 6. Be willing to undergo at least four cycles of anthracycline or taxane-based chemotherapy; 7. Adequate hematological, liver, and kidney functions Pregnancy or lactation; 2. History of other malignancy or secondary breast cancer; 3. History of thyroid disease; 4. History of drug addiction or abuse; 5. History of immunodeficiency disease; 6. Treatment with drugs capable of influencing thyroid gland functions within 3 months prior to study entry; 7. Nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases; 8. Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials; 9. Inability to understand and agree to 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, Invasive Breast Carcinoma Stage II Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA 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 Patients must have had ER analysis performed on the primary breast tumor collected prior to 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. Patients who have a primary tumor that is hormone receptor-positive or hormone receptor-negative are eligible Patients must have had HER2 testing performed on the primary breast tumor collected prior to neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer; patients who have a primary tumor that is HER2-positive, HER2-equivocal, or HER2-negative are eligible Patients must have had a biopsy marker placed within the tumor bed with imaging confirmation (preferably mammogram but ultrasound or magnetic resonance imaging [MRI] is acceptable) of marker placement prior to neoadjuvant chemotherapy Patients with operable focal or multifocal (T1-T3, stage II or III invasive ductal carcinoma [all receptor phenotypes]), and who have completed neoadjuvant chemotherapy with a clinical complete response (by clinical examination) Patients with synchronous bilateral breast cancer are eligible if at least one of the synchronous breast cancers has a cCR, and the side with a cCR meets criteria. (Patients with previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible.) Patients must have achieved a complete or near complete radiologic tumor response on breast imaging with mammogram, ultrasound, and MRI during or after completion of appropriate neoadjuvant chemotherapy defined as Mammogram with malignant appearing calcification or mass ≤ 1 cm; or Ultrasound with a hypoechoic area ≤ 2 cm; or T4 tumors including inflammatory breast cancer Patients with distant metastatic disease Lumpectomy performed prior to study entry Patients with any history of prior radiation therapy in the affected breast Patients with a prior history of ipsilateral invasive breast cancer; (patients with previous ipsilateral/contralateral DCIS or previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible) Patients with invasive lobular carcinoma Patients who have multicentric disease Patients treated with neoadjuvant hormonal therapy only are not eligible Patients who are medically unfit to undergo surgical resection Patients without breast biopsy marker documented by imaging at tumor bed site prior to initiation of neoadjuvant 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 diagnosis of breast cancer by core needle bipsy aged 18 years or more who had a preoperative magnetic resonance imaging who had a preoperative 3D optical scan who had two intraoperative optical scans (with and without pen marking for tumor localisation who had a preoperative radioguided occult lesion localization who had a breast conservation surgery not opposed to the use of their personal health data patients aged under 18 requiring tutorship or guardianship who had neoadjuvant therapy
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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 Invasive Breast Cancer Female; age ≥18 years Pathologically proven diagnosis of invasive breast cancer, clinically stage I-II Clinically lymph node negative, confirmed by clinical exam and/or ultrasound imaging Estrogen and/or progesterone-receptor-positive tumor, defined ≥1% positively staining cells by immunohistochemistry, according to the current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines HER2/neu must be negative by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Pretreatment evaluations (minimum diagnostic workup) within 28 days prior to study Qualify for anti-endocrine treatment (per medical oncologist) Informed consent provided American Joint Committee on Cancer (AJCC) clinical T4, N1-3 or M1, breast cancer Synchronous non-breast malignancy (exceptions non-melanomatous skin cancer, carcinoma in situ of the cervix) Purely noninvasive breast cancer (i.e., ductal carcinoma in situ, lobular carcinoma in situ) Men with breast cancer Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent 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): 20.0-80.0, Advanced Breast Cancer All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies Body tumor 1-6, with at least one tumor length > 2 cm KPS ≥ 70, lifespan > 6 months Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L Patients with cardiac pacemaker Patients with brain metastasis Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
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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, Mother-Child Relations Preterm Birth Infant Development Breast Feeding Physical Activity Pregnancy Related Medicine, Narrative live births mothers living in urban area of the city delivered during 2015 stillbirths below 500g mothers living outside Pelotas
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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): 17.0-999.0, Manual Rotation of A Liveborn Singleton pregnancies >37 weeks of pregnancy Fetus in cephalic presentation Fetal weight estimation P10-90 Fetal head in a posterior position in the moment of full cervical dilatation do not give or do not be able to give written consent
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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): 18.0-99.0, Breast Cancer Clinical, mammographic, MR-tomographic and/or ultrasonographic verification of a suspicious breast lesion (BIRADS 4 and 5) Age > 18 years Written informed consent Histopathological verification of the lesions either by core biopsy or by surgical excision Unstable or non-compliant patients Pregnant or lactating patients or patients with suspected pregnancy Known contraindication to the intravenous administration of US contrast agents Acute or chronic renal insufficiency Pre or post-transplant patients
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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, Advanced Breast Carcinoma Locally Advanced Breast Carcinoma Metastatic Breast Carcinoma Recurrent Breast Carcinoma Stage III Breast Cancer AJCC v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Stage IV Breast Cancer AJCC v6 and v7 PRE-REGISTRATION Women who have disease that is amenable to biopsy and agree to undergo a standard of care and /or research biopsy Note: If a standard of care biopsy was recently obtained =< 2 months of pre-registration, eligible patients should agree to a research biopsy of recurrent or metastatic breast cancer prior to the start of protocol treatment to collect additional core samples for research purposes Patients must satisfy one of the following for prior therapy First line setting: No prior endocrine therapy in the metastatic setting with no more than one prior line of chemotherapy in the advanced/metastatic setting Second line setting: Progression on one prior line of endocrine based therapy monotherapy either in the adjuvant or advanced/metastatic setting; either one or two prior lines of chemotherapy in the advanced setting are allowed Note: Patients receiving bisphosphonate or denosumab therapy prior to registration may continue at the same intervals used prior to study registration First line therapy setting only: The intention to begin palbociclib and letrozole as treatment for locally advanced or metastatic breast cancer Second line therapy setting only: The intention to begin palbociclib and fulvestrant as treatment for metastatic breast cancer (after progression on first line endocrine therapy) Note: Patients who are to receive second line endocrine therapy are allowed to remain on their most recent treatment (tamoxifen or an aromatase inhibitor during the pre-registration period as well as after registration while awaiting insurance approval for the use of palbociclib PRE-REGISTRATION History of metastatic ER negative or HER2 positive breast cancer Prior treatment in the metastatic setting with everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway Uncontrolled intercurrent illness including, but not limited to Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Uncontrolled symptomatic cardiac arrhythmia Uncontrolled hypertension (defined as blood pressure > 160/90) Other active second malignancy other than non-melanoma skin cancers =< 3 years of pre-registration; Note: a second malignancy is not considered active if all treatment for that malignancy is completed and the patient has been disease-free for =< 3 years prior to pre-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, Breast Cancer Participants must have histologically or cytologically confirmed inoperable locally advanced or metastatic ER+ breast cancer. To fulfill the requirement for ER+ disease, a breast cancer must express, by immunohistochemistry (IHC), ER in ≥10% of cells, on the most recent biopsy. If ER quantification is not available, a determination of ER+ by IHC will suffice. Central confirmation of ER status is not required Participants must have documented HER2+ disease by overexpression and/or gene amplification on the most recent biopsy, per current ASCO-CAP (American Society of Clinical Oncology College of American Pathologists) guidelines. Central confirmation of HER2 status is not required Participants must have received prior therapy with the following agents in any combination, and in setting (i.e., neoadjuvant, adjuvant, metastatic, etc.). These therapies do not need to be the most recent line of therapy Trastuzumab Pertuzumab Ado-trastuzumab emtansine (T-DM1) Participants must agree to undergo a research biopsy of a reasonably accessible metastatic lesion (chest wall, skin, subcutaneous tissue, lymph nodes, skin, breast, bones, lung, and liver metastases). If a reasonably accessible metastatic lesion is not available, the patient may go on study provided that archived tissue is available. However, if a reasonably accessible site is available for biopsy, the patient must agree to biopsy. Any patients not undergoing biopsy must be approved for study enrollment by the Overall Principal Investigator at DFCI. Biopsies may be done with local anesthesia or intravenous conscious sedation, according to institutional guidelines. If a biopsy requires general anesthesia, then it is only allowed if acquisition of tissue is clinically indicated, and excess tissue may be collected for research purposes. Patients without sites available for biopsy must have available tissue [archived formalin-fixed paraffin embedded blocks (FFPB), blocks from which slides can be created, or fresh frozen tissue from original diagnosis or metastatic setting] for correlative studies. Tissue needs to be located and available at the time of registration See Section 9.3 for more details Women ≥ 18 years of age. Men are not eligible Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (see Appendix A) Participants who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to neratinib or fulvestrant Participants who have known hypersensitivity to any component of loperamide or colestipol Participants who have received previous therapy with neratinib Participants who have received anti-cancer therapy (including chemotherapy, biological therapy, investigational agents, hormonal therapy, or other anti-cancer therapy) or radiotherapy within ≤14 days prior to the planned initiation of investigational products, or those who have not recovered to grade ≤1from adverse events due to their most recent therapy (excepting alopecia) Participants who have had any major surgery ≤28 days prior to the planned initiation of study therapy, or those who have not recovered from adverse events due to agents/surgery administered more than 4 weeks earlier Participants who are receiving any other investigational agents Participants with known brain metastases that are untreated, symptomatic, or require therapy to control symptoms. Participants with a history of treated central nervous system (CNS) metastases are eligible. Treated brain metastases are defined as those without ongoing requirement for corticosteroids, as ascertained by clinical examination and/or brain imaging (magnetic resonance imaging or CT scan) completed during screening. Any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for ≥ 7 days prior to registration. Treatment for brain metastases may whole brain radiotherapy, radiosurgery, surgery or a combination as deemed appropriate by the treating physician. Radiation therapy must be completed at least 14 days prior to registration Participant has active, uncontrolled cardiac disease, including cardiomyopathy, congestive heart failure (New York Heart Association functional classification of ≥2), unstable angina, myocardial infarction within 12 months of enrollment, or ventricular arrhythmia Participant has a QTc interval >470 ms or known history of QTc prolongation or Torsade de Pointes Participant has an active infection or unexplained fever >38.5°C (101.3°F)
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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): 18.0-74.0, Breast Cancer Triple Negative Breast Cancer Subjects must have histologically or cytologically confirmed invasive breast cancer which meets the following 1. Estrogen Receptor (ER) and Progesterone Receptor (PR)-negative as defined by local standard clinical immunohistochemistry (IHC) < 1%. 2. HER2-negative using local standard testing. Negative is defined as IHC 0 or 1+ (if 2+, must reflex to ISH method). If ISH method is used, ratio < 2 is considered negative. 3. Clinical tumor size of at least 2.1 cm (T2) by palpation or imaging, regardless of the ipsilateral regional lymph node status, or any tumor size but with ipsilateral regional lymph nodes involved by the tumor (any T if ipsilateral regional node positive). Subjects with inflammatory breast cancer are eligible. If bilateral breast cancer is present, the subject is eligible if the contralateral tumor is DCIS only (without any invasive disease on biopsy) or another invasive breast cancer of any size that is also ER, PR and HER2 negative. 4. Any radiographic abnormal ipsilateral regional lymph nodes or any clinically concerning ipsilateral regional lymph nodes with the exception of internal mammary nodes should be sampled with percutaneous biopsy, but no sentinel axillary lymph node mapping/biopsy is allowed before chemotherapy. If clinically node negative (cNO), pre-chemotherapy ipsilateral sentinel axillary lymph node mapping/biopsy is not allowed. 2. Candidate for neoadjuvant chemotherapy. 3. Age > 18 years and < 75 years 4. ECOG Performance Status < 1. 5. Left ventricular ejection fraction (LVEF) ≥ LLN (per institutional normal) determined by 6. Adequate organ and marrow function as determined by study protocol 7. Non Pregnant. Women of childbearing potential must have a negative pregnancy test (HCG serum or urine) within 30 days prior to study registration and to be repeated if not done within 7 days of starting chemotherapy. 1. Female subjects must meet one of the following Natural postmenopausal before the screening visit defined as no menses at any time in the preceding 12 consecutive months, or Prior bilateral oophorectomy or bilateral tubal ligation, or If they are of childbearing potential, agree to practice two effective methods of contraception per discussion with the treating physicians from 2. Male subjects, even if surgically sterilized (i.e., status post vasectomy) must agree to one of the following Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose, or Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.) 8. Ability to understand a written informed consent document, and the willingness to sign it Prior chemotherapy or radiation therapy for invasive breast cancer within 6 months before registration. 2. Prior investigational drugs or interventions for invasive breast cancer within 6 months before registration are not allowed. Prior participation in window-of-opportunity trials without therapeutic intent is allowed if intervention is no more than 3 weeks duration. 3. Stage IV metastatic breast cancer 4. History of allergic reactions attributed to compounds of similar chemical composition to chemotherapy to be used in this study. 5. Breastfeeding women. Cytotoxic chemotherapy is drug with the potential for teratogenic or abortifacient effects. Due to unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cytotoxic chemotherapy, breastfeeding should be discontinued. 6. Baseline peripheral neuropathy of severity > grade 1 7. Other invasive cancer diagnosis within the past 5 years other than non-melanoma skin cancer. 8. Prior axillary lymph node dissection that preclude patient from surgical evaluation of axillary lymph node status
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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, Pancreatic Neoplasms a solid pancreatic lesion with diameter larger than 20mm, with or without a cystic component, with unknown histology age above 18 years old signed informed consent a solid pancreatic mass with a diameter less than 20mm or with known histology a cystic pancreatic mass, without a solid component coagulation disorder (international normalized ratio above 1.5, activated partial thromboplastin time above 42 seconds, platelet count less than 60000/mmc) or impossibility to stop antiaggregants or anticoagulants according to the European Society of Digestive Endoscopy guidelines European Cooperative Oncology Group status 4 American Society of Anesthesiology score higher than 3 pregnant women age under 18 years old refusal or impossibility to sign informed consent
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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 Atypical Ductal Hyperplasia Breast Atypical Lobular Hyperplasia Breast Ductal Carcinoma In Situ Breast Lobular Carcinoma In Situ Invasive Breast Carcinoma Participants must be at high risk as defined by a history of breast cancer (invasive or ductal breast carcinoma in situ [DCIS]) and be at least 5 years out from diagnosis, or lobular carcinoma in situ (LCIS), or proliferative benign breast disease such atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH) or genetic test confirmation of BRCA 1/2 mutation carrier or have a breast cancer risk assessment >= 1.7% in 5 years or a lifetime risk >= 20% No evidence of disease (in situ or invasive cancer that would normally be treated by resection) at trial entry as determined by the investigator; diagnosis of invasive cancer must be at least 5 years prior to initiation on trial Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) Leukocytes >= 3,000/microliter Absolute neutrophil count >= 1,500/microliter Platelets >= 100,000/microliter Total bilirubin within normal institutional limits Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional upper limit of normal (ULN) Creatinine =< 1.5 x institutional ULN Hemoglobin >= 10 g/dL History of allergic reactions attributed to compounds of similar chemical or biologic composition to bexarotene gel, oral or topical retinoids Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, thromboembolic disease, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant, or had given birth, or nursed at any time during the last 12 months Women with a history of any cancer within the last 3 years, except for non-melanoma skin cancer; history of breast cancer must be at least > 5 years from diagnosis Prior bilateral breast surgery (mastectomy, segmental mastectomy, or breast augmentation surgery including breast implants or breast reductions) or combination of breast radiation and surgery involving both breasts Prior history or evidence of metastatic breast cancer Prior history of histologically confirmed bilateral invasive breast cancer Current use or < 6 months since use of selective estrogen receptor modulator (SERMS) or aromatase inhibitors or any other investigational treatment for breast cancer prevention or therapy Skin lesions that disrupt the stratum corneum (e.g., eczema, ulceration) or any breakdown of the skin Current use of a retinol containing agent or any retinoid analogue drug within the last 30 days
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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): 40.0-69.0, Endometrial Cancer Postmenopausal Bleeding postmenopausal woman referrals for the symptom of PMB dementia mental retardation
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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 Invasive Breast Carcinoma Stage 0 Breast Cancer Stage I Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Histologically confirmed invasive carcinoma and/or ductal carcinoma in situ (DCIS) of the breast Final pathologic Tis, T1-T3, all must be N0 and M0 status Negative inked histologic margins from lumpectomy, with the exception of a focus of positive margin at the pectoralis fascia Radiation oncologist does not plan to treat regional lymph nodes beyond standard whole breast tangent fields Lumpectomy with negative lymph node on surgical evaluation (Isolated tumor cells in lymph nodes will be permitted). Patients with invasive carcinoma ≥ 70 yrs and with ER+ positive tumor ≤ 2.0cm may enroll without surgical lymph node evaluation, per section 5.1. Patients with Ductal Carcinoma In Situ (DCIS) of the breast only may enroll without surgical lymph node evaluation Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of child-bearing potential =< 7 days prior to registration A female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1 Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines Prior radiation therapy to the chest, neck or axilla Prior history of ipsilateral breast cancer (invasive disease or DCIS); lobular carcinoma in situ (LCIS) and benign breast disease is allowed History of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowed Active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis Significant post lumpectomy complications requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation or nodal evaluation is acceptable Co-existing medical conditions with life expectancy < 5 years 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 Neoadjuvant chemotherapy or adjuvant chemotherapy delivered before radiation Neuroendocrine carcinoma or sarcoma histology Concurrent radiation sensitizing medications concurrent with radiation, per treatment physician
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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 Female sex Age 35 years or older Any ethnicity Have an abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE), or have an abnormality detected by an imaging modality. Will undergo study imaging within four weeks from the date of diagnostic mammography, prior to breast biopsy (if needed). Able to provide informed consent Post-menopausal, surgically sterile, or effective birth control. For women of childbearing potential, negative pregnancy test or has signed pregnancy test waiver If required by standard of care, eGFR >45 within 48 hours to 6 weeks of CE-CBBCT exam Pregnancy Lactation Unknown pregnancy status AND has refused pregnancy testing and has refused to sign a pregnancy test waiver Women who are unable or unwilling to understand or to provide informed consent Women 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. Women who are unable to tolerate study constraints. Women who have received radiation treatments to the thorax or breast area 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 Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram. Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to): Tuberculosis Severe scoliosis Additional Due To Contrast Injection: Allergic to iodinated contrast material Previous non-ionic contrast reaction Any conditions below regardless of eGFR Renal Disease Chronic renal dysfunction Renal Transplant (or waiting for a transplant) One kidney or other birth defect Polycystic Kidneys Renal Tumor/Renal Cancer History of liver failure/cirrhosis/liver transplant/pending liver transplant Congestive heart failure Multiple myeloma Hyperthyroidism Pheochromocytoma Sickle Cell Disease Asthma requiring daily use of inhaler Additional due to machine limitations Patient's body weight is over the limit of the scanner table (440 lbs or 200kg)
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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 Cancer invasive ductal carcinoma diagnosed by biopsy clinically positive node diagnosed by contrast enhance computer tomography (CECT), the number of strengthened nodes at Level I ≥ 1 with the longest diameter of the strengthened node ≥ 2cm NAC regimen followed the NCCN guideline no prior history of breast cancer or other malignancies the cycle number of neo-adjuvant chemotherapy is equal to or less than 2
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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): 0.0-70.0, Invasive Breast Cancer Invasive breast cancer diagnosed with core needle needle biopsy Staging cT1b-2N0M0 ER/PR positive cells ratio <10%, or HER2 positive (according to ASCO-CAP guidelines),and with chemotherapy indications Without chemotherapy contraindications, and planned or has started neoadjuvant chemotherapy (HER2 positive breast cancer neoadjuvant anti-HER2 treatment, or have adjuvant anti-HER2 treatment plan) With axillary sentinel lymph node biopsy indications confirmed prior to neoadjuvant therapy Voluntarily join the study and sign an informed consent form History of malignant tumors With chemotherapy contraindications Recieved any form of surgery of primary tumor or axillary lymph nodes Refuse neoadjuvant chemotherapy Refuse assessment examinations Refuse to join 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): 18.0-65.0, Breast Neoplasms Women Age 18-65 Diagnosed with breast cancer, undergoing breast surgery Functional independence prior to the operation Ability to communicate in Hebrew Cognitive disorders, patients unable to sign the consent form Back and spinal morbidity Fibromyalgia or chronic pain disorders Neurological disorders Renal failure with the need for dialysis Lymphedema prior to surgery History of breast surgery Shoulder surgery or shoulder injuries with limited ROM Ischemic heart disease, heart failure and radical heart insufficiency Radical mastectomy, LD and DEIP reconstruction, exchange breast prosthesis
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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): 0.0-100.0, Breast Cancer Female. 2. Operated for centimeter or subcentimeter breast cancer Previous breast cancer. 2. Metastatic breast cancer at diagnosis
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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-negative Breast Cancer PRIOR TO Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy. The primary breast tumor must be palpable and measure greater than or equal 2.0 cm on physical exam. The regional lymph nodes can be cN0, cN1, or cN2a. Histological grade II or III tumor. Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound, and/or MRI) within 6 weeks prior to initiating chemotherapy. If suspicious or abnormal, FNA or core biopsy is recommended, also within 6 weeks prior to initiating chemotherapy. Findings of these evaluations will be used to determine the nodal status prior to initiating chemotherapy Nodal status negative: Imaging of the axilla is negative; Imaging is suspicious or abnormal but the FNA or core biopsy of the questionable node(s) on imaging is negative Nodal status positive: FNA or core biopsy of the node(s) is cytologically or histologically suspicious or positive. Imaging is suspicious or abnormal but FNA or core biopsy was not performed. Tumor specimen obtained at the time of diagnosis must have ER and progesterone receptor (PgR) analysis assessed by current ASCO/CAP Guidelines. Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors. Tumor specimen obtained at the time of diagnosis must have been determined to be HER2-negative as follows Immunohistochemistry (IHC) 0-1+; or IHC 2+ and in situ hybridization (ISH) non-amplified with a ratio of HER2 to chromosome enumeration probe 17 (CEP17) less than 2.0, and if reported, average HER2 gene copy number less than 4 signals/cells; or ISH non-amplified with a ratio of HER2 to CEP17 less than 2.0, and if reported, average HER2 gene copy number less than 4 signals/cells. Blood counts performed within 6 weeks prior to initiating chemotherapy must meet the following absolute neutrophil count (ANC) must be greater than or equal 1200/mm3 platelet count must be greater than or equal 100,000/mm3; and T4 tumors including inflammatory breast cancer. FNA alone to diagnose the breast cancer. Excisional biopsy or lumpectomy performed prior to initiating chemotherapy. Surgical axillary staging procedure prior to initiating chemotherapy. Pre-neoadjuvant therapy sentinel node biopsy is not permitted. (FNA or core biopsy is acceptable.) Definitive clinical or radiologic evidence of metastatic disease. Required imaging studies must have been performed within 6 weeks prior to initiating chemotherapy. Synchronous bilateral invasive breast cancer. (Patients with synchronous and/or previous contralateral ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] are eligible.) Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.) Previous therapy with anthracycline, taxanes, trastuzumab, or other HER2 targeted therapies for any malignancy. Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. (These patients are eligible if this therapy is discontinued prior to initiating chemotherapy.) 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 2 years prior to initiating chemotherapy. Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function; history of documented congestive heart failure (CHF); and documented cardiomyopathy. Uncontrolled hypertension defined as sustained systolic BP greater than 150 mmHg or diastolic BP greater than 90 mmHg. (Patients with initial BP elevations are eligible prior to initiating chemotherapy if initiation or adjustment of BP medication lowers pressure.) Active hepatitis B or hepatitis C with abnormal liver function tests. Intrinsic lung disease resulting in dyspnea. Poorly controlled diabetes mellitus. Active infection or chronic infection requiring chronic suppressive antibiotics. Patients known to be HIV positive. Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) greater than or equal to grade 2, per the CTCAE v4.0. Malabsorption syndrome, ulcerative colitis, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal function. Other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or would prevent required follow-up. Conditions that would prohibit administration of corticosteroids. Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids). Known hypersensitivity to any of the study drugs or any of the ingredients or excipients of these drugs (e.g., Cremophor EL), including sensitivity to benzyl alcohol. Pregnancy or lactation at the initiation of chemotherapy. (Note: Pregnancy testing must be performed within 2 weeks prior to initiating chemotherapy according to institutional standards for women of childbearing potential.) 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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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): 18.0-85.0, Pain, Postoperative elective primary total knee arthroplasty ASA I-III written consent rearthroplasty ASA IV-V inadequate spoken finnish for reliable pain assessment Dementia or otherwise impaired cognition contraindication for any medication or substance used in survey protocol weight <50kg or BMI ≥35 kg/m2 preoperative SpO2 less than 93% clinical suspicion that subject can not use PCA adequately history of substance abuse or current excessive use of alcohol preoperative use of either pregabalin, gabapentin or strong opiates
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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 Adult female patients with breast cancer Presence of another cancer, excluding basal cell cancers or pre-neoplastic lesions of the cervix Subject under guardianship or subject deprived of liberty Impossibility of collecting information on exposure (subjects recently arrived in France, foreign language, etc.) Male patients
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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): 18.0-75.0, Breast Cancer Neoadjuvant Therapy Neoplasm Staging Estrogen Receptor Histological Grade HER2 Prognosis Predictive Value of Tests A patient will be eligible for in this study if he or she meets all of the following 1. Has operable, histologically confirmed, Stage I, IIA, IIB, IIIA, IIIB or IIIC invasive carcinoma of the breast. 2. Has had neoadjuvant chemotherapy before operation for this breast cancer. 3. Age >=18 to <=75 years old. 4. Has known ER and PR status. 5. Has known HER-2 status. 6. Has known menopausal status. 7. Before PST, Lymph nodes were evaluated by fine needle biopsy (FNB) if the clinically positive, or by sentinel lymph nodes biopsy (SLNB) if the clinically or FNB negative. 8. Has complete surgical resection of the primary breast tumor after PST: either lumpectomy or mastectomy with sentinel lymph node biopsy or axillary dissection, with clear margins for both invasive and ductal carcinoma in situ (DCIS). 9. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. 10. Has laboratory values of White blood cell count >3000/mm3 Absolute neutrophil count (ANC) ≥1500/mm3 Hemoglobin ≥9.0 g/dL Total bilirubin <ULN Serum creatinine ≤1.5 mg/dL Platelet count ≥100,000/mm3 ULN = upper limit of normal 11. Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase (ALP) within any of the ranges shown below ALP ≤ upper limits of normal(ULN),and AST or ALT ≤ 5 ULN ULN < ALP ≤2.5 ULN, and AST or ALT ≤ 1.5 ULN A patient will be excluded from this study if she meets any of the following 1. Has bilateral synchronous breast cancer. 2. Has any evidence of metastatic disease: staging work-up, biopsy or physical examination suspicious for malignant disease. 3. Has a history of severe hypersensitivity reaction to chemotherapy drugs or formulation. 4. Has a history of heart failure, uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or electrocardiographic evidence of acute ischemic changes. 5. Has peripheral neuropathy >Grade 1. 6. Has had a major organ allograft or condition requiring chronic immunosuppression (ie, kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases). Patients who have received corneal transplants or cadaver skin or bone transplants are eligible. 7. Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious viral [including clinically defined acquired immune deficiency syndrome (AIDS)], bacterial or fungal infection; or history of uncontrolled seizures, or diabetes, or central nervous system (CNS) disorders deemed by the Treating Physician to be clinically significant, precluding informed consent. 8. Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be human immunodeficiency virus (HIV) positive. 9. Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin, carcinoma in situ of uterine cervix, DCIS), which could affect the diagnosis or assessment of any of the study drugs. 10. Is deemed unable to comply with requirements of 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 Neoplasms Gastric Cancer Colon Cancer All consecutive patients undergoing therapeutic surgery (curative or palliative) for breast, gastric, and colorectal cancer should be included Surgery is defined as a procedure requiring a skin incision performed under general or neuraxial (e.g. regional, epidural or spinal) anaesthesia Both elective and emergency procedures should be included. patients in whom the pre-operative diagnosis was thought to be benign, but was subsequently found to be cancer, e.g. bowel obstruction found to be due to cancer during surgery patients in whom the pre-operative diagnosis was thought to be cancer, but was subsequently found to be benign disease (ensure the "pathology" variable indicates not cancer; will not be included in primary analysis) Laparoscopic, laparoscopic-converted, robotic, and open cases should be included Patients aged 18 years and over should be included Surgery may be with curative or palliative intent. patients in whom curative surgery was attempted but abandoned, e.g. open/close laparotomy Operations where breast, gastric, or colorectal cancer is not suspected to be the primary pathology should be excluded Patients undergoing a procedure purely for diagnosis or staging should be excluded, e.g. open breast biopsy, staging laparoscopy Patients undergoing a procedure which does not require a skin incision should be excluded, e.g. colonoscopy/endoscopy alone, chemo/radiotherapy alone Patients presenting with recurrence of breast, colorectal or gastric cancer should be excluded
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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): 19.0-80.0, Breast Cancer All patients enrolled before initiation of any treatment Any other malignant or benign tumors Active inflammatory or autoimmune diseases Renal or liver diseases
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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, Early Breast Cancer Germline BRCA 1/2 Mutation Positive Women and men at least 18 years of age or older Histologically confirmed invasive adenocarcinoma of the breast HER2 negative breast cancer as defined by ASCO-CAP Tumor greater than or equal toT1, N0-3 No evidence of distant metastasis Adequate bone marrow, hepatic, and renal function ECOG performance status 0 or 1 Any other previous antitumor therapies for the current cancer event. Treatment for ductal carcinoma in situ (DCIS) is allowed; ie, surgery, hormonal therapy and radiation Evidence of distant metastasis apparent prior to randomization Patients with inflammatory breast carcinoma Malignancy within the last 3 years, except: Stage 1 melanoma which does not require any further treatment after adequate surgical excision; adequately treated non melanoma skin cancer; Curatively treated in situ cancer of the cervix; Stage 1, Grade 1 endometrial carcinoma; or Adequately treated contralateral breast carcinoma which has been disease free for a year; Other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for 5 years Previous or concomitant systemic anti cancer therapies used for the treatment of cancer in the last 3 years Prior treatment with a PARP inhibitor in any disease setting Concomitant use of Strong P gp inhibitors or inducers or BCRP inhibitors Patients who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol Major surgery within 14 days prior to study entry Known history of cardiac disease, for example : Myocardial infarction or symptomatic cardiac ischemia within 24 weeks before screening; Congestive heart failure New York Heart Association Class III or IV; History of clinically significant ventricular arrhythmias within one year prior to randomization; History of Mobitz II second degree or third degree heart block, uncontrolled hypertension
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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 Written informed consent and any locally required authorization (e.g., EU Data Privacy Directive in the EU) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations 2. Age ≥18 years at time of study entry 3. Histologically confirmed MIUC (also termed TCC) of the bladder. Patients with mixed histologies are required to have a dominant transitional cell pattern (urothelial carcinoma must be > 50%) 4. Localized MIUC of the bladder with clinical stage T2-T4a and ≤N1 disease ( the single lymph node must be < 15 mm (short axis) on imaging 5. Patients with urothelial carcinoma of the prostatic urethra 6. Bodyweight >45kg 7. Patients eligible for cisplatin-based neoadjuvant chemotherapy, including Creatinine clearance (CL) >60 mL/min based on the Modification of Diet in Renal Disease Study (MDRD) formula Cardiac left ventricular ejection fraction (LVEF) ≥50% 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 9. Absence of metastasis, as confirmed by a negative baseline CT or MRI scan of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization. Patients with clinical stage N1 disease are eligible if the single lymph node measures ≤2 cm in greatest dimension. 10. Adequate organ and marrow function as defined below (obtained within 14 days prior to the first study treatment) Hemoglobin ≥10.0 g/dL (patients may be transfused to meet this criterion) Absolute neutrophil count (ANC) ≥1500 cells/μL (without G-CSF support within 2 weeks prior to Cycle 1, Day 1) WBC counts >2500/µL Platelet count ≥100,000/µL (without transfusion within 2 weeks prior to Cycle 1, Day 1) Serum bilirubin ≤1.0 x institutional upper limit of normal (ULN). Patients with known Gilbert disease who have serum bilirubin level ≤3 x ULN may be enrolled AST, ALT, and alkaline dehydrogenase ≤2.5 x ULN Partial thromboplastin time/prothrombin time (PTT/PT) ≤1.5 x ULN or international normalized ratio (INR) <1.7 x ULN 11. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply Urothelial carcinoma of the upper tract 2. Any approved anti-cancer therapy for urothelial carcinoma, including chemotherapy, or immunotherapy prior to initiation of study treatment. Of note, previous intravesical BCG injections are allowed if administered for non-muscle invasive urothelial carcinoma 3. Primary chemoradiation for bladder preservation for urothelial carcinoma of the bladder 4. Impaired renal function (glomerular filtration rate [GFR]<60 mL/min); GFR should be assessed by calculation from serum/plasma creatinine (MDRD formula) 5. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent 6. Grade 2 or greater hearing loss that contraindicates cisplatin use. Threshold shift of >25 decibel averaged at 2 contiguous test frequencies in least one ear. 7. Grade 2 or greater peripheral neuropathy 8. Oral anticoagulation treatment (vitamin K antagonist should be replaced by low-molecular-weight heparin). 9. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug 10. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study 11. Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable 12. Major surgical procedure (as defined by the Investigator) other than for diagnosis within 28 days prior to Cycle 1 13. History of prior organ transplantation, including stem cell allografting 14. History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and type I diabetes mellitus on stable dose of insulin may be eligible for this study 15. All micropapillary and plasmacytic forms, with or without squamous cell adenocarcinoma 16. Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia 17. Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1 18. Receipt of therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1 19. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina 20. History of another primary malignancy within 3 years prior to Cycle 1, Day 1, except for: Localized low-risk prostate cancer (defined as Stage ≤T2b, Gleason score ≤7, and prostate-specific antigen [PSA] at prostate cancer diagnosis ≤20 ng/mL [if measured]) treated with curative intent and without PSA recurrence Low-risk prostate cancer (defined as Stage T1/T2a, Gleason score <7, and PSA ≤10 ng/mL) who are treatment-naive and undergoing active surveillance Patients with malignancies of a risk of metastasis/death (e.g., risk of metastasis or death <5% at 5 years) are eligible after investigator's approval if they meet both of the following Malignancy treated with expected curative intent, and no evidence of recurrence or metastasis by follow-up imaging and any disease-specific tumor markers 21. History of leptomeningeal carcinomatosis 22. History of idiopathic pulmonary fibrosis, organizing pneumonia 23. Serum albumin <25 g/L 24. LVEF <50% 25. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms (ECGs) within 15 minutes at 5 minutes apart 26. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if PCR is negative for HCV RNA 27. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 28. Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and for up to 30 days after the last dose of study treatment 29. Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy 30. Known allergy or hypersensitivity to chimeric or humanized antibodies or fusion proteins, or to any of the study drugs or study drug excipients 31. Prior randomisation or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of treatment arm assignment 32. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the Investigator, makes the patient unsuitable for participation in the study Procedures for withdrawal of incorrectly enrolled patients are presented in Section 4.3 If a patient withdraws from participation in the study, then his or her enrollment/randomization code cannot be reused. Withdrawn patients will not be replaced
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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): 60.0-999.0, Breast Cancer Participants must have histologically or cytologically confirmed HER2-positive disease by local pathology, defined as immunohistochemistry (IHC) 3+ or amplification by FISH (HER2/CEP17 ratio ≥2 or an average of ≥6 HER2 gene copies per nucleus) AND confirmed by Central Pathology Review (Dr. Deborah Dillon at Brigham and Women's Hospital, Boston, MA) prior to patient being registered to begin protocol therapy. See section 3.4. http://ascopubs.org/doi/full/10.1200/jco.2013.50.9984 NOTE: DCIS components should not be counted in the determination of HER2 status Age ≥60 years at the time of study registration (men and women eligible) Participants must have histologically or cytologically confirmed Stage I-III breast cancer with the following met If node-negative or if node status unknown (because it was not assessed), tumor must be >5 mm of any hormone receptor subtype (document ER/PR status: if some ER/PR staining is present, ER and PR negative are defined as being positive in <10% cells [per local pathology read]) If node-positive (N1-N3), T1mi, T1a, T1b, T1c, T2, or T3 tumors are eligible (see below for further details on defining node-negative disease) Definition of node-negative disease (when node status known): If the patient has had a negative sentinel node biopsy and/or a negative axillary dissection, then the patient is determined to be node-negative. Axillary nodes with single cells or tumor clusters ≤ 0.2 mm by either H&E or IHC will be considered node-negative. Any axillary lymph node with tumor clusters between 0.02 and 0.2cm is considered a micrometastasis. Patients with a micrometastasis are eligible even if their tumor is </= 5mm. An axillary dissection is not required to be performed in patients with a positive sentinel node and management of the axilla will be left up to the treating provider. In cases where the specific pathologic size of lymph node involvement is subject to interpretation, the principal investigator will make the final determination as to eligibility. In these special situations, the investigator must document this approval in the patient medical record ER/PR determination assays performed by IHC methods according to the local institution standard protocol Standard chemotherapy/trastuzumab declined by patient OR patient is deemed by physician for any reason to not be a candidate for standard therapy (i.e. patient and/or provider choose not to pursue standard trastuzumab-based chemotherapy regimen because of concerns related to toxicity or provider/patient preference) For patients with bilateral or multifocal/multicentric breast cancers, one of the following must be met to enroll: (1) each cancer individually meets for enrollment (only ONE tumor has to undergo central confirmation for HER2), (2) at least one tumor meets (per tumor size/nodes/subtype outlined above) and the other foci in the ipsilateral or contralateral breast are also HER2-positive but are too small for enrollment (e.g., a patient is eligible if a cancer is T2N0 and HER2-positive in one breast, but the contralateral breast has a T1a HER2+ cancer that isn't eligible on its own, (3) there is at least one qualifying tumor of >5mm but there are other small foci of disease that are too small to test for ER/PR/HER2 and are felt to be a part of the same tumor or similar tumor, OR (4) at least one tumor meets and the other foci in the ipsilateral or contralateral breast are HER2-negative and do not meet for adjuvant chemotherapy per provider discretion (e.g. if a patient has a HER2-positive tumor meeting but also has a second, HER2-negative, small, node-negative, ER+, low grade cancer present, she is still eligible for enrollment). However, in the specific case that a second breast cancer is stage III and HER2-negative, that patient is excluded (because the second cancer is high-risk and likely will require non-HER2-directed therapy) All tumor removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy) Evidence of metastatic disease Patients will not require baseline staging PET or CT chest, abdomen, pelvis or bone scan to rule out metastatic disease prior to enrollment. Any staging scans will be ordered at the treating provider's discretion. If metastatic disease is found on any staging studies done, patients will not be eligible for enrollment Locally advanced tumors at diagnosis (T4), including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes (diffuse brawny cutaneous induration with an erysipeloid) Patients with stage III, HER2-negative cancer in the contralateral breast (see 3.1.6 above) Positive Hepatitis B (Hepatitis B surface antigen and antibody) and/or Hepatitis C (Hepatitis C antibody test) as indicated by serologies conducted ≤3 months prior to registration if liver function tests are outside of the normal institutional range. NOTE: A hepatitis panel is required of all participants as part of screening. Patients with positive Hepatitis B or C serologies indicating active infection without known active disease must meet the requirements for ALT, AST, total bilirubin, INR, PTT, and alkaline phosphatase on at least two consecutive occasions, separated by at least 1 week. Patients with laboratory evidence of vaccination to Hepatitis B (e.g., positive antibodies) are eligible Active liver disease, for example, due to autoimmune hepatic disorder, or sclerosing cholangitis Significant, active cardiopulmonary dysfunction (i.e. uncontrolled heart issues)as indicated by MUGA or echocardiogram performed ≤60 days prior to registration and/or by presence of any of the following History of NCI CTCAE (Version 4.0) Grade ≥3 symptomatic congestive heart failure (CHF) or NYHA Class ≥ II Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia [ventricular tachycardia], or higher-grade atrioventricular [AV]-block [second degree AV-block Type 2 [Mobitz 2] or third degree AV-block]); if adequately and safely treated, patient may be eligible
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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): 0.167-5.0, Child Pneumonia Children between the ages of 2 to 59 months who is presenting with at least one of the following in the last 72 hours patient reported symptoms (cough, coryza, reported fast breathing) AND WHO (FAST (≥50 /min age if 2-12months, ≥40/min if age 1-5years) AND/OR CHEST and SIGNS (unable to drink, persistent vomiting, convulsions, lethargic or unconscious, stridor in a calm child, severe malnutrition) AND/ OR AND/OR Oxygen saturation < 96% OR CXR/CT pneumonia OR MD diagnosed pneumonia ● Patients admitted for non-respiratory symptoms may be included in the absence of (this group will only be considered for the study if interim analysis reveals low recruitment of patients with a normal lung POCUS appearance) patients that previously underwent lung POCUS by the same lung POCUS operator during the same visit to AKUH chest tube insertion or video-assisted thoracoscopic surgery (VATS) during the current visit to AKUH (since the equipment in situ and/or dressing might bias POCUS interpretation) inability to understand informed consent
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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 Carcinoma Fallopian Tube Carcinoma Ovarian Carcinoma Primary Peritoneal Carcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Solid Neoplasm History of known or suspected solid tumor At least one lesion >= 1.0 cm that is seen on standard imaging (e.g. computed tomography [CT], magnetic resonance imaging [MRI], ultrasound, fludeoxyglucose [FDG] PET/CT) Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential < 2 weeks prior to screening as standard of care Inability to tolerate imaging procedures in the opinion of an investigator or treating physician Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in 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): 20.0-999.0, Salivary Duct Carcinoma Histologically-confirmed HER2 positive (immunohistochemistry [IHC] 3+, and/or fluorescence in situ hybridization[FISH] positive with ≥ two-fold amplification) salivary duct carcinoma(SDC), and other salivary gland carcinomas which are similar to SDC in histopathological findings, including adenocarcinoma, not otherwise specified, acinic cell carcinoma, squamous cell carcinoma, anaplastic carcinoma, high grade mucoepidermoid carcinoma, and carcinoma ex pleomorphic adenoma stage IV or recurrent cancer age ≥ 20 years ECOG performance status 0-2 At least one measurable tumor lesion according to 1.1 Expected survival for approximately 12 weeks or longer No prior systemic chemotherapy At least 4 weeks later after surgery or radiotherapy Written informed consent Severe or unstable cardiac disease, including (for example) coronary artery disease requiring increased doses of anti-anginal medication and/or coronary angioplasty (including stent placement) within the preceding 24 months(congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias) Uncontrolled systemic illness such as DM, hypertension, hypothyroidism and infection Pregnant and nursing women (women of reproductive potential have to agree to use an effective contraceptive method) Current, known CNS malignancy (history of completely resected or irradiated brain metastases by WBRT or stereotactic radiosurgery allowed) Patients with alcohol abuse
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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 Radiation Toxicity Tumor characteristics Histologically confirmed invasive adenocarcinoma of the breast Tumors must be ≤ 3 cm. Gross disease must be unifocal. Negative lymph nodes Hormone receptor status: Estrogen receptor (ER) status known Progesterone status known if ER analysis is negative Marginal or borderline results are considered positive Surgery Tumor removed with conservative breast surgery with adequate margin Re-excision of surgical margins allowed No prior breast implants Prior axillary staging required for patients including 1 of the following Sentinel node biopsy alone (if sentinel node is negative) Sentinel node biopsy followed by axillary dissection if sentinel node is positive) Multicentric carcinoma in more than 1 quadrant or separated by ≥ 4 cm Non-epithelial breast malignancies (e.g., sarcoma or lymphoma) Positive axillary nodes 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 Suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless biopsied and found to be benign Paget's disease of the nipple Previous history of invasive breast cancer or DCIS Synchronous bilateral invasive or non-invasive breast cancer Collagen vascular disease (e.g., systemic lupus erythematosus or scleroderma), specifically dermatomyositis with a CPK level above normal, or active skin rash Psychiatric or addictive disorder that would preclude study therapy
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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 All Cohorts Women age 18 and older Understand and provide informed consent and HIPAA Authorization prior to initiation of any study-specific procedures Cohort A Recent abnormal mammogram followed by a breast biopsy Initial diagnosis of Stage I, II, III or IV invasive breast cancer Cohort B Recent abnormal mammogram followed by a breast biopsy Diagnosed benign breast tumor with high-risk pathology. This would but is not limited to, atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), flat epithelia atypia and phylloides Cohort C Recent abnormal mammogram followed by a breast biopsy Diagnosed benign breast tumor. This would but is not limited to, fibroadenoma, papilloma, fibrocystic changes, and Pseudoangiomatous stromal hyperplasia (PASH) Cohort D: • Normal screening mammogram within the last 6 months All Cohorts Men Unable or unwilling to give written informed consent Cohort A: • History of cancer other than non-melanoma basal or squamous cell skin carcinoma, ductal carcinoma in situ (DCIS) and cervical carcinoma in situ. Cohort B: • History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ. Cohort C: • History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ. Cohort D History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ History of or current autoimmune disease including but not limited to Sjogrens Syndrome, Systemic Sclerosis (SSc), Scleroderma (Scl) and Dermatomyositis, Systemic Lupus Erythematosus, Multiple Sclerosis, Type I Diabetes, Rheumatoid Arthritis History of abnormal 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): 18.0-99.0, Breast Cancer Pathologically proven invasive mammary carcinoma, Invasive ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) of the breast. Medullary, papillary, mucinous (colloid) and tubular histologies are allowed Age>50 Maximum pathologic tumor size <2.0cm if invasive carcinoma or < 2.5cm if pure DCIS Estrogen receptor (ER) positive (>10%) Must be eligible for breast conservation therapy and receive a lumpectomy with pathologic margins of at least 2mm Must be clinically node negative by physical examination. Sentinel node dissection is not required, but if undertaken, the patient must be pathologically node negative Zubrod Performance Status 0-2 Multifocal or multicentric cancer Reception of neoadjuvant chemotherapy Pure invasive lobular histology Surgical margins<2mm Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan Measured maximum PTV of >124cc Lumpectomy cavity within 5mm of body contour
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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, Porocarcinoma Sentinel Lymph Node patients affected to moderate and high risk porocarcinoma, in according to hystophatological findings, submitted to SNLB. 1. Thickness greater than or equal to 5mm 2. mitoses per 10 high-power field greater than or equal to 7 3. Immunohistochemical (IHC) analysis positive for :carcinoembryonic antigen (CEA), cytokeratin (CK) 5,7 and epithelial membrane antigen (EMA). 4. Informed consent obtained for the SNLB procedure
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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 Have histologically confirmed new diagnosis of breast cancer according to biopsy or surgery Patients who are not mentally capable of giving written informed consent Serum samples doesn't qualified Patients who refuse follow-up on their conditions Patients with prior cancer history Patients with a diagnosis of other severe acute or chronic medical may increase the risk associated with study participation or may interfere with the interpretation of the study results and, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study
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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): 0.0-999.0, Breast Cancer Invasive Invasive breast cancer, unifocal T=max 10mm Clinical node negative and clinical M0 Histological grade 1 or 2 Both screening / clinical detected accepted Radical operation = free margins in breast specimen Partial mastectomy and mastectomy accepted Fit to understand Previous breast cancer diagnosis, including carcinoma in situ Previous ipsilateral axillary dissection Non radical operation = no free margins Multifocal cancer Previous treatment for other cancer Unable to understand information (informed consent) Bilateral breast cancer at diagnosis
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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, Outcome of Breast Cancer Patients with invasive ductal carcinoma of the breast Patients who received surgery for primary invasive breast cancer between 2010 and 2015 Patients with metastasis at the diagnostic
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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 Tumor Women requiring image guided pre-operative breast tumor localization Tumors deeper than 6 cm from the skin surface More than one tumor requiring localization Tumors requiring bracketing Tumors requiring Magnetic Resonance Imaging localization Inability to complete survey Pregnancy
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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, Acute Pain Hysteroscopy Patients: will all women of at least 18 years of age, planned for an office hysteroscopy. Staff: will the clinician performing the outpatient hysteroscopy and the nurse supporting the clinic Patients Hearing impairments and blindness Any known anatomical characteristics that may make performing the office procedure more difficult (e.g., cervical conization, Manchester Fothergill) The denial or withdrawal of oral informed consent Staff: The denial or withdrawal of informed consent
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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): 20.0-60.0, Breast Fibroadenoma complain from non-cyclic mastalgia aged from 20 to 60 with VAS > 4 cyclical mastalgia extra-mammary mastalgia patients refusal suspicion of malignancy acute inflammatory breast conditions presence of polycystic ovarian diseases or cervical hyperplasia pregnant patients and patients during lactation period coagulopathy disorder sepsis at the side of injection history of thromboembolic 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): 18.0-999.0, Breast Cancer Patients must have Stage II or III (according to AJCC cancer staging manual anatomic staging table, 8th edition) histologically confirmed invasive carcinoma of the breast. A minimum tumor size of 1.5 cm determined by physical exam or imaging (whichever is larger) is required. Patients with inflammatory breast carcinoma (T4d) are NOT eligible Tumors must be HER-2 positive, as assessed by standard local institutional protocol (central testing is not required) IHC 3+ FISH positive based on one of the three following Single-probe average HER2 copy number ≥ 6.0 signals/cell; OR Dual-probe HER2/CEP17 ratio <2.0 with an average HER2 copy number ≥ 6.0 signals/cell; OR Dual-probe HER2/CEP17 ratio ≥2.0 ER/PR determination is required. ER and PR-assays should be performed by immunohistochemical methods according to the local institution standard protocol Bilateral breast cancers are allowed as long as both cancers are HER2-positive (as defined in 3.1.2), or the contralateral cancer is a <1 cm, ER+, and HER2- tumor Patients with multifocal or multicentric disease are eligible as long as all tumor foci that were tested for HER2 status at the local institution are HER2-positive, and at least one tumor focus meets criteria Pregnant or nursing women due to the teratogenic potential of the study drugs Active, unresolved infection Receipt of intravenous antibiotics for infection within 7 days prior to registration Uncontrolled hypertension (systolic >180 mm Hg and/or diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) Class II or higher (see Appendix B), or serious cardiac arrhythmia requiring medication Significant symptoms (Grade ≥ 2) from peripheral neuropathy Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes Any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation, or experimental 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): 18.0-65.0, Benign Biliary Stricture Biliary Stricture Cholangitis Bile Duct Stricture Bile Duct Injury Confirmed benign postsurgical biliary stricture by presence of all 3 of the following: Ultrasound imaging or Magnetic resonance cholangiopancreatography (MRCP) showing biliary dilatation, Raised bilirubin and or alkaline phosphatase, History of biliary tree surgery within the previous year Naïve to endoscopic therapy Age > 18 years Coagulopathy Inability of patient to adhere to regular follow-up Living-donor liver transplant patients
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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): 0.0-75.0, Breast Cancer Stage III Ability to understand the study procedures and contents, and willingness to voluntarily sign the written informed consent form; 2. Age≤75 years old, female; 3. Histologically confirmed breast cancer; 4. Histologically or cytologically confirmed ipsilateral supraclavicular lymph node metastasis； 5. cT0-T3； 6. low and moderate risk for anesthesia Absolute and relative contraindication for surgery or radiation； 2. existing distant metastasis before surgery； 3. non-invasive breast cancer； 4. with contralateral breast cancer； 5. Previous history of breast cancer or other malignancies； 6. ECOG≥2； 7. inflammatory breast cancer； 8. pregnancy； 9. any serious complications which caused patients not suitable to participate 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, Breast Cancer Female have aged 18 years old or older have DCIS or Invasive breast cancer that is eligible for breast-conserving surgery have not had previous chest radiotherapy understand the study purpose, requirements, and risks able and willing to give informed consent None
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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 Has a localized invasive breast ductal adenocarcinoma, confirmed by the local pathologist, that includes either T1c-T2 (tumor size ≥2 cm), clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2. Note: Inflammatory breast cancer is allowed Has centrally confirmed ER+/HER2-, Grade 3 breast cancer of ductal histology, according to the most recent American Society of Clinical Oncology/College of American Pathologist guidelines Provides a new or recently obtained core needle biopsy, consisting of multiple cores, taken from the primary breast tumor(s) for central determination of HR status (ER and progesterone receptor), HER2, grade, and PD-L1 status Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to initiation of study treatment Male participants must agree to use contraception during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment and refrain from donating sperm during this period Female participants must agree to use effective contraception during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment with pembrolizumab or placebo Has adequate organ function Has a history of non-infectious pneumonitis that required treatment with steroids or has current pneumonitis Has breast cancer with lobular histology Has bilateral invasive breast cancer Has metastatic (Stage IV) breast cancer Has multi-centric breast cancer (presence of more than 1 tumor in different quadrants of the breast) Has any of the following clinical lymph node staging per current American Joint Committee on Cancer (AJCC) staging for breast cancer staging based on radiological and/or clinical assessment: cN3, cN3a, cN3b, or cN3c Has ER-, progesterone receptor positive breast cancer Has undergone excisional biopsy of the primary tumor and/or axillary lymph nodes or has undergone sentinel lymph node biopsy prior to study treatment Has a known additional, invasive, malignancy that is progressing or required active treatment in the last 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal breast carcinoma in situ, or cervical carcinoma in situ that has undergone potentially curative therapy are not excluded Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study 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 Confirmed diagnosis of HER2-positive breast cancer, and hormonal and PD-L1 status, as documented through central testing of a representative tumor tissue specimen Primary breast tumor size of > 2 cm by any radiographic measurement Stage at presentation: T2-T4, N1-N3, M0 as determined by AJCC staging system, 8th edition Pathologic confirmation of nodal involvement with malignancy must be determined by fine needle aspiration or core-needle biopsy. Surgical excision of lymph nodes is not permitted Patients with multifocal tumors are eligible provided at least one focus is sampled and centrally confirmed as HER2-positive Patients with multicentric tumors are eligible provided all discrete lesions are sampled and centrally confirmed as HER2-positive Eastern Cooperative Oncology Group Performance Status of 0 or 1 Baseline LVEF >= 55% measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans Adequate hematologic and end-organ function obtained within 14 days prior to initiation of study treatment For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs Prior history of invasive breast cancer Stage IV (metastatic) breast cancer Patients with synchronous bilateral invasive breast cancer Prior systemic therapy for treatment of breast cancer Previous therapy with anthracyclines or taxanes for any malignancy Ulcerating or inflammatory breast cancer Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes Sentinel lymph node procedure or axillary lymph node dissection prior to initiation of neoadjuvant therapy History of other malignancy within 5 years prior to screening, with the exception of those patients who have a negligible risk of metastasis or death Cardiopulmonary dysfunction
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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, Gastric Carcinoma Pathologically or cytologically confirmed gastric or residual gastric or gastroesophageal junction carcinoma; 2. Patients received apatinib treatment at least once No specific in this real world 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): 0.0-999.0, Colorectal Medullary Carcinoma colorectal cancer diagnosis, medullary carcinoma none
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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): 60.0-80.0, Vitamin D Deficiency Postmenopausal Caucasian Total plasma 25-hydroxy vitamin D < 50 nmol/L Understand oral and written Danish Able to consent Known allergic reaction/intolerance to Vitamin D supplementation / milk products / juice Known chronic kidney disease (creatinine > 90 µmol/L), previous kidney transplantation or known kidney artery stenosis Known liver disease Known gastrointestinal malabsorption Current malignant disease Hypercalcemia (ionised calcium ≥ 1.33 mmol/L) Treatment with diuretics, lithium or current use of steroids Current use of calcium and/or vitamin D supplementation Planned travel during the intervention period to areas where sun exposure is expected Use of solarium
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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 ER-positive and/or PR-positive breast cancer HER2-negative breast cancer Unresectable locally advanced or metastatic breast cancer Confirmed disease progression while in the last aromatase inhibition-containing regimen in the metastatic setting At least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant setting Patients with no prior line of chemotherapy in the metastatic setting At least 1 and up to 3 prior lines of endocrine therapy in the metastatic setting ECOG score 0 or 1 Patients have adequate bone marrow and organ function Patients must have measurable disease (RECIST v.1.1) Have received radiation therapy or limited-field palliative radiotherapy within two weeks prior to Cycle 1, Day 1, or patients who have not recovered from radiotherapy-related toxicities Have received prior chemotherapy for locally advanced or metastatic disease Have peripheral neuropathy grade 2 or greater QTc > 480 msec on basal assessments, history of congenital or personal history of long QT syndrome, Brugada syndrome, or Torsade de Pointes (TdP), or uncontrolled electrolyte disorders Child-bearing potential women not using highly effective methods of contraception Known hypersensitivity to eribulin, endocrine therapy or its excipients Other malignancies within the previous two years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of cervix or breast Known uncontrolled metastases to the central nervous system (CNS) or any progressing CNS disease Have a serious concomitant systemic disorder incompatible with the study Major surgical procedure or significant traumatic injury within 28 days 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): 18.0-999.0, Triple Negative Breast Cancer Early-stage Breast Cancer HER2-positive Breast Cancer The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and i institutional guidelines for the pre-entry research core biopsy for CELx HSF testing and for initiating chemotherapy Patients must be female Patients must be ≥ 18 years old Patient must have an ECOG performance status of 0 or 1 The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy The primary breast tumor must be palpable and measure ≥ 1.0 cm on physical exam The regional lymph nodes can be cN0 or cN1 The tumor size can be T1c or T2 Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound, and/or MRI) within 6 weeks prior to initiating chemotherapy. If suspicious or abnormal, FNA or core biopsy is recommended, also within 6 weeks prior to initiating chemotherapy. Findings of these evaluations will be used to determine the nodal status prior to initiating chemotherapy Nodal status T3 or T4 tumors including inflammatory breast cancer FNA alone to diagnose the breast cancer Excisional biopsy or lumpectomy performed prior to initiating chemotherapy Surgical axillary staging procedure prior to initiating chemotherapy. Pre neoadjuvant therapy sentinel node biopsy is not permitted. (FNA or core biopsy is acceptable.) Definitive clinical or radiologic evidence of metastatic disease. Required imaging studies must have been performed within 6 weeks prior to initiating chemotherapy Synchronous bilateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.) Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.) Previous therapy with anthracycline, taxanes, trastuzumab, or other HER2 targeted therapies for any malignancy Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. (These patients are eligible if this therapy is discontinued prior to initiating 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): 18.0-80.0, Lymph Node Metastases Phase I: 1. aged from 18 years old to 80 years old; 2. the primary treatment of patients with right or bilateral PTC; 3. patients will voluntarily enter the study after informed consent. Phase II: 1. aged from 18 years old to 80 years old; 2. the primary treatment of patients with right or bilateral PTC predicted to have no LN-prRLN metastasis by the "prediction model of LN-prRLN"; 3. patients will voluntarily enter the study after informed consent patients refused to participate in the study; 2. non first operation patients; 3. other malignant tumor history; 4. distant metastasis; 5. history of neck trauma
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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 patients with a histological diagnosis of breast cancer with known HER2 status ((8 positive and 8 negative). 2. Written informed consent prior to admission in the study. 3. Target lesion diameter of ≥15mm that has not been previously irradiated. 4. Female patients aged ≥ 18 years of age. 5. For all patients: histologically confirmed locally advanced/metastatic breast cancer with a biopsy within the last 12 months confirming HER2 status by either immunohistochemistry (IHC), Silver In Situ Hybridization (SISH) or Fluorescent In Situ Hybridization (FISH). 6. ECOG performance status 0-2 7. Negative urine pregnancy test (within 2 hours prior to injection of imaging agent) in women of child bearing age and willingness to use contraception (barrier, abstinence, non-hormonal) for 3 weeks after injection of [18F]GE-226 8. Life expectancy > 3 months 9. Adequate organ function as defined by Hb≥10g/L WBC≥3.0 x 109/L PLT≥80 x 109/L Serum creatinine ≤1.4mg/dl SGOT and SGPT ≤2 x ULN Total bilirubin ≤ 2 x ULN or 3.0 mg/dl in patients with Gilbert's syndrome 10. Patients must have been appropriately staged using FDG-PET within 42 days of study entry and additional imaging according to local standard of care Pregnant or lactating women. 2. History of cardiac disease (myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis). 3. Evidence of significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial. 4. Participants with severe claustrophobia or who are unable to lie flat or fit into the scanner (≥350 lbs (160 Kg)). 5. Prior use within 14 days of enrolment or concurrent therapy with any other investigational agent. 6. Patients classified as radiation workers 7. Patients on therapeutic doses of anticoagulants, or with a raised prothrombin time
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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): 18.0-80.0, Bile Duct Neoplasms Intraductal Papillary Mucinous Neoplasm Clinical diagnosis of IPNBs ECOG Performance status of 0, 1, or 2 Adequate liver function, bilirubin < 1.5 times ULN, ALT or AST < 2.5 times ULN Adequate renal function: creatinine < 1.8 Must be at least 18 Diagnosis of hepatic mucinous cystadenoma (MCN) Complicated with other Malignancy Pregnancy
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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, Relationship and Consistency Analysis breast cancer in stage I-III, tumor size>0.5cm 2. lymph nodes negative 3. hormone receptor positive （ER+/PR+,ER+/PR-,ER-/PR+） 4. HER2 negative（IHC 0 or +， FISH negative） 5. receive endocrine therapy only 6. enough FFPE samples within 10 years（3~6 10μm ） 7. patients with integrated medical records Tumor cells <5% 2. Isolated RNA<500ng
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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 Biopsy Female subjects ≥ 18 years old with ultrasound visible breast abnormalities (BI-RADS 3*, 4A, 4B, 4C, and 5) referred for ultrasound-guided core needle biopsy or fine needle aspiration *note that while a BI-RADS 3 assessment is probably benign, a subset of patients with this assessment choose to undergo biopsy rather than follow up imaging) Willing and able to provide informed consent Lesions located in the darkly pigmented nipple-areolar complex area Subjects with breast implants Abnormality in the mirror image location of the contralateral breast Additional abnormalities in the same region of the breast that would be included in US-guided DOT imaging of the abnormality undergoing biopsy Previous breast irradiation of the mirror image location of the contralateral breast Lesions located at previous biopsy sites when biopsy occurred within the last six months Small lesions of less than 1 cm located at skin or close to the skin Pregnancy Superficial abnormalities located entirely within (i.e. less than) 5mm of the overlying skin
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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 General (All Patients) 1. Age 18 years of age or older 2. ER Positive Tumours (≥1% positive cells or Allred score ≥ 2 (Appendix 1)) 3. Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer (0-1 by IHC or FISH <2.0) 4. No evidence of metastatic disease on CT, bone scan or other imaging 5. Fit for consideration of chemotherapy as determined by the Investigator 6. Adequate performance status (Eastern Cooperative Oncology Group (ECOG) 0 or 1 (Appendix 2)) Cohort 1 (Postoperative Patients): N= 75 1. Adequate surgical excision of breast tumour (mastectomy or lumpectomy) and lymph nodes (sentinel lymph biopsy or axillary dissection) 2. Any tumour size (T stage (Appendix 3)) 3. Involvement of 1-3 lymph nodes (N1, including micrometastases) Cohort 2 (Preoperative Patients): N= 75 1. Candidates for preoperative therapy for early breast cancer 2. T2-T4 tumours 3. Involvement of at least one lymph node, (including micrometastases) on biopsy 4. Adequate tissue from core biopsy for 21 gene RS testing (approximate minimum 5mm) (All patients): 1. ER negative tumour (Allred score 0-1) 2. HER2 positive tumours as defined by IHC 3+ or FISH ≥ 2.0 3. Node negative disease, including those with Isolated tumour cells only (node negative i+/i-) 4. Known metastatic breast cancer 5. Performance status ≥ 2 6. Patients not considered by their treating physician to be fit to undergo chemotherapy. 7. Men with 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): 18.0-65.0, Lymph Node Dissection Lymph Node Metastases Differentiated Thyroid Carcinoma Accurately diagnosing primary differentiated thyroid carcinoma according to pathological diagnostic Differentiated thyroid carcinoma with cN0(Clinically N0) was diagnosed by thyroid ultrasound text and/or neck CT,and was confirmed with differentiated thyroid carcinoma by postoperative pathological examination The age is more than 18 years old and less than 65 years old. There is no gender restriction Untreated patients who have not received surgery, interventional therapy,chemotherapy, biotherapy, and radiation therapy Physical condition score of Eastern Cooperative Oncology Group（ECOG）: 0-2; no major organ dysfunction; oxygen partial pressure ≥ 10.64 kilopascal（kPa）; white blood cell count≥ 4 × 109/ L; hemoglobin≥ 9.5g/dL; neutrophil absolute count ≥ 1.5 × 109 / L; platelet count ≥ 100× 109 / L; total bilirubin ≤ 1.5 times of the upper limit of normal value;creatinine ≤ 1.25 times of the upper limit of normal value; and creatinine clearance ≥ 60ml / min Be able to obtain complete follow-up information, understand the situation of this study and sign informed consent • ①Bilateral DTC(differentiated thyroid cancer) patients ②Non-DTC(differentiated thyroid cancer)patients ③ Non-cn0(Clinically N0) patients ④ cN0(Clinically N0) patients but could not be operated on Poorly controlled diabetics (fasting blood glucose levels > 200 mg/dL). In addition to four types of malignant tumors that can be treated with radical resection, such as cervical cancer in situ, basal or squamous cell skin cancer, (breast) ductal carcinoma in situ, and organ localized prostate cancer, suffering from any other malignant tumors within 5 years.• Breastfeeding and/or pregnant women Patients with severe bleeding tendencies (prothrombin time less than 50%,cannot be corrected by treatment with vitamin K, etc.) Recent severe hemoptysis, severe cough, dyspnea or patients are not able to cooperate People with severe emphysema, pulmonary congestion, and pulmonary heart disease Researchers believe that the subject may not be able to complete this study or may not be able to comply with the requirements of this study (for management reasons or other 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, Bladder Adenocarcinoma Bladder Clear Cell Adenocarcinoma Bladder Mixed Adenocarcinoma Bladder Neuroendocrine Carcinoma Bladder Small Cell Neuroendocrine Carcinoma Bladder Squamous Cell Carcinoma Bladder Urachal Adenocarcinoma Chromophobe Renal Cell Carcinoma Collecting Duct Carcinoma Infiltrating Bladder Lymphoepithelioma-Like Carcinoma Infiltrating Bladder Urothelial Carcinoma Infiltrating Bladder Urothelial Carcinoma With Giant Cells Infiltrating Bladder Urothelial Carcinoma, Nested Variant Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant Infiltrating Bladder Urothelial Carcinoma, Sarcomatoid Variant Kidney Medullary Carcinoma Large Cell Neuroendocrine Carcinoma Metastatic Bladder Carcinoma Metastatic Bladder Large Cell Neuroendocrine Carcinoma Metastatic Bladder Small Cell Neuroendocrine Carcinoma Metastatic Bladder Squamous Cell Carcinoma Metastatic Infiltrating Bladder Urothelial Carcinoma, Clear Cell Variant Metastatic Infiltrating Bladder Urothelial Carcinoma, Lipid-Rich Variant Metastatic Infiltrating Bladder Urothelial Carcinoma, Micropapillary Variant Metastatic Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant Metastatic Infiltrating Bladder Urothelial Carcinoma, Sarcomatoid Variant Metastatic Kidney Medullary Carcinoma Metastatic Malignant Genitourinary System Neoplasm Metastatic Penile Carcinoma Metastatic Prostate Small Cell Neuroendocrine Carcinoma Metastatic Sarcomatoid Renal Cell Carcinoma Metastatic Urethral Carcinoma Papillary Renal Cell Carcinoma Sarcomatoid Renal Cell Carcinoma Stage IV Bladder Cancer AJCC v8 Stage IV Penile Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8 Stage IV Renal Cell Cancer AJCC v8 Stage IV Urethral Cancer AJCC v8 Stage IVA Bladder Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Bladder Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Testicular Leydig Cell Tumor Testicular Sertoli Cell Tumor Urethral Clear Cell Adenocarcinoma Metastatic disease defined as new or progressive lesions on cross-sectional imaging or bone scan. Patients must have at least One measurable site of disease as per Response Evaluation in Solid Tumors (RECIST) version (v) 1.1 One bone lesion on bone scan (tec99 or sodium fluoride [NaF] positron emission tomography [PET]/computed tomography [CT], CT, or magnetic resonance imaging [MRI]) for the bone-only cohort Histologically confirmed diagnosis of one of the following metastatic cohorts Small cell/ neuroendocrine carcinoma of the bladder All urothelial carcinomas with any amount of neuroendocrine differentiation (including small cell differentiation) will be included. If the tumor is purely neuroendocrine, metastasis from another site of origin should be clinically excluded Adenocarcinoma of the bladder, or urachal adenocarcinoma, or bladder/urethra clear cell adenocarcinoma must be pure (per World Health Organization [WHO] definition), (i.e. urothelial carcinoma with glandular differentiation is not considered a pure adenocarcinoma Squamous cell carcinoma of the bladder must be pure (i.e. urothelial carcinoma with squamous differentiation is not considered a pure squamous cell carcinoma)
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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 Fibroadenoma Atypical Ductal Hyperplasia Atypical Lobular Hyperplasia Lobular Carcinoma in Situ Flat Epithelial Atypia Phyllodes; Fibroadenoma Phyllodes Breast Tumor Radial Scar Breast Papilloma Complex Sclerosing Papillary Lesion of the Breast Women over age 18 with a core biopsy proven borderline or high-risk breast lesion that requires further excision for management based on the surgeon's assessment Informed consent must be obtained Women who are considered high-risk based on a greater than 25% lifetime risk of breast cancer as per the IBIS (International Breast Cancer Intervention Study) Breast Cancer Risk Evaluation Tool Pathology that is felt to be discordant with imaging Extensive calcifications extending more than 20 mm and/or masses greater than 30 mm The following lesions will be excluded based on their increased risk of upstaging; lesions (other than fibroadenomas, phyllodes and papillomas) that are associated with a palpable mass, ADH (atypical ductal hyperplasia) with high-risk features (ADH with zonal necrosis, significant cytological atypia or more than 2 foci), LCIS (lobular carcinoma in situ) with high-risk features (associated with ADH, pleomorphic LCIS, zonal necrosis and > 4 foci) or discordant with imaging, papilloma with atypia, and spindle cell lesion (especially if there is atypia) Lesions that are suspicious for borderline or malignant Phyllodes, DCIS (ductal carcinoma in situ), invasive mammary carcinoma, or encapsulated papillary carcinoma Any lesion that either the radiologist, pathologist or surgeon feels is not amenable to VAPE or surgical excision
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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 Breast Carcinoma Breast Tumor Histological evidence of breast cancer Histological and/or radiological evidence of metastases Metastasis within 10 years of registry initiation Signed informed consent (if a patient has already died at the time of entry, the entry can be made without a declaration of consent) Due to the non-interventional design of the registry there are no specific criteria
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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 Histological diagnosis of newly diagnosed breast cancer Known ER and HER2 receptor status Tumour diameter ≥1cm on imaging Female Age 18 or above Written informed consent Previously treated invasive breast cancer Primary systemic therapy for breast cancer prior to biopsy Oestrogen replacement therapy (HRT) within 14 days of biopsy in ER-positive tumours Pregnancy or breastfeeding Not considered suitable by clinical team
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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 patients aged 18 years and over diagnosis of early stage I to III breast cancer confirmed by histopathology test according to local guidelines human epidermal growth factor receptor 2 (HER2)-positive tumor by immunohistochemistry or FISH (Fluorescence In Situ Hybridization), as per the 2018 ASCO assessment guideline [J Clin Oncol 36:2105, 2018] use of at least one dose of biosimilar trastuzumab (Zedora) as adjuvant therapy, regardless of previous neoadjuvant trastuzumab or Zedora use or the type of chemotherapy combined with the antibody Signing of the informed consent form (ICF) use of biosimilar trastuzumab (Zedora) differently from the provisions in the label patients enrolled in and followed up by Programa Vida Plena [Full Life Program]
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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, Ductal Breast Carcinoma in Situ Core needle biopsy demonstrating DCIS (ductal carcinoma in situ) of non-palpable, image-detected breast abnormality Mammographic or MRI non-mass lesion (calcifications, non-mass enhancement on MRI) measuring 3 cm or less in greatest dimension Estrogen receptor positive or negative, progesterone receptor positive or negative; HER2 positive or negative DCIS Diagnostic needle biopsy within 16 weeks of randomization Patients must have a biopsy marker placed within the tumor bed confirmed on post biopsy imaging and evidence of residual radiographic abnormality. The post-biopsy mammogram must be performed within 6 weeks of randomization date Placement of Savi scout optical reflectance marker for contouring of tumor bed area for partial breast irradiation treatment planning via mammography, CT, or MRI and for image-guiding of surgery Planned lumpectomy. Mastectomy will be acceptable if lumpectomy fails by virtue of involved margins or size of lesion, or patient chooses this approach Evaluation by Radiation Oncologist to ascertain feasibility of PBI prior to randomization. Planned breast irradiation should encompass less than 30% of the breast volume Patients who had a prior contralateral invasive or non-invasive (DCIS) cancer are eligible Eastern cooperative oncology group (ECOG) performance status 0, 1, or 2 Invasive carcinoma on core needle biopsy, including microinvasive carcinoma Radiographic extent of DCIS >3.0 cm Mass lesion on breast imaging or palpable tumor No residual radiographic lesion after diagnostic percutaneous core needle biopsy Prior history of ipsilateral invasive or noninvasive breast cancer Pregnant or breastfeeding Prior ipsilateral breast or chest irradiation Multicentric or multifocal DCIS Synchronous contralateral invasive or non-invasive breast cancer Pagets' disease of the breast
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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): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment
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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 Ability to comply with the study protocol, in the investigator's judgment Histologically confirmed invasive breast carcinoma, with all of the following characteristics: Primary tumor greater than or equal to (≥)1.5 centimeters (cm) in largest diameter by ultrasound; Stage I-III operable breast cancer; Documentation confirming the absence of distant metastasis (M0) as determined by institutional practice ER-positive tumor and HER2-negative breast cancer as per local laboratory testing Postmenopausal status Breast cancer eligible for primary surgery Submission of a representative tumor tissue specimen Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (≤)1 Adequate organ function Diagnosis of inflammatory breast cancer Diagnosis of bilateral breast cancer Concurrent use of hormone replacement therapies Previous systemic or local treatment for the primary breast cancer currently under investigation Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry Current treatment with any systemic anti-cancer therapies Major surgery within 4 weeks prior to enrollment Radiation therapy within 2 weeks prior to enrollment Diagnosis of any secondary malignancy within 3 years prior to enrollment, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric 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): 18.0-65.0, Breast Cancer Organoids Patients with breast cancer and the largest tumor diameter ≥ 3cm No previous chemotherapy regimen age 18-65 years old Can obtain the tumor tissue specimens required for culture Heart, liver, kidney and bone marrow hematopoietic function is good Know and sign the informed consent form Pregnant or lactating women Also suffering from other cancer patients There are serious uncontrolled medical diseases or acute infections Those who are known to be allergic to this study drug or a variety of previous drugs The patient cannot understand the purpose of the study or disagree with the requirements of the study. Other investigators believe that patients who are not suitable for this study group
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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, Advanced Breast Cancer Obtention and signing of the molecular preselection consent regarding the mutational BRCA status confirmation prior to provision of the informed consent. 2. Provision of informed consent prior to any study specific procedures. 3. Male or female ≥18 years of age at the time of signing the Informed Consent Form (ICF). 4. Histologically and/or cytologically confirmed breast cancer with evidence of advanced disease (locoregionally recurrent or metastatic) not amenable to resection or radiation therapy with curative intent. 5. Patients with histologically and/or cytologically locally confirmed diagnosis of Human Epidermal Growth Factor Receptor 2 (HER2)-positive breast cancer according to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) May 2018 criteria. 6. Patients with documented germinal mutation in Breast Cancer (BRCA)1 or BRCA2 genes that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function). Patients with germinal BRCA1/2 mutations that are considered to be non-detrimental (e.g., "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favor polymorphism" or "benign polymorphism," etc.) will not be eligible for the study. Patients with known germinal BRCA status prior to enrollment are considered eligible to participate. 7. of resistance to trastuzumab defined as Relapse on (neo) adjuvant treatment or within 6 months from completion, or Progression on a trastuzumab regimen for advanced disease. No limitations on the number of prior trastuzumab regimens. 8. At least one prior systemic regimen for advanced disease including a pertuzumab or T-DM1 based regimen. No limitations on the number of prior systemic regimens. 9. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1. 10. Life expectancy greater or equal to 16 weeks. 11. Patients must have evaluable or measurable disease by Computed Tomography (CT) scan or Magnetic resonance imaging (MRI), according to Response Evaluation in Solid Tumors (RECIST) 1.1 criteria. 12. Patients must have normal organ and bone marrow function within 35 days prior to administration of study treatment as defined below Hematological: White blood cell (WBC) count >3.0 x 109/L, absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet count ≥100.0 x109/L, and hemoglobin ≥ 10 g/dL Hepatic: bilirubin ≤ 1.5 times the upper limit of normal (x ULN) (≤2.0 in patients with known Gilberts syndrome) or direct bilirubin ≤ 1 x ULN; alkaline phosphatase (ALP), Aspartate aminotransferase (AST) / Serum Glutamic Oxaloacetic Transaminase (SGOT), and Alanine aminotransferase (ALT) / Serum Glutamic Pyruvate Transaminase (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN Renal: Serum creatinine ≤ 1.5 x ULN or based on a 24-hour urine test or estimated creatinine clearance ≥ 51 mL/min using the Cockcroft-Gault equation: Estimated creatinine clearance = (140-age [years]) x weight (kg) (x F)a serum creatinine (mg/dL) x 72a where F=0.85 for females and F=1 for males. 13. Patients have been informed about the nature of study, including the exploratory studies and has agreed to participate and signed the ICF prior to participation in any study-related activities. 14. Males, postmenopausal and premenopausal women. Premenopausal women of childbearing potential (not undergoing to tubal ligation or hysterectomy) must have a negative blood or urine pregnancy test within 28 days prior to the start of study treatment and confirmed on Day 1 prior to commencing treatment Postmenopausal status is defined as either Prior bilateral oophorectomy; Or Age > 60 years; Or Age < 60 years and amenorrhoeic for 12 months in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression, and Follicle-stimulating hormone (FSH) and estradiol in postmenopausal range; Or Age < 60 years and taking tamoxifen or toremifene and FSH and plasma estradiol level in postmenopausal ranges; Or Radiation-induced castration with >1-year interval since last menses. Premenopausal status is defined as all those women who do not meet any of above criteria. Note: Documented hysterectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 highly effective forms of contraception in combination male condom plus an acceptable hormonal or non-hormonal method) throughout the study. Information must be captured appropriately within the site's source documents. Correct forms of contraception for males and females are detailed in Appendix 5: Acceptable birth control methods. 15. Patients is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations. 16. Snap frozen or formalin fixed paraffin-embedded (FFPE) tumor sample is mandatory for exploratory central testing. 17. Patients must fulfil the relative field on the informed consent for donating blood samples and serial biopsies at baseline and on disease progression for the exploratory biomarker studies Patients that have previously received any poly(ADP-ribose) polymerase (PARP) inhibitor (PARPi) for any reason, including olaparib. 2. Involvement in the planning and/or conduct of the study (applies to both Sponsor's staff and/or staff at the study site). 3. Patients simultaneously enrolled in any interventional clinical trial. 4. Patients who have received any systemic chemotherapy during the last 3 weeks prior initiating protocol therapy. 5. Patients who have had radiation therapy encompassing >20% of the bone marrow within 3 weeks prior to start of treatment, excepting for palliative radiation therapy to a small field >1-week prior to Day 1 of study. 6. Resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome. 7. Concomitant use of known strong Cytochrome P450 (CYP)3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, boosted protease inhibitors, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks. 8. Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents. 9. Persistent toxicities (Common Terminology for Adverse Events (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia. 10. Patients with Myelodysplastic syndrome (MDS) / Acute myeloid leukemia (AML) or with features suggestive of MDS/AML. 11. Patients having diagnosis, detection, or treatment of another type of cancer during the last 5 years prior to initiating protocol therapy (except adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, definitively treated ductal carcinoma in situ, stage 1, grade 1 endometrial carcinoma), or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≤5 years). 12. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. 13. Patients considered a high medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution CT scan or any psychiatric disorder that prohibits obtaining informed consent. 14. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication. 15. Immunocompromised patients (e.g., patients who are known to be serologically positive for human immunodeficiency virus and those with undetectable viral load). 16. Patients with a known hypersensitivity to olaparib or trastuzumab or any of the excipients of the products. 17. Clinically significant cardiovascular disease (stroke, unstable angina pectoris, or documented myocardial infarction) within 6 months prior to study entry; history of documented congestive heart failure (New York Heart Association II-III-IV); symptomatic pericarditis; documented cardiomyopathy; ventricular arrhythmias with the exception of benign premature ventricular contractions; conduction abnormality requiring a pacemaker; other arrhythmias not controlled with medication]. 18. Left ventricular ejection fraction below 55% as determined by multiple-gated acquisition (MUGA) scan or echocardiography (ECHO). 19. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) despite adequate antihypertensive treatment. 20. Patients currently receiving anti-coagulant therapy (low molecular weight heparin and warfarin with careful monitoring of patients are permitted), or another immunosuppressive agent (standard premedication for chemotherapy and local applications are allowed). 21. Patients with pulmonary disease requiring continuous oxygen therapy. 22. Previous history of bleeding diathesis. 23. Patients with known active hepatitis (i.e. Hepatitis B or C). 24. Patients with moderate or severe hepatic impairment. 25. Chronic daily treatment with corticosteroids with a dose of ≥ 10 mg/day methylprednisolone equivalent (excluding inhaled steroids), except for prophylaxis use. 26. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation. 27. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment and in a dose < 10 mg/day methylprednisolone equivalent. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days. Female patients who are pregnant or breastfeeding, or adults of reproductive potential who are not using effective birth control methods. Patients unwilling to or unable to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
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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 signed an approved consent form conforming with institutional guidelines Patients must be ≥ 50 years old Patients should have a life expectancy of at least 10 years taking into consideration comorbid conditions Surgical treatment of the breast must have been partial mastectomy. The margins of the resected specimen must be histologically free of tumor for invasive disease and with at least a 2mm margin for in situ disease. Reexcision of surgical margins is permitted to obtain negative margins. Postoperative mammogram of the surgical specimen or breast must be performed to confirm that all abnormal calcifications were removed at the time of surgery. Surgical clips must be placed at the partial mastectomy site by the surgeon at the time of excision Patients must have American Joint Committee on Cancer 8th edition pathology stage Tis, T1, or T2 and N0 as assessed by sentinel lymph node biopsy or axillary lymph node dissection for invasive disease. The tumor size must be 3cm or less in greatest dimension On histologic examination, the tumor must be ductal carcinoma in situ (low or intermediate grade), invasive ductal carcinoma (any grade), or invasive lobular carcinoma Patients must have unicentric disease with limited or focal lymphovascular space invasion (LVSI) Patients must have an estrogen reception (ER) analysis performed and the primary tumor should be ER positive The target partial mastectomy cavity must be clearly delineated and the target partial mastectomy cavity/whole breast reference volume must be ≤ 30% based on the post- operative scan. The partial mastectomy cavity must be > 5mm from the skin. This can be confirmed at time of CT simulation for radiation treatment planning Patients must enroll within 42 days following the last surgery for breast cancer (partial mastectomy or re-excision of margins) Male Patients < 50 years of age Tumor > 3cm in greatest dimension or American Joint Committee on Cancer 8th edition pathologic stage T3 or T4 or node positive disease If patients have invasive carcinoma and no nodal assessment was performed, specifically the patient did not undergo sentinel lymph node biopsy or axillary lymph node dissection Patients with persistently positive margins despite attempted re-excision Proven multicentric disease or extensive LVSI Clear delineation of the extent of the target partial mastectomy cavity is not possible Patients who have undergone oncoplastic reconstruction Any patients who received neoadjuvant chemotherapy or hormonal therapy prior to surgical excision of the tumor Any patients who require adjuvant chemotherapy following lumpectomy
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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 Breast Tissue Neoplasm Patients with pathologically confirmed invasive ductal carcinoma (Grade 2 or 3) Undergoing wide local excision surgery or mastectomy Started hormone or chemotherapy treatment before recruitment Undergoing treatment for concurrent cancer diagnosis Taking antibiotics, proton pump or vegetable dietary supplement
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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, HER2 Positive Breast Cancer female patients, 18 years ≤ age ≤ 75 years. 2. Performance Status Eastern Cooperative Oncology Group (ECOG) 0-1. 3. Histologically confirmed invasive breast cancer:early stage or locally advanced,Primary tumour greater than 2 cm diameter 4. HER2 positive (HER2+++ by IHC or FISH+) 5. Subjects received neoadjuvant therapy with trastuzumab 2 weeks post-imaging evaluation Patients with a price of PD or SD. 6. Known hormone receptor status. 7. Required laboratory values including following parameters: ANC: ≥ 1.5 x 10^9/L;Platelet count: ≥ 100 x 10^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN (or ≤ 5×ULN in patients with liver metastases);BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: < 470 ms for female and < 450 ms for male. 8. Signed the informed consent form prior to patient entry metastatic disease (Stage IV) or inflammatory breast cancer. 2. Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix. 3. clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); 4. Unable or unwilling to swallow tablets
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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, Recurrent or Metastatic Breast Cancer Confirmed by pathology and/or histology/cytology as breast cancer; 2. Patients with recurrent or metastatic breast cancer who are 18 to 75 years old, not limited to the first relapse or metastasis; 3. There are evaluable tumor lesions; 4. Physical strength: ECOG score 0-1; 5. The expected survival period is more than 3 months; 6. Agree to be collected tissue specimen; 7. The patient has no major organ dysfunction, agrees and can implement a treatment plan based on the patient's condition. 8. Voluntary enrollment, good compliance, can be followed up and observed Severe vital organs (heart, liver, kidney) dysfunction; clinically significant heart disease, classified by New York Heart Association (NYHA) as grade III-IV heart failure or more severe congestive heart failure or severe Arrhythmia requiring drug intervention; uncontrolled angina, uncontrolled arrhythmia or uncontrollable hypertension, electrocardiogram (ECG)-confirmed myocardial infarction within 6 months; 2. Have a history of organ transplantation, splenectomy; 3. Patients with other malignancies, except cured non-melanoma skin cancer, cervical carcinoma in situ, or other tumors that have been cured for at least 5 years; 4. Moderate or severe renal impairment [creatinine clearance equal to or lower than 50ml/min (calculated according to Cockroft and Gault equations)], or serum creatinine > normal upper limit (ULN); pulmonary function test FEV1 < 50% of estimated value; 5. Parallel surgical treatment of other diseases is required; 6. Patients who are pregnant or breast-feeding (women of childbearing age need to be examined for pregnancy); women of childbearing age must take contraceptive measures that the investigator considers effective; 7. Patients with or showing signs of disseminated spongiform encephalopathy or family members have the disease; 8. In the active period of other acute infectious diseases or chronic infectious diseases; 9. Have uncontrolled epilepsy, central nervous system disease or a history of mental disorders; 10. People with disabilities or with no legal capacity or legal capacity is limited; 11. Those who received a research medication or formulation/treatment (ie, participated in other trials) within 4 weeks prior to enrollment; 12. Other situations when the investigators believe that patients should not participate in this trial. Quitting 1. The patient suffers from other diseases and needs to be immediately taken to other therapists, and is no longer suitable for sampling test; 2. Diagnosis of encephalitis and other inflammatory neuropathies; 3. After the enrollment, it is clearly determined that the subject does not meet the requirements of the subject; 4. The investigator believes that the withdrawal of the trial is in the best interest of the subject; 5. Pregnancy; 6. Poor compliance, two consecutive failures to accept testing as planned; 7. The patient him/herself or the researcher believes that it is medically required to be withdrawn from the study. 8. For subjects who discontinued the study early, the reason for the early withdrawal should be recorded, and the time of the last visit should be recorded, and the inspection items at the time of early termination of the study should be completed in the last visit as much as possible
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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, Biliary Stricture Pancreas Cancer Cholangiocarcinoma Bile Duct Cancer Bile Duct Neoplasms Malignant Bile Duct Neoplasms Bile Duct Lesions Bile Duct Obstruction Bile Duct Diseases Bile Duct Obstruction, Extrahepatic Bile Duct Stenosi Bile Duct Adenoma Pancreatic Duct Stricture Pancreatic Duct Stenosis Pancreatic Duct Obstruction Pancreatic Ductal Adenocarcinoma Primary Sclerosing Cholangitis VLE clips featuring indeterminate biliary or pancreatic duct stricture with confirmed diagnosis on pathology -
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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): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
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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 Breast Ductal Carcinoma In Situ Breast Fibrocystic Change Breast Lobular Carcinoma In Situ 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 Triple-Negative Breast Carcinoma PRE-REGISTRATION: Clinical T1-4, N0-3, M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging version 8 Note: Benign breast disease, lobular carcinoma in situ (LCIS) or ductal carcinoma in situ (DCIS) in the contralateral breast is allowed Note: Contralateral invasive breast cancer is allowed if disease is of clinically lower stage, and the higher stage lesion will be the study lesion for all biopsies and tissue samples PRE-REGISTRATION: Histological confirmation of triple negative invasive breast cancer (defined as estrogen receptor [ER] =< 10%, progesterone receptor [PR] =< 10% and HER2 not amplified by in situ hybridization [ISH] or immunohistochemistry [IHC] 0/1) at diagnosis PRE-REGISTRATION: Neoadjuvant chemotherapy (NAC) with one of the following regimens that was not discontinued early due to intolerability with less than 50% of planned treatment given due to disease progression or patient request Paclitaxel or docetaxel followed by one of the following: the combination of doxorubicin and cyclophosphamide (AC); the combination of epirubicin and cyclophosphamide (EC) or the combination of 5-fluorouracil, epirubicin and cyclophosphamide (FEC) Note: Carboplatin may be added to these regimens AC or EC or FEC followed by docetaxel or paclitaxel Note: Carboplatin may be added to these regimens Docetaxel in combination with doxorubicin and cyclophosphamide (TAC) PRE-REGISTRATION: History of deep venous thrombosis (DVT) or pulmonary embolisms (PE) =< 12 months prior to preregistration; OR Active DVT and/or PE requiring anti-coagulant therapy NOTE: Patients who are on anti-coagulant therapy for maintenance are eligible as long as the DVT and/or PE was > 12 months prior to enrollment and there is no evidence for active thrombosis (either DVT or PE) NOTE: Patients on anticoagulation are eligible; however peri-biopsy and peri-surgical management of anticoagulation is per the institutional standard of care PRE-REGISTRATION: Prior treatment with CDK 4/6 inhibitors (e.g. palbociclib, ribociclib, abemaciclib, etc.) PRE-REGISTRATION: Prior treatment with immunotherapy or radiation for this breast cancer PRE-REGISTRATION: Prior incisional or excisional breast biopsy for this cancer PRE-REGISTRATION: Any contraindications to pre-registration biopsy (such as bleeding diatheses, etc.) PRE-REGISTRATION: Receiving any investigational agent which would be considered as a treatment for the primary neoplasm PRE-REGISTRATION: Other active malignancy =< 5 years prior to registration Non-melanotic skin cancer or carcinoma-in-situ of the cervix
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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, Cervical Cancer Breast Cancer Contraceptive Usage Sexually Transmitted Diseases -Scheduled to leave jail within 3 days not actively intoxicated not show severe psychological distress
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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): 18.0-99.0, Breast Cancer Histological diagnosis of breast cancer, availability of primary tumor tissue and plasma DNA with a high ctDNA content Patient rejects the participation
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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): 20.0-85.0, Cataract Age of 20 years or older Cataract Amblyopia Keratoconus Previous corneal or refractive surgery Chronic or recurrent uveitis Acute ocular disease Previous ocular surgeries Glaucoma Any ocular disease which could possible affect the postoperative visual acuity
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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, Oropharyngeal Carcinoma De-escalation Histological diagnosis of squamous cell carcinoma of oropharynx with IHC p16 positive or PCR HPV16 positive T1-2/N1-3M0（except T1N1M0 and single LN<3cm）or T3-4N0-3M0 according to UICC/AJCC 8th staging system Age ≥18 No prior anti-tumor treatment Karnofsky Performance Score (KPS)≥70 Adequate blood supply Informed consent obtained cannot take contrast-MRI imaging Pregnant Combined with other malignant tumor (except basal cell carcinoma of skin)
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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 Age: 18 ≤75 years 2. Breast carcinoma with infiltrating histotype 3. Tumor size: cT1 cT2 cT3 4. Positive axillary lymph nodes (cN +) at the initial diagnosis by clinical, ultrasound and cyto-microhistology evaluation 5. Neoadjuvant chemotherapy performed 6. Negative axillary lymph nodes (cN-) from the NAC by clinical and ultrasound assessment 7. Absence of distant metastases (M0) 8. Negative medical history for previous infiltrating breast cancer Current pregnancy or lactation status 2. Inflammatory breast cancer 3. In situ breast cancer 4. Synchronous contralateral breast cancer 5. Co-morbidity and/or medical disorder precluding any adjuvant therapy 6. Co-morbidity and/or medical/mental disorder making impossible making a regular follow-up 7. Other cancers in the previous 3 years (except forcarcinoma in situ of the uterine cervix, basalioma, squamous cell carcinoma or non-melanoma skin 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 HER2-positive Breast Cancer Women aged 18-75 years old; HR positive and HER2 positive (immunohistochemistry or FISH test confirmed). 2. ECOG score ≤ 2, expected survival ≥ 3 months. 3. Histology or cytology confirmed as breast cancer. 4. Prior to trastuzumab and endocrine therapy and progression/recurrence. 5. At least one 1.1 defined measurable lesions. 6. Normal function of major organs pregnant or lactating women 2. Patients who have relapsed or progressed within 12 months of end of adjuvant or neoadjuvant therapy, including chemotherapy, target therapy (eg lapatinib， trastuzumab), or other anti-tumor therapy. Except for endocrine therapy. 3. Severe chronic gastrointestinal diseases with diarrhea as the main symptom (such as Crohn's disease, malabsorption, or ≥2 grade diarrhea caused by any cause at baseline). 4. Rapid progress of organ invasion (such as liver and lung disease greater than 1/2 organ area or liver dysfunction, etc.) 5. Patients with central nervous system disorders or mental disorders 6. Bone metastasis lesions only, no other measurable lesions. 7. Hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg) without ideal control. 8. Uncontrolled heart disease. 9. Have congenital long or short QT syndrome or have a family history or personal history of Brugada syndrome. 10. Uncontrolled rain metastasis
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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 Ductal Carcinoma in Situ Women 2. New histologically diagnosed breast ductal carcinoma in situ (DCIS). 3. Age ≥ 40 years 4. Low risks of BRCA (breast cancer)1 and BRCA2: Manchester Score < 10 5. The DCIS must be detected by mammogram and must be unicentric, and no-mass lesion. 6. Status post breast conserving surgery 7. Pathological characteristics (all characteristics) 7.1 Lesions ≤ 2.5 cm in greatest dimension on pathologic specimen (use the largest measured size from the pathology report to obtain the required measurement of ≤ 2.5 cm). 7.2 Must be classified as low or intermediate nuclear grade DCIS but without comedo necrosis according to Pathologic Guidelines (section 9.2.2) 7.3 Margins as assessed by the ink method will be 3 mm or greater. 7.4 Must be estrogen receptor (ER)-positive DCIS, ER percentage must be ≥10% 8. Clinically node negative Known BRCA1 or BRCA2 mutation 2. Age < 40 years 3. Women whose DCIS is palpable at the time of diagnosis, or multi-centric (mammography), or mass (mammography), or who have bloody nipple discharge. 4. Pathological characteristics 4.1 Lesions measuring greater than 2.5 cm in greatest dimension on pathologic specimen. 4.2.High-grade lesions or low to intermediate grade with comedo necrosis as classified by the Guidelines. 4.3. Margins as assessed by the ink method will be less than 3 mm. 4.4. ER-negative DCIS or ER-positive percentage < 10% in tumor cells 5. Post-mastectomy patients 6. Prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer. 7. Evidence of clinically significant cardiac disease, as defined by cardiac disease (New York Cardiac disease grade II), history of myocardial infarction, cerebral stroke, unstable arrhythmia, and unstable angina pectoris within 12 months before study entry. 8. Pregnant or lactating status
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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 Patients with histological and imaging findings-confirmed hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer postmenopausal patients eligible patients receiving one or more treatment strategies who are followed up in the center where they receive treatment provision of written informed consent Age < 18 years pregnant woman participating in other clinical trials
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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, Advanced Renal Cell Carcinoma Chromophobe Renal Cell Carcinoma Clear Cell Renal Cell Carcinoma Collecting Duct Carcinoma Kidney Medullary Carcinoma Metastatic Malignant Neoplasm in the Bone Papillary Renal Cell Carcinoma Stage IV Renal Cell Cancer AJCC v8 Unclassified Renal Cell Carcinoma Documented histologic or cytologic diagnosis of renal cell cancer (RCC). All subtypes of RCC are eligible including but not limited to clear cell, papillary, chromophobe, translocation, collecting duct carcinoma, medullary carcinoma, and unclassified categories. Enrollment of non-clear cell patients will be limited to 20% of the total sample size (~ 42 patients). Once this goal is met, accrual of non-clear cell patients will be discontinued (a notice will be sent out 2 weeks in advance). Sarcomatoid and rhabdoid differentiation are allowed Presence of at least 2 metastatic bone lesions not treated with prior radiation is required The presence of bone metastases can be detected by computed tomography (CT), magnetic resonance imaging (MRI), Tc-99m bone scan or positron emission tomography (PET) (fludeoxyglucose F-18 [FDG] or sodium fluoride [NaF]) imaging. Patients with non-measurable bone-only disease are allowed. Patients may have received prior radiation therapy for bone metastases or other external radiation >= 14 days prior to registration, as long as they still have at least 2 metastatic bone lesions that were not treated with radiation. Patients with visceral metastases are allowed, as long as they have at least two untreated bone metastases No more than 2 prior lines of systemic therapy including but not limited to anti-angiogenic therapy, checkpoint inhibitors, mammalian target of rapamycin (mTOR) inhibitors, clinical trial compounds or cytokine-based therapy. Prior radiation therapy does not count as a prior systemic therapy No prior treatment with cabozantinb No treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitors) within 2 weeks or 5 half-lives (whichever is shorter) of registration or receipt of any anti-cancer therapy (including investigational therapy, monoclonal antibodies, cytokine therapy) within 3 weeks of registration No prior hemibody external radiotherapy No prior therapy with radium-223 dichloride or systemic radiotherapy (such as samarium, strontium) No major surgery within 6 weeks of randomization. Procedures such as thoracentesis, paracentesis, percutaneous biopsy, Moh's or other topical skin surgery, Lasik eye surgery are not considered major surgery. Patients who have had a nephrectomy may be registered >= 3 weeks after surgery, providing there are no wound-healing complications. Subjects with clinically relevant ongoing complications from prior surgery are not eligible Recovery to baseline or =< grade 1 CTCAE version 5.0 from toxicity related to any prior treatment, unless adverse events are clinically nonsignificant and/or stable on supportive 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 stage 1: 1. female 2. ≥18 years old 3. invasive ductal carcinoma or DCIS proved by core needle biopsy 4. tumor size ≤ 5cm 5. negative preoperative axillary assessment(including body examination, ultrasound and MR examination) 6. patients is accessible for the following axillary surgery and pathological test(including sentinel lymph node biopsy and axillary lymph node dissection) stage 2: 1. female 2. ≥18 years old 3. invasive carcinoma proved by core needle biopsy 4. has plan for breast conserving surgery and adjuvant radiation after surgery 5. negative preoperative axillary assessment(including body examination, ultrasound and axillary PET mSUV<0.27) 6. patients is accessible for the follow up stage 1: 1. distant metastases 2. in the procedure of neoadjuvant therapy 3. positive preoperative axillary assessment (including body examination, ultrasound and MR examination) 4. pregnancy or breastfeeding 5. axillary biopsy or axillary surgery before LymphPET 6. suffer from diabetes mellitus and without well control of bloodglucose 7. previous malignancy 8. allergic to tracer of LymphPET stage 2: 1. distant metastases 2. in the procedure of neoadjuvant therapy 3. positive preoperative axillary assessment (including body examination, ultrasound and PET mSUV≥0.27) 4. pregnancy or breastfeeding 5. axillary biopsy or axillary surgery before LymphPET 6. suffer from diabetes mellitus and without well control of bloodglucose 7. previous malignancy 8. allergic to tracer of LymphPET
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0
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