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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 Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship)
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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, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment
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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, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months
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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, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL
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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 Capecitabine Triple Negative Breast Cancer Female aged 18 years old Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable) Newly diagnosed conditions allowing direct surgery without any absolute contraindication for surgery No mass or microscopic tumor residue after surgery resection Initiate adjuvant chemotherapy within 30 days after surgery Axillary lymph node positive (including the sentinel lymph node positive and lymph node positive after axillary dissection), for example, axillary lymph node negative requires that primary tumor size must be greater than 1cm Definite reports on ER/PR(progesterone receptor)/Her2 receptor showing all ER/PR/Her2 negative (specific definitions: immunohistochemical detection of ER <10% tumor cells is defined as ER negative, PR <10% positive tumor cells is defined as PR-negative, Her2 is 0~1+ or 2+ but determined negative via FISH or CISH detected (no amplification) is defined as Her2 negative) No relevant clinical or imaging evidence of metastasis showing in the preoperative examination (M0) Bilateral breast cancer or carcinoma in situ (DCIS / LCIS) Metastasis at any location Any tumor > T4a (UICC1987) (accompanied by skin involvement, lump adhesion and fixation, inflammatory breast cancer) Any of ER, PR or Her-2 is positive Contralateral breast clinically or radiologically suspected to be malignant but not confirmed which needs a biopsy Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone therapy Previously suffering from malignant tumors (except for basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer Already enrolled into other clinical trials Severe systemic disease and/or uncontrollable infection, unable to be enrolled in this study LEVF <50% (echocardiography) Suffering from severe cardiovascular and cerebrovascular diseases within six months before the randomization (such as: unstable angina, chronic heart failure, uncontrollable high blood pressure > 150/90mmHg, myocardial infarction or brain vascular accident)
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-100.0, Breast Cancer Breast cancer patients eligible for sentinel node dissection Invasive ductal or invasive lobular carcinoma Ductal carcinoma in situ undergoing total mastectomy Clinically node-negative 100 years Inflammatory breast cancer Pregnant or lactating Preoperative chemotherapy Prior axillary ultrasound guided core needle biopsy
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Patient ≥ 18 years old Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care Female patient is either post-menopausal or surgically sterilized or commits continued abstinence from heterosexual intercourse during the duration of the study or is willing to use two methods of birth control, one highly effective method and one additional effective method at the same time, at least 4 weeks before starting carfilzomib and bendamustine therapy, during carfilzomib and bendamustine therapy and for at least 4 weeks after stopping carfilzomib and bendamustine therapy. Highly effective methods are hormonal contraceptives (birth control pills, injections, and implants), intrauterine device, tubal ligation and partner's vasectomy. Additional effective methods are condom, diaphragm, and cervical cap. Women with child bearing potential must have two negative pregnancy tests (sensitivity at least 50 mIU/mL) prior starting carfilzomib and bendamustine therapy. The first pregnancy test must be performed 10 days and the second within 24 hours before starting carfilzomib and bendamustine therapy. Pregnancy testing for the first 4 weeks of study therapy must be performed weekly and thereafter every 4 weeks if menstrual cycles are regular or every 2 weeks if menstrual cycles are irregular Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study and for 6 months after stopping study therapy Patient with relapsed or/and refractory multiple myeloma after failure of two or more treatment regimens (previous bortezomib is allowed) Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein (M-protein) value (generally, but not necessarily, ≥ 0.5 g/dL of M-protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours. For patients with oligo or non-secretory MM, it is required that they have measurable plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or an abnormal free light chain ratio (n.v.: 0.26-1.65). We anticipate that less than 10% of patients admitted to this study will be oligo or non-secretory MM with free light chains only in order to maximize interpretation of benefit results Pregnant or lactating females Patient has active infectious hepatitis type B or C or HIV Patients with active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention Peripheral neuropathy (PN) > CTCAE grade 2 and ≥ grade 2 painful PN (with the difference being in the of patients with Grade 2 painful PN) Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib) Known history of intolerability to high dose dexamethasone Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and anti-platelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment Subject with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to baseline Patient has any other clinically significant illness that would, in the investigator's opinion, increase the patient's risk for toxicity Patient with a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma of the skin, or in situ cancer of the cervix or breast, or localized prostate cancer of Gleason score <7 with a stable PSA)
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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 Surgery Infiltrating breast carcinoma histologically proven (lobular, ...) 2. unifocal, 3. T <3 cm (clinical), palpable or non-palpable tumor (smaller than a centimetre allowed), 4. N0 clinical axillary 5. Conservative surgery, 6. GS detection by isotopic or combined method, 7. Age <65 (for more frequent activity), and> 18 years. 8. Social protection 9. Signed Informed consent Recurrence of breast carcinoma, 2. History of ipsilateral breast reduction surgery, 3. Radical surgery. 4. History of lumpectomy 5. Neoadjuvant chemotherapy 6. Multi-focality 7. Neoadjuvant hormone therapy 8. < 18 years old 9. Pregnant or nursing patient or of childbearing age without effective contraception, 10. Legal incapacity or limited legal capacity. Medical or psychological conditions not allowing the subject to understand the study and sign the consent
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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-positive Breast Cancer Male Breast Cancer Recurrent Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Pathologically confirmed diagnosis of breast cancer (central confirmation is not required) Patients must be at least 18 years of age Metastatic or advanced breast cancer that is evaluable OR metastatic or advanced breast cancer that is measurable for response as per Response Evaluation in Solid Tumors (RECIST) 1.1 Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy of at least 3 months as assessed by the investigator Patients with estrogen receptor (ER)+ breast cancer must have received prior treatment with at least one hormone therapy Absolute neutrophil count ≥ 1,500 cells/uL Platelets ≥ 100,000/uL Hemoglobin ≥ 9.0g/dL Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) Fewer than 21 days since last anti-tumor therapy, including chemotherapy, biologic except trastuzumab, experimental, immune, radiotherapy for the treatment of breast cancer, with the following exceptions Hormone therapy Palliative radiation therapy involving =< 25% of marrow-bearing bone is allowed if completed within >= 14 days prior to first study treatment Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable/evaluable disease Major surgery within 4 weeks prior to first dose of ganetespib Poor venous access for study drug administration Study drug administration via indwelling catheters is allowed only if the catheter is made of silicone material No prior chemotherapy in the metastatic setting is allowed Prior pertuzumab is not allowed in the metastatic setting. Pertuzumab given in the neoadjuvant and/or adjuvant setting is allowed History of intolerance or hypersensitivity to trastuzumab and/or pertuzumab
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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, Metastatic Breast Cancer Breast Carcinoma HER-2 Positive Breast Cancer Subjects must have histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to any local treatment with curative intent. Metastatic disease must be demonstrated either radiographically or histologically Primary tumors and/or metastatic lesions must demonstrate HER2-neu overexpression, per the 2013 recommendations, i.e. immunohistochemistry (IHC 3+) or amplification by in situ hybridization based on the following: 1. Single-probe average HER2 copy number ≥6.0 signals/cell 2. Dual-probe HER2/Chromosome 17 centromere (CEP17) ratio ≥2.0 with an average HER2 copy number ≥4.0 signals/cell 3. Dual-probe HER2/CEP17 ratio ≥2.0 with an average HER2 copy number <4.0 signals/cell 4. Dual-probe HER2/CEP17 ratio < 2.0 with an average HER2 copy number > 6.0 signals/cell Patients should have progressed on at least two lines of HER2-directed therapy in the metastatic setting, and prior therapy for metastatic disease should both pertuzumab and ado-trastuzumab unless contraindicated or declined by the patient There is no upper limit on the number prior therapies Patients may have measurable disease only, non-measurable disease only, or both (RECIST 1.1). Concomitant treatment with bone-targeted therapies such as Receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitors or bisphosphonates is allowed. It is anticipated that most patients will have measurable disease, given the behavior of HER2+ metastatic breast cancer Because no dosing or adverse event data are currently available on the use of ruxolitinib in combination with trastuzumab in patients <18 years of age, children are excluded from this study Women and men of all races and ethnic groups are eligible for this trial Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky equal to or greater than 60) Left ventricular ejection fraction greater than or equal to 50 percent by transthoracic echocardiography or multi-gated acquisition scan (MUGA) within 28 days prior to the first dose of the study drug The subject has a baseline corrected QT interval less than or equal to 480ms Patients who have had chemotherapy, hormonal therapy, or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier Patients who are receiving any other investigational agents or have received other investigational agents within 2 weeks or 5 half-lives of the compound or active metabolites, whichever is longer before the first dose of the study treatment Patients who have previously been treated with an interleukin-6 (IL-6), Janus kinase (JAK) or Signal Transducers and Activators of Transcription (STAT) inhibitor for any indication, such as ruxolitinib or tocilizumab The subject has untreated, symptomatic, or progressive brain metastases. History of Central Nervous System (CNS) metastases or cord compression is allowable if patient has been clinically stable for at least 6 weeks since completion of definitive treatment and is off steroids without symptoms for at least 28 days History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib or trastuzumab The effects of ruxolitinib on the developing human fetus are unknown. For this reason and because Janus kinase 2 (JAK2) inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the principal investigator immediately Patients receiving any medications or substances that are strong inhibitors of cytochrome P450 (CYP450) 3A4 isoenzyme are ineligible. Patients must be off the strong inhibitor for at least 1 week prior to being deemed eligible Patients may not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements Patients must not have clinically significant cardiovascular disease (New York Heart Association Class III or IV heart failure), uncontrolled clinically significant atrial or ventricular cardiac arrhythmias, or any of the following within the past 6 months: myocardial infarction, new evidence of transmural infarction on electrocardiogram (ECG), unstable angina, coronary angioplasty Pregnant women are excluded from this study because ruxolitinib is a Class C agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ruxolitinib, breastfeeding must be discontinued if the mother is treated with ruxolitinib. These potential risks also apply to trastuzumab, which can cause fetal harm when administered to a pregnant woman
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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, Female Breast Cancer The patients signed the written informed consent The patients present with histologically proven operable invasive breast cancers without distant metastasis The breast tumor's positive ER/PR rate is <1%, and positive ER-beta rate is ≥1% by immuno-histochemistry(IHC) The patients have no history of neoadjuvant hormone therapy The patients' Karnofsky performance score ≥70% Female patient who is ≥ 18yrs, and ≤ 80yrs The patients are non-pregnant, and disposed to practice contraception during the whole trial The patients underwent neoadjuvant chemotherapy plus surgery or directly modified radical mastectomy or breast-conserving surgery (plus sentinel lymph node biopsy or axillary lymph node dissection) after diagnosis of breast cancer The patients underwent chemotherapy, radiation therapy after surgery according to the 2013 NCCN guideline The results of patients' blood tests are as follows: Hb≥90g/L; WBC≥4.0×109/L; Neutrophils≥1.5×109/L; Plt≥100×109/L; alanine aminotransferase(ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN); total bilirubin(TBIL) ≤ 1.5×ULN; Creatinine ≤ 1.25×ULN The patients have a previous history of invasive malignant disease (breast cancer at any time, other malignant disorders within the past 10 years excluding squamous or basal-cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied) The patients have any severe concomitant disease which will place the patient at unusual risk or confound the results of the trial The patients have history of neoadjuvant hormone therapy The patients are undergoing current administration of anti-cancer therapies, or are attending other clinical trials The patients are pregnant or lactational, or they refuse to practice contraception during the whole trial The patients are unwilling to stop any hormonal drug including hormone replacement therapy(HRT) The patients can't understand the written informed consent; such as they have dementia The patients have allergic history or contraindication of toremifene/anastrozole
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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): 25.0-999.0, Mass Lesion Female Age 25 or older A bra cup size of A through DDD Willing and able to provide written, signed Informed Consent Form (ICF) after the nature of the study has been explained, all questions have been answered, and prior to any research-related procedure(s) Willing and able to comply with all study procedure(s), including possible aspiration for a simple cyst Complete digital mammography views Craniocaudal and Medio-lateral Oblique (CC and MLO) for one or both breasts Mammographically-detected lesion(s) seen on at least one mammographic view and a corresponding HHUS correlate(s) Does not meet all Currently breastfeeding History of breast cancer in the past 12 months, except for Fine Needle Aspirations (FNA) or Cyst Aspiration History of breast surgeries or interventional breast procedures in the past 12 months Normal mammogram at the time of this evaluation Physical inability to tolerate the procedure on the scanner, i.e. inability to lie prone and still for up to 30 minutes at a time Open wounds, sores or skin rash present on the breast(s) or nipple discharge from the scanned breast Breasts too large for scanner, i.e. bra size larger than DDD or inability to successfully "fit" breast after the subject is placed on scanner Body weight greater than 400 lbs. (180 kg) Has a concurrent disease or condition which in the judgment of the principal investigator disqualifies the subject, from participating in the study
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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): 18.0-94.0, Common Bile Duct Stones Patients with common bile duct stones (CBDS)
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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, Advanced Gastric Carcinoma Histologically confirmed gastric cancer Disease at clinical stage of resectable or potentially resectable(T3-4, N0-3, M0) by CT and endoscopic ultrasonography (EUS) Karnofsky performance status(KPS） ≥ 70 No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy Life expectancy more than 3 months Adequate organ function as defined below:White Blood Cell Count （WBC） ≥ 3.0*10^9/l, Absolute Neutrophil Count （ANC） ≥ 1.5*10^9/l, Hemoglobin ≥ 100 g/l, Platelets ≥ 100*10^9/l, Total Bilirubin （TBIL） ≤ 1.5mg/dl, Aspartate Aminotransferase（AST） and Alanine Aminotransferase(ALT) ≤ 2.5×ULN, Alkaline pPosphatase( ALP) ≤ 2.5×ULN, Renal Serum Creatinine < 1.5mg/dl Adequate lung and heart function ≥ grade 2 neuropathy History of malignancy With uncontrolled central nervous system metastasis Concurrent disease or condition that would interfere with the subject's safety (including current active hepatic, biliary, renal, respiratory disease, acute infection, severe malnutrition, uncontrolled diabetes hypertension et al) Severely inadequate intake of water or diet
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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, Estrogen Receptor-positive Breast Cancer Invasive Ductal Breast Carcinoma Invasive Ductal Breast Carcinoma With Predominant Intraductal Component Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate Mucinous Ductal Breast Carcinoma Papillary Ductal Breast Carcinoma Progesterone Receptor-positive Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Tubular Ductal Breast Carcinoma The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines Patient must be ≥ 50 years Core biopsy demonstrating breast cancer and receptors that are ER or PR positive Core tissue must have HER 2 negative followed by current ASCO/CAP guidelines The patient must have clinical node negative, stage I breast cancer The surgical treatment must be intended to be a lumpectomy The biopsy site must have been demarcated by a clip(s) Gross disease must be unifocal on Mammo/ MRI imaging Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis performed on core biopsy Patient must be able to tolerate lying in the prone position with arms extended forward Age < 50 years Hormone unresponsive breast cancer T-2 ( > 3.0 cm), T-3, Stage III, or Stage IV breast cancer N-1, N-2, or N-3 clinical axillary nodes Mastectomy intended Unwilling to undergo anti-endocrine therapy Suspicious microcalcification, densities, or palpable abnormalities ( in the ipsilateral or contralateral breast) unless biopsied and found to be benign Non-epithelial breast malignancies such as sarcoma or lymphoma Paget's disease of the nipple Proven multicentric carcinoma (invasive or DCIS) in more than one quadrant or separated by > 4 centimeters
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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, Toxicity Due to Radiotherapy The patient must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines. 2. Patients must be ≥ 18 years old. 3. On histological examination, the tumor must be DCIS or invasive carcinoma of the breast. 4. Surgical treatment of the breast must have been lumpectomy or quadrantectomy. The margins of the resected specimen must be histologically free of tumor (DCIS and invasive). Reexcision of surgical margins is permitted. 5. Patients with invasive breast cancer are required to have axillary staging which can sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). (Axillary staging is not required for patients with DCIS.) 6. The patient must be randomized within 45 days following the last surgery for breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure) or within 30 days following the last chemotherapy cycle. 7. Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension. 2. One or more positive non-axillary sentinel node(s). (Note that intramammary nodes are staged as axillary nodes.) 3. 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. 4. Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign. 5. Non-epithelial breast malignancies such as sarcoma or lymphoma. 6. Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. 7. Paget's disease of the nipple. 8. Synchronous bilateral invasive or non-invasive breast cancer. 9. Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by reexcision, the patient is eligible.) 10. Breast implants. (Patients who have had implants removed are eligible.) 11. Prior breast or thoracic radiation therapy for any condition. 12. Collagen vascular disease, specifically dermatomyositis with a creatine phosphokinase level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma. 13. Pregnancy or lactation at the time of proposed randomization. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy. 14. Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-70.0, Tubular Breast Cancer Mucinous Breast Cancer Invasive Ductal Breast Cancer Inflammatory Breast Cancer Women aged ≥18years and ≤70 years; 2. At least on measurable disease according to the Response Evaluation in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-3M0; 3. ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER and/or PR positive was defined as >1% stained cells.HER2-positive is defined as immuno-histochemistry (IHC) 3+ or the ratio of HER2 gene signals to chromosome 17 signals >2.0 or HER2 gene copy >6.0. 4. No prior systemic or loco-regional treatment of breast cancer; 5. Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit (UNL), creatinine≤1.5 UNL, bilirubin≤1.5UNL; 6. No obvious main organs dysfunction Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug; 2. Patient is pregnant or breast feeding; 3. Inflammatory breast cancer and metastatic breast cancer; 4. Any evidence of sense or motor nerve disorders; 5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection; 6. Any concurrent malignancy other than breast cancer; 7. Know severe hypersensitivity to any drugs in this study
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Patients must have a histologically confirmed diagnosis of hormone receptor positive, HER2 negative invasive breast carcinoma Tumors must be estrogen and/or progesterone receptor positive according to ASCO/CAP 2010 guidelines as either ER or PR ≥ 1% positive nuclear staining by immunohistochemistry. Estrogen and/or progesterone receptor results by Oncotype Dx will not be accepted Tumors must be HER2 negative as defined according to ASCO/CAP 2013, as HER2 0 by IHC or non-amplified FISH or CISH. If HER2 IHC is 2+, FISH/CISH must be performed and must not be positive (must be a ratio of < 2), but otherwise FISH/CISH is not required if IHC is 0 or 1+ by institutional standards Patients must not have had prior ipsilateral breast-conserving surgery or total mastectomy and be eligible for neoadjuvant treatment Clinical Stage II-IIIC (T2-4 N0-3 M0) by mammogram, ultrasound or MRI Baseline Oncotpye Dx recurrence score < 25 Staging studies with a CT scan of the chest and abdomen and bone scan, or a PET/CT is required for clinical stage III, and are considered optional for stage II breast cancers Patients with multifocal, multicentric and synchronous bilateral breast cancers are allowed Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant Patients must not have inflammatory breast cancer (T4d) and must not have metastatic breast cancer (Stage IV disease) Patients must not have prior exposure to mTOR inhibitors (e.g. rapamycin, everolimus, sirolimus, temsirolimus, deforolimus) Patients must not have prior treatment with any investigational drug within the preceding 28 days and must not be planning to receive any other investigational drug for the duration of the study Patient may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) Uncontrolled diabetes mellitus as defined by HbA1c >8% within 28 days prior to registration despite adequate therapy Patients who have any severe and/or uncontrolled cardiac disease within ≤ 6 months prior to start of everolimus, including: unstable angina pectoris, Symptomatic congestive heart failure of New York heart Association Class III or IV, myocardial infarction, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease Patients must not have an organ allograft or other history of immune compromise Patients must not be receiving chronic, systemic treatment with corticosteroids or other immunosuppressive agent. Topical or inhaled corticosteroids are allowed Patients must not have a known history of HIV seropositivity Patients must not have a known diagnosis of hepatitis B or C. Patients with the following risk factors must have hepatitis screening pre-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): 30.0-49.0, Cervical Neoplasia Cervical Cancer female, age 30-49, able to give informed consent pregnancy, gross cervical mass, prior cervical cancer, unable to give informed consent, prior complete hysterectomy, allergic to acetic acid
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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, Neonatal Infection Health Centers: historically, a health center which providing services for more than 20 births per month Individuals: women in the last trimester of pregnancy with any ethnicity, age is equal or older than 18 years, and pregnancy results in a live birth Birth of baby with known congenital malformation Inability to obtain informed consent or adhere to protocol
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 40.0-999.0, Breast Cancer Breast single tumor Clearly visible by ultrasound Diameter < 2 cm Located >1 cm from the chest wall and skin Ductal carcinoma according to previous biopsy < 20% of intraductal carcinoma Breast cancer in men Personal history of ipsilateral breast cancer Age <40 years Pregnancy or breastfeeding Suspicion of intraductal extension or multifocality by mammography or MRI Tumour not visible by ultrasound Diameter > 2 cm Distance to muscle or skin <1 cm Lobular carcinoma Intraductal carcinoma in > 20% of the biopsy sample
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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, Breast Cancer Histologically documented invasive adenocarcinoma (any subtype) of the breast with clinical stage T1-2 (0-5 cm) and pathologic stage N0-1, M0 disease Lumpectomy with 1-2 cm margin required within 9 weeks of initiation of protocol radiotherapy Axillary dissection required for premenopausal patients and recommended for postmenopausal patients (Irradiation of clinically negative axilla is an acceptable alternative to axillary dissection in postmenopausal patients) Residual microcalcification on postoperative mammogram Gross residual disease in the breast (re-excision allowed if there is gross residual disease after first surgical procedure) Multiple foci of tumor in more than 1 quadrant Previous or concurrent malignant tumor in contralateral breast In situ carcinoma of the breast, without invasive tumor Tumorectomy performed more than 9 weeks before the start of radiotherapy in cases where no adjuvant chemotherapy is given and more than 6 months before the start of radiotherapy if chemotherapy is given Previous history of malignant disease, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin Concurrent pregnancy or lactation Eastern Cooperative Oncology Group performance scale more than 2
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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 years or older Eastern Cooperative Oncology Group (ECOG) performance status 0,1 AJCC stage I III non-inflammatory, HER2-positive (according to ASCO-CAP guidelines 5) breast cancer Completed neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy and underwent surgery with final pathology showing evidence of residual disease in the breast or axilla (residual ductal carcinoma in situ or microinvasive disease not eligible) or underwent surgery as a first intervention and was found to be pathologically node-positive: ≥ 4 positive lymph nodes (pN2 or pN3) regardless of hormone receptor status or 1-3 positive lymph nodes (pN1) if hormone receptor negative. Patients with micrometastases (pN1mi) are not eligible Completed an approved regimen of neoadjuvant or adjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy with plan for completion of one year of trastuzumab therapy Completed appropriate surgical therapy to 1. Total mastectomy and axillary staging with sentinel lymph node dissection or axillary lymph node dissection (level I/II). Patients with a positive sentinel lymph node must have undergone a completion axillary lymph node dissection. 2. Breast conserving surgery (BCS) and axillary staging with sentinel lymph node dissection or axillary lymph node dissection. Patients undergoing surgery as a first intervention with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II unless they had clinically node negative T1-T2 tumors and fewer than 3 involved lymph nodes. Patients receiving neoadjuvant chemotherapy that have a positive sentinel lymph node must have undergone a completion axillary lymph node dissection. 3. Completed or receiving appropriate radiation therapy if indicated: For patients undergoing total mastectomy surgery as a first intervention, post-mastectomy radiation to the chest wall, infraclavicular and supraclavicular areas is required for patients with ≥ 4 positive lymph nodes. Radiation to the internal mammary lymph nodes is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patients with 1-3 positive lymph nodes, post-mastectomy radiation to the chest wall, infraclavicular, supraclavicular, and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist For patients undergoing breast conserving surgery (BCS) as a first intervention, whole breast irradiation with or without a boost, and radiation to the infraclavicular and supraclavicular areas is required for patients with ≥ 4 positive lymph nodes. Radiation to the internal mammary lymph nodes is not required but is allowed at the discretion of the patient's treating radiation oncologist. For patients with 1-3 positive lymph nodes, whole breast irradiation with or without a boost is required. Radiation to the infraclavicular, supraclavicular, and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating medical oncologist For patient's undergoing mastectomy after neoadjuvant chemotherapy post-mastectomy radiation to the chest wall, infraclavicular and supraclavicular areas is required for patients presenting with clinical N2 or N3 disease or with ≥ 4 positive lymph nodes identified pathologically at the time of surgery. Radiation to the internal mammary lymph nodes is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patients with 0-3 positive lymph nodes identified pathologically, post-mastectomy radiation to the chest wall, infraclavicular, supraclavicular and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist For patient's undergoing BCS after neoadjuvant chemotherapy, whole breast irradiation with or without a boost is required. For patients with clinical N2 or N3 disease or with ≥ 4 positive lymph nodes identified pathologically at the time of surgery, radiation to the infraclavicular and supraclavicular areas is required. Radiation to the internal mammary lymph nodes is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patients with 0-3 positive lymph nodes identified pathologically, radiation to the infraclavicular, supraclavicular and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist AJCC Stage IV breast cancer NYHA stage 3 or 4 congestive heart failure Immune deficiency disease or known history of HIV, HBV, HCV Receiving immunosuppressive therapy including chronic steroids, methotrexate, or other known immunosuppressive agents Pregnancy (assessed by urine HCG) Breast feeding Any active autoimmune disease requiring treatment, with the exception of vitiligo Active pulmonary disease requiring medication to multiple inhalers (>3 inhalers including one containing steroids) Involved in other experimental protocols except with permission of other PI
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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, Cancer of the Breast Anomaly of Breast Women Age 18 > y/o If patient has had lumpectomy and radiation, need to be at least 3 years out from completion of radiation Must be a Kaiser Permanente Northwest Member Active smokers, cannot quit smoking for at least one month before and after procedures Patients who have such extensive skin scarring that elasticity is lost Patients who have little to no subcutaneous donor fat Patients with BIRAD's 3 or greater mammograms after treatment Patients with aggressive cancer for which cure is the goal (do not want to patients that want palliative procedure) inflammatory breast cancer Patients with triple negative cancer ER -, PR -, Her2-neu - Patients with BRCA or CHEK-2 gene mutations or those with strong family history of breast cancer [more than 2 first degree relatives with breast cancer] Patients that have had a lumpectomy for breast cancer who have declined radiation therapy when it was recommended to reduce risk of local recurrence (should not patients over 70 y/o who have elected to have lumpectomy and anti-estrogen therapy instead of lumpectomy and radiation)
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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, HER-2 Positive Breast Cancer Breast Cancer Stage II Breast Cancer Stage III Breast Cancer Patients must have HER2-positive Stage II or III histologically confirmed invasive carcinoma of the breast. A minimum tumor size of 2 cm determined by physical exam or imaging is required HER-2 positive, confirmed by central testing (Clarient labs): IHC 3+ and/or FISH positive based on one of the three following Single-probe average HER2 copy number≥6.0 signals/cell OR Dual-probe HER2/CEP17 <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 Bilateral breast cancers are allowed if both cancers are HER2-positive Patients with multifocal or multicentric disease are eligible as long as one area meets criteria Breast imaging should the ipsilateral axilla. For subjects with a clinically negative axilla, a sentinel lymph node biopsy will be performed either before or after preoperative therapy at the discretion of the subject's physicians. For subjects with a clinically positive axilla, a needle aspiration, core biopsy or SLN procedure will be performed to determine the presence of metastatic disease in the lymph nodes Men and women (with any menopausal status) ≥ 18 years of age 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 enrollment Patients with active liver disease, for example, due to hepatitis B virus, hepatitis C virus, autoimmune hepatic disorder, or sclerosing cholangitis 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) Grade II or higher, or serious cardiac arrhythmia requiring medication Significant symptoms (Grade ≥2) 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): 18.0-999.0, Breast Cancer Infiltrating, ductal carcinoma of the breast. 2. Treated with conservative surgery (tumorectomy or quadrantectomy) without lymphadenectomy. 3. Sentinel lymph node assessed by OSNA, with TTL in the range 250 000 copies/μL. 4. Age ≥ 18 yrs old. 5. Karnofsky Index ≥ 70 %. 6. Signed Informed Consent Other types of breast cancer different from infiltrating ductal carcinoma. 2. Bilateral breast cancer. 3. Males. 4. Mastectomy or axillary homolateral lymph node dissection. 5. Previous thoracic irradiation therapy. 6. Systemic neoadjuvant therapy previous to surgery. 7. Contraindications of radiotherapy (pregnancy, severe collagen diseases). 8. Other neoplasms. 9. Severe associated comorbidities that, according to the investigator may interfere with the study evaluations
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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): 50.0-99.0, Breast Cancer DCIS Invasive Ductal Carcinoma -Newly diagnosed Stage 0 or I breast cancer On histological examination, the tumor must be DCIS or invasive non-lobular carcinoma of the breast Surgical treatment of the breast must have been wide excision, lumpectomy or partial mastectomy Age 50 years or greater ER positive: (≥1% of breast tumor cells express ER in their nuclei) PR (progesterone receptor) positive: (≥ 1% of breast tumor cells express PR in their nuclei) Her2 negative (IHC 0-1+; for IHC 2+, FISH (fluorescence in situ hybridization) must be non-amplified) Subjects with invasive tumors should undergo axillary sentinel lymph node evaluation or axillary lymph node dissection Negative inked surgical margins of excision or re-excision, clear of invasive tumor (no cells on ink) and DCIS by at least 1 mm Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications with no remaining suspicious calcifications in the breast before radiotherapy. Alternatively, a specimen radiograph can be obtained showing all the suspicious calcifications -Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma Patients with tumors greater than 2 cm Patients with surgical margins which cannot be microscopically assessed or not cleared by at least 2mm at pathological evaluation Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy. Breast MRI will be recommended to multicentric disease and additional suspicious areas will require biopsy to malignancy Patient with lymphovascular space invasion (LVSI) Patients with involved axillary nodes Patients with collagen vascular diseases Patient with known deleterious BRCA1/2 mutations or known mutations in other high penetrance genes (TP53, STK11, PTEN-phosphatase and tensin homolog, CDH1) Patients with prior ipsilateral breast irradiation Patients with prior ipsilateral thoracic irradiation
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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): 60.0-999.0, Breast Cancer Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer Patient agrees to evaluation of the axilla with sentinel lymph node biopsy Post-menopausal women age > 60, defined as women who have experienced no menstrual period in the past 12 months BRCA1 and 2 gene mutation negative, if tested. [genetic testing is NOT required based upon personal or family history] Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) < 2.0 cm in diameter, primary T-stage of T1 (AJCC criteria) Grade 1, 2 acceptable Associated LCIS is allowed Estrogen receptor (ER) status of positive Negative margins at ink on gross pathologic examination Patient is node-negative, defined as N0 (i-) or N0 (i+) Prior breast malignancy or other malignancy if metastatic, or with expected survival of < 5 years Immuno-compromised status Pregnancy Women with an active connective tissue disorder (i.e. scleroderma, lupus and others) Breast cancer that involves the skin or chest wall, locally advanced breast cancer Pure DCIS, all grades Invasive lobular carcinoma Evidence of lymphovascular invasion (LVI) Invasive carcinoma with extensive intraductal component (EIC) Neoadjuvant chemotherapy indicated
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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 Newly diagnosed infiltrating ductal carcinoma (IDC) of the breast >= 1.0 cm primary tumor Calculated creatinine clearance >= 50 mL/min Willing and able to provide informed consent Age ≥ 18 years ECOG performance status 0-2 Informed of the investigational nature of this study Allergy to iodinated contrast agent Use of metformin, aminoglycosides, other nephrotoxic medications, or daily use of NSAIDs Diabetes mellitus History of severe claustrophobia Presence of electrically, magnetically, or mechanically activated implants including cardiac pacemakers, cochlear implants, magnetic surgical clips or prosthesis that would preclude MRI Use of > 1 antihypertensive drug Pregnancy or breastfeeding Paraproteinemia syndromes or multiple myeloma Collagen vascular disease Active hyperthyroidism
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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 Neoplasms Tumor diameter < 5 cm Low grade ductal carcinoma in situ Candidate for breast-conserving surgery Must have undergone lumpectomy with negative margins or minimal margin involvement Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection No evidence of metastatic disease Informed consent No informed consent Tumor size > 5 cm Intermediate or high grade ductal carcinoma in situ Invasive carcinoma No indication for a boost
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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): 17.0-80.0, Breast Neoplasms Tumor diameter ≤3 cm Tumor from the papilla>2cm Low grade ductal carcinoma in situ Candidate for breast-conserving surgery Must have undergone lumpectomy with negative margins or minimal margin involvement Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection No evidence of metastatic disease Informed consent No informed consent Tumor size > 3 cm Tumor from the papilla≤2cm Intermediate or high grade ductal carcinoma in situ Invasive carcinoma No indication for a boost
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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, Polycythemia Vera Essential Thrombocythemia (Patient should meet all the criteria) JAK2V617F-positive PV or JAK2V617F-positive ET (confirmed by WHO diagnostic criteria) High risk ET/PV [age >60; history of thrombosis] or low risk disease with symptoms [recurrent headaches, paresthesias, pruritus] Previously treated with at least one other agent [hydroxyurea, interferon, anagrelide] and determined to be either intolerant/resistant -≥18 years of age Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 Acceptable pre-study organ function during screening as defined as: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) unless due to Gilbert's disease or hemolysis, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN, Serum creatinine ≤ 1.5 x ULN Women of childbearing potential and males must agree to use adequate contraception (i.e., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female subject become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately Ability to understand and willingness to sign a written informed consent document Meets the for post ET/PV MF as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Blast phase disease (>20% blasts in the marrow or peripheral blood) Acute thrombosis within 3 months of screening Uncontrolled intercurrent illness including, but not limited to hepatitis, human immunodeficiency virus (HIV) positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with 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): 18.0-999.0, Postpartum Hemorrhage A patient will be considered for in the study if she meets all of the following She has a term (≥37 completed weeks) live singleton gestation in cephalic presentation and has been admitted to the Labor and Delivery Unit She is in the latent phase of labor or has been admitted for induction of labor or at prenatal clinic visit She has had fewer than four prior vaginal deliveries She reports no allergy to misoprostol. The following factors or conditions will a patient from consideration as a subject The fetus has a known major fetal malformation or chromosome abnormality The gestation is multiple There is a breech or other malpresentation The patient reports involvement in another clinical trial currently or previously in this pregnancy The patient is expected to have a cesarean delivery
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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, HER2 Positive Metastatic Breast Cancer Aged ≥18 and ≤70 years ECOG performance status of 0 to 1 Life expectancy of more than 12 weeks At least one measurable lesion exists.(RECIST 1.1) Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies 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;BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: < 470 ms for female and < 450 ms for male Signed informed consent Received previous therapy with lapatinib, neratinib, pyrotinib or any other HER2 directe tyrosine kinase inhibitor Received previous therapy with capecitabine within 3 months
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Newly diagnosed with Multiple Myeloma requiring treatment The patient must be able to speak and understand Danish and be able to give his/her informed consent Patients with spinal cord compression Unstable vertebral fracture (SINS score >12) (52) Untreated cardiac failure and untreated cardiac arrythmia Severe chronic cardiac failure (NYHA 3-4) Other severe comorbidity that will not allow physical training, e.g. neurological or uncompensated liver failure and psychological or psychiatric disorder that will not allow compliance in physical training
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Women over the age of 18 with both incidental in situ and infiltrating breast cancer Lymphoma, sarcoma, lobular carcinoma in situ and inflammatory carcinoma of the breast are excluded
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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, Estrogen Receptor Negative HER2/Neu Negative Invasive Breast Carcinoma Progesterone Receptor Negative Stage II Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage III Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Triple-Negative Breast Carcinoma FOR AND (STEP 0) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 2 weeks prior to screening Female and male patients must have histologically confirmed invasive breast cancer that meets the following Clinical stage II-III (American Joint Committee on Cancer [AJCC] 7th edition) at diagnosis, based on initial evaluation by clinical examination and/or breast imaging; no metastatic disease allowed and PR should meet one of the following =< 10% cells stain positive, with weak intensity score (equivalent to Allred score =< 3) =< 1% cells stain positive, with weak or intermediate intensity score (equivalent to Allred score =< 3) HER2 negative (not eligible for anti-HER2 therapy) will be defined as Immunohistochemistry (IHC) 0, 1+ without in situ hybridization (ISH) HER2/neu chromosome 17 ratio OR
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 50.0-999.0, Breast Cancer Female Age ≥ 50 years at diagnosis Grade 1-3 invasive ductal, mucinous, tubular, colloidal, or pure ductal carcinoma in situ (DCIS) measuring ≤ 2cm (clinical stage T1) Estrogen Receptor (ER)+ (ER DCIS meeting other are eligible) Unicentric: Patients with microscopic multifocality are eligible as long as the total pathologic tumor size is <2cm Surgical treatment of the breast must have been lumpectomy The final margins of the resected specimen must be histologically free of tumor Pathologically node negative Note: For patients with T1a, T1b, T1c invasive breast cancer (except T1mi), an axillary staging procedure should be performed (either sentinel lymph node biopsy alone or axillary dissection and the axillary node must be pathologically negative). Patients with N0 (i+) tumors on sentinel lymph node mapping or dissection (i.e., if the tumor deposit is 0.2mm or less as determined by immunohistochemistry or hematoxylin and eosin staining) will also be eligible ECOG Performance Status of 0 or 1 Negative pregnancy test done ≤7 days prior to registration, for women of childbearing potential only Any of the following because this study involves therapy that has known genotoxic, mutagenic and teratogenic effects Pregnant women Nursing women Women of childbearing potential who are unwilling to employ adequate contraception Neoadjuvant chemotherapy Prior history of ipsilateral breast cancer Prior radiation therapy to the ipsilateral breast or thorax Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens Active collagen-vascular disease that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient Paget's disease of the breast
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1
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Breast Cancer Right or Left Breast Mammary Reconstruction Malignant Neoplasm Reconstruction by Tattoo of Areola of Female Breast technology areola tattoo realized as part of 1 breast mammary reconstruction following an operated breast cancer Two breasts operated patient surgical reconstruction
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Women (age 18-100) undergoing preoperative evaluation at the University of Kansas Cancer Center (KUCC) for a new diagnosis of breast cancer Patients with a diagnosis of breast cancer by either core needle biopsy or excisional biopsy Bilateral mammography and hand-held ultrasound (if clinically indicated) performed prior to the MRI and ABUS If a breast MRI is advised and there is no contraindication to MRI, a breast MRI and ABUS will performed at KUCC (Study Arm 1) If a breast MRI is not performed, an ABUS exam without MRI will be performed (Study Arm 2) The MRI and ABUS exam must be obtained within 2 weeks of each other Males Pregnant women Lactating women Patients < 18 and > 100 years of age Patients with breast implants
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Flat Epithelia Atypia Intraductal Papilloma Without Atypia Women all races and ethnic groups are eligible for this trial. This trial is open to the accrual of women only Patients must be women Patients must be at least 18 years of age Patients must have an imaging abnormality that necessitated a core needle biopsy The imaging abnormality must have been categorized as Breast Imaging-Reporting and Data System (BIRADS) level 1-4 lesion There is documented concordance* between the initial breast imaging finding and the core biopsy pathology report. The core needle biopsy must contain FEA or IPWA, according to the local pathologist. (It is possible that the central pathology review which is done after the patient is registered on this protocol will have a diagnosis discrepant from that made by the original institution's pathologist. In that case, the study team will communicate this to the original institution's site investigator within one week of the date of the central pathology review having been finalized). Patients may have a personal history of prior or concurrent fibroadenoma and a prior history of proliferative breast lesions with or without atypia Patients must be registered on study within 100 days after core needle biopsy Patients must have an ability to understand and the willingness to sign a written informed consent document. The patient is still eligible for this study even if she declines consent for her tissue to be used for any (or all) of the correlative studies described in this document and/or if she declines consent for her tissue to go into a tissue bank for future unspecified research Concordance is a determination by the radiologist (or his or her covering provider) performing an image-guided core needle biopsy that the pathology report from this procedure corresponds to the imaging appearance of a given lesion and that the said lesion's most representative portion has been sampled Personal history and/or concomitant diagnosis of invasive breast cancer or DCIS Palpable abnormality diagnosed by core needle biopsy to be FEA or IPWA Pathologic nipple discharge associated with IPWA (spontaneous bloody or clear persistent single duct discharge) A 5 lesion Discordance between the initial breast imaging finding and the core biopsy pathology report The presence of atypical ductal hyperplasia (ADH) on core biopsy Known current pregnancy. A pregnancy test is not required for this Women who are breastfeeding Patient registered on study more than 100 days since the date of core needle biopsy
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Patients attending the breast clinic undergoing mammography and/or ultrasound who can give written informed consent The investigators aim to recruit 150 patients likely to have breast cancer clinically and 150 patients who have normal breasts/benign abnormalities Patients unable to give written informed consent Patients not having appropriate imaging (mammography +/ ultrasound)
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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 Node-positive Breast Cancer Breast Adenocarcinoma Invasive Breast Carcinoma Lobular Breast Carcinoma In Situ Karnofsky performance status of 70-100% Histologic documentation of invasive adenocarcinoma of the breast One of the breast disease stages listed below Note: In the definitions below, definitive surgery is defined as the final surgery performed to obtain clear surgical margins Neoadjuvant chemotherapy was not administered ** If neoadjuvant chemotherapy was NOT administered, pathologic staging must be T1-3, N1-2a following definitive surgery Neoadjuvant chemotherapy was administered If prior to initiation of neoadjuvant chemotherapy clinical staging was T1-3, N0, pathologic staging must be T1-3, N1-2a following definitive surgery If prior to initiation of neoadjuvant chemotherapy clinical staging was T1-3, N1, pathologic staging must be T0-3, N0-2a following definitive surgery If prior to initiation of neoadjuvant chemotherapy there was cytologic or pathologic confirmation of axillary nodal involvement (per any of the listed below), pathologic staging must be T0-3, N0-2a following definitive surgery Positive fine-needle aspiration (FNA) (ie, demonstrating malignant cells) Known definitive clinical or radiologic evidence of metastatic disease T4 tumors including inflammatory breast cancer Clinical nodal staging of N2 or N3 disease Pathologic nodal staging of N2b, N2c, or N3 disease Microscopic positive margins after definitive surgery * Note: Patients with microscopically focally positive margins following lumpectomy or mastectomy are not excluded if re-excision is not technically feasible and/or there is no benefit to further surgery based on the extent and location of the positive margin Any history, not including the index cancer, of ipsilateral or contralateral invasive breast cancer or ipsilateral or contralateral DCIS treated with radiation therapy (RT) * Note: Patients with synchronous or previous ipsilateral LCIS are eligible Any radiation therapy (RT) for the currently diagnosed breast cancer prior to study enrollment History of ipsilateral or contralateral breast or thoracic RT for any condition History of ipsilateral or contralateral axillary surgery for any condition History of lymphedema involving the ipsilateral or contralateral arm at present or at any time in the past
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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): 45.0-999.0, Ductal Breast Carcinoma In Situ Estrogen Receptor Positive Invasive Breast Carcinoma Progesterone Receptor Positive Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Must sign informed consent Surgical treatment of the breast must have been lumpectomy; the margins of the resected specimen must be histologically free of tumor (negative surgical margins per National Surgical Adjuvant Breast and Bowel Project [NSABP] criteria) On histologic examination, the tumor must be ductal carcinoma in situ (DCIS) and/or invasive breast carcinoma For patients with invasive breast cancer, an axillary staging procedure must be performed (either sentinel node biopsy [SNB] alone or axillary dissection [with a minimum of six axillary nodes removed], and the axillary node[s] must be pathologically negative); patients over 70 with estrogen receptor positive (ER+) tumors no greater than 2 cm do not require axillary evaluation, but MUST be clinically node negative on examination and all available imaging (clinical N0) The T stage must be Tis, T1, or T2; if T2, the tumor must be =< 3.0 cm in maximum diameter Estrogen receptor positive tumor and/or progesterone receptor positive tumor Pregnant or breast-feeding Active collagen-vascular disease Paget's disease of the breast Prior history of DCIS or invasive breast cancer Prior breast or thoracic radiation therapy (RT) for any condition Multicentric carcinoma (DCIS or invasive) Synchronous bilateral invasive or non-invasive breast cancer Surgical margins that cannot be microscopically assessed or that are positive Positive axillary node(s) T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage >= 3
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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): 18.0-70.0, Intrahepatic Cholangiocarcinoma Male or female patients > 18 years and <=70 years of age Diagnosis of intrahepatic cholangiocarcinoma ( through imaging, serology, intraoperative frozen, etc.) No lymph node metastasis preoperatively or intraoperatively Tumors can be completely resected of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value Patients who can understand this trial and have signed information consent. Criteria:Lymph node metastasis preoperatively Tumors can not be resected Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment of Intrahepatic cholangiocarcinoma Patients with a medical history of other malignant tumors Subjects 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): 18.0-80.0, Pain, Postoperative Postoperative Nausea and Vomiting Primary breast cancer without known extension beyond the breast and axillary nodes (i.e. believed to be Tumor Stage 1-3, Nodes 0-2) Scheduled for unilateral or bilateral mastectomy with or without implant (isolated "lumpectomy" will not qualify) Isolated "lumpectomy" with axillary node dissection (anticipated removal of at least five nodes) Written informed consent, including willingness to be randomized to opioids or regional analgesia Dutch speaking Previous surgery for breast cancer (except diagnostic biopsies) Inflammatory breast cancer Scheduled free flap reconstruction ASA Physical Status ≥ 4 Any contraindication to locoregional analgesia (including coagulopathy, abnormal anatomy) Any contraindication to midazolam, propofol, sevoflurane, sufentanyl, tramadol or piritramide Other cancer not believed by the attending surgeon to be in long-term remission Systemic disease believed by the attending surgeon to present ≥ 25% two-year mortality Obesity defined as BMI ≥ 30 kg/m2 Chronic use of pain medication (started > 3 months ago)
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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 Neoplasms Women aged ≥18 years and < 70 years with life expectancy > 12 months 2. Have finished radical operation, pathologically verified no lymph node involvement 3. Operation specimens are available for ER, progesterone receptor (PR) and Her2 detection, patients should be with ER positive, Her2 negative tumor. 4. Adequate bone marrow function 5. Adequate liver and renal function 6. Has Eastern Cooperative Oncology Group (ECOG0 Performance Score 0-1; 7. Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study; 8. Written informed consent according to the local ethics committee requirements Prior systemic or loco-regional treatment of breast cancer, including chemotherapy; 2. Metastatic breast cancer; 3. With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma; 4. Patients with medical conditions that indicate intolerant to adjuvant chemotherapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitus, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease; 5. Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive; 6. History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension; 7. Has peripheral neuropathy ≥ grade 1; 8. Patient is pregnant or breast feeding; 9. Known severe hypersensitivity to any drugs in this study; 10. Treatment with any investigational drugs within 30 days before the beginning 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): 9.0-999.0, Hyperhidrosis Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance Male or females Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with glycopyrronium contraindicated Male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy Any other condition which, in the judgement of the Investigator, would put the subject at unacceptable risk for 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): 18.0-999.0, Foot Ulcer, Diabetic Epidermal Growth Factor DM type 1 or 2 diagnosis 2. DFU persisting for a minimum of 4 weeks If the participant have more than one DFU, then it will be treated the one with the largest extension and that follows the and 3. DFU 's rating according to the PEDIS system:Perfusion: grades 1 or 2; Extension: Area ≥ 2 cm2; Depth: grades 2 or 3; Infection: grades 1 or 2; Sensitivity: grade 2 If the consented participant is classified as having infection grade 3 without the presence of osteomyelitis, it will be possible to treat it with antibiotics empirically. However, randomization will be made only after this treatment and only if the infection has regressed to grade 1 or 2 Age less than 18 years; 2. Pregnancy or breastfeeding (women in childbearing age will need to use a contraception method); 3. Evidence of bone involvement : direct visualization of bone structures; positive survey (probe to bone) ; image investigation (simple x-ray or MRI); 4. Urgent or imminent need of amputation; 5. Eminent indication for revascularization; 6. Glycated hemoglobin (HbA1c) counted greater than 11 % 7. Use of drugs that can affect or contribute to the healing of ulcers as corticosteroids; immunosuppressive; chemotherapy; other growth factors; 8. Clinical signs of malnutrition or serum albumin <30 g / L; 9. Angina pectoris classified as 3 or 4 (according to the Canadian Cardiovascular Society Angina Classification); 10. Congestive heart failure class IV (according to the New York Heart Association); 11. Severe hepatic impairment, defined as ALT and / or AST greater than 5 (five) times the normal maximum reference value; 12. Acute renal failure, defined as serum creatinine levels equal or higher than 1.5 times the baseline value in the last 7 days (according to KDIGO and RIFLE classification); 13. End-stage renal disease (creatinine clearance equal or lower than 30 ml / min or on dialysis); 14. History or suspected neoplasia (according to previous laboratory tests, imaging or biopsy); 15. Psychiatric disorders that may alter the participants evaluation, or prevent proper consent and / or cognitive aspects that demonstrate the possibility of noncompliance with treatment or the adoption of aseptic criteria; 16. Occurrence of the following events 30 days prior to in the protocol: participation in other clinical studies; hypoglycemic coma (blood glucose less than or equal to 30 mg / dL with loss of consciousness or need for help); diabetic ketoacidosis or hyperosmolar state within 30 days prior to inclusion; 17. Occurrence of the following events 60 days prior to in the protocol: hospitalization for acute coronary syndrome, percutaneous intervention (eg cardiac, cerebrovascular, aortic) or greater cardiac surgery; myocardial infarction; cerebrovascular accident; cardiac arrest; sustained ventricular tachycardia; acute coronary syndrome, in investigator opinion; uncontrolled severe hypertension, defined as systolic blood pressure equal or higher than 180 mmHg and / or diastolic blood pressure equal or higher than 110 mmHg
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer women breast cancer diagnosis all races will be included men those with no breast cancer (ductal carcinoma in situ) pregnant women children
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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): 65.0-999.0, Breast Cancer Female age 65 and older Staging: 1. Patients enrolled prior to surgery: Diagnosis of clinical T1-2N0 ER+ invasive breast cancer as determined by treating physician. DCIS or LCIS may be present with invasive cancer. 2. Patients enrolled after surgery: pT1-2NX, or pT1-2N0, ER+ invasive breast cancer. DCIS or LCIS may be present with invasive cancer Plan to undergo lumpectomy within 3 months of study registration, or underwent lumpectomy within 60 days of study registration (without sentinel node biopsy) Patients in whom lymph nodes are palpable and not suspicious who are found to be nodal tumor-free by nodal core needle biopsy are permitted, but those with biopsy-proven nodal metastases are excluded Patients with diagnosis of ductal or lobular carcinoma in situ Patients with diagnosis of inflammatory breast cancer Patients who have undergone neoadjuvant chemotherapy for current primary breast cancer (past treatments for other cancers are acceptable) Patients planning to have mastectomy or had a mastectomy of the ipsilateral breast Prior history of ipsilateral (invasive or DCIS) breast cancer Diagnosis of clinical T3 or T4 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): 18.0-999.0, Breast Cancer Women years and older Histologically proven infiltrating carcinoma of the breast on diagnostic biopsy. NOTE: Individuals planning bilateral mastectomy procedures (for either bilateral cancers or contralateral prophylactic procedures) either at the same time or in the future will be asked to have tissue removed for the study from both breasts ER-negative, any PR status, and any HER2 status (i.e., ER-, PR any, HER2 or ER-, PR any, HER2+; "triple positive" breast cancers are not eligible) Unresected, untreated breast cancer planning surgical management with mastectomy (with or without axillary nodal evaluation/dissection and/or with any other clinical assessment) Willing and able to sign an informed consent form 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): 55.0-999.0, Carcinoma, Ductal, Breast Menopausal Non inflammatory unilateral and unifocal breast cancer with indication of lumpectomy Menopausal women with age > 55 years Tumor size <= 15 mm by ultrasonography Histological confirmation (by biopsy) of invasive ductal carcinoma with SBR (Scarff-Bloom-Richardson) grade (modified by Ellis & Elston) 1 or 2; hormone receptors positive (Estrogen Receptor and/or Progesterone Receptor) and negative Human epidermal growth factor receptor (HER2) Good lesion boundary with ultrasonography and MRI Minimal distance of 5 mm between the skin and the tumor Performance Status 0-1 Ability to understand and willingness to sign a written informed consent document Covered by a medical insurance Signed informed consent Invasive lobular carcinoma Tumor with retro-nipple location Extended microcalcifications (> 15 mm) with mammography Xylocaine allergy Patient deprived of freedom
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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 Samples that fulfill all of the will be evaluated for the study Samples of women aged greater than or equal to (>/=) 18 and less than (<) 75 years Tumor samples already diagnosed based on the IHC score of 0 to +3 Samples of primary lesions excluding lymph nodes percent (%) neutral buffered formalin-fixed and paraffin embedded tissue samples Samples that fulfill any of the below will not be included in the study Non-invasive ductal carcinoma (NOS) samples Tru-cut biopsies Non-breast cancer pathological samples
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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, Nail Abnormalities Age 18 years old or above 2. Being diagnosed nail surface abnormalities stably more than 3 months Having severe or uncontrolled concomitant diseases 2. Having nail infection 3. History of manicure within the last 1 month 4. Use of Biotin or other nail modifying drugs within the previous 3 months 5. Pregnancy or lactation
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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 Neoplasm Carcinoma, Ductal, Breast Carcinoma, Intraductal, Noninfiltrating Female patients at least 21 years old Patients with invasive ductal carcinoma staged T1 or T2 with estrogen receptor and progesterone receptor positive (ER+/PR+) who are scheduled for sentinel lymph node biopsy Patients with Ductal Carcinoma In Situ (DCIS) (high or low grade) who are scheduled for sentinel lymph node biopsy including Patients having a mastectomy Patients with palpable DCIS Patients undergoing breast conservation with large (>5cm) area of DCIS Patients with signed consent to participate Preoperative palpable axillary lymphadenopathy Preoperative ultrasound demonstrating suspicious adenopathy Previous axillary dissection or previous lymph node biopsy Patients with Invasive Lobular Carcinoma Patients who are pregnant
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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, Choledocholithiasis Bile Duct Diseases Bile Duct Carcinoma Patients 18 years of age or older Patients with choledocholithiasis, benign biliary strictures, malignant biliary strictures Biliary pathology suggested or confirmed by imaging with abdominal ultrasonography, CT scan, MRI/MRCP scan, or endoscopic ultrasonography (EUS) Pregnancy (self reported) Presence of cholangitis before ERCP Prior history of surgery on the stomach or duodenum that precludes conventional ERCP or prior biliary tree surgery (not including cholecystectomy) Failure to selectively cannulate the bile duct Life expectancy less than 30 days Prisoners Patients unable to give 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): 18.0-75.0, Breast Cancer histologically confirmed primary breast cancer by core needle biopsy or excisional biopsy 2. abnormal para-sentinel lymph node was found by ultrasound examination 3. ultrasound-guided fine needle aspiration cytology of these nodes were performed 4. the result of fine needle aspiration cytology was negative (no tumour cell was found) 5. patient planed to perform SLNB pathological diagnosed ductal carcinoma in situ by excisional biopsy 2. the result of fine needle aspiration cytology was positive 3. patient has received neo-adjuvant system therapy
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Breast Cancer Postmenopausal women (one year after menses stop) 2. Confirmed diagnosis of breast cancer 3. Tumors with higher expression PR > 50 % measured by IHC and PRA/RPB ratio equal or higher than 1.5 measured by WB 4. All clinical stages with tumor size greater than 1.5 cm to allow obtaining material from biopsy cores 5. OMS condition: 1 Adequate function of organs and systems Hematopoietic parameters Hemoglobin: 10 gr/mL Neutrophil counting: 1.500/mm3 CD4 counting: 400/mm3 Platelets counting: 100.000/mm3 Liver parameters Total albumin: 1.5 fold normal limit AST/ALT: 1.5 fold normal limit Renal Creatinine: 1.5 fold normal limit 6. Absence of other controlled disease 7. Patients willing to sign consent Patients with no recommended surgery 2. Patients which have received any other treatment for this cancer 3. Patients expressing ER but expressing PRA/PRB levels lower than 1.5 4. Hepatitis infection (HBV o HCV) 5. HIV infection. 6. Cognitive alterations which limit the understanding of the protocol or compliance to the protocol 7. Prolonged QT/QTc basal interval
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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, Osteoarthritis Arthroplasty Patients undergoing unilateral primary total hip arthroplasty by Dr. James Verner at Beaumont Hospital Royal Oak Have a diagnosis of primary osteoarthritis (i.e. degenerative joint disease) Surgical approach is anterior Minors (age less than 18 years) Pregnant (surgically sterile, post-menopausal, or negative blood test) Previous ipsilateral hip surgery Lumbar instrumentation Acute trauma Rheumatoid arthritis Avascular necrosis Hip dysplasia Known sensitivity, allergy, or contraindication to anesthetics being used in the study Narcotic sensitivity
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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 Samples derived from men and women of age greater than or equal to (>/=) 18 years Samples derived from participants with any stage of histologically confirmed invasive breast cancer with HER2 diagnostics performed within routine (histo-)pathological workup or (Histo-)Pathological work-up of the tumor sample as at or after start of this study Available information on the year of birth of the participant No pre-selection of tumor samples is allowed. Tumor samples have to be documented consecutively in the order of their (histo-)pathological work-up Sample derived from participants with any stage of breast cancer with no HER2 diagnostics performed at the time of routine (histo-)pathological work-up Samples derived prior to the start of this study
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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 Eligible to receive chemotherapy and endocrine therapy as defined by a good Karnofsky index (≥80) and no hematologic, cardiologic or hepatic contraindications, nor any impeding comorbidity Informed consent form signed on the same day or before enrollment ≥ 18 years of age at time of consent Per study arm Histologically proven invasive stage I and II breast cancer and Hormone Receptor positive (ER+ PR-, ER PR+ or ER+ PR+) according to local standards & HER2 negative: IHC 0-1+, or FISH or other ISH non-amplified (locally assessed) IMPACt study; version 1 2015 September 1 Page 10 Axillary lymph node status: 0-3 involved (macro metastases i.e. >2mm OR micro metastases i.e. >0.2-2mm) OR Histologically proven invasive T1a or T1b breast cancer & Hormone receptor negative (ER- and PR-) according to local standards & HER2 negative: IHC 0-1+, or FISH or other ISH non-amplified (locally assessed) & Axillary lymph node status: 0-1 involved (macro metastases i.e. >2mm OR micro metastases i.e. >0.2-2mm) OR Histologically proven invasive T1a or T1b breast cancer & Hormone receptor negative or positive (ER-PR-, ER+PR-, ER-PR+, ER+PR+) according to local standards & HER2 positive: IHC 3+, or FISH or other ISH amplified (locally assessed) & Axillary lymph node status: 0-1 involved (macro metastases i.e. >2mm OR micro metastases i.e. >0.2-2mm) Previous diagnosis of breast malignancy unless disease free for 10 years Metastatic disease Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC Women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy for current breast cancer
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Early Stage Breast Cancer Ductal carcinoma in situ (DCIS) or invasive epithelial (ductal, medullary, papillary, mucinous (colloid), or tubular histologies Willing and able to provide consent Age >=18 years Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Appropriate staging studies identifying as American Joint Committee on Cancer (AJCC) stage 0, I, or II breast cancer. If stage II, the tumor size must be 3 cm or less Surgical treatment of the breast with lumpectomy Clinical Target Volume (CTV) margin up to 5 cm in maximum dimension with histologically confirmed margins free of tumor (negative margins defined as no tumor on ink in all directions). Re-excision of surgical margins is permitted Gross disease within the breast must be unifocal. (Patients with microscopic multifocality are eligible as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension 3 cm or less) Patients with invasive disease are required to have axillary staging including: sentinel node biopsy alone if sentinel node is negative, sentinel node biopsy followed by axillary dissection with a minimum of 6 axillary nodes sampled if sentinel node is positive, or axillary dissection alone (with a minimum of 6 axillary nodes). Patients with DCIS are not required to have axillary staging Patients with a history of non-breast invasive malignancies are eligible if they have been disease-free for 3 or more years prior to entry into the study T2 (>3.0 cm), T3, stage III, or stage IV breast cancer More than 3 histologically positive axillary lymph nodes or axillary lymph nodes with microscopic or macroscopic extracapsular extension Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign Non epithelial breast malignancies such as sarcoma or lymphoma Multicentric gross breast carcinoma (either DCIS or invasive cancer) or microscopic breast carcinoma occupying a volume with maximum dimensions of more than 3 centimeters Synchronous bilateral invasive or non-invasive breast cancer Paget's disease of the nipple Previous breast radiation on ipsilateral side or thoracic radiation on the ipsilateral side Treatment plan that includes regional nodal irradiation
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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, Infiltrating Bladder Urothelial Carcinoma Histologically confirmed muscle-invasive urothelial cancer (no histology will be excluded) No pelvic nodal metastases or distant metastases (based on computed tomography [CT], positron emission tomography [PET] or magnetic resonance imaging [MRI]) Karnofsky performance status (KPS) >= 70 Ability to understand, and willingness to sign, the written informed consent Patient will have either opted for bladder-sparing treatment as compared to radical cystectomy, or deemed medically inoperable Following the recent recommendations from the International Consultation on Urological Diseases-European Association of Urology International Consultation on Bladder Cancer, eligible patients will be those with no hydronephrosis, no extensive carcinoma in situ (CIS), and no tumor invasion into the stroma of the prostate Patients with any evidence of distant metastases Prior pelvic radiotherapy History of Crohn's disease or ulcerative colitis Unable to receive chemotherapy Histologies other than urothelial (eg. squamous cell carcinoma, adenocarcinoma, small cell)
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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, Androgen Receptor Positive Estrogen Receptor Negative HER2/Neu Negative Invasive Breast Carcinoma Progesterone Receptor Negative Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage II Breast Cancer AJCC v6 and v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Stage III Breast Cancer AJCC v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Triple-Negative Breast Carcinoma Patients must be willing to sign the protocol-specific written informed consent Patients with histologically confirmed intact primary cancer that is confirmed invasive carcinoma of the breast, with at least 1.0 cm residual disease as measured by mammography, ultrasound, or breast magnetic resonance imaging (MRI) after neoadjuvant anthracycline based chemotherapy Patients must have triple-negative breast cancer defined as estrogen receptor (ER) < 10%; progesterone receptor (PR) < 10% by immunohistochemistry (IHC) and human epidermal growth factor receptor 2 (HER2) 0-1+ by IHC or 2+, fluorescence in situ hybridization (FISH) non-amplified Androgen receptor will be quantified using a Clinical Laboratory Improvement Act (CLIA)-compliant assay for AR on a biopsy specimen obtained prior to the start of treatment; AR-positivity is defined as >= 10% of nuclear staining Patient's disease state must be American Joint Committee on Cancer (AJCC) 7th edition stage I-III Patients must have a performance status of 0 on the Eastern Cooperative Oncology Group (ECOG) performance scale A negative serum or urine pregnancy test must be done within 72 hours before the first dose of the study medication for women of childbearing potential as per institutional guidelines; post-menopausal women (defines as no menses for at least 1 year) and surgically sterilized women are not required to undergo pregnancy test Men on study must use a condom if having sex with a pregnant woman Male patients and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration Patients who have received any other previous antitumor therapies (other than anthracycline-based neoadjuvant chemotherapy for the current cancer event) Breast-feeding at screening or planning to become pregnant during the course of therapy Patients who have had major surgery within 21 days before cycle 1, day 1 Patients with known history of hypersensitivity to paclitaxel that did not resolve with pre-medication Patients with left ventricular ejection fraction < 50% or 10% decrease from baseline on echocardiogram after anthracycline based chemotherapy Patients with gastrointestinal impairment that would affect the absorption of enzalutamide or previous history of colitis Subjects requiring daily corticosteroids, other than those given as premedication for the anthracycline-based chemotherapy Patients with known or suspected brain metastasis or active leptomeningeal disease History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma) at any time in the past; also, history of loss of consciousness or transient ischemic attack within 12 months of day 1 visit Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication
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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): 20.0-65.0, Breast Cancer ECOG. (Eastern Cooperative Oncology Group): 0-2 2. Histologic documentation of invasive duct or lobular adenocarcinoma of the breast 3. If neoadjuvant chemotherapy was NOT administered: pathologic T1-3, N1-2 following definitive surgery 4. If neoadjuvant chemotherapy was administered, pathology from the definitive surgery must confirm pathologic T1-3, N1-2 disease and also meet one of the following Clinical T1-3, N1-2 or Pathologic confirmation of axillary nodal involvement at presentation (ie, before neoadjuvant therapy) based on any of the following: Positive fine-needle aspiration (FNA), Positive core needle biopsy. 5. Complete resection of known breast disease by one of the following surgeries Lumpectomy with axillary lymph node dissection with no more than 12 resected lymph nodes. Mastectomy and axillary lymph node dissection with no more than 12 resected lymph nodes. 5 ER(estrogen-receptor), PR (progesterone-receptor), and HER2(human epidermal growth factor receptor 2) testing performed on the primary breast tumor; when applicable, testing must have been performed before receiving neoadjuvant chemotherapy. 6-Margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the pathologist. 7-The surgical wound should be completely healed without any signs of infection. 8-Interval between the last surgery for breast cancer or the completion of adjuvant chemotherapy and study enrollment must be ≤ 56 days (ie, a maximum of 8 weeks). 9-If adjuvant chemotherapy is received there should be at least 10 days gap between the last day of chemotherapy and the enrollment in the study to avoid skin toxicity. 10-Women of child-bearing potential must agree to use a medically accepted form of pregnancy prevention for the duration of study treatment 11-Ability to understand and willingness to sign the consent form written in Arabic Patients with surgical margins less than or equal to 2mm. 2. Patients with axillary dissection of more than 12 lymph nodes due to high incidence of arm lymphedema. 3. Women with Huge pendulous breast. 4. Patients with bad breast conservative surgery ( Surgery that impair the cosmetic outcome before starting radiotherapy). 5. T4 tumors including inflammatory breast cancer. 6. Known definitive clinical or radiologic evidence of metastatic disease. 7. Patients re operated for microscopic positive margins after definitive surgery. 8. Previous radiation therapy for the currently diagnosed breast cancer prior to study enrollment 9. History of ipsilateral or contralateral breast or thoracic radiotherapy for any condition 10. History of ipsilateral or contralateral axillary surgery for any condition 11. History of lymphedema involving the ipsilateral or contralateral arm at present or at any time in the past 12. Active collagen vascular disease, specifically dermatomyositis with a creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma. 13. Pregnancy or breastfeeding 14. Second primary cancer
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 12.0-999.0, Lymphoma, Non-Hodgkin Multiple Myeloma Advanced Solid Tumors years of age or older (*Restrictions apply. Not all therapies are available for patients <18) Histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma who is no longer benefiting from standard anti-cancer treatment or for whom, in the opinion of the treating physician, no such treatment is available or indicated Performance status 0-2 (Per Eastern Cooperative Oncology Group (ECOG) criteria) Patients must have acceptable organ function as defined below. However, as noted above, drug-specific inclusion/ specified in the protocol appendix for each agent will take precedence for this and all 1. Absolute neutrophil count ≥ 1.5 x 106/µl 2. Hemoglobin > 9.0 g/dl 3. Platelets > 75,000/µl 4. Total bilirubin < 2.0 mg/ dl, except in patients with Gilbert's Syndrome 5. Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) < 2.5 x institutional upper limit of normal (ULN) (or < 5 x ULN in patients with known hepatic metastases) 6. Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2 Patients must have disease that can be objectively measured by physicial or radiographic exam or evaluable disease (per v1.1 for solid tumor, Lugano for non Hodgkin lymphoma or International Myeloma Working Group for multiple myeloma), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral computed tomography (CT) scan, Magnetic Resonance Imaging (MRI), or a subcutaneous or superficial lesion that can be measured with calipers by clinical exam. For lymph nodes, the short axis must be ≥15 mm. Patients who have assessable disease by physical or radiographic examination but do not meet these definitions of measurable disease are eligible and will be considered to have evaluable disease. Patient's whose disease cannot be objectively measured by physical or radiographic examination (e.g., elevated serum tumor marker only, bone-only disease without an identifiable soft tissue component, or patients with only assessable non-measurable disease) are NOT eligible Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited or New York State accredited (for labs offering services to residents of NY) laboratory. Labs that have registered the test with the NIH Genetic Testing Registry or that provide a report that has been designated as optimized for TAPUR participation are preferred, but not required. The genomic or IHC test used to qualify a patient for participation in TAPUR may have been performed on any specimen of the patient's tumor obtained at any point during the patient's care at the discretion of the patient's treating physician. Genomic assays performed on cell-free DNA in plasma ("liquid biopsies") will also be acceptable if the genomic analysis is performed in a laboratory that meets the described above Ability to understand and the willingness to sign a written informed consent/assent document Have a tumor genomic profile for which single agent treatment with one of the FDA approved targeted anti-cancer drugs included in this study has potential clinical benefit based on the described in protocol For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome Because of the risks of drug treatment to the developing fetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study or if she is the partner of a male participant in this study and becomes pregnant while he is participating in this study, she should inform her or her partner's treating physician immediately as well as her obstetrician. Female study patients who become pregnant must immediately discontinue treatment with any study therapy. Male patients should avoid impregnating a female partner. Male study patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and for a specified amount of time the last dose of study drug, or completely abstain from sexual intercourse. Note: TAPUR does not explicitly any type of solid tumor, but the patient must have measurable and evaluable disease per v1.1 Patients whose disease is not measurable or cannot be assessed by radiographic imaging or physical examination (e.g., elevated serum tumor marker only) are not eligible Patients with primary brain tumors or leptomeningeal metastases are excluded Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 3 months prior to registration. All patients with previously treated brain metastases must be clinically stable for at least 1 month after completion of treatment and off steroid treatment for one month prior to study enrollment
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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): 40.0-64.0, Healthy Volunteers Female greater than or equal to 40 years Presenting to UM Breast Center and BWMC for breast imaging: screening or diagnostic mammogram, breast ultrasound (US), breast MRI, stereotactic core needle biopsy, ultrasound core needle biopsy, MRI guided breast biopsy Patients with a recent screening diagnosis of breast cancer < = 3months Patients presenting with mammogram findings with of 0-6 < =3 months Able to understand and the willingness to sign a written informed consent document Patients with a personal history of stage 0-4 breast cancer >3months Patients who have known severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation in the study, or personal history of other malignancies Patients who are unfit or unable to comply with having breast imaging studies such as mammogram, ultrasound, and MRI or breast biopsy or with study procedures-blood draw Patients with personal history of ovarian cancer or other cancers Patients with a personal history of breast biopsy positive for atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ (LCIS)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 50.0-999.0, Breast Neoplasms Histological diagnosis of invasive or in-situ ductal carcinoma (DCIS) Treated by breast conserving surgery with axillary node dissection (with a minimum of 6 nodes sampled) or sentinel lymph node biopsy Surgical margins clear for invasive carcinoma (no tumor at ink margin) or superior or equal to 2 mm for in-situ ductal carcinoma (DCIS) A maximum tumor size of 3 cm Age ≥50 years old Informed consent signed if participating in the Registry No previous cancer unless in remission for more than 2 years Active auto immune disorder with severe vasculitis component Uncontrolled and complicated insulin-dependent diabetes Pregnancy Cosmetic breast implants Psychiatric or addictive disorder that would preclude attending follow-up Post-operative breast infection requiring prolonged antibiotic therapy Lobular features on histology (pure or mixed) or sarcoma histology Node macroscopically positive on axillary dissection or in the sentinel lymph node biopsy Extensive in
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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 The patients signed the written informed consent The patients present with non-metastatic unilateral invasive ER-positive, HER2-negative breast cancer with a primary breast tumor > 2cm by imaging or an axillary lymph node > 2cm by imaging Postmenopausal women with age less than 70 years old The patients have no history of hormone therapy, chemotherapy, breast cancer surgery and radiotherapy The patients have normal cardiac functions by echocardiography The patients' ECOG scores are ≤2 The patients can swallow pills The results of patients' blood tests are as follows Hb≥90g/L WBC≥4E+9/L The patients have other cancers at the same time or have the history of other cancers except controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix uterus The patients have active infections that were not suitable for chemotherapy The patients have severe non-cancerous diseases The patients have bilateral breast cancers or multifocal breast cancers or inflammatory breast cancers The patients have a history of previous treatment with mTOR inhibitors The patients are undergoing current administration of anti-cancer therapies, or are attending other clinical trials The patients are in some special conditions that they cannot understand the written informed consent, such as they are demented or hawkish The patients have allergic history or contraindication of any of the interventional drugs
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Estrogen Receptor Negative HER2/Neu Negative Progesterone Receptor Negative Triple-Negative Breast Carcinoma The patient has proven TNBC, defined by standard pathologic assays as negative for estrogen receptor (ER) and progesterone receptor (PR) (< 10% tumor staining) and negative for human epidermal growth factor 2 (HER2) (immunohistochemistry [IHC] score < 3, gene copy number not amplified) TNBC patients who are previously untreated and enrolled in the prospective Institutional Review Board (IRB) approved clinical trial: 2014-0185 Patients who are able to understand and give consent to participating in the study Is pregnant (confirmed by the patient as imaging clinic standard of care) or nursing mother Has lesions involving chest wall Has known allergy to Tc99m sestamibi Has known contraindications to MRI Has contraindication to MRI contrast
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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 Documentation of Disease: 1.1 Subjects must have histologically confirmed invasive breast cancer and registration must occur within 14 months after the first histologic diagnosis of invasive breast cancer A core biopsy interpreted as invasive cancer meets this criterion; if no core biopsy is performed, the date of first histologic diagnosis will be the date of first surgical procedure that identifies invasive cancer (biopsy, lumpectomy or mastectomy) Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery; for neoadjuvant patients can be defined by either clinical stage prior to therapy or pathologic stage at surgery; if patient is eligible based on either, they are eligible for the study Bilateral breast carcinoma is allowed provided diagnoses are synchronous that is, within 3 months of one another and at least one of the two breast carcinomas meet the and neither Her-2 positive or inflammatory No evidence of metastatic disease 1.2 Her-2 negative, defined as In-situ hybridization (ISH) ratio of < 2.0 (if performed) Immunohistochemistry (IHC) staining of 0-2+ (if performed) Deemed to not be a candidate for Her-2 directed therapy. 1.3 Eligible tumor-node-metastasis (TNM) Stages
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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): 55.0-70.0, Obesity Post-menopausal women between the ages of 55 and 70 without untreated medical illness Fluency in the English language Body mass index (BMI) ≥30 kg/m2 Able to walk for at least 10 minutes without needing to stop or without symptom onset Significant untreated medical illness as evidenced by abnormal electrolytes or liver function tests Systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than or equal to 95 mmHg with or without treatment Abnormal thyroid stimulating hormone Abnormal late night salivary cortisol Untreated diabetes mellitus Any severe psychiatric condition Loss or gain of greater than or equal to 4 pounds in the past 6 months Pharmacologic treatment for weight loss within three months before screening Treatment with a very low calorie diet within six months before screening Use of systemic corticosteroids within three months
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Carcinoma Breast Stage IV Subject for Part 1: Safety Run-in study 1. Women diagnosed with pathologically confirmed metastatic triple negative invasive breast cancer (centrally confirmed immunophenotype negative for all three receptors ER, PR and HER2). 2. Hormone receptor status (ER and PR) both ≤ 5% by immunohistochemistry, and HER2 status confirmed by means of immunohistochemistry (with 0 or 1+ indicating negative status) or fluorescence in situ hybridization (with amplification ratio < 2.0 indicating negative status). 3. Have either Evaluable disease, or have measurable clinical disease: Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by (version v1.1). 4. Age > 18 years. 5. Disease stage: Unresectable metastatic disease. 6. Patients received up to 2 prior regimens for their disease in the metastatic setting. 7. Patients are candidates for chemotherapy with carboplatin and gemcitabine. 8. ECOG performance status 0 9. Adequate organ function tests and hematologic indices within 10 days of registration. 10. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 11. Female subjects of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. 12. Signed written Informed Consent in accordance with regulatory and institutional guidelines Subject for Part 1: Safety Run-in study 1. Patients participating in another trial of an investigational agent within 4 weeks of the first dose of the study. 2. Patients who received prior therapy using carboplatin/gemcitabine within 12 months prior to enrollment or subjects whose tumor progressed while on treatment with carboplatin or cisplatin. 3. Patients with baseline grade 2 neuropathy. 4. Patients with Hormone-receptor positive breast cancer (ER and/or PR > 5%), and with HER-2 positive breast cancer (by means of immunohistochemistry with 3+ indicating positive status or fluorescence in situ hybridization with amplification ratio ≥2.0 indicating positive status). 5. Diagnosis of immunosuppression or receiving steroid therapy or other immunosuppressive therapy within 4 weeks of the study. 6. Active autoimmune disease or a documented history of autoimmune disease, or a syndrome that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thryoxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects who require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the study. 7. Has evidence of interstitial lung disease or active, non-infectious pneumonitis. 8. Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 9. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. 10. If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. 11. Known additional malignancy that progressed and/or required treatment in the last 5 years. Except that for basal and squamous cell carcinoma of the skin or in situ cervical carcinoma that has completed potentially curative therapy. 12. Life expectancy of less than 3 months. 13. Patients known to be carriers of Human Immunodeficiency Virus (HIV1/2). 14. Patients known to be carriers of hepatitis virus B and C. 15. Prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death 1 ligand (PDL-1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte -associated antigen-4 (CTLA-4) antibody. 16. Pregnant, breastfeeding, or expecting to conceive children within the projected time of the trial, starting with the pre-screening or screening visit and through 120 days after the last dose of trial treatment. 17. Active infection requiring systemic therapy. 18. Active substance abuse or psychiatric disorders. 19. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. 20. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 21. Has received a live vaccine within 30 days prior to the first dose of trial treatment. Subject for Part 2 (Randomized Phase II Clinical Trial) 1. Women diagnosed with pathologically confirmed triple negative invasive breast cancer, metastatic (locally confirmed immunophenotype negative for all three receptors ER, PR, HER2). 2. Hormone receptor status (ER and PR) both ≤ 5% by immunohistochemistry, and HER2 status confirmed by means of immunohistochemistry (with 0 or 1+ indicating negative status) or fluorescence in situ hybridization (with amplification ratio < 2.0 indicating negative status). 3. Age > 18 years. 4. Disease stage IV, metastatic unresectable disease. 5. Have measurable clinical disease: Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by (version v1.1). 6. Patients received up to 3 prior regimens for their metastatic disease. Prior hormone therapy will not be counted towards the line of therapies. 7. Patients are candidates for chemotherapy with carboplatin and gemcitabine. 8. ECOG performance status 0-2. 9. Adequate organ function tests and hematologic indices within 10 days of registration. 10. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 11. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. 12. Signed written Informed Consent in accordance with regulatory and institutional guidelines. 13. Have provided tissue from a newly obtained biopsy (an archival tissue sample may be substituted if new biopsy cannot be obtained and by discretion of Principal Investigator only) from a local or distant site and agreed to providing a second newly obtained biopsy after completion of 2 cycles of the study drugs. Subject for Part 2 (Randomized Phase II Clinical Trial) 1. Patients participating in another trial of an investigational agent within 4 weeks of the first dose of the study. 2. Patients with tumors that cannot be measured or clinically followed (i.e. evaluable disease). 3. Patients with metastatic breast cancer who received prior therapy using carboplatin/gemcitabine within 12months prior to their enrollment or subjects whose tumor progressed while on treatment with carboplatin or cisplatin. 4. Patients with baseline grade 2 neuropathy. 5. Patients with Hormone-receptor positive breast cancer (ER and/or PR > 5%), and with HER-2 positive breast cancer (by means of immunohistochemistry with 3+ indicating positive status or fluorescence in situ hybridization with amplification ratio ≥2.0 indicating positive status). 6. Diagnosis of immunosuppression or receiving steroid therapy or other immunosuppressive therapy within 4 weeks of the study. 7. Active autoimmune disease or a documented history of autoimmune disease, or a syndrome that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thryoxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects who require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the study. 8. Has evidence of interstitial lung disease or active, non-infectious pneumonitis. 9. Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 10. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. 11. If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. 12. Known additional malignancy that progressed and/or required treatment in the last 5 years. Except that for basal and squamous cell carcinoma of the skin or in situ cervical carcinoma that has completed potentially curative therapy. 13. Life expectancy of less than 3 months. 14. Patients known to be carriers of Human Immunodeficiency Virus (HIV1/2). 15. Patients known to be carriers of hepatitis virus B and C . 16. Prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death 1 ligand (PDL-1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte -associated antigen-4 (CTLA-4) antibody. 17. Pregnant, breastfeeding, or expecting to conceive children within the projected time of the trial, starting with the pre-screening or screening visit and through 120 days after the last dose of trial treatment. 18. Active infection requiring systemic therapy. 19. Active substance abuse or psychiatric disorders. 20. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. 21. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 22. Has received a live vaccine within 30 days prior to the first dose of trial treatment. 23. Subjects who do not consent to providing pre and post treatment tissue sample for future research would not be eligible to participate in the trial
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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 I to III histologically confirmed invasive carcinoma of the breast. A minimum tumor size of at least 1.5 cm determined by physical exam or imaging (whichever is larger) is required Patients must have histologically confirmed hormone receptor positive (ER and/or PR), HER2 negative, invasive breast cancer. ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting in the US or certified laboratories for Non-US regions. Cut-off values for positive/negative staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines. Central confirmation is not required for ER, PR, or HER statuses Patients with equivocal HER2 in situ hybridization results according to current ASCO/CAP guidelines are allowed, as long as the clinician has determined that they should be treated as HER2 negative For the window phase: Patients must have histologically confirmed invasive lobular carcinoma or invasive ductal carcinoma. No central confirmation of histological subtype is necessary for enrollment For the treatment phase: Patients with any histological subtype are eligible Women 18 years of age. Men are not eligible ECOG performance status 0 or 1 Required laboratory values Absolute neutrophil count ≥ 1,500/mm3 Platelets ≥ 100,000/mm3 Concurrent therapy with other Investigational Products Prior therapy with any CDK inhibitor Patients with Stage IV breast cancer are not eligible. Baseline staging to document absence of metastatic disease is not required, however is recommended as determined by institutional practice (in patients where there may be a reasonable suspicion of advanced disease e.g., large tumors, clinically positive axillary lymph nodes, signs and symptoms). If performed, reports of these examinations must be available. Examination type for staging, i.e. X-ray, sonography, bone scans, CT, MRI, and/or PET-CT, is at the discretion of the investigator History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib Patients receiving any medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation Pregnant women, or women of childbearing potential without a negative pregnancy test (serum or urine) within 7 days prior to randomization, irrespective of the method of contraception used, are excluded from this study because the effect of palbociclib on a developing fetus is unknown. Breastfeeding must be discontinued prior to study entry Patients with a history of any malignancy are ineligible except for the following circumstances Patients with a malignancy history other than invasive breast cancer are eligible if they have no active malignancy and are deemed by the investigator to be at low risk for recurrence of that malignancy Patients with the following cancers are eligible: ductal carcinoma in situ of the breast, cervical cancer in situ, and non-metastatic non-melanomatous skin cancers
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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, Invasive Breast Cancer • histologically confirmed primary invasive breast cancer by core needle biopsy • pathological diagnosed ductal carcinoma in situ or microinvasive breast cancer by core needle biopsy patient plans to receive neo-adjuvant system 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): 5.0-67.0, Brain Concussion Cerebral Concussion Concussion, Intermediate Concussion, Mild Concussion, Severe Trauma, Nervous System Craniocerebral Trauma Brain Injuries Provide written informed consent Be between the ages of 4 and 67 years old Have a diagnosis of traumatic brain injury with a potential for concussion Subjects must have baseline vision correctable to within 20/500 bilaterally Subjects must have intact ocular motility Subjects must have ability to provide a complete ophthalmologic, medical and neurologic history as well as medications/drugs/alcohol consumed within the 24 hours prior ER visit has been more than 2 weeks since the injury which may have caused the concussion Have received penetrating trauma or have a head CT demonstrating evidence of acute brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read) Suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability Blind (no light perception), are missing eyes, do not open eyes It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant Previous history of: ocular motility dysfunction or extensive prior eye surgery Any physical or mental injury or baseline disability rendering task completion difficult Obvious intoxication or blood alcohol level greater than 0.2
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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): 30.0-70.0, Breast Cancer A. Subjects who are asymptomatic and scheduled to undergo routine screening mammography OR B. Subjects scheduled for image guided needle biopsy as a result of findings obtained during standard of care imaging modalities AND C. Subjects has a prior mammogram and have been diagnosed with extremely or heterogeneously dense breast tissue (Density C or D) Male by birth. 2. Individual is less than 30 and greater than 70 years old. 3. Contraindication to bilateral mammography or MRI 4. Subjects who are unable to read, understand and execute the informed consent procedure. 5. Subjects who have had mammography ultrasound or MRI examination performed on the day of the study prior to MIRA scan. 6. Subjects who have significant existing breast trauma. 7. Subjects who have undergone lumpectomy/mastectomy. 8. Subjects who have undergone breast reduction or breast augmentation. 9. Subjects who have undergone any other type of breast surgery, excluding surgical biopsy. 10. Subjects who have large breast scar / Breast deformation 11. Subjects who have undergone a breast needle biopsy or a surgical biopsy within the 6 month period prior to their intended enrollment into the study. 12. Subjects who have a temperature > 100° F (37.8C) degrees on the day of the MIRA imaging 13. Subjects who are pregnant or lactating 14. Subjects with known Raynaud's Disease 15. Subjects that are claustrophobic or have physical limitations that do allow them to sit in the system chair for the required imaging session. 16. Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices 17. Subject with kidney failure 18. Subject with known allergy to gadolinium 19. Subject with a history of multiple contrast MRI scans (more than 4 MRI scans over the past two year) 20. Inmates (45 CFR 46.306) or mentally disabled individuals 21. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy) 22. Subjects currently participating in another investigational clinical study 23. Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase
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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 Mass Women aged 18 years and above presenting for a diagnostic ultrasound secondary to a palpable mass, abnormal mammogram, follow-up ultrasound abnormality, or discharge were asked to participate in the study Unable to give informed consent breast abnormality greater than one quadrant
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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, Healthy Premenopausal Period menstruating, pre-menopausal - pregnant, lactating, post-menopausal, smoking, on birth control pills -
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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 Adenocarcinoma Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Recurrent Breast Carcinoma Stage IV Breast Cancer Histologically confirmed adenocarcinoma of the breast that is HER2 (human epidermal growth factor receptor 2) negative; based on ASCO(american society of clinical oncology)/ CAP (college of American Pathologists) guidelines as: (a) IHC (immuno-histochemistry) 1+ negative or IHC 0 negative; or (b) ISH (in situ hybridization ) negative using single probe ISH( average HER2 copy number < 4.0 signals/cell), or dual probe ISH ( HER2/CEP17 ratio <2.0, average HER2 copy number <4.0 signals/cell) 2. Metastatic breast cancer not amenable to potentially curative surgery. Patients must have disease that is measurable and/or non-measurable as defined by 1.1 3. Prior chemotherapy and/or endocrine therapy. Patients will be assigned to arm A or arm B depending on their prior exposure to paclitaxel and eribulin Arm A: Rebastinib plus paclitaxel: Up to two prior non-taxane chemotherapy regimens for metastatic or incurable locally advanced disease permitted (no prior paclitaxel, docetaxel, or eribulin for metastatic disease)..Prior therapy with paclitaxel or docetaxel in the neo/adjuvant setting is allowable if there is at least a 6 month interval between the last adjuvant/neoadjuvant paclitaxel or docetaxel dose and recurrence Arm B: Rebastinib plus Eribulin: Patients must have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease (no prior eribulin, but prior paclitaxel, nab-paclitaxel, or docetaxel allowed). Prior therapy should have included a taxane in either the adjuvant or metastatic setting Arms A and B: Patients with hormone receptor positive disease must have had progressive disease and at least 2 lines of endocrine therapy, including one endocrine regimen used in combination with an approved CDK 4/6 (cyclin-dependent kinase ) inhibitor (eg, palbociclib). Relapse while receiving or within 6 months of completing adjuvant endocrine therapy may be considered failure of one prior endocrine regimen 4. Female and age >18 years. Because breast carcinoma is a disease of adults that rarely occurs in children, children are excluded from this study. In addition, the safety of rebastinib in pediatric patients has not been evaluated. 5. ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1. 6. Normal organ and marrow function as defined below within 2 weeks of registration (except where specified otherwise): Leukocytes >3,000/µL ; Absolute neutrophil count >1,500/µL ; Platelets >100,000/ µL Hemoglobin > 9 g/dL ; Total bilirubin (within normal institutional limits) AST (aspartate aminotransferase)/ALT (alanine aminotransferase) <2.5 X institutional upper limit of normal ; Creatinine (within normal institutional limits) ; EKG QTc < 450 msec (females) Left ventricular ejection fraction at or above institutional lower limits of normal (by echocardiogram within 12 weeks of registration) ; Glucose (within normal limits) Serum calcium & phosphorus (within normal institutional limits); Negative urine or serum B-HCG(Beta-Human Chorionic Gonadotropin) 7. No significant ocular disease: No prior known history of retinal neovascularization, macular edema or macular degeneration. Patients without such a history are required to have a baseline ophthalmologic exam as part of screening, and must not have evidence of retinal neovascularization, macular edema or macular degeneration on the screening exam in order to be eligible. 8. No other active cancer: Patients must be disease-free of prior invasive malignancies for > 2 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix. Patient with the following prior or concurrent diagnoses are eligible: lobular carcinoma in situ, contralateral ductal carcinoma in situ, or contralateral invasive ductal and/or lobular carcinoma. 9. Women of child-bearing potential must not be pregnant or breast feeding. They must also agree to use adequate contraception (hormonal or barrier method of birth control) and not be breast feeding prior to study entry, for the duration of study participation, and for up to 30 days after completion of all protocol therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study or up to 30 days after completion of protocol therapy, she should inform her treating physician immediately. 10. Ability to understand and the willingness to sign a written informed consent document. 11. At least 30 days from major surgery before study enrollment, with full recovery. 12. Concomitant therapy with bisphosphonates, RANKL inhibitors or growth-colony-stimulating factor (G-CSF) is allowed as per physician decision. 13. Expansion cohort: Patients for the expansion cohort must have a CTC (TelomeScan) drawn in the screening phase if other are met, and must be CTC-positive in order to be eligible for enrollment in the expansion cohort History of allergic reactions attributed to compounds of similar chemical or biologic composition to Rebastinib or other agents used in the study (e.g., Cremophor) 2. History of cardiac disease, including: (a) myocardial infarction within 6 months of the start of study, (b) history of QTc(corrected QT interval ) prolongation or QTc >/= 450 msec on screening EKG, history of additional risk factors for Torsade de pointes( e.g., heart failure, hyperkalemia, and family history of long QT syndrome. (c) Use of concomitant drugs that prolong QT/QTc interval.(see "Study reference manual" for further details) (d) New York Heart Association class III or IV heart disease, (e), active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy. 3. bIntercurrent illness that would substantially increase the risk of treatment associated complications (e.g., active infection, uncontrolled diabetes mellitus or hypertension) and/or psychiatric illness/social situations that would interfere with the patient's ability to comply with the treatment regimen. 4. Patients with HIV infection are excluded from the study because of possible pharmacokinetic interactions with Rebastinib and antiretroviral therapy. 5. Patients with untreated brain metastasis are excluded. Patients with a prior history of brain metastasis are eligible if they have received prior brain radiation, have improved or stable intracranial disease for at least 3 months after completion of last course of radiation, and are not taking corticosteroids for treatment of brain metastasis. Patients with a prior history of brain metastases who meet other 6. Treatment with other chemotherapy regimen within the past 2 weeks. 7. Treatment with trastuzumab, bevacizumab or other targeted therapies within the past 4 weeks. 8. Patients who have not recovered (i.e., CTCAE Grade ≤1 or baseline) from an adverse event due to a previously administered agent, excluding alopecia. 9. Patients with Grade >1 neuropathy 10. Patients with uncontrolled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 90 mm/mg). 11. Patients that have a malabsorption syndrome or other illness which could affect oral absorption
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 50.0-999.0, HIV Neurocognitive Impairment Stable HIV participants (CD4+ lymphocyte count > 350 cells/mm3) for at least two years prescribed their current cART regimen for at least six months) with mild to moderate cognitive impairment Drug/alcohol abuse History of Parkinsons Alzheimers, stroke or traumatic brain injury diabetes mellitus renal insufficiency
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 30.0-999.0, Breast Neoplasms Patients aged 30 or over 2. A uni-focal invasive ductal breast carcinoma or discrete uni-focal site which is deemed suitable for PDT within a multifocal invasive ductal carcinoma in a single breast. 3. Patients who have opted for mastectomy or wide local excision as primary treatment. 4. Capable of giving written informed consent Patients who are not undergoing surgery as their primary treatment. 2. Patients undergoing surgery for DCIS without invasive breast cancer. 3. Patients with Lobular cancer 4. Patients with Necrotic tumours 5. Distant metastatic disease. 6. Patients will be excluded if they have porphyria or are sensitive to verteporfin (visudyne). 7. Patients who have severe cardiovascular disease. 8. Patients with severe or uncontrolled systemic disease e.g. hepatic impairment. 9. Patients with laboratory findings that make it undesirable for the patient to participate in the trial. 10. Male breast cancer patients 11. Pregnancy and lactation. 12. No patients with any psychiatric disorder making reliable informed consent impossible. 13. Patients will be excluded if taking part in any other trial of an experimental medicine 14. Patients will be excluded if taking endocrine therapy drugs that could confound the results
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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 patient with breast cancer 2. Age > 18 years old 3. Available primary breast tumor sample with adjacent normal epithelial structures 4. Informed consent obtained and signed Primary tumor size < 1cm 2. Surgical tumor sample without available adjacent normal epithelial structures
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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): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 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 any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
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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 ≥ 18 years of age with histologically proven infiltrating ductal carcinoma of breast no severe major organ dysfunction Patients must have adequate hematopoietic function as evidenced by: white blood cells (WBC) ≥ 3,000/μl absolute neutrophil count (ANC) ≥ 1,500/μl Platelet count ≥ 100,000/μl hemoglobin (HGB) ≥ 10 g/dl and not transfusion dependent Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10% above upper limit of normal Individuals of child-bearing potential must have a negative serum or urine pregnancy test within 72 hours of Cycle 1 Day 1 World Health Organization (WHO) performance status of 0 or 1 No prior or concurrent cancer-associated chemotherapy, no initiation of new hormonal therapy Hormone receptor (estrogen receptor (ER), progesterone receptor (PR), epidermal growth factor receptor 2 (Her2)) status not specified Menopausal status not specified Patients or their legal representatives must be willing and able to provide written informed consent Age < 18 Severe major organ dysfunction WHO performance status of >1 Prior cancer chemotherapy Stage IV Patients with symptomatic central nervous system (CNS) metastases from breast cancer Patients with a history of another invasive malignancy within the last 3 years History of loss of consciousness or transient ischemic attack within 12 months before study treatment initiation Patients who have known active HIV, Hepatitis B, or Hepatitis C infections Patients with any other condition which in the opinion of the investigator would preclude 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): 18.0-999.0, Breast Cancer Cancer of Breast Breast Carcinoma Newly diagnosed clinical stage II or III ER+/HER2+ breast cancer with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal, staging is to be based on AJCC 7 Tumor size at least 2 cm in one dimension by clinical or radiographic exam (World Health Organization (WHO) criteria). Patients with histologically confirmed palpable lymph nodes may be enrolled regardless of breast tumor size. A palpable mass is not required as long as the mass is at least 2 cm in one dimension by radiographic exam At least 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 Normal bone marrow and organ function as defined below Leukocytes ≥ 3,000/mcL Absolute neutrophil count ≥ 1,500/mcl Platelets ≥ 100,000/mcl Total bilirubin ≤ institutional upper limit of normal (IULN) AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN Prior systemic therapy for indexed breast cancer Indeterminate or negative HER2 status Inflammatory breast cancer A history of other malignancy ≤ 5 years from diagnosis of indexed BC 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 Currently receiving any other investigational agents or received any within the past 28 days Know to be HIV positive Known hepatitis B or C infection A history of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib, letrozole, trastuzumab, any other aromatase inhibitor, any other monoclonal antibody, or other agents used in the study Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors (i.e., grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delavirdine) or inducers (i.e. dexamethasone, glucocorticoids, progesterone, rifampin, phenobarbital, St. John's wort)
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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 Ductal Breast 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 Sporadic Breast Carcinoma Newly diagnosed ductal breast carcinoma in situ (DCIS) or stage I-III sporadic unilateral invasive breast cancer Able to speak read or write English Patients with previous breast cancer Prior history of bilateral prophylactic mastectomy Known to have a germline mutation that predisposes them to an increased risk of breast cancer (e.g. BRCA1/2) and/or they are considered at high risk for contralateral breast cancer on the basis of a strong family history of 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): 21.0-999.0, Breast Cancer Patient scheduled to undergo lumpectomy for breast cancer at BIDMC Core needle biopsy revealing invasive breast cancer or DCIS Female Minimum age of 21 years Eligible for breast conserving surgery, lumpectomy and radiation Estrogen receptor positive (ER+) on core needle biopsy, or if estrogen receptor negative (ER-), have evaluable estrogen receptor status with positive internal control on core biopsy Progesterone receptor positive (PR+) on core needle biopsy if biopsy indicates invasive cancer, or if progesterone receptor negative (PR-) on biopsy indicating invasive cancer, have evaluable progesterone receptor status with positive internal control on core biopsy HER2 IHC and/or FISH ordered on core biopsy, if biopsy indicates invasive cancer Oncotype DX or other genetic assay performed on core biopsy or not requested Ability to understand and the willingness to sign a written informed consent document Contraindicated for radiation therapy Pregnancy. (Pregnant women will be excluded from this study because radiation therapy is contraindicated during pregnancy.) Current invasive cancer or DCIS at the site of a previous surgery Any systemic neoadjuvant (or preoperative) therapy between the core biopsy and lumpectomy Involvement in another therapeutic trial for breast cancer at Dana Farber or elsewhere Risk of poor cosmetic outcome after initial lumpectomy and possible additional excision, as assessed by a study surgeon Recommendation for mastectomy based on radiology Patients that have complex DCIS as indicated on radiology, which would require excising a large tissue volume No or equivocal ER, PR or HER2 testing performed prior to surgery if biopsy indicates invasive cancer No or equivocal ER testing performed prior to surgery if biopsy indicates ductal carcinoma in situ
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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): 40.0-99.0, DCIS Ductal Carcinoma in Situ Diagnosis of unilateral, bilateral, unifocal, multifocal, or multicentric DCIS without invasive breast cancer (date of diagnosis defined as the date of the first pathology report that diagnosed the patient with DCIS) OR: atypia verging on DCIS OR: DCIS + LCIS (mix and/or separate locations in the same breast) A patient who has had a lumpectomy or partial mastectomy with margins positive for DCIS (i.e. <2mm/ink on tumor) as part of their treatment for a current DCIS diagnosis is also eligible (post-excision bilateral mammogram required at enrollment to establish a new baseline) No previous DCIS or invasive breast cancer in ipsilateral breast 5 years prior to current DCIS diagnosis years of age or older at time of DCIS diagnosis ECOG performance status 0 or 1 No contraindication for surgery Baseline imaging (must dimensions) Unilateral DCIS: contralateral normal mammogram ≤ 6 months of registration and ipsilateral breast imaging ≤ 120 days of registration (must ipsilateral mammogram; can also ultrasound or breast MRI) Bilateral DCIS: bilateral breast imaging ≤ 120 days of registration (must bilateral mammogram; can also ultrasound or breast MRI) DCIS s/p lumpectomy: post excision mammogram on side of excision ≤ 60 days of registration Male DCIS Grade III DCIS Concurrent diagnosis of invasive or microinvasive breast cancer in either breast Documented mass on examination or mass/hypoechoic area on imaging at site of DCIS prior to biopsy yielding diagnosis of DCIS, with exception of: subsequent lumpectomy or partial mastectomy (with positive DCIS margins i.e. <2mm/ink on tumor) followed by a post-surgery MMG; fibroadenoma at a distinct/separate site from site of DCIS; or diagnosis of mass/hypoechoic area as a cyst or a papilloma. In cases of uncertainty about whether the mass was present on physical examination prior to biopsy, the following should be applied: if mammogram noting abnormal findings is diagnostic MMG = symptomatic/if mammogram noting abnormal findings is screening MMG = asymptomatic. If a patient has a mass on imaging that is biopsied (worked-up) and does not show invasive breast cancer, they are eligible. If a patient has a mass on initial MMG that is not seen on subsequent MMG, they are eligible (if initial mass occurred due to additional work-up) Any color/bloody nipple discharge (ipsilateral breast) Mammographic finding of 4 or greater within 6 months prior to registration at site of breast other than that of known DCIS, without pathologic assessment Use of investigational cancer agents within 6 weeks prior to diagnosis of DCIS Any serious and/or unstable pre-existing medical, psychiatric, or other existing condition that would prevent compliance with the trial or consent process Pregnancy. If a woman has been confirmed as pregnant, she will not be eligible to take part in the trial. If she suspects there is a chance that she may be pregnant, a pregnancy test should be undertaken, although a pregnancy test for all women of child-bearing potential is not mandatory. In addition, if a woman becomes pregnant once registered to the trial, she can continue to be followed (endocrine therapy is not a mandatory requirement of the study) Documented history of prior tamoxifen, aromatase inhibitor, or raloxifene use in the 6 months prior to registration
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Initially diagnosed with breast cancer Has a proven result of HER2 testing by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or any other in situ hybridization (ISH) method Alive or not alive Inconclusive, equivocal or unavailable result of HER2/neu overexpression by IHC and FISH
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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 0 Breast Cancer AJCC v6 and v7 Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage II Breast Cancer AJCC v6 and v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Stage III Breast Cancer AJCC v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Triple-Negative Breast Carcinoma STEP 1 Patients must have histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR) and HER2-negative (triple-negative, TNBC) or ER-, PR weakly positive and/or HER2 equivocal status and must not have received and not be planning to receive adjuvant anti-HER2 or endocrine therapies after completion of neoadjuvant chemotherapy; patients who are HER2-positive by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines are ineligible; HER2-negative and HER2-equivocal cases as per ASCO CAP guidelines that do not receive HER2-targeted therapy are eligible; patients with weakly ER or PR positive disease, defined as ER and/or PR less than or equal to (=<) 5% by immunohistochemistry, are eligible if the treating physician considers the patient not eligible for adjuvant endocrine therapy; residual disease must be >= 1 cm in greatest dimension, and/or have positive lymph nodes (ypN1mi, ypN1, ypN2, ypN3) observed on pathologic exam NOTE: If the ER and/or HER2 results are discordant between the initial, pre-chemotherapy, and post-chemotherapy surgical tissue, the receptor status of the residual disease has to be used to determine eligibility. Immunohistochemistry (IHC)-positive isolated tumor cells in the lymph node (N0 [i+]) are not considered node-positive and these patients also must have >= 1 cm residual invasive cancer in the breast to be eligible Patients must not have metastatic disease (i.e., must be clinically M0 or Mx; systemic staging studies with imaging should follow routine practice as per National Comprehensive Cancer Network [NCCN] and ASCO guidelines); patients must not have locally recurrent disease It is preferred that axillary lymph node sampling is performed after completion of neoadjuvant chemotherapy to allow more accurate assessment of pathologic response; complete axillary lymph node dissection (ALND) after neoadjuvant chemotherapy is recommended in the following situations Patients had documented pathologic involvement of the axillary nodes (fine needle aspiration [FNA] or core biopsy) before neoadjuvant chemotherapy and had sentinel node biopsy after neoadjuvant chemotherapy with positive sentinel node(s) Patient had documented pathologic involvement of the axillary nodes (FNA or core biopsy) before neoadjuvant chemotherapy and had only 1 sentinel lymph node removed after neoadjuvant chemotherapy
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-65.0, Stress Disorders, Post-Traumatic Intimate Partner Violence Alcohol-Related Disorders Female Veterans Lifetime history of ST with at least one risk factor: heavy drinking within the past 3 months, screen positive for current PTSD or for IPV within last 12 months Age 18-65 Seeking treatment through the Women's Primary Care Clinics at the Central Texas VA Healthcare System Ability to understand study procedures in English Not actively in suicidal or homicidal crisis warranting imminent hospitalization
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Adenocarcinoma Estrogen Receptor- Negative Breast Cancer Estrogen Receptor-positive Breast Cancer HER2/Neu Negative Invasive Breast Carcinoma Progesterone Receptor Negative Progesterone Receptor Positive Tumor Stage II Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Triple-negative Breast Carcinoma Invasive adenocarcinoma of the breast diagnosed by core needle biopsy Breast cancer determined to be HER2-negative per current American Society of Clinical Oncologists/College of American Pathologists (ASCO/CAP) HER2 Guidelines (If IHC was performed, IHC 0 or 1+; if fluorescence in situ hybridization [FISH] or other in situ hybridization test, dual probe HER2/CEP17 ratio < 2.0 with an average HER2 copy number < 4.0 signals/cell) Breast cancer determined to be hormone receptor-positive or hormone receptor-negative defined as follows Hormone receptor-positive: ≥ 10% staining by IHC for either estrogen receptor (ER) or progesterone receptor (PgR) Hormone receptor-negative: < 10% staining by IHC for both ER and PgR Locally advanced breast cancer defined as any of the following per American Joint Committee on Cancer (AJCC) Staging T2 based on tumor measurements by physical examination or imaging with clinically positive regional lymph nodes (cN1 or cN2), irrespective of hormone receptor status Hormone receptor-negative breast cancer patients with tumor size of 3-5 cm measured by physical examination or imaging with clinically negative regional lymph nodes (cN0) Any T3 based on tumor measurements by physical examination or imaging Any T4 (including inflammatory breast cancer), irrespective of hormone receptor status Breast cancer treatment for the currently diagnosed breast cancer including radiation therapy, chemotherapy, targeted therapy, or endocrine therapy prior to study registration Administration of a live vaccine within 30 days prior to initiating study treatment Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are permitted; however, intranasal influenza vaccines (eg, Flu-Mist) are live attenuated vaccines, and are not allowed Administration of a monoclonal antibody within 4 weeks prior to initiating study treatment or has not recovered (ie, ≤ grade 1 or at baseline) from AEs due to a monoclonal antibody administered more than 4 weeks earlier Administration of any investigational agent within 4 weeks prior to initiating study treatment Evidence of metastatic disease that is extensive enough to preclude consideration of subsequent definitive surgery for the primary tumor History of ipsilateral invasive breast cancer or ipsilateral ductal carcinoma in situ (DCIS) Note: Patients with history of ipsilateral lobular carcinoma in situ (LCIS) are eligible History of solid organ or allogeneic stem cell transplant Previous therapy for any malignancy with an anthracycline or taxane for Cohorts A and B and carboplatin for Cohort A Cardiac disease that would preclude administration of the drugs included in the study treatment regimen including, but not limited to Angina pectoris that requires the current use of anti-anginal medication
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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 Ductal Breast Carcinoma In Situ Hot Flashes Lobular Breast Carcinoma In Situ No Evidence of Disease History of breast cancer, ductal breast carcinoma in situ (DCIS), or lobular carcinoma in situ (LCIS) (currently without evidence of malignant disease) OR a concern about taking estrogen for fear of breast cancer Bothersome hot flashes (defined by their occurrence of >= 28 times per week and of sufficient severity to prompt the patient to seek therapeutic intervention) Presence of hot flashes for > 30 days prior to study entry Ability to complete questionnaire(s) by themselves or with assistance Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1 Ability to provide informed written consent Life expectancy >= 6 months Willing to work with the enrolling institution for follow-up (during the active monitoring phase of the study) Any of the following current (=< 4 weeks prior) or planned therapies Antineoplastic chemotherapy (anti-HER2 agents allowed) Androgens Estrogens (any delivery route) Progestogens Tamoxifen, raloxifene and aromatase inhibitors are allowed, but patient must have been on a constant dose for at least 28 days and must not be expected to stop the medication during the study period Selective serotonin reuptake inhibitors (SSRIs)/serotonin?norepinephrine reuptake inhibitors (SNRIs), when being used for hot flash management or other indications such as depression, is allowed, assuming the dose will remain unchanged for the study duration Gabapentin/pregabalin, when being used for hot flash management (use for other indications, such as pain, is allowed, assuming the dose will remain unchanged for the study duration) Clonidine Agents with known potent anticholinergic activity; agents with mild-moderate anticholinergic activity are allowed
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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, Wrist Injuries Postoperative Pain Control Patients scheduled for wrist arthroscopy American Society of Anesthesiologists (ASA) physical status I -III Mentally competent and able to give consent for enrollment in the study Patient younger than 18 years old Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone and any of the drugs included in the standard of care Patients opting to go under light anesthesia and those refusing the block Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 6 months prior to the surgery BMI of 40 or more
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 21.0-80.0, Triple Negative Breast Cancer Be willing and able to provide written informed consent/assent for the trial. 2. Be > or = 21 years of age on day of signing informed consent. 3. Histologically proven invasive breast carcinoma with triple negative receptor status (Estrogen receptor, Progesterone receptor and HER2 negative by IHC and FISH). Patients who are weekly positive for the estrogen or progesterone receptor (i.e., < or = 10%) are eligible. 4. Clinically ≤ 3 cm unifocal lesion by imaging or physical examination. 5. Clinically node negative, no evidence of metastatic disease. 6. No prior anti-cancer therapy including investigational agents, radiation therapy, or breast resection within 6 months of study entry. 7. Breast size B cup or larger, to allow for IORT procedure. 8. Have a performance status of 0 or 1 on the ECOG Performance Scale. 9. Demonstrate adequate organ function. 10. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 11. Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication Multifocal disease within the breast. 2. Has primary lesion > 3 cm in size radiographically or by physical examination. Pathologically proven nodal disease at diagnosis is not allowed. 3. Has metastatic disease. 4. Has a known additional malignancy that is progressing or requires active treatment in the last 5 years. Exceptions basal cell carcinoma of the skin, squamous cell carcinoma of the skin, DCIS of the breast, or in situ cervical cancer that has undergone potentially curative therapy. 5. Patients for whom radiotherapy for breast cancer is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation). 6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 7. Has a known history of active TB (Bacillus Tuberculosis). 8. Has severe hypersensitivity (≥ Grade 3) to pembrolizumab or any of its excipients. 9. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 10. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. 11. Has an active infection requiring systemic therapy. 12. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 14. Is pregnant or breastfeeding, or expected to conceive children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. The effects of MK-3745 on the developing human fetus are unknown. For this reason and because monoclonal antibody neoplastic agents are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. 15. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). 16. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). 17. Has received a live vaccine within 30 days of planned start of study therapy. 18. Has a medical history of allogenic stem cell transplant 19. Has received a solid organ transplant
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-70.0, Breast Cancer Female Estrogen receptor-positive and HER2-negative breast cancer patients, with histological stage of IIa-IIIc. 2. Without previous chemotherapy or endocrine therapy. 3. ECOG scores of 0-2 points 4. With measurable and evaluable breast tumor pathologically confirmed as invasive ductal carcinoma 5. Age: 18-70 years 6. Lateral breast cancer 7. Normal or acceptable kidney, liver, cardiovascular, and bone marrow functions Pregnant women or nursing mothers 2. With distant metastasis 3. With a history of malignant tumor or complicated with other malignant tumors in addition to breast cancer, except for non-melanoma skin cancer, in situ cervical cancer or other cured malignant tumor without the basis of recurrence for at least five years 4. With mental illness or other conditions affecting the patient compliance 5. With other serious diseases or medical conditions: 1. Congestive heart failure or unstable angina pectoris, myocardial infarction within 6 months before the enrollment, uncontrolled hypertension and uncontrolled high-risk arrhythmia considered by the investigator 2. Obvious neurological or psychiatric disorders, including psychosis, epileptic dementia and other diseases may affect the understanding and sign of the informed consent for 3. Uncontrolled acute infection 6. Concurrent use of other investigational drugs; or participating in other clinical trials involving investigational drugs within 30 days before this study 7. With allergic constitution and any known or suspected drug allergy 8. Not suitable for the trial considered by the investigator
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Dental Research Pharmaceutical Preparations, Dental Patients included if they had clinical diagnosis of pulpitis/dental apical abscess and physical exam revealed pain with percussion of the affected tooth/teeth plus or minus evidence of periapical abscess (gingival erythema, swelling, draining pus). Written informed consent was obtained from each patient prior to enrollment in the study.- Younger than 18 years old 2. Immunosuppression : HIV patient, transplant patient, chemotherapy 3. History of diabetes 4. Recent (<1 month) or chronic steroid use 5. Hospitalization required due to intractable vomiting/pain 6. Pregnancy, self report
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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, Analgesia Is scheduled to undergo primary unilateral TKA under general anesthesia Has not previously undergone TKA in either knee Has an American Society of Anesthesiologists Physical Status of I, II, or III Is able to demonstrate motor function by performing a timed 20-meter walk unassisted, but with the optional use of a 4-legged walker for balance Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives Has a planned concurrent surgical procedure (eg, bilateral TKA) Has a pre-existing concurrent acute or chronic painful/restrictive physical condition that may require analgesic treatment in the postoperative period for pain Has a contraindication or a known or suspected history of hypersensitivity or idiosyncratic reaction to required study medications Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months Has taken NSAIDs within 10 days prior to the scheduled surgery Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting) Has been administered bupivacaine within 5 days prior to the scheduled surgery Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments
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0
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