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nli4ct_semeval2024

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[ "Adverse Events 1:", " Total: 102/403 (25.31%)", " Anaemia 1/403 (0.25%)", " Febrile neutropenia 1/403 (0.25%)", " Granulocytopenia 0/403 (0.00%)", " Neutropenia 1/403 (0.25%)", " Thrombocytopenia 1/403 (0.25%)", " Cardiac failure 1/403 (0.25%)", " Vertigo 1/403 (0.25%)", " Hypercalcaemia of malignancy 0/403 (0.00%)", " Vision blurred 1/403 (0.25%)", " Abdominal discomfort 0/403 (0.00%)", " Abdominal pain 4/403 (0.99%)", "Adverse Events 2:", " Total: 41/184 (22.28%)", " Anaemia 2/184 (1.09%)", " Febrile neutropenia 7/184 (3.80%)", " Granulocytopenia 1/184 (0.54%)", " Neutropenia 2/184 (1.09%)", " Thrombocytopenia 1/184 (0.54%)", " Cardiac failure 0/184 (0.00%)", " Vertigo 0/184 (0.00%)", " Hypercalcaemia of malignancy 1/184 (0.54%)", " Vision blurred 0/184 (0.00%)", " Abdominal discomfort 1/184 (0.54%)", " Abdominal pain 3/184 (1.63%)" ]

[ "INTERVENTION 1: ", " Exercise", " an acute bout of exercise performed 24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise", "INTERVENTION 2: ", " Usual Care", " no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines" ]

[ "Outcome Measurement: ", " Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes", " pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy.", " Time frame: From the start of the study until the time of surgery (average of 221.9 days [standard deviation of 23.65 days] after study entry)", "Results 1: ", " Arm/Group Title: AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib", " Arm/Group Description: Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.", " Overall Number of Participants Analyzed: 93", " Measure Type: Number", " Unit of Measure: Participants 16" ]

[ "Outcome Measurement: ", " Pathologic Assessment After Study Treatment", " Pathologic Assessment After 12 weeks of lapatinib and trastuzumab with or without endocrine therapy. Pathologic complete response: no invasive cancer in the residual breast. Near pathologic complete response: residual disease of less than 1 cm in breast.", " Time frame: 12 weeks", "Results 1: ", " Arm/Group Title: Lapatinib + Trastuzumab", " Arm/Group Description: All study participants received lapatinib 1000mg daily and trauzumab 4mg/kg loading dose and then 2mg/kg every week", " Overall Number of Participants Analyzed: 64", " Measure Type: Number", " Unit of Measure: participants Complete Pathologic Response: 18", " Near Complete Pathologic Response: 16", " Not Pathologic response: 30" ]

[ "Inclusion Criteria:", " Female patients with histologically or cytologically confirmed carcinoma of the breast", " Patients with advanced/metastatic disease that is not amenable to curative therapy (either surgery or radiation therapy)", " Patients must have measurable disease by the RECIST criteria, defined as at least one lesion that can be accurately measured in at least one diameter (at least 10 mm in longest diameter (LD) by spiral computer tomography (CT) scan, or at least 20 mm by standard techniques; If the only measurable lesion is a lymph node, it must measure at least 20 mm in LD. If a single lesion is identified as the target lesion, a cytological or histological confirmation of breast carcinoma is required.", " Patients must have had prior treatment with an anthracycline and a taxane (either sequential or in combination) and may have had prior treatment with other agents as well.", " Patients must have progressed within six months of the last dose of chemotherapy, or experienced disease progression while receiving chemotherapy for advanced/metastatic disease.", " Resolution of all chemotherapy or radiation-related toxicities to less than grade 1 severity", " Age 18 years", " Eastern Cooperative Oncology Group (ECOG) Performance Status (APPENDIX 4) of 0 or 1", " Life expectancy of 3 months", " Adequate renal function as evidenced by serum creatinine 1.5 mg/dL or calculated creatinine clearance 50 mL/minute (min) per the Cockcroft and Gault formula", " Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) 1.5 x 10^9/L, hemoglobin 10.0 g/dL (a hemoglobin <10.0 g/dL would be acceptable if it can be corrected by growth factor or transfusion), and platelet count 100 x 10^9/L", " Adequate liver function as evidenced by bilirubin 1.5 mg/dL and alkaline phosphatase, alanine transaminase (ALT), and aspartate transaminase (AST) 3 times the upper limits of normal (ULN) (in the case of liver metastases 5 x ULN)", " Patients willing and able to complete the FACT-B questionnaire, Analgesic Diary, Pain VAS, and the tumor-related symptomatic assessment", " Patients willing and able to comply with the study protocol for the duration of the study", " A sample from the diagnostic biopsy (paraffin block) must be available", " Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice", "Exclusion Criteria:", " Patients who have received chemotherapy, radiation, hormonal therapy, or Herceptin within 2 weeks of E7389 treatment start", " Radiation therapy encompassing > 10% of marrow", " Failure to recover from any chemotherapy related or other therapy related toxicity at study entry that is deemed to be clinically significant by the study investigator", " Prior treatment with Mitomycin C or nitrosoureas", " Prior high dose chemotherapy with hematopoietic stem cell rescue in the past two years", " Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen", " Active symptomatic brain metastasis; Patients with central Nervous System (CNS) metastasis are considered eligible if they have completed local therapy and discontinued from corticosteroids for at least two weeks before starting treatment with E7389", " Patients with meningeal carcinomatosis", " Patients who require therapeutic anti-coagulant therapy with Warfarin or related compounds; Mini dose warfarin for catheter related thrombosis prophylaxis is permitted", " Women who are pregnant or breast-feeding; Women of childbearing potential with either a positive pregnancy test at Screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.", " Severe /uncontrolled intercurrent illness/infection", " Significant cardiovascular impairment (history of congestive heart failure > NYHA grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia)", " Patients with organ allografts", " Patients with known positive HIV status", " Patients who have had a prior malignancy, other than carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated 5 years previously with no subsequent evidence of recurrence", " Patients with pre-existing neuropathy > Grade 1", " Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative", " Patients who participated in a prior E7389 clinical trial", " Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study" ]

[ "Inclusion criteria:", " DISEASE CHARACTERISTICS:", " Scheduled to undergo screening mammogram at one of the Boston Medical Center-affiliated primary care clinics and meets 1 of the following criteria:", " Dense breast tissue", " At high-risk for breast cancer", " PATIENT CHARACTERISTICS:", " Has 1 of the following racial or ethnic backgrounds based on the patient's country of birth or the mother and father's country of birth:", " Hispanic", " Haitian Creole", " African American", " Caucasian", " PRIOR CONCURRENT THERAPY:", " None specified", "Exclusion criteria:", " No history of breast cancer, palpable breast mass, abnormal nipple discharge, or other focal complaints warranting diagnostic mammogram" ]

[ "Inclusion Criteria:", " Female or male 18 years of age.", " Newly diagnosed ER-positive, HER2-negative breast cancer. ER-positive is defined as 1% immunohistochemical (IHC) staining of any intensity. HER2 test result is negative if a single test (or both tests) performed show:", " IHC 1+ or 0", " In situ hybridization negative based on:", " Single-probe average HER2 copy number < 4.0 signals/cell", " Dual-probe HER2/CEP17 ratio < 2 with an average HER2 copy number < 4.0 signals/cell.", " Patients with stage II-III breast cancer are eligible if they are deemed appropriate for neoadjuvant endocrine therapy by the referring or treating medical oncologist. Patients with stage I disease are eligible if they are deemed borderline candidates for breast conservation and the treating surgeon recommends preoperative therapy to increase the chances of breast conservation.", " Eastern Cooperative Oncology Group performance status and/or other performance status of 1.", " Female patients who:", " Are postmenopausal for at least 1 year before the screening visit, OR", " Are surgically sterile, OR", " If they are of childbearing potential, agree to practice 1 effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the ICF through 90 days (or longer, as mandated by local labeling [e.g., United Surgical Partners International, summary of product characteristics, etc.] after the last dose of the study drugs, OR", " Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condom should not be used together).", " Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:", " Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of the study drugs, OR", " Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient", " Agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of the study drugs.", " Screening clinical laboratory values as specified below:", " Bone marrow reserve consistent with: absolute neutrophil count 1.5 x 109/L, platelet count 100 x 109/L, and hemoglobin 9 g/dL (without transfusion) within 1 week preceding the administration of the study drugs;", " Hepatic status: Serum total bilirubin 1 x upper limit of normal (ULN; in the case of known Gilbert's syndrome, a higher serum total bilirubin [< 1.5 x ULN] is allowed), aspartate aminotransferase and alanine aminotransferase 1.5 x ULN, and alkaline phosphatase 1.5 x ULN;", " Renal status: Creatinine clearance 50 mL/min based on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour);", " Metabolic status: HbA1c < 7.0%, fasting serum glucose 130 mg/dL, and fasting triglycerides 300 mg/dL.", " Ability to swallow oral medications.", " Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.", " Negative serum pregnancy test within 7 days prior to the administration of the study drugs for female patients of childbearing potential.", " Patient must be accessible for treatment and follow-up.", " Patient must be willing to undergo breast biopsies as required by the study protocol.", "Exclusion Criteria:", " Any patient with metastatic disease.", " Other clinically significant comorbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise the patient's participation in the study.", " Known human immunodeficiency virus infection.", " Known hepatitis B surface antigen-positive or known or suspected active hepatitis C infection.", " Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the protocol-specified treatment.", " Diagnosed or treated for another malignancy within 2 years before administration of the first dose of the study drugs or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.", " Breastfeeding or pregnant.", " Manifestations of malabsorption due to prior gastrointestinal surgery, gastrointestinal disease, or an unknown reason that may alter the absorption of TAK-228. Patients with enteric stomata are also excluded.", " Treatment with any investigational products within 2 weeks before administration of the first dose of the study drugs.", " Poorly controlled diabetes mellitus (defined as HbA1c > 7%). Patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in the study if all other inclusion criteria and none of the other exclusion criteria are met.", " History of any of the following within the last 6 months before administration of the first dose of the study drugs:", " Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures", " Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures", " Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, and ventricular tachycardia)", " Placement of a pacemaker for control of rhythm", " New York Heart Association Class III or IV heart failure", " Pulmonary embolism", " Significant active cardiovascular or pulmonary disease including:", " Uncontrolled hypertension (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg). Use of antihypertensive agents to control hypertension before week 1, day 1 is allowed.", " Pulmonary hypertension", " Uncontrolled asthma or O2 saturation < 90% by arterial blood gas analysis or pulse oximetry on room air", " Significant valvular disease, severe regurgitation, or stenosis by imaging independent of symptom control with medical intervention or history of valve replacement", " Medically significant (symptomatic) bradycardia", " History of arrhythmia requiring an implantable cardiac defibrillator", " Baseline QTc prolongation (e.g., repeated demonstration of QTc interval > 480 milliseconds or history of congenital long QT syndrome or torsades de pointes)", " Treatment with strong inhibitors and/or inducers of CYP3A4, CYP2C9, or CYP2C19 within 7 days preceding the first dose of the study drugs.", " Patients receiving systemic corticosteroids (either IV or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of the study drugs.", " Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of the study drugs.", " Patients unwilling or unable to comply with the study protocol.", " Patients previously treated with hormonal therapy (tamoxifen, AI) or PI3K, AKT, dual PI3K/mTOR, TORC1/2, or mTORC1 inhibitors.", " Patients who are currently being treated with cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) other than the trial therapy.", " Patients with hypersensitivity to mTOR inhibitors or tamoxifen." ]

[ "Adverse Events 1:", " Total: 27/50 (54.00%)", " Febrile neutropenia * 4/50 (8.00%)", " Anaemia * 1/50 (2.00%)", " Neutropenia * 1/50 (2.00%)", " Cardiac failure * 1/50 (2.00%)", " Diarrhoea * 1/50 (2.00%)", " Gastritis * 1/50 (2.00%)", " Nausea * 1/50 (2.00%)", " Oesophagitis * 1/50 (2.00%)", " Pyrexia * 7/50 (14.00%)", " Mucosal inflammation * 1/50 (2.00%)", " Drug hypersensitivity * 1/50 (2.00%)", " Cellulitis * 2/50 (4.00%)" ]

[ "Adverse Events 1:", " Total: 158/482 (32.78%)", " Anaemia 7/482 (1.45%)", " Disseminated intravascular coagulation 1/482 (0.21%)", " Lymphadenopathy 0/482 (0.00%)", " Neutropenia 0/482 (0.00%)", " Thrombocytopenia 2/482 (0.41%)", " Anaemia 28/482 (1.66%)", " Disseminated intravascular coagulation 21/482 (0.21%)", " Febrile neutropenia 21/482 (0.21%)", " Lymphadenopathy 20/482 (0.00%)", " Neutropenia 20/482 (0.00%)", "Adverse Events 2:", " Total: 37/238 (15.55%)", " Anaemia 2/238 (0.84%)", " Disseminated intravascular coagulation 0/238 (0.00%)", " Lymphadenopathy 1/238 (0.42%)", " Neutropenia 1/238 (0.42%)", " Thrombocytopenia 0/238 (0.00%)", " Anaemia 22/238 (0.84%)", " Disseminated intravascular coagulation 20/238 (0.00%)", " Febrile neutropenia 21/238 (0.42%)", " Lymphadenopathy 21/238 (0.42%)", " Neutropenia 21/238 (0.42%)" ]

[ "Inclusion Criteria:", " Subjects will only be included in the study if they meet all of the following criteria:", " Subjects who have given informed consent", " Subjects that agree not to drink alcoholic beverages or use any drugs during the study", " Subject with blood parameters within normal ranges", " Age: at least 18 years old", " Patients will only be included in the study if they meet all of the following criteria:", " Patients who have given informed consent", " Patients that agree not to drink alcoholic beverages or use any drugs during the study", " Age: at least 18 years old", " Patients with local, locally advanced or metastatic HER2+ breast carcinoma as diagnosed on biopsied tissue by immunohistochemistry or fluorescence in situ hybridization (FISH).", "Exclusion Criteria:", " Patients will not be included in the study if one of the following criteria applies:", " Pregnant patients", " Breast feeding patients", " Patients with occupational exposure to ionizing irradiation", " Patients with previous thyroid disorders", " Patients that received radiolabeled compounds with a long half-life (>7h) for diagnostic or therapeutic purposes within the last 2 days.", " Patients with absolute contra-indications for thyroid blockage with potassium iodide.", " Patients with abnormal liver: ALT/AST > 2 times normal values; bilirubin > 1.5 time normal values.", " Patients with abnormal kidney function: < 50 ml/min/1,73 m2", " Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom", " Patients with any serious active infection", " Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical", " Patients who cannot communicate reliably with the investigator", " Patients who are unlikely to cooperate with the requirements of the study", " Patients at increased risk of death from a pre-existing concurrent illness", " Patients who participated already in this study", " Patients who participated in a previous trial with Anti-HER2 VHH1", " Subjects will not be included in the study if one of the following criteria applies:", " Pregnant subjects", " Breast feeding subjects", " Subjects with occupational exposure to ionizing irradiation", " Subjects with clinical significant disease or on concomitant therapy (except contraception)", " Subjects with previous thyroid disorders", " Subjects that received radiolabeled compounds with a long half-life (>7h) for diagnostic or therapeutic purposes within the last 2 days.", " Subjects with absolute contra-indications for thyroid blockage with potassium iodide.", " Subjects with abnormal liver: ALT/AST > 2 times normal values; bilirubin > 1.5 time normal values.", " Subjects with abnormal kidney function: < 50 ml/min/1,73 m2", " Subjects with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom", " Subjects with any serious active infection", " Subjects who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test radiopharmaceutical", " Subjects who cannot communicate reliably with the investigator", " Subjects who are unlikely to cooperate with the requirements of the study", " Subjects at increased risk of death from a pre-existing concurrent illness", " Subjects who participated already in this study", " Subjects who participated in a previous trial with Anti-HER2 VHH1" ]

[ "INTERVENTION 1: ", " Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)", " Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.", " vorinostat: Given PO", " laboratory biomarker analysis: Correlative studies", " biopsy: Optional correlative studies", " F-18 16 alpha-fluoroestradiol: Correlative studies", " positron emission tomography: Correlative studies", " anastrozole: Given PO", " letrozole: Given PO", " exemestane: Given PO", " gene expression analysis: Correlative studies" ]

[ "INTERVENTION 1: ", " 6-Mercaptopurine and Methotrexate (6MP/MTX)", " 6-Mercaptopurine: 6MP 75mg/m2 body surface area, administered orally (PO) once a day (od) in the morning 1 hour after eating, on a continuous schedule. One cycle is 28 days. Treatment is given continuously until disease progression.", " Methotrexate: Methotrexate 20mg/m2 will be taken orally, once a week, in the morning. One cycle is 28 days. Treatment is given continuously until disease progression.", " Update: These original doses were reduced following an Urgent Safety Measure in August 2012 due to a large proportion of patients requiring a dose reduction or treatment delay due to incidences of myelo-suppression.", " The reduced doses were 55mg/m2 of 6MP orally once a day, and 15mg/m2 of Methotrexate orally once a week." ]

[ "INTERVENTION 1: ", " IPAS", " Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction", "IPAS" ]

[ "INTERVENTION 1: ", " Zr89-trastuzumab PET/CT", " Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm" ]

[ "INTERVENTION 1: ", " Diagnostic (FLT PET)", " Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.", " Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.", " Positron Emission Tomography: Undergo FLT PET", " Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen." ]

[ "INTERVENTION 1: ", " Arm A", " Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO", "INTERVENTION 2: ", " Arm B", " Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO" ]

[ "Adverse Events 1:", " Total: 67/349 (19.20%)", " Anaemia * 3/349 (0.86%)", " Leukopenia * 1/349 (0.29%)", " Neutropenia * 3/349 (0.86%)", " Thrombocytopenia * 1/349 (0.29%)", " Atrial fibrillation * 2/349 (0.57%)", " Cardiac arrest * 1/349 (0.29%)", " Cardiac failure * 0/349 (0.00%)", " Cardiac failure acute * 0/349 (0.00%)", " Cardio-respiratory arrest * 2/349 (0.57%)", " Cardiovascular insufficiency * 0/349 (0.00%)", "Adverse Events 2:", " Total: 69/353 (19.55%)", " Anaemia * 2/353 (0.57%)", " Leukopenia * 1/353 (0.28%)", " Neutropenia * 1/353 (0.28%)", " Thrombocytopenia * 1/353 (0.28%)", " Atrial fibrillation * 0/353 (0.00%)", " Cardiac arrest * 1/353 (0.28%)", " Cardiac failure * 4/353 (1.13%)", " Cardiac failure acute * 1/353 (0.28%)", " Cardio-respiratory arrest * 0/353 (0.00%)", " Cardiovascular insufficiency * 1/353 (0.28%)" ]

[ "Inclusion Criteria:", " Age 18 and 85 years", " Postmenopausal status defined as: no menstrual cycle in the past 12 months hysterectomy with bilateral oophorectomy hysterectomy with intact ovaries if age > 55 years", " Newly diagnosed with incident, primary, invasive, estrogen receptor positive clinical stage II or lower breast cancer", " ECOG performance status of 1 or less", " Willingness to comply with study guidelines and procedures", " Willingness and ability to provide informed consent", " Usual consumption of soy no more than 1 time per week and willingness to avoid whole soy foods or concentrated soy sources (soy milk, tofu, substitute meat products, meal replacement bars) during the intervention period", " Willingness to avoid herbal and dietary supplements (not including vitamins), aspirin, and ibuprofen during the intervention period", " No competing neoadjuvant or chemotherapy treatment", " Time between pre-surgical visit and surgery must be at least 2 weeks", " No chemotherapy in the past 12 months", "Exclusion Criteria:", " Inability to read and write English", " Previous invasive breast cancer", " Insulin dependent Type I or II diabetes diagnosed by physician", " History of coagulopathy, thrombocytopenia, or bleeding disorder", " Current (past 30 days) regular (at least once per week) use of reproductive hormone therapy, Tamoxifen, aromatase inhibitors, or other estrogen inhibitors, flaxseed, or antibiotics", " Current chemotherapy or neoadjuvant chemotherapy", " Allergies to flaxseed, nuts, or other seeds", " Renal dysfunction defined as creatinine > 1.5 mg/dl", " History of Crohns' disease, ulcerative colitis, irritable bowel syndrome, celiac sprue, or other malabsorption syndrome, diverticulitis, diverticulosis, or other bowel diagnosis which, in the opinion of the breast surgeon, would contraindicate large doses of dietary fiber or would impair nutrient absorption", " Current, regular (more than once weekly) use of prescription blood-thinning agents including coumadin, heparin and heparin related drugs, clopidogrel bisulfate" ]

[ "Inclusion Criteria:", " Patient evaluated and treated at INCAN", " Patients must provide informed consent", " Patient must be 18 years of age.", " Life expectancy 6 months", " Clinical locally advance breast cancer (Stage IIB or III)", " Pathologically confirmed diagnosis of estrogen receptor (ER)-positive or progesterone receptor (PR)-positive breast cancer with ER or PR Allred Score > 4", " Patient must have an ECOG Performance Status of 0-2", " Patients must be able to swallow and retain oral medication", "Exclusion Criteria:", " Patient must not have received any prior chemotherapy, radiation therapy, or biologic therapy for invasive breast cancer within the past five years", " Patient must not be pregnant or nursing", " Patient must not have had any prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.", " Women of childbearing age unable or unwilling to use contraception" ]

[ "Inclusion Criteria:", " Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided written informed consent", "Exclusion Criteria:", " Medical history of chemotherapy or endocrine therapy for breast cancer, or with treatment history of radiotherapy. Unwillingness to stop taking any drug known to affect sex hormone status (including hormone replacement therapy (HRT)." ]

[ "INTERVENTION 1: ", " Lidocaine Patch", " Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.", "INTERVENTION 2: ", " Placebo Patch", " Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day." ]

[ "INTERVENTION 1: ", " Letrozole, Breast Enhancement, Safety", " Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI." ]

[ "Adverse Events 1:", " Total: 3/31 (9.68%)", " Edema: limb * 2/31 (6.45%)", " Neutrophils/granulocytes (ANC/AGC) * 0/31 (0.00%)", " Cardiac General - Other (Specify, __) * [1]0/31 (0.00%)", " Cardiac General - Other (Specify, __) * [2]0/31 (0.00%)", " Left ventricular diastolic dysfunction * 0/31 (0.00%)", " Supraventricular and nodal arrhythmia - Atrial tachycardia/Paroxysmal Atrial Tachycardia * 0/31 (0.00%)", "Adverse Events 2:", " Total: 8/25 (32.00%)", " Edema: limb * 1/25 (4.00%)", " Neutrophils/granulocytes (ANC/AGC) * 0/25 (0.00%)", " Cardiac General - Other (Specify, __) * [1]1/25 (4.00%)", " Cardiac General - Other (Specify, __) * [2]0/25 (0.00%)", " Left ventricular diastolic dysfunction * 1/25 (4.00%)", " Supraventricular and nodal arrhythmia - Atrial tachycardia/Paroxysmal Atrial Tachycardia * 0/25 (0.00%)" ]

[ "INTERVENTION 1: ", " Intelligent Breast Exam, iBE", " Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation.", " intelligent Breast Exam, iBE: A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual. If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit." ]

[ "INTERVENTION 1: ", " Phase 1: Addition of Supine MRI to Conventional Imaging", " Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)" ]

[ "Outcome Measurement: ", " Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan", " -The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her.", " Time frame: Within 1 year of protocol registration", "Results 1: ", " Arm/Group Title: Cohort 1 (36 Gy)", " Arm/Group Description: 36 Gy in 9 fractions BID x 4 1/2 treatment days", " Partial Breast Irradiation (PBI)", " Overall Number of Participants Analyzed: 50", " Measure Type: Number", " Unit of Measure: percentage of participants 100", "Results 2: ", " Arm/Group Title: Cohort 2 (40 Gy)", " Arm/Group Description: 40 Gy in 10 fractions BID over 5 treatment days", " Partial Breast Irradiation (PBI)", " Overall Number of Participants Analyzed: 50", " Measure Type: Number", " Unit of Measure: percentage of participants 100" ]

[ "Adverse Events 1:", " Total: 6/21 (28.57%)", " Hypertension 3/21 (14.29%)", " Edema 3/21 (14.29%)", " Nausea 2/21 (9.52%)", " Fracture 1/21 (4.76%)", " Dizziness 3/21 (14.29%)", " Syncope 2/21 (9.52%)", " Headache 2/21 (9.52%)", " Dyspnea 2/21 (9.52%)", " Hypoxia 3/21 (14.29%)" ]

[ "Adverse Events 1:", " Total: 1/40 (2.50%)", " Hypertension 0/40 (0.00%)", " Lower GI bleed 1/40 (2.50%)", " Death 0/40 (0.00%)", " Headache 0/40 (0.00%)", " Dyspnea 0/40 (0.00%)", " Sinusitis 0/40 (0.00%)", " Wound Dehiscence 0/40 (0.00%)", "Adverse Events 2:", " Total: 3/41 (7.32%)", " Hypertension 1/41 (2.44%)", " Lower GI bleed 0/41 (0.00%)", " Death 0/41 (0.00%)", " Headache 0/41 (0.00%)", " Dyspnea 0/41 (0.00%)", " Sinusitis 1/41 (2.44%)", " Wound Dehiscence 1/41 (2.44%)" ]

[ "Inclusion Criteria:", " Female gender;", " Age 18 years;", " Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1", " Histologically confirmed invasive breast cancer:", " Primary tumor greater than 1 cm diameter, measured by clinical examination and mammography or ultrasound.", " Any N,", " No evidence of metastasis (M0) (isolated supra-clavicular node involvement allowed);", " Over expression and/or amplification of HER2 in the invasive component of the primary tumor and confirmed by a certified laboratory prior to randomization.", " Known hormone receptor status.", " Hematopoietic status:", " CBC not less than .75 of institutional lower limit. Absolute neutrophil count 1,5 x 10^9/L, Platelet count 100 x 10^9/L, Hemoglobin at least 9 g/dl,", " Hepatic status:", " Serum total bilirubin 2 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (< 1.5 x ULN) is allowed, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 3.5 times ULN, Alkaline phosphatase 2.5 times ULN, Renal status: Creatinine 1.5mg/dL,", " Cardiovascular: Baseline left ventricular ejection fraction (LVEF) ³ 50% measured by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan,", " Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential within 2-weeks (preferably 7 days) prior to randomization.", " Fertile patients must use effective contraception (barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed)", " Signed informed consent form (ICF)", " Patient accepts to make available tumor samples for submission to central laboratory to conduct translational studies as part of this protocol.", "Exclusion Criteria:", " Previous (less than 5 years) or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin; Carcinoma in situ of the cervix.", " Patients with a prior malignancy diagnosed more than 5 years prior to randomization may enter the study.", " Preexisting peripheral neuropathy grade 2", " Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ( 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen;", " Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety;", " Unresolved or unstable, serious adverse events from prior administration of another investigational drug;", " Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;", " Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;", " Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies);", " Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;", " Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab Emtansine, trastuzumab, lapatinib, paclitaxel, abraxane or their components;", " Pregnant or lactating women;", " Concomitant use of CYP3A4 inhibitors or inducers", " Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol", " Patients have an active infection and require IV or oral antibiotics.", " Pregnant or breast-feeding women", " Patients unwilling or unable to comply with the protocol" ]

[ "Inclusion Criteria :", " women with primary breast cancer, without ongoing support for substance use.", " An AUDIT-C score >1 or more than one cigarette smoked per day.", " Individuals able to consent to benefit of intervention focused on substance use. (Karnofsky Index >70).", " Exclusion Criteria :", " Patients who currently use substances for which a second-line care is already committed.", " Patients with a Karnofsky index <70." ]

[ "Outcome Measurement: ", " Percentage of Participants With Progressive Disease at Week 12 in Cohort 1", " The percentage of participants with progressive disease (PD) 12 weeks after randomization was measured. Per Response Evaluation Criteria In Solid Tumors (RECIST), a response of PD is defined as a >=20% increase in target lesions. Participants were also classified as having PD if their response at Week 12 was unknown or missing. Response was determined by an independent radiologist and by an investigator.", " Time frame: Week 12", "Results 1: ", " Arm/Group Title: Cohort 1: Lapatinib 1500 mg", " Arm/Group Description: Lapatinib 1500 milligrams (mg) administered orally once a day", " Overall Number of Participants Analyzed: 72", " Measure Type: Number", " Unit of Measure: percentage of participants Independently Evaluated: 38.9", " Investigator Evaluated: 43.1", "Results 2: ", " Arm/Group Title: Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg", " Arm/Group Description: Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day", " Overall Number of Participants Analyzed: 69", " Measure Type: Number", " Unit of Measure: percentage of participants Independently Evaluated: 36.2", " Investigator Evaluated: 37.7" ]

[ "DISEASE CHARACTERISTICS:", " History of histologically confirmed breast cancer, meeting 1 of the following staging criteria:", " Ductal carcinoma in situ", " Stage I-III invasive breast cancer", " At least 3 months since completion of all intended local and systemic therapy, including mastectomy or lumpectomy with or without radiotherapy, adjuvant chemotherapy, and/or endocrine therapy", " May have declined recommended treatment provided all treatment intended/agreed upon by the patient and treating physician was completed 3 months ago", " At least 1 healthy intact breast", " No prior radiotherapy or mastectomy", " Prior biopsies allowed", " Any hormone-receptor status", " PATIENT CHARACTERISTICS:", " Female", " Pre- or post-menopausal", " ECOG performance status 0-2", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective nonhormonal contraception", " No active liver disease", " AST and ALT 3 times upper limit of normal", " Creatinine clearance 30 mL/min", " No prior hypersensitivity to any 3-hydroxyl-3-methylglutaryl-Coenzyme A (HMG-CoA) reductase inhibitor or any of its components", " No other concurrent infectious, inflammatory, or autoimmune diseases (at the discretion of principal investigator)", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " No daily alcohol use > 3 standard drinks per day", " Standard drink defined as 10 grams of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor", " No selective estrogen receptor modulator or aromatase inhibitor within the past 3 months", " No hormone replacement therapy (HRT) within the past 3 months", " No prior estrogen and/or progesterone HRT 5 years in duration", " Vaginal estrogen preparations allowed", " No concurrent HRT", " No other cholesterol-lowering drug, including a statin, within the past 3 months", " No concurrent itraconazole, ketoconazole, nefazodone, cyclosporine, HIV protease inhibitors, clarithromycin, erythromycin, mibefradil, carbamazepine, bosentan, chaparral, amiodarone, or verapamil", " No concurrent daily grapefruit juice consumption > 8 ounces per day", " No other concurrent agents or therapies intended to treat or prevent in situ or invasive breast cancer" ]

[ "Inclusion Criteria:", " Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided written informed consent", "Exclusion Criteria:", " Medical history of chemotherapy or endocrine therapy for breast cancer, or with treatment history of radiotherapy. Unwillingness to stop taking any drug known to affect sex hormone status (including hormone replacement therapy (HRT)." ]

[ "Adverse Events 1:", " Total: 20/167 (11.98%)", " Cardiac failure acute 0/167 (0.00%)", " Diarrhoea 5/167 (2.99%)", " Colitis 2/167 (1.20%)", " Enterocolitis 1/167 (0.60%)", " Enterocolitis haemorrhagic 1/167 (0.60%)", " Stomatitis 1/167 (0.60%)", " Impaired healing 1/167 (0.60%)", " Sudden death 1/167 (0.60%)", " Postoperative wound infection 2/167 (1.20%)", " Erysipelas 2/167 (1.20%)", " Bacterial diarrhoea 1/167 (0.60%)", "Adverse Events 2:", " Total: 4/167 (2.40%)", " Cardiac failure acute 1/167 (0.60%)", " Diarrhoea 0/167 (0.00%)", " Colitis 0/167 (0.00%)", " Enterocolitis 0/167 (0.00%)", " Enterocolitis haemorrhagic 0/167 (0.00%)", " Stomatitis 0/167 (0.00%)", " Impaired healing 0/167 (0.00%)", " Sudden death 0/167 (0.00%)", " Postoperative wound infection 1/167 (0.60%)", " Erysipelas 0/167 (0.00%)", " Bacterial diarrhoea 0/167 (0.00%)" ]

[ "Adverse Events 1:", " Total: 19/51 (37.25%)", " Febrile neutropenia 6/51 (11.76%)", " Anaemia 1/51 (1.96%)", " Leukopenia 1/51 (1.96%)", " Neutropenia 1/51 (1.96%)", " Thrombocytopenia 0/51 (0.00%)", " Pericarditis 1/51 (1.96%)", " Atrial flutter 0/51 (0.00%)", " Cardiac failure congestive 0/51 (0.00%)", " Visual impairment 0/51 (0.00%)", " Dysphagia 1/51 (1.96%)", " Abdominal pain 0/51 (0.00%)", " Chills 1/51 (1.96%)", "Adverse Events 2:", " Total: 17/50 (34.00%)", " Febrile neutropenia 0/50 (0.00%)", " Anaemia 1/50 (2.00%)", " Leukopenia 0/50 (0.00%)", " Neutropenia 1/50 (2.00%)", " Thrombocytopenia 1/50 (2.00%)", " Pericarditis 0/50 (0.00%)", " Atrial flutter 1/50 (2.00%)", " Cardiac failure congestive 1/50 (2.00%)", " Visual impairment 1/50 (2.00%)", " Dysphagia 0/50 (0.00%)", " Abdominal pain 1/50 (2.00%)", " Chills 0/50 (0.00%)" ]

[ "Inclusion Criteria:", " Female breast cancer patients over the age of 18 will be recruited for this study. Patients enrolled in the study will meet standard criteria for whole breast XRT.", "Exclusion Criteria:", " Subjects will be excluded for a number of medical conditions that are contraindications to XRT and/or might confound the relationship among fatigue, and inflammation, including pregnancy, major psychiatric disorders, autoimmune or inflammatory disorders, chronic infectious diseases (e.g. HIV, hepatitis B or C), neurologic disorders and uncontrolled cardiovascular, metabolic, pulmonary or renal disease (as determined by medical history, physical examination and laboratory testing). Subjects with a history of a major psychiatric disorder including Schizophrenia or Bipolar Disorder or a diagnosis of Substance Abuse or Dependence within the past 1 year (as determined by standardized psychiatric interview) will be excluded. Subjects taking drugs known to affect the immune system (e.g. glucocorticoids, methotrexate) will also be excluded. Subjects using supplements or other natural products with one week of starting medications, excluding vitamins and calcium supplementation or at the discretion of the attending physician, will be excluded. Patients who have evidence of infection as determined by history, physical exam or laboratory testing (complete blood count and urinalysis) at baseline will be excluded. In addition, patients who develop evidence of infection (as determined by history, physical exam or laboratory testing) during the study will be discontinued from the study." ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed primary adenocarcinoma of the breast", " Stage I-III disease", " No evidence of metastatic disease", " Must have undergone lumpectomy or total mastectomy for primary disease within the past 12 weeks, or have completed chemotherapy within the past 8 weeks", " Axillary evaluation per institutional standards", " Currently receiving or planning to receive standard adjuvant systemic therapy comprising chemotherapy, hormonal therapy, or combined chemotherapy/hormonal therapy for breast cancer", " Patients who are at low risk for disease recurrence and for whom adjuvant systemic therapy will not be prescribed are not eligible", " Patients who receive biologic agents only or local radiotherapy only (without chemotherapy and/or hormone therapy) are not eligible", " Additional therapies are allowed including radiotherapy and biologic agents (e.g., trastuzumab [Herceptin^®], bevacizumab, or hematopoietic growth factors)", " Neoadjuvant therapy or hormonal therapy alone is allowed provided study entry occurs 12 weeks after completion of surgery", " Patients with skeletal pain are eligible provided bone scan and/or roentgenological exam are negative for metastatic disease", " Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy", " Hormone receptor status:", " Not specified", " PATIENT CHARACTERISTICS:", " Age", " 18 and over", " Sex", " Female", " Menopausal status", " Not specified", " Performance status", " Zubrod 0-2", " Life expectancy", " Not specified", " Hematopoietic", " Not specified", " Hepatic", " Not specified", " Renal", " Creatinine 2 times upper limit of normal", " Creatinine clearance 30 mL/min", " No renal failure", " Other", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception", " No history of esophageal stricture or motility disorders", " Gastroesophageal reflux disorder allowed", " No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission", " PRIOR CONCURRENT THERAPY:", " Biologic therapy", " Prior or concurrent hematopoietic growth factors allowed", " HER-2-targeted therapies allowed", " Antiangiogenics allowed", " Chemotherapy", " See Disease Characteristics", " Endocrine therapy", " See Disease Characteristics", " Radiotherapy", " Concurrent radiotherapy to the breast, chest wall, or lymph node group allowed at the discretion of the treating physician", " Surgery", " See Disease Characteristics", " Other", " Prior neoadjuvant therapy allowed", " Prior bisphosphonates for bone density allowed", " No other concurrent bisphosphonates as adjuvant therapy or for treatment of osteoporosis", " No concurrent enrollment in clinical trials with bone density as an endpoint", " Concurrent enrollment on any other locoregional or systemic therapy breast cancer study (including cooperative group studies) allowed" ]

[ "Outcome Measurement: ", " Primary Endpoint : Compare Best Overall Response Rate (ORR) (According to Response Evaluation Criteria in Solid Tumor [RECIST] 1.1 Criteria) at Week 24 of MYL-1401O Plus Taxane Versus Herceptin® Plus Taxane in the ITT1 Population", " Tumor measurements were perform by centralized blinded reviewers using RECIST 1.1 criteria. Per RECIST 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm.Partial Response (PR): >/= 30% decrease sum of the diameters of target lesions from baseline sum diameters.", " Progressive Disease (PD): </= 20% increase in the sum of the diameters of target lesions, from the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions* denotes disease progression.", " Stable Disease (SD): Neither sufficient decrease or increase. Evaluation of Non-Target Lesions Complete Response (CR): Disappearance of all non-target lesions. Non-complete Response/Non-Progressive Disease: Persistence of one or more non-target lesions. Progressive Disease (PD): Substantial, unequivocal progression of existing non-target lesions.", " Time frame: from time of First treatment to week 24", "Results 1: ", " Arm/Group Title: Herceptin + Taxane", " Arm/Group Description: Part 1: Herceptin (trastuzumab) intravenously+ paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.", " Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Herceptin (trastuzumab) alone once every 3 weeks until DP or subject withdrawal .", " Overall Number of Participants Analyzed: 228", " Measure Type: Count of Participants", " Unit of Measure: Participants Complete Response: 0 0.0%", " Partial Response: 146 64.0%", " Stable Disease: 49 21.5%", " Progressive Disease: 20 8.8%", " Not Evaluable: 13 5.7%", "Results 2: ", " Arm/Group Title: MYL-1401O Trastuzumab + Taxane", " Arm/Group Description: Part 1:Myl 1401OTrastuzumab Intravenously + paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.", " Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Myl 1401O( Mylan Trastuzumab) alone once every 3 weeks until DP or subject withdrawal.", " Overall Number of Participants Analyzed: 230", " Measure Type: Count of Participants", " Unit of Measure: Participants Complete Response: 3 1.3%", " Partial Response: 157 68.3%", " Stable Disease: 48 20.9%", " Progressive Disease: 9 3.9%", " Not Evaluable: 13 5.7%" ]

[ "Outcome Measurement: ", " Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12", " Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.", " Time frame: 12 months", "Results 1: ", " Arm/Group Title: Denosumab 60 mg Q6M", " Arm/Group Description: [Not Specified]", " Overall Number of Participants Analyzed: 123", " Least Squares Mean (95% Confidence Interval)", " Unit of Measure: Percent Change from Baseline 4.8 (4.3 to 5.4)", "Results 2: ", " Arm/Group Title: Placebo", " Arm/Group Description: [Not Specified]", " Overall Number of Participants Analyzed: 122", " Least Squares Mean (95% Confidence Interval)", " Unit of Measure: Percent Change from Baseline -.7 (-1.3 to -.1)" ]

[ "Adverse Events 1:", " Total: 3/19 (15.79%)", " Febrile neutropenia 1/19 (5.26%)", " Colitis 1/19 (5.26%)", " Pain in extremity 0/19 (0.00%)", " Nephrolithiasis 0/19 (0.00%)", " Pulmonary embolism 1/19 (5.26%)", " Dyspnoea 0/19 (0.00%)", " Haematoma 0/19 (0.00%)", "Adverse Events 2:", " Total: 4/30 (13.33%)", " Febrile neutropenia 1/30 (3.33%)", " Colitis 0/30 (0.00%)", " Pain in extremity 1/30 (3.33%)", " Nephrolithiasis 1/30 (3.33%)", " Pulmonary embolism 0/30 (0.00%)", " Dyspnoea 1/30 (3.33%)", " Haematoma 1/30 (3.33%)" ]

[ "Outcome Measurement: ", " Objective Response Rate (ORR)", " Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", " Time frame: Up to 2 years.", "Results 1: ", " Arm/Group Title: NKTR-102 14 Day", " Arm/Group Description: NKTR-102: NKTR-102 given on a q14 day schedule", " Overall Number of Participants Analyzed: 35", " Measure Type: Number", " Unit of Measure: percentage of subjects 28.6 (14.6 to 46.3)", "Results 2: ", " Arm/Group Title: NKTR-102 21 Days", " Arm/Group Description: NKTR-102: NKTR-102 given on a q21 day schedule", " Overall Number of Participants Analyzed: 35", " Measure Type: Number", " Unit of Measure: percentage of subjects 35 (14.6 to 46.3)" ]

[ "Outcome Measurement: ", " Percentage of Participants With Overall Response Rate (ORR)", " Overall Response Rate (ORR) was defined as the proportion of patients whose best overall response was either complete response (CR) or partial response (PR) according to RECIST 1.0 for target lesions and assessed by CT: Complete Response (CR), disappearance of all target lesions for a period of at least one month; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (ORR) = CR + PR. Only descriptive statistics.", " Time frame: From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 15 months", "Results 1: ", " Arm/Group Title: Everolimus + Letrozole", " Arm/Group Description: All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.", " Overall Number of Participants Analyzed: 43", " Measure Type: Number", " Unit of Measure: Percentage of Participants 37.2" ]

[ "INTERVENTION 1: ", " Cabozantinib", " Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity." ]

[ "INTERVENTION 1: ", " Phase I: Cyclophosphamide, Doxil, Trastuzumab", " Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.", " pegylated liposomal doxorubicin hydrochloride: Given IV", " cyclophosphamide: Given orally", " trastuzumab: Given IV" ]

[ "Inclusion Criteria:", " Recurrent or residual metastatic breast carcinoma", " Zubrod performance status less than 2", " 18-60 years old", " Related donor human leukocyte antigen (HLA)-compatible for allogeneic transplantation or unrelated HLA-compatible donor.", " No major organ dysfunction or active infection", "Exclusion Criteria: None" ]

[ "Inclusion Criteria:", " Patient must be postmenopausal defined as meeting one or more of the following:", " Age 60 years", " Amenorrheic for at least 12 months", " Surgically sterile- having undergone bilateral oophorectomy,", " FSH level in postmenopausal range according to institutional standards (note follicle-stimulating hormone (FSH) laboratory testing must be ordered as standard of care to determine optimal treatment and should not be ordered simply to confirm eligibility to this study)", " OR Pre-menopausal for whom standard estradiol treatment (ET) is planned with ovarian suppression (imaging on study should be completed prior to start of ovarian suppression)", " Patient must have histological or cytological confirmed breast cancer and fall into one of the following categories:", " New diagnosis with plans for at least 6 months of neoadjuvant ET or any amount of neoadjuvant ET if surgery is planned as this will be used for response assessment .", " Patients with newly diagnosed metastatic breast cancer or patient with known metastatic disease who has progressed while on therapy (no washout period is needed if the patient was treated with AIs or chemotherapy, but 2 months washout period is needed if the patient was treated with tamoxifen) who are going to be treated with ET.", " Patient must have any one of the following types of breast cancer (primary or metastatic): ER+/PgR+/HER2- or ER+/PgR-/HER2-.", " ER+ is defined as Allred score of at least 4 and greater.", " PgR+ is defined as Allred score of at least 4 and greater.", " Immunohistochemistry (IHC) is the primary assay methodology for HER2. HER2- refers to HER2 of 0, 1+ by IHC or negative by fluorescence in situ hybridization (FISH)", " Patient must have at least one measurable lesion according to RECIST 1.1 by radiological evaluation (ultrasound, mammography, MRI, CT, PET) or physical examination.", " Patients with evaluable osseous metastasis that are lytic or mixed lytic-sclerotic are eligible.", " Patients with hepatic lesions may be eligible provided the location of the lesion is peripheral or not too close to hepatic ducts. Decision on hepatic lesion eligibility will be made by the principal investigator or sub-investigator after careful review of all available imaging to ensure evaluation of the lesion will not be obscured by normal hepatobiliary excretion of 18F-FFNP.", " Patient must be able to understand and willing to sign a written informed consent document.", " Prior chemotherapy or endocrine therapy is allowed", " The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or, based on the judgment of the treating medical oncologist, can tolerate imaging and at least 6 months of ET", " The patient should have a life expectancy of > 6 months.", "Exclusion Criteria:", " Patient with other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in-situ, who had (or have) any evidence of the other cancer present within the last 5 years", " Unable to tolerate up to 60 min of PET imaging per imaging session.", " Patients with non-measurable non-evaluable lesions such as pleural effusion are not eligible to participate.", " Patients with vertebral lesions that, in the opinion of the Principal Investigator and the treating medical oncologist, pose an imminent risk for cord compression." ]

[ "Inclusion Criteria:", " Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.", " Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.", " Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.", " If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.", " Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.", " Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.", " Subject must have adequate bone marrow, renal and hepatic function.", " Subject must not be pregnant or plan to conceive a child.", "Exclusion Criteria:", " Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1.", " More than 2 prior lines of cytotoxic chemotherapy.", " Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor.", " Prior taxane therapy for metastatic breast cancer.", " A history of or evidence of brain metastases or leptomeningeal disease.", " A history of uncontrolled seizure disorder.", " Pre-existing neuropathy from any cause in excess of Grade 1.", " Known history of allergic reaction to cremophor/paclitaxel.", " Clinical significant uncontrolled conditions, active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.", " Pregnant or breastfeeding." ]

[ "INCLUSION CRITERIA:", " Undergoing core needle biopsy for a breast abnormality suspicious for breast cancer.", " Has undergone a core needle biopsy demonstrating breast cancer and has not yet had any further therapy, provided the core needle biopsy is available for analysis.", " No prior therapy for breast cancer within the past 5 years.", " 18 years of age or older.", " Ability to understand and the willingness to sign a written informed consent document.", "EXCLUSION CRITERIA:", " History of parathyroid disease, hypercalcemia, or kidney stones.", " Supplemental vitamin D other than from a standard multiple vitamin or from standard formulations of calcium and vitamin D (eg, calcium citrate with vitamin D) within the prior 6 months.", " History of renal failure requiring dialysis or kidney transplantation.", " Pregnant or nursing", " Receiving supplemental calcium > 1200 mg calcium per day during study.", " Initial treatment of breast cancer will not be with breast-conserving surgery or mastectomy.", " Locally-advanced breast cancer", " Plans for neoadjuvant chemotherapy, hormonal therapy, or other systemic therapy", " Plans for preoperative radiation therapy", " Plans for breast cancer surgery, and does not allow for at least 10 days of vitamin D intervention.", " Any condition potentially interfering with subjects ability to comply with taking study medication.", " Any medical condition that would potentially interfere with vitamin D absorption, such as celiac sprue, ulcerative colitis.", " Current participation in another research study that would increase risk to subject, in the opinion of the investigators" ]

[ "INTERVENTION 1: ", " CMRM Versus UMRM", "[Not Specified]" ]

[ "Adverse Events 1:", " Total: 13/24 (54.17%)", " FEBRILE NEUTROPENIA 5/24 (20.83%)", " HAEMATOTOXICITY 0/24 (0.00%)", " NEUTROPENIA 3/24 (12.50%)", " LYMPHADENOPATHY 0/24 (0.00%)", " PERICARDIAL EFFUSION 1/24 (4.17%)", " ATRIAL FIBRILLATION 1/24 (4.17%)", " APLASIA 0/24 (0.00%)", " NAUSEA 0/24 (0.00%)", " PYREXIA 1/24 (4.17%)", " EXTRAVASATION 0/24 (0.00%)", " CHOLECYSTITIS 1/24 (4.17%)", " PATHOLOGICAL FRACTURE 1/24 (4.17%)", "Adverse Events 2:", " Total: 6/24 (25.00%)", " FEBRILE NEUTROPENIA 0/24 (0.00%)", " HAEMATOTOXICITY 1/24 (4.17%)", " NEUTROPENIA 0/24 (0.00%)", " LYMPHADENOPATHY 1/24 (4.17%)", " PERICARDIAL EFFUSION 0/24 (0.00%)", " ATRIAL FIBRILLATION 0/24 (0.00%)", " APLASIA 1/24 (4.17%)", " NAUSEA 1/24 (4.17%)", " PYREXIA 0/24 (0.00%)", " EXTRAVASATION 1/24 (4.17%)", " CHOLECYSTITIS 0/24 (0.00%)", " PATHOLOGICAL FRACTURE 0/24 (0.00%)" ]

[ "Outcome Measurement: ", " Number of Patients With a Pathological Complete Response (pCR) Who Received Targeted Therapy With Trastuzumab and Pertuzumab or Bevacizumab Predicted by Genomically-derived Molecular Subtypes.", " Number of patients with a pathological complete response (pCR) who received targeted therapy with trastuzumab and pertuzumab or bevacizumab predicted by genomically-derived molecular subtypes (HER2 positive or HER2 negative. pCR is defined as absence of invasive cancer in breast or lymph nodes after neoadjuvant chemotherapy.", " Time frame: Up to 30 days after last cycle of treatment", "Results 1: ", " Arm/Group Title: Cohort 1P (HER2 Positive)", " Arm/Group Description: Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 5", " Measure Type: Count of Participants", " Unit of Measure: Participants 4 80.0%", "Results 2: ", " Arm/Group Title: Cohort 1T (HER2 Positive)", " Arm/Group Description: Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 6", " Measure Type: Count of Participants", " Unit of Measure: Participants 6 100.0%" ]

[ "INTERVENTION 1: ", " Treatment (Enzyme Inhibitor Therapy)", " Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity." ]

[ "Outcome Measurement: ", " Progression Free Survival", " Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment.", " Time frame: From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)", "Results 1: ", " Arm/Group Title: Standard of Care (SOC)", " Arm/Group Description: Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.", " Overall Number of Participants Analyzed: 1048", " Median (95% Confidence Interval)", " Unit of Measure: Months 7.4 (7.1 to 7.6)", "Results 2: ", " Arm/Group Title: Epoetin Alfa", " Arm/Group Description: Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.", " Overall Number of Participants Analyzed: 1050", " Median (95% Confidence Interval)", " Unit of Measure: Months 7.4 (6.9 to 7.6)" ]

[ "Adverse Events 1:", " Total: 9/33 (27.27%)", " Febrile neutropenia * 1/33 (3.03%)", " Cardiac failure * 1/33 (3.03%)", " Pyrexia * 2/33 (6.06%)", " Chest pain * 1/33 (3.03%)", " Medical device complication * 1/33 (3.03%)", " Cellulitis * 1/33 (3.03%)", " Sepsis * 1/33 (3.03%)", " Hip fracture * 1/33 (3.03%)", " Back pain * 1/33 (3.03%)", " Menorrhagia * 1/33 (3.03%)", " Thrombosis * 1/33 (3.03%)", "Adverse Events 2:", " " ]

[ "Adverse Events 1:", " Total: 10/48 (20.83%)", " NEUTROPENIA 1/48 (2.08%)", " THROMBOCYTOPENIA 0/48 (0.00%)", " VOLUME BLOOD DECREASED 1/48 (2.08%)", " FIBRILLATION ATRIAL 1/48 (2.08%)", " HYPOTENSION 1/48 (2.08%)", " ABDOMINAL PAIN 1/48 (2.08%)", " APPETITE DECREASED 0/48 (0.00%)", " DEHYDRATION 4/48 (8.33%)", " DIARRHEA 4/48 (8.33%)", " NAUSEA 3/48 (6.25%)", " VOMITING 2/48 (4.17%)", " FEVER 1/48 (2.08%)", " RIGORS 0/48 (0.00%)", "Adverse Events 2:", " Total: 5/53 (9.43%)", " NEUTROPENIA 1/53 (1.89%)", " THROMBOCYTOPENIA 1/53 (1.89%)", " VOLUME BLOOD DECREASED 0/53 (0.00%)", " FIBRILLATION ATRIAL 0/53 (0.00%)", " HYPOTENSION 0/53 (0.00%)", " ABDOMINAL PAIN 0/53 (0.00%)", " APPETITE DECREASED 1/53 (1.89%)", " DEHYDRATION 0/53 (0.00%)", " DIARRHEA 0/53 (0.00%)", " NAUSEA 1/53 (1.89%)", " VOMITING 1/53 (1.89%)", " FEVER 1/53 (1.89%)", " RIGORS 1/53 (1.89%)" ]

[ "Outcome Measurement: ", " Objective Response Rate", " Patient response rates will be measured by the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI. Responses include the following: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) best response from the start of treatment until disease progression.", " Time frame: Baseline to 6 months", "Results 1: ", " Arm/Group Title: Abraxane + Tigatuzumab", " Arm/Group Description: Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.", " Overall Number of Participants Analyzed: 39", " Measure Type: Number", " Unit of Measure: percentage of patients 28 (14.9 to 45.0)", "Results 2: ", " Arm/Group Title: Abraxane Alone", " Arm/Group Description: Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).", " Overall Number of Participants Analyzed: 21", " Measure Type: Number", " Unit of Measure: percentage of patients 38 (18 to 61.1)" ]

[ "Adverse Events 1:", " Total: 2/4 (50.00%)", " Atrial fibrillation 0/4 (0.00%)", " Dehydration 1/4 (25.00%)", " Fatigue (asthenia, lethargy, malaise) 1/4 (25.00%)", " Pain - Back 1/4 (25.00%)", " Urinary tract infection 0/4 (0.00%)", " Dyspnea (shortness of breath) 0/4 (0.00%)", " Pericardial effusion 0/4 (0.00%)", " Thrombosis 0/4 (0.00%)", " Skin infection 0/4 (0.00%)", " Rash: hand-foot skin reaction 0/4 (0.00%)", "Adverse Events 2:", " Total: 0/3 (0.00%)", " Atrial fibrillation 0/3 (0.00%)", " Dehydration 0/3 (0.00%)", " Fatigue (asthenia, lethargy, malaise) 0/3 (0.00%)", " Pain - Back 0/3 (0.00%)", " Urinary tract infection 0/3 (0.00%)", " Dyspnea (shortness of breath) 0/3 (0.00%)", " Pericardial effusion 0/3 (0.00%)", " Thrombosis 0/3 (0.00%)", " Skin infection 0/3 (0.00%)", " Rash: hand-foot skin reaction 0/3 (0.00%)" ]

[ "INTERVENTION 1: ", " Laser Therapy Alone", " therapist administered laser treatment", " laser: therapist administered laser", "INTERVENTION 2: ", " Mld Alone", " therapist administered manual lymphatic drainage", " manual lymphatic drainage: therapist administered massage therapy" ]

[ "INTERVENTION 1: ", " Part A Abemaciclib: HR+, HER2+ Breast Cancer", " Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.", "INTERVENTION 2: ", " Part B Abemaciclib: HR+, HER2- Breast Cancer", " Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET).", " Participants may continue to receive treatment until discontinuation criteria are met." ]

[ "Adverse Events 1:", " Total: 3/24 (12.50%)", " Disseminated intravascular coagulation 0/24 (0.00%)", " Death NOS 0/24 (0.00%)", " Edema limbs 0/24 (0.00%)", " Fatigue 0/24 (0.00%)", " Hepatic failure 1/24 (4.17%)", " Alanine aminotransferase increased 1/24 (4.17%)", " Aspartate aminotransferase increased 1/24 (4.17%)", " Blood bilirubin increased 0/24 (0.00%)", " Ejection fraction decreased 1/24 (4.17%)", "Adverse Events 2:", " Total: 9/22 (40.91%)", " Disseminated intravascular coagulation 1/22 (4.55%)", " Death NOS 1/22 (4.55%)", " Edema limbs 1/22 (4.55%)", " Fatigue 1/22 (4.55%)", " Hepatic failure 0/22 (0.00%)", " Alanine aminotransferase increased 0/22 (0.00%)", " Aspartate aminotransferase increased 1/22 (4.55%)", " Blood bilirubin increased 1/22 (4.55%)", " Ejection fraction decreased 1/22 (4.55%)" ]

[ "Adverse Events 1:", " Total: 5/33 (15.15%)", " Left Ventricular Thrombus * 1/33 (3.03%)", " Nausea * 1/33 (3.03%)", " Acute Cholecystitis * 1/33 (3.03%)", " Renal Failure * 1/33 (3.03%)", " Pneumonia * 1/33 (3.03%)" ]

[ "Adverse Events 1:", " Total: 26/69 (37.68%)", " Thrombophlebitis * 1/69 (1.45%)", " Anaemia NOS * 1/69 (1.45%)", " Acute febrile neutrophilic dermatosis * 1/69 (1.45%)", " Cardiac failure NOS * 2/69 (2.90%)", " Ejection fraction decreased * 1/69 (1.45%)", " Intestinal obstruction NOS * 1/69 (1.45%)", " Diarrhoea NOS * 2/69 (2.90%)", " Febrile neutropenia * 12/69 (17.39%)", " Mucosal inflammation NOS * 1/69 (1.45%)" ]

[ "Inclusion Criteria:", " Signed and dated PICF obtained prior to initiation of any study-specific procedure and treatment.", " Female 18 years old.", " Histologically proven invasive breast carcinoma (through either a core needle biopsy or an incisional biopsy) for which surgery is indicated as the primary treatment modality. Patients for which Neoadjuvant Systemic Therapy (NAST) is indicated are also eligible provided they are willing to undergo a biopsy after completing treatment with darolutamide and prior to NAST start.", " Known ER, PgR and HER2 statuses.", " Tumor must be confined to either the breast or to the breast and ipsilateral axilla (Note: patinets with multifocal/multicentric tumors are eligible). Patient must have (according to TNM 7th edition rules):", " T1 with T 1.0cm, T2 or T3 by at least one radiographic or clinical measurement", " Either clinically positive (N1 only) or clinically negative axillary nodes (N0)", " M0", " Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.", " Adequate organ function within 28 days prior to enrollment, as defined by the following criteria:", " Hematology: Hemoglobin 9.0 g/dl; ANC 1.5 × 109/L; Platelet count 100 × 109/L", " Liver function: ALT and AST 2.5 × ULN; Total bilirubin 1.5 × ULN (or 3 times ULN for patients with documented Gilbert's syndrome or for whom indirect bilirubin concentrations suggest an extra-hepatic source of elevation)", " Renal function: Creatinine 2.0 × ULN", " No more than 42 days should elapse from the day study-specific tumor sample is taken at initial diagnosis (or subsequent procedure) to the day of the first intake of darolutamide.", " Women of childbearing potential (WoCBP)* must agree to use acceptable non-hormonal contraceptive methods of birth control from the day of the screening pregnancy test and up to 3 months after the last intake of darolutamide.", " For WoCBP* negative serum pregnancy test within 7 days of enrollment.", " Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and biopsies as detailed in the protocol.", " Note: WoCBP are any women between menarche and menopause who have not been permanently sterilized, capable of procreation. Permanent sterilization includes hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy but excludes bilateral tubal ligation/occlusion. Postmenopause is defined as: Bilateral oophorectomy; Age 60; Age < 60 and amenorrheic for 12 months in the absence of an alternative medical cause and FSH and estradiol in postmenopausal ranges.", "Exclusion Criteria:", " Any T0, Tis, T1 < 1.0 cm, T4; or N2-3; or M1 BC.", " Bilateral invasive BC.", " Patient that underwent excisional biopsy of the primary tumor.", " Medical indication or patient desire to undergo BC surgery or start NAST prior to completing at least 14 days of treatment with darolutamide, and or refusal of patient to undergo corresponding biopsy in case NAST is planned.", " Prior or concurrent systemic anticancer therapy for BC treatment(immunotherapy, hormonotherapy, biologic/targeted therapy, chemotherapy, investigational agents).", " Prior or concurrent ipsilateral radiation therapy for invasive or noninvasive BC.", " Prior or concurrent treatment or preventative use of any hormonal agent such as aromatase inhibitors (AI), fulvestrant, raloxifene, tamoxifen or other SERM, or with any other hormonal agent used for the treatment or prevention of BC or for any other indication (e.g. osteoporosis).", " Concurrent use of ovarian hormone replacement therapy. Prior treatment should be stopped at least 28 days prior to registration.", " Prior or concurrent treatment with AR antagonists or CYP17 enzyme inhibitor.", " Use of other investigational drug within 28 days of enrollment.", " Major surgery* within 28 days before enrollment.", " Any concurrent or previous malignancy within 5 years prior to enrollment except for basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasive/in-situ neoplasm, all of which must have been adequately and radically treated. A patient with previous history of invasive malignancy (other than adequately and radically treated basal or squamous skin cancer) is eligible provided that she has been disease free for more than 5 years.", " Severe or uncontrolled concurrent disease, infection or comorbidity.", " Known active viral hepatitis, HIV or chronic liver disease.", " Other serious illness or medical condition within 6 months before enrollment, including any of the following: Concurrent congestive heart failure NYHA Class III or IV, severe/unstable angina pectoris, myocardial infarction, uncontrolled hypertension, coronary/peripheral artery bypass graft, high-risk uncontrolled arrhythmias, stroke.", " Any contraindication to oral agents or gastrointestinal disorder or procedure which expects to interfere significantly with absorption of protocol treatment.", " History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.", " Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.", " Known allergy to darolutamide or any of the excipients.", " Pregnant or lactating darolutamide. * Note: Major surgery defined as requiring a general anesthesia or respiratory assistance; involving openings into the great cavities of the body, organs removed, or normal anatomy altered; implying risks of severe hemorrhage; implying risk for life of the patient or severe disability." ]

[ "Inclusion Criteria:", " Prospectively confirmed HER2-positive (i.e., IHC 3+ or IHC 2+ and gene amplified by fluorescence in situ hybridization [FISH] positive) as assessed on primary tumor and/or metastatic site", " Documented progression of unresectable, locally advanced, or mBC, determined by the investigator", " Left ventricular ejection fraction (LVEF) >/= 50% by echocardiogram (ECHO)", " Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1", " A negative serum Beta-Human Chorionic Gonadotropin (Beta-HCG) test for women of childbearing potential (premenopausal or not meeting the definition of postmenopausal i.e. >/= 12 months of amenorrhea), and women who have not undergone surgical sterilization (i.e., absence of ovaries and/or uterus)", " For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate non-hormonal methods of contraception, including at least one method with a failure rate of <1% per year, during the treatment period and for at least 7 months after the last dose of study drug", " For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm. With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 7 months plus 90 days (a spermatogenesis cycle) after the last dose of study drug. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 7 months after the last dose of study drug.", "Exclusion Criteria:", " Prior treatment with trastuzumab emtansine", " Prior treatment with lapatinib or lapatinib with capecitabine or non-comparable biologic or biosimilar of trastuzumab", " Peripheral neuropathy of Grade >/= 3 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE [version 4.03])", " History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above", " History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to enrollment except hormone therapy, which can be given up to 7 days prior to enrollment; recovery of treatment-related toxicity consistent with other eligibility criteria", " History of exposure to cumulative doses of anthracyclines, as defined in the protocol", " History of radiation therapy within 14 days of enrollment", " Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as a history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) before enrollment", " CNS only disease", " History of a decrease in LVEF to < 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment", " History of symptomatic chronic heart failure (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment", " History of myocardial infarction or unstable angina within 6 months of enrollment", " Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy", " Current severe, uncontrolled systemic disease", " Pregnancy or lactation", " Concurrent, serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV) or active hepatitis B and/or hepatitis C. For patients who are known carriers of hepatitis B virus (HBV), active hepatitis B infection must be ruled out, based on negative serologic testing and/or determination of HBV DNA viral load per local guidelines", " Presence of conditions that could affect gastrointestinal absorption: malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis", " History of intolerance (such as Grade 3-4 infusion reaction) or known hypersensitivity to trastuzumab or murine proteins or any component of the product", " Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol" ]

[ "Inclusion Criteria:", " Female gender;", " Age 18 years;", " Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1", " Histologically confirmed invasive breast cancer:", " Primary tumor greater than 1 cm diameter, measured by clinical examination and mammography or ultrasound.", " Any N,", " No evidence of metastasis (M0) (isolated supra-clavicular node involvement allowed);", " Over expression and/or amplification of HER2 in the invasive component of the primary tumor and confirmed by a certified laboratory prior to randomization.", " Known hormone receptor status.", " Hematopoietic status:", " CBC not less than .75 of institutional lower limit. Absolute neutrophil count 1,5 x 10^9/L, Platelet count 100 x 10^9/L, Hemoglobin at least 9 g/dl,", " Hepatic status:", " Serum total bilirubin 2 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (< 1.5 x ULN) is allowed, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 3.5 times ULN, Alkaline phosphatase 2.5 times ULN, Renal status: Creatinine 1.5mg/dL,", " Cardiovascular: Baseline left ventricular ejection fraction (LVEF) ³ 50% measured by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan,", " Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential within 2-weeks (preferably 7 days) prior to randomization.", " Fertile patients must use effective contraception (barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed)", " Signed informed consent form (ICF)", " Patient accepts to make available tumor samples for submission to central laboratory to conduct translational studies as part of this protocol.", "Exclusion Criteria:", " Previous (less than 5 years) or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin; Carcinoma in situ of the cervix.", " Patients with a prior malignancy diagnosed more than 5 years prior to randomization may enter the study.", " Preexisting peripheral neuropathy grade 2", " Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ( 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen;", " Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety;", " Unresolved or unstable, serious adverse events from prior administration of another investigational drug;", " Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;", " Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;", " Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies);", " Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;", " Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab Emtansine, trastuzumab, lapatinib, paclitaxel, abraxane or their components;", " Pregnant or lactating women;", " Concomitant use of CYP3A4 inhibitors or inducers", " Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol", " Patients have an active infection and require IV or oral antibiotics.", " Pregnant or breast-feeding women", " Patients unwilling or unable to comply with the protocol" ]

[ "Outcome Measurement: ", " Progression-Free Survival (PFS) Rate", " PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.", " Time frame: Baseline up to Week 16", "Results 1: ", " Arm/Group Title: Bosutinib", " Arm/Group Description: Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.", " Overall Number of Participants Analyzed: 73", " Measure Type: Number", " Unit of Measure: percentage of participants 39.6 (28.1 to 50.8)" ]

[ "Outcome Measurement: ", " Phase I Portion: Maximum Tolerated Dose/MTD of Dasatinib When Administered in Combination With a Fixed Dose of Weekly Paclitaxel.", " [Not Specified]", " Time frame: Through completion of Phase I, up to 1 year", "Results 1: ", " Arm/Group Title: Dasatinib and Paclitaxel", " Arm/Group Description: The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel.", " The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel.", " Dasatinib and Paclitaxel: A treatment cycle will consist of 28 days, according to the following schedule:", " Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.", " The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel.", " Overall Number of Participants Analyzed: 15", " Measure Type: Number", " Unit of Measure: mg of dasatinib 120" ]

[ "Adverse Events 1:", " Total: 8/113 (7.08%)", " Febrile neutropenia [1]0/113 (0.00%)", " Anemia with trombocytopenia 0/113 (0.00%)", " Neutropenia 1/113 (0.88%)", " Paroxism of atrial fibrillation 0/113 (0.00%)", " Ventricular extrasystolone RYAN-1 0/113 (0.00%)", " Gastrointestinal hemorrhage 1/113 (0.88%)", " Death for unknown reason 1/113 (0.88%)", " Diarrhea with vomiting and weakness 0/113 (0.00%)", "Adverse Events 2:", " Total: 13/110 (11.82%)", " Febrile neutropenia [1]1/110 (0.91%)", " Anemia with trombocytopenia 1/110 (0.91%)", " Neutropenia 1/110 (0.91%)", " Paroxism of atrial fibrillation 2/110 (1.82%)", " Ventricular extrasystolone RYAN-1 1/110 (0.91%)", " Gastrointestinal hemorrhage 0/110 (0.00%)", " Death for unknown reason 1/110 (0.91%)", " Diarrhea with vomiting and weakness 1/110 (0.91%)" ]

[ "Adverse Events 1:", " Total: 23/120 (19.17%)", " Febrile neutropenia 4/120 (3.33%)", " Leukopenia 2/120 (1.67%)", " Neutropenia 8/120 (6.67%)", " Cardiac tamponade 0/120 (0.00%)", " Ventricular arrhythmia 1/120 (0.83%)", " Ascites 0/120 (0.00%)", " Oesophagitis 0/120 (0.00%)", " Large intestine polyp 0/120 (0.00%)", " Death 1/120 (0.83%)", " Liver injury 1/120 (0.83%)", " Pneumonia 3/120 (2.50%)", "Adverse Events 2:", " Total: 30/122 (24.59%)", " Febrile neutropenia 3/122 (2.46%)", " Leukopenia 3/122 (2.46%)", " Neutropenia 9/122 (7.38%)", " Cardiac tamponade 2/122 (1.64%)", " Ventricular arrhythmia 0/122 (0.00%)", " Ascites 1/122 (0.82%)", " Oesophagitis 1/122 (0.82%)", " Large intestine polyp 0/122 (0.00%)", " Death 1/122 (0.82%)", " Liver injury 0/122 (0.00%)", " Pneumonia 5/122 (4.10%)" ]

[ "Adverse Events 1:", " Total: 47/254 (18.50%)", " Anaemia 1/254 (0.39%)", " Febrile neutropenia 1/254 (0.39%)", " Lymphadenopathy 1/254 (0.39%)", " Acute myocardial infarction 1/254 (0.39%)", " Angina pectoris 0/254 (0.00%)", " Angina unstable 0/254 (0.00%)", " Bundle branch block left 0/254 (0.00%)", " Cardiac failure 4/254 (1.57%)", " Coronary artery disease 0/254 (0.00%)", " Coronary artery stenosis 1/254 (0.39%)", "Adverse Events 2:", " Total: 56/269 (20.82%)", " Anaemia 1/269 (0.37%)", " Febrile neutropenia 0/269 (0.00%)", " Lymphadenopathy 0/269 (0.00%)", " Acute myocardial infarction 0/269 (0.00%)", " Angina pectoris 3/269 (1.12%)", " Angina unstable 1/269 (0.37%)", " Bundle branch block left 1/269 (0.37%)", " Cardiac failure 1/269 (0.37%)", " Coronary artery disease 1/269 (0.37%)", " Coronary artery stenosis 0/269 (0.00%)" ]

[ "Adverse Events 1:", " Total: 107/383 (27.94%)", " Anaemia 4/383 (1.04%)", " Febrile neutropenia 7/383 (1.83%)", " Haemoytique anaemia 0/383 (0.00%)", " Leukopenia 1/383 (0.26%)", " Neutropenia 6/383 (1.57%)", " Thrombocytopenia 2/383 (0.52%)", " Anginal pectoris 1/383 (0.26%)", " Cardiomyopathy 0/383 (0.00%)", " Ear pain 0/383 (0.00%)", " Abdominal distension 1/383 (0.26%)", " Abdominal pain 6/383 (1.57%)", "Adverse Events 2:", " Total: 85/383 (22.19%)", " Anaemia 3/383 (0.78%)", " Febrile neutropenia 2/383 (0.52%)", " Haemoytique anaemia 0/383 (0.00%)", " Leukopenia 0/383 (0.00%)", " Neutropenia 1/383 (0.26%)", " Thrombocytopenia 1/383 (0.26%)", " Anginal pectoris 0/383 (0.00%)", " Cardiomyopathy 1/383 (0.26%)", " Ear pain 1/383 (0.26%)", " Abdominal distension 0/383 (0.00%)", " Abdominal pain 3/383 (0.78%)" ]

[ "Outcome Measurement: ", " Objective Response Rate (ORR)", " Tumor response evaluation was performed using RECIST 1.0 using CT/MRI. Proportion of patients achieving a CR or PR is considered in the overall response.", " Time frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.", "Results 1: ", " Arm/Group Title: Pralatrexate", " Arm/Group Description: Study drug 190 mg/m^2 for 2 to 4 weeks.", " Overall Number of Participants Analyzed: 22", " Measure Type: Number", " Unit of Measure: participants 1" ]

[ "Outcome Measurement: ", " Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event", " This table summarizes the cardiotoxicity events of different grades. Grade 1 is a decline of left ventricular ejection fraction(LVEF) >=10% but <20% of baseline value. Grade 2 is LVEF below LLN (50%) or decline of LVEF >=20% of baseline value. Grade 3 is congestive heart failure responsive to treatment. Please note that only a subset of patients reported cardiotoxic events so the totals will not add up to the total number of participants.", " Time frame: Baseline, after cycle 4 (~84 days), after cycle 8 (~168 days), and 30 or more days after last cycle of induction therapy", "Results 1: ", " Arm/Group Title: Arm I: Doxorubicin and Taxotere", " Arm/Group Description: Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.", " Overall Number of Participants Analyzed: 16", " Measure Type: Number", " Unit of Measure: participants Grade 1 After Cycle 4 (approx. 84 days): 2", " Grade 1 After Cycle 8 (approx. 168 days): 4", " Grade 1 After 30 days or more after last cycle: 1", " Grade 2 After Cycle 4 (approx 84 days): 3", " Grade 2 After Cycle 8 (approx 168 days): 4", " Grade 2 After 30 days or more after last cycle: 1", " Grade 3 After Cycle 4 (approx 84 days): 1", " Grade 3 After Cycle 8 (approx 168 days): 0", " Grade 3 After 30 days or more after last cycle: 0", "Results 2: ", " Arm/Group Title: Arm II: Doxorubicin, Taxotere, and Herceptin", " Arm/Group Description: Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.", " Overall Number of Participants Analyzed: 37", " Measure Type: Number", " Unit of Measure: participants Grade 1 After Cycle 4 (approx. 84 days): 12", " Grade 1 After Cycle 8 (approx. 168 days): 8", " Grade 1 After 30 days or more after last cycle: 10", " Grade 2 After Cycle 4 (approx 84 days): 0", " Grade 2 After Cycle 8 (approx 168 days): 2", " Grade 2 After 30 days or more after last cycle: 5", " Grade 3 After Cycle 4 (approx 84 days): 0", " Grade 3 After Cycle 8 (approx 168 days): 0", " Grade 3 After 30 days or more after last cycle: 0" ]

[ "Inclusion Criteria:", " Patients must be female.", " The patient must be greater than/equal to 18 years old", " The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.", " Patients must have clinical Stage IIIA, IIIB, or IIIC disease (American Joint Committee on Cancer [AJCC] staging criteria) with a primary breast tumor that is greater than/equal to 2.0 cm measured by clinical exam, unless the patient has inflammatory breast carcinoma, in which case measurable disease is not required.", " Patients must have the ability to swallow oral medication.", " The patient's Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.", " At the time of study entry, blood counts must meet the following criteria:", " Absolute neutrophil count (ANC) must be greater than/equal to 1200/mm3.", " Platelet count must be greater than/equal to 100,000/mm^3.", " Hemoglobin must be greater than/equal to 10 g/dL.", " The following criteria for evidence of adequate hepatic function must be met:", " total bilirubin must be less than/equal to upper limit of normal (ULN) for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and", " alkaline phosphatase must be less than 2.5 x ULN for the lab; and", " aspartate aminotransferase (AST) must be less than/equal to 1.5 x ULN for the lab.", " Alkaline phosphatase and AST may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than/equal to 2.5 x ULN, then the AST must be less than/equal to the ULN. If the AST is greater than the ULN but less than/equal to 1.5 x ULN, then the alkaline phosphatase must be less than/equal to ULN.", " Patients with either skeletal pain or alkaline phosphatase that is greater than ULN but less than/equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan or positron emission tomography (PET) scan does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are confirmed as benign by x-ray, magnetic resonance imaging (MRI), or biopsy.", " Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (computed tomography [CT], MRI, or PET scan) does not demonstrate metastatic disease and adequate hepatic function.", " The following criteria for evidence of adequate renal function must be met:", " Serum creatinine less than/equal to ULN for the lab.", " Calculated creatinine clearance must be greater than 50 mL/min.", " Urine protein/creatinine (UPC) ratio must be less than 1.0.", " Patients must have their left ventricular ejection fraction (LVEF) assessed by multigated acquisition (MUGA) scan or echocardiogram within 3 months prior to study entry. The LVEF must be greater than/equal to the lower limit of normal (LLN) for the cardiac imaging facility performing the MUGA scan or echocardiogram. Note: If the cardiac imaging facility cannot provide a LLN, use 50% as the LLN value.", " Note: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments to determine if bevacizumab therapy can be continued following doxorubicin and cyclophosphamide (AC) and postoperatively, it is critical that this baseline study be an accurate assessment of the patient's LVEF. If the baseline LVEF is greater than 65%, the MUGA scan or echocardiogram must be repeated prior to study entry. The lower of the two LVEF values should be used as the baseline LVEF.", " Patients must have an electrocardiogram (EKG) within 3 months prior to study entry.", "Exclusion Criteria:", " Tumor determined to be strongly HER2-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (positive for gene amplification).", " Excisional biopsy for this primary tumor.", " Synchronous bilateral invasive breast cancer.", " Surgical axillary staging procedure prior to study entry (Exceptions: 1) fine needle aspiration (FNA) of an axillary node is permitted for any patient, and 2) although not recommended, a sentinel lymph node biopsy for patients with clinically negative axillary nodes is permitted.)", " History of any of the following cancers:", " Ipsilateral breast cancer: invasive, ductal carcinoma in situ (DCIS) treated with any therapy other than excision", " Contralateral breast cancer: invasive within the past 5 years (Patients with history of DCIS or synchronous DCIS are eligible)", " History of non-breast malignancies within the 5 years prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the previous 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.", " Prior therapy with anthracyclines, taxanes, capecitabine, or bevacizumab for any malignancy.", " Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to study entry. The only exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before study entry. In such a case, hormonal therapy must stop at or before study entry and be re-started, if indicated, following chemotherapy.", " Any of the following cardiac conditions:", " angina pectoris that requires the use of anti-anginal medication;", " history of documented congestive heart failure;", " serious cardiac arrhythmia requiring medication;", " severe conduction abnormality;", " valvular disease with documented cardiac function compromise; or", " uncontrolled hypertension defined as blood pressure greater than 150/90 on antihypertensive therapy. (Patients with hypertension that is well controlled on medication are eligible.)", " History of myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function.", " History of transient ischemic attack (TIA) or cerebrovascular accident (CVA).", " History of other arterial thrombotic event within 12 months before study entry.", " Symptomatic peripheral vascular disease.", " Any significant bleeding within 6 months before study entry.", " Serious or non-healing wound, skin ulcers, or bone fracture.", " Gastroduodenal ulcer(s) determined by endoscopy to be active.", " Invasive procedures defined as follows:", " Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to planned start of study therapy. (Note: Placement of a vascular access device is not considered a major surgical procedure.)", " Anticipation of need for major surgical procedures (other than the required breast surgery) during the course of the study.", " Known bleeding diathesis or coagulopathy. (Patients on warfarin with an in-range international normalized ratio [INR] [usually between 2 and 3] are eligible.)", " Other nonmalignant systemic disease (cardiovascular, renal, hepatic, diabetes, etc.) that would preclude the patient from receiving study treatment or would prevent required follow-up.", " Sensory/motor neuropathy greater than/equal to grade 2, as defined by the NCI's Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0).", " Conditions that would prohibit administration of corticosteroids.", " History of hypersensitivity reaction to drugs formulated with polysorbate 80.", " Therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention. Patients are eligible only if these medications are discontinued prior to study entry.", " Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. These patients are eligible if this therapy is discontinued prior to study entry. (Women of reproductive potential must agree to use an effective non-hormonal method of contraception during study therapy and for at least 3 months after completion of bevacizumab.)", " Pregnancy or lactation at the time of study entry.", " Use of any investigational agent within 4 weeks prior to enrollment in the study.", " Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements." ]

[ "Inclusion Criteria:", " Gail risk >= 1.7% and/or relative risk >= 3 times that for 5-year age group", " Premenopausal", " More than 6 months since initiating or discontinuing oral contraceptives", " At increased risk for breast cancer, as indicated by >= 1 of the following risk factors:", " BRCA1/2 mutation characterized as deleterious or of uncertain significance", " Prior atypical ductal hyperplasia, ductal carcinoma in situ, or lobular carcinoma in situ", " Prior random periareolar fine needle aspiration (RPFNA) showing atypical hyperplasia", " Family history consistent with hereditary breast cancer, as indicated by 1 of the following criteria:", " >= 4 relatives with breast cancer", " >= 2 relatives diagnosed with breast cancer at 50 years of age", " Breast and ovarian cancer diagnosed in same relative", " No suspicion for breast cancer on baseline mammogram performed between days 1-10 of menstrual cycle within 3 months prior to screening baseline RPFNA", " Exhibits hyperplasia with or without atypia (Masood score >= 14) with >= 500 cells AND Ki-67 positivity >= 2% by RPFNA performed within 6 months prior to initiation of study drug", " Estimated visual mammographic breast density category >= 5% on mammogram performed within 6 months prior to initiation of study drug", " Has regular menstrual cycles (between 21 and 35 days) unless using extended regimen oral contraceptives or a contraceptive device (e.g., Mirena IUD) Values for metabolic profile and blood count within normal limits", " Absolute granulocyte count > 1,000/mm^3", " Platelets > 100,000/mm^3", " Hemoglobin > 10 g/dL", " Bilirubin < 2.0 mg/dL", " AST < 2 times upper limit of normal (ULN)", " Albumin > 3.0 g/dL", " Creatinine < 1.5 mg/dL", " Alkaline phosphatase < 2 times ULN", " Concurrent hormonal contraceptives allowed provided patient remains on the same hormonal regimen from 3 months prior to baseline aspiration until the completion of study treatment", " Fertile patients must use effective contraception during and for 3 months after completion of study treatment", " Willing to ingest recommended dose of calcium and vitamin D for premenopausal bone health (1,200 mg calcium and 800 IU vitamin D daily)", " Negative pregnancy test prior to receiving study agent", " Exclusion Criteria", " pregnant or nursing", " nursing within the past 6 months", " Known osteoporosis or severe osteopenia (T-score -2 or worse by DEXA)", " History of symptomatic endometriosis with pelvic pain, poorly controlled migraines, or hot flashes", " History of deep venous thrombosis", " History of allergic reactions attributed to compounds of similar chemical or biological composition to the study agent", " Other condition or concurrent illness that, in the opinion of the investigator, would make the patient a poor candidate for RPFNA", " Less than 1 year since prior use of aromatase inhibitors (e.g., anastrozole, exemestane, or letrozole) or selective estrogen receptor modulators (e.g., tamoxifen citrate, raloxifene, or arzoxifene hydrochloride)", " Other concurrent chemopreventive agents", " Concurrent anticoagulants", " Other concurrent investigational agents", " Bilateral breast implants" ]

[ "Adverse Events 1:", " Total: 9/90 (10.00%)", " Febrile neutropenia 2/90 (2.22%)", " Ascites 0/90 (0.00%)", " Nausea 0/90 (0.00%)", " Vomiting 0/90 (0.00%)", " Death NOS 1/90 (1.11%)", " Fever 0/90 (0.00%)", " Other general disorders, administration site conditions 0/90 (0.00%)", " Other hepatobiliary disorders 1/90 (1.11%)", " Lung infection 2/90 (2.22%)", " Sepsis 2/90 (2.22%)", " Spinal fracture 0/90 (0.00%)", "Adverse Events 2:", " Total: 12/89 (13.48%)", " Febrile neutropenia 0/89 (0.00%)", " Ascites 1/89 (1.12%)", " Nausea 1/89 (1.12%)", " Vomiting 1/89 (1.12%)", " Death NOS 2/89 (2.25%)", " Fever 1/89 (1.12%)", " Other general disorders, administration site conditions 1/89 (1.12%)", " Other hepatobiliary disorders 0/89 (0.00%)", " Lung infection 0/89 (0.00%)", " Sepsis 1/89 (1.12%)", " Spinal fracture 1/89 (1.12%)" ]

[ "Outcome Measurement: ", " The Percentage of Patients Achieving Pathological Complete Response Defined as the Absence of Invasion Tumor Cells in the Breast and in Axillary Lymph Nodes, Regardless of Ductal Carcinoma in Situ (DCIS)", " Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.", " The primary endpoint, Pathological complete response, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.", " Time frame: After Neo-adjuvant therapy and Surgery (up to 30 weeks)", "Results 1: ", " Arm/Group Title: CT-P6", " Arm/Group Description: Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.", " Overall Number of Participants Analyzed: 248", " Measure Type: Number", " Unit of Measure: percentage of responders 46.77 (40.43 to 53.19)", "Results 2: ", " Arm/Group Title: Herceptin", " Arm/Group Description: Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.", " Overall Number of Participants Analyzed: 256", " Measure Type: Number", " Unit of Measure: percentage of responders 50.39 (44.10 to 56.68)" ]

[ "INTERVENTION 1: ", " Manual Lymph Drainage", " Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb", " Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.", "INTERVENTION 2: ", " Negative Pressure", " PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb", " PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia." ]

[ "INTERVENTION 1: ", " No Exercise", " Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week", "INTERVENTION 2: ", " Exercise", " Exercise Arm: Exercise consisting of progressive walking and resistance band training", " Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise" ]

[ "Adverse Events 1:", " Total: 21/337 (6.23%)", " Blood/Bone Marrow-Other 0/337 (0.00%)", " Febrile neutropenia 0/337 (0.00%)", " Hemoglobin 2/337 (0.59%)", " Atrioventricular block - 2nd degree Mobitz Type II 0/337 (0.00%)", " Cardiac-ischemia/infarction 1/337 (0.30%)", " Left ventricular diastolic dysfunction 0/337 (0.00%)", " Left ventricular systolic dysfunction 1/337 (0.30%)", " Restrictive cardiomyopathy 1/337 (0.30%)", "Adverse Events 2:", " Total: 48/348 (13.79%)", " Blood/Bone Marrow-Other 1/348 (0.29%)", " Febrile neutropenia 1/348 (0.29%)", " Hemoglobin 1/348 (0.29%)", " Atrioventricular block - 2nd degree Mobitz Type II 1/348 (0.29%)", " Cardiac-ischemia/infarction 2/348 (0.57%)", " Left ventricular diastolic dysfunction 1/348 (0.29%)", " Left ventricular systolic dysfunction 0/348 (0.00%)", " Restrictive cardiomyopathy 0/348 (0.00%)" ]

[ "Adverse Events 1:", " Total: 15/52 (28.85%)", " Anaemia * 1/52 (1.92%)", " Febrile neutropenia 24/52 (7.69%)", " Neutropenia 28/52 (15.38%)", " Cardiac failure chronic 21/52 (1.92%)", " Vomiting 23/52 (5.77%)", " Diarrhoea 21/52 (1.92%)", " Gastric ulcer 21/52 (1.92%)", " Gastritis 21/52 (1.92%)", " Nausea 21/52 (1.92%)", " Fatigue 21/52 (1.92%)", " Pyrexia 21/52 (1.92%)", " Gastroenteritis 21/52 (1.92%)" ]

[ "Adverse Events 1:", " Total: 2/7 (28.57%)", " Anaemia * 0/7 (0.00%)", " Iron Deficiency Anaemia * 0/7 (0.00%)", " Pericardial Effusion * 0/7 (0.00%)", " Adrenal Insufficiency * 1/7 (14.29%)", " Abdominal Pain * 0/7 (0.00%)", " Gastritis Erosive * 0/7 (0.00%)", " Urosepsis * 0/7 (0.00%)", " Pneumonia * 0/7 (0.00%)", " Urinary Tract Infection * 0/7 (0.00%)", " Enterocolitis infectious * 0/7 (0.00%)", "Adverse Events 2:", " Total: 1/8 (12.50%)", " Anaemia * 1/8 (12.50%)", " Iron Deficiency Anaemia * 0/8 (0.00%)", " Pericardial Effusion * 0/8 (0.00%)", " Adrenal Insufficiency * 0/8 (0.00%)", " Abdominal Pain * 0/8 (0.00%)", " Gastritis Erosive * 0/8 (0.00%)", " Urosepsis * 0/8 (0.00%)", " Pneumonia * 0/8 (0.00%)", " Urinary Tract Infection * 0/8 (0.00%)", " Enterocolitis infectious * 0/8 (0.00%)" ]

[ "Inclusion Criteria:", " Histologically confirmed stage I-III colorectal or breast cancer", " Undergone curative-intent complete surgical resection and completed all adjuvant therapy (if indicated) at least 2 months prior to enrollment", " Note: Breast cancer subjects on hormonal therapy or trastuzumab only therapy and colorectal cancer subjects on adjunctive therapies not considered cytotoxic chemotherapy (including those participating in CALGB 80702 receiving only celecoxib/placebo) are eligible.", " Participants will be allowed to receive concomitant adjuvant endocrine therapy for breast cancer; however, all endocrine agents must be initiated at least 1 month prior to enrollment in the study and continued throughout the duration of study participation.", " Less than 120 minutes of exercise per week", " Approval by oncologist or surgeon", " English speaking and able to read English", " No planned surgery anticipated in the 3 month intervention period", " At least one month from any major surgery to start of intervention including colostomy reversal", "Exclusion Criteria:", " Concurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in-situ cervical cancer)", " Metastatic disease", " Scheduled to receive any form of further adjuvant cancer therapy", " Currently on medication for diabetes treatment", " Pregnant or breast-feeding", " Any condition associated with increased risk of metformin-associated lactic acidosis (prior renal failure or liver failure, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)", " Known hypersensitivity or intolerance to metformin" ]

[ "Inclusion Criteria:", " The patient has provided written informed consent with HIPAA authorization before participating in the study, as has his/her responsible caregiver, if applicable.", " The patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan.", " The patient is at least 18 years of age at the time of consent.", " The patient has an ECOG performance status of Grade 0 - 2 [8].", " The patient has a clinical negative node status at the time of study entry.", " If of child bearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.", " The patient is currently not participating in another investigational drug study.", " Melanoma Patients", " The patient has a diagnosis of primary melanoma.", " Breast Cancer Patients", " The patient has a diagnosis of primary breast cancer.", " Patients with pure ductal carcinoma in situ (DCIS) or non-invasive carcinoma if lymph node biopsy is part of the surgical plan.", "Exclusion Criteria:", " The patient is pregnant or lactating;", " The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes (i.e., all patients should be any T,N0,M0);", " The patient has a known hypersensitivity to Lymphazurin or Patent Bleu V.", " Melanoma Patients", " The patient has a tumor with a Breslow depth less than 0.75mm.;", " Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy;", " Patients diagnosed with a prior invasive melanoma that would occur on the same body region or potentially draining to the same nodal basin or patients with truncal or extremity primary melanoma who has had a prior breast cancer potentially draining to the same axillary nodal basin;", " Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary melanoma;", " Patients who have undergone a wide excision for their primary melanoma (>1 cm in dimension) or complex reconstruction (rotation, free flap or skin graft of any type).", " Breast Cancer Patients", " The patient has bilateral primary breast cancers or multiple tumors within their breast;", " Patients that have had prior surgical procedures such as breast implants, reduction mammoplasty or axillary surgery;", " Patients scheduled for bilateral mastectomy for any reason;", " Patients that have had preoperative radiation therapy to the affected breast or axilla" ]

[ "Adverse Events 1:", " Total: 46/127 (36.22%)", " Febrile neutropenia 4/127 (3.15%)", " Neutropenia 1/127 (0.79%)", " Atrial fibrillation 2/127 (1.57%)", " Cardiac failure 0/127 (0.00%)", " Left ventricular dysfunction 4/127 (3.15%)", " Mitral valve disease 1/127 (0.79%)", " Myocardial ischaemia 1/127 (0.79%)", " Sinus tachycardia 1/127 (0.79%)", " Myocardial infarction 1/127 (0.79%)", " Adrenal haemorrhage 1/127 (0.79%)", "Adverse Events 2:", " Total: 28/124 (22.58%)", " Febrile neutropenia 2/124 (1.61%)", " Neutropenia 1/124 (0.81%)", " Atrial fibrillation 0/124 (0.00%)", " Cardiac failure 1/124 (0.81%)", " Left ventricular dysfunction 0/124 (0.00%)", " Mitral valve disease 0/124 (0.00%)", " Myocardial ischaemia 0/124 (0.00%)", " Sinus tachycardia 0/124 (0.00%)", " Myocardial infarction 0/124 (0.00%)", " Adrenal haemorrhage 0/124 (0.00%)" ]

[ "INTERVENTION 1: ", " Arm I", " Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.", " doxorubicin hydrochloride: Given IV", " cyclophosphamide: Given orally", " filgrastim: Given SC", " paclitaxel albumin-stabilized nanoparticle formulation: Given IV", " trastuzumab: Given IV", " laboratory biomarker analysis: Correlative studies", " quality-of-life assessment: Ancillary studies" ]

[ "Adverse Events 1:", " Total: 1/6 (16.67%)", " Goitre 0/6 (0.00%)", " Haemorrhoid Operation 0/6 (0.00%)", " Sciatica 0/6 (0.00%)", " Renal Failure 0/6 (0.00%)", " Varicose Vein 1/6 (16.67%)", "Adverse Events 2:", " Total: 2/7 (28.57%)", " Goitre 1/7 (14.29%)", " Haemorrhoid Operation 1/7 (14.29%)", " Sciatica 1/7 (14.29%)", " Renal Failure 1/7 (14.29%)", " Varicose Vein 0/7 (0.00%)" ]

[ "Inclusion Criteria:", " Women 18 and 75 years of age.", " Voluntary signed informed consent form (ICF).", " Proven diagnosis of metastatic breast cancer (MBC).", " At least one, but no more than three, prior chemotherapy regimens for MBC.", " Patients with known HER-2 overexpressing MBC must have failed at least one prior trastuzumab-containing regimen for metastatic disease.", " Disease evaluable for response by specific appropriate criteria.", " No or minimal disease-related symptoms not affecting patient daily activities.", " Adequate major organ function (normal or minimal alteration in liver, kidney, hematological, metabolic and cardiac function)", " Wash out periods prior to Day 1 of Cycle 1:", " At least three weeks since the last chemotherapy (six weeks in some particular cases) and At least four weeks since the last radiotherapy (RT) > 30 Gy) and At least one week since the last hormonal therapy and At least two weeks since the last biological/investigational therapy", " Minimal or no ongoing toxicity from immediately prior therapy according to specific appropriate criteria. Mild ongoing toxicity is allowed in case of alopecia, skin toxicity, fatigue and/or finger numbness or tumbling.", " Patients of child-bearing potential must agree to use a medically approved contraception method until at least six weeks after the last study drug administration.", " Known deleterious germline mutation of BRCA1/2 (Patients in Cohorts A and A1)", " Prior treatment with PARP inhibitors (Patients in Cohort A1)", "Exclusion Criteria:", " Prior treatment with PM01183 or trabectedin.", " Extensive prior RT.", " Prior or concurrent malignant disease unless cured for more than five years.", " Exceptions are breast cancer in the other breast.", " Uncommon or rare subtypes of breast cancer.", " Symptomatic or progressive brain metastases.", " Bone-limited and exclusively metastases.", " Relevant diseases or clinical situations which may increase patient's risk:", " History of cardiac disease. Moderate breathing difficulties or oxygen requirement Active uncontrolled infection. Unhealed wound or presence of any external drainage. Chronically active viral hepatitis. Immunocompromised patients, including those known to be infected by human immunodeficiency virus (HIV).", " Known muscular disease or functional alteration", " Pregnant or breastfeeding women.", " Impending need for immediate RT for symptomatic relief.", " Limitation of the patient's ability to comply with the treatment or to follow-up the protocol." ]

[ "INTERVENTION 1: ", " Arm 1: BREASTChoice (Decision Tool)", " Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.", "INTERVENTION 2: ", " Arm 2: Enhanced Usual Care (Surgical Care Booklet)", " Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet \"Breast Reconstruction.\" They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes." ]

[ "INTERVENTION 1: ", " ARM 1 Daily Boost", " Radiation Therapy", " Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.", " Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.", "INTERVENTION 2: ", " ARM 2 Weekly Boost", " Radiation Therapy", " Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.", " Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed." ]

[ "Outcome Measurement: ", " Progression-free Survival (PFS)", " PFS is defined as the number of months from the date of randomization to the earlier of progressive disease (PD) or death due to any cause.", " Time frame: From date of randomization to discontinuation due to disease progression or death up to primary completion date (Median follow-up 6 months)", "Results 1: ", " Arm/Group Title: Exemestane 25 mg + Placebo", " Arm/Group Description: Exemestane (Aromasin ) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.", " Overall Number of Participants Analyzed: 66", " Median (95% Confidence Interval)", " Unit of Measure: months 2.27 (1.81 to 3.68)", "Results 2: ", " Arm/Group Title: Exemestane 25 mg + Entinostat 5 mg", " Arm/Group Description: Exemestane (Aromasin ) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.", " Overall Number of Participants Analyzed: 64", " Median (95% Confidence Interval)", " Unit of Measure: months 4.28 (3.26 to 5.36)" ]

[ "Adverse Events 1:", " Total: 15/131 (11.45%)", " Disseminated intravascular coagulation 1/131 (0.76%)", " Febrile neutropenia 5/131 (3.82%)", " Hemoglobin decreased 7/131 (5.34%)", " Lymphatics 1/131 (0.76%)", " Transfusion: pRBCs 0/131 (0.00%)", " Arrhythmia supraventricular 0/131 (0.00%)", " Cardiac disorder 1/131 (0.76%)", " Edema 0/131 (0.00%)", " Left ventricular failure 0/131 (0.00%)", " Myocardial ischemia 1/131 (0.76%)", "Adverse Events 2:", " Total: 17/181 (9.39%)", " Disseminated intravascular coagulation 0/181 (0.00%)", " Febrile neutropenia 1/181 (0.55%)", " Hemoglobin decreased 13/181 (7.18%)", " Lymphatics 0/181 (0.00%)", " Transfusion: pRBCs 1/181 (0.55%)", " Arrhythmia supraventricular 1/181 (0.55%)", " Cardiac disorder 0/181 (0.00%)", " Edema 0/181 (0.00%)", " Left ventricular failure 1/181 (0.55%)", " Myocardial ischemia 0/181 (0.00%)" ]

[ "Inclusion Criteria:", " stage I-III breast cancer", " adjuvant or neoadjuvant anthracycline-based chemotherapy", "Exclusion Criteria:", " under age 18", " pregnancy", " metastatic or inoperable (including inflammatory) breast cancer", " confounding underlying medical illnesses", " history of mania", " history of other axis-I psychiatric disorder", " other physical or psychological impairments -" ]

[ "Outcome Measurement: ", " Progression-Free Survival (PFS) Rate", " PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.", " Time frame: Baseline up to Week 16", "Results 1: ", " Arm/Group Title: Bosutinib", " Arm/Group Description: Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.", " Overall Number of Participants Analyzed: 73", " Measure Type: Number", " Unit of Measure: percentage of participants 39.6 (28.1 to 50.8)" ]

[ "Inclusion criteria:", " Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer", " Locally advanced or metastatic disease", " Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1)", " For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment", " Investigator-confirmed diagnosis of Inflammatory Breast Cancer", " Must have biopsiable disease", "Exclusion criteria:", " Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population)", " Must not have received prior vinorelbine treatment" ]

[ "INCLUSION CRITERIA:", " Postmenopausal female.", " Postmenopausal defined as no menses for at least 12 months or bilateral oophorectomy. In unclear cases, (e.g. 50 year old who has had hysterectomy) chemical confirmation of postmenopausal status may be confirmed with follicle stimulating hormone (FSH) greater than 35 U/L.", " Elevated risk for developing invasive breast cancer by virtue of one of the following criteria:", " Gail Model risk of greater than or equal to 1.7% over 5 years from study entry. (This is the same minimum level of risk required for a subject to be eligible for the recently completed NSABP-P1 tamoxifen breast cancer prevention trial).", " Lobular neoplasia.", " Atypical ductal hyperplasia.", " DCIS (ductal carcinoma in situ) that has been previously treated with mastectomy or lumpectomy and radiation, +/- tamoxifen.", " Deleterious mutations in BRCA1 or 2 OR A priori risk assessment of 20% chance or greater of carrying BRCA1/2 gene mutation. The BRCAPRO and Couch model will both be used to asses this risk. If a woman has a 20% risk of carrying a BRCA1/2 mutation by either model, she will meet eligibility criteria.", " Prior stage I or II breast cancer at least 2 years out from treatment for invasive disease and no prior use of aromatase inhibitors.", " Subjects should be willing to abstain from use of hormonal therapies (e.g. tamoxifen, hormone replacement therapy, oral contraceptive pills, hormone-containing intrauterine devices (IUDs). E-string is acceptable). Venlafaxine will be offered as supportive care for women with menopausal symptoms.", " Eastern Cooperative Oncology Group (ECOG) performance status 0-1.", " Subject has been counseled regarding her options and has signed the informed consent document.", " Baseline dual-emission x-ray absorptiometry (DEXA) scan with bone mineral density (BMD) T-score greater than or equal to 2.5 at antero posterior (AP) spine.", " Hemoglobin greater than or equal to 11 g/dl.", " Creatinine less than 1.5 times the upper limits of normal.", " Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 2.5 times upper limit of normal.", " No investigational agent for the past 30 days.", " If history of cancer (other than squamous or basal cell skin cancers), subject must have no evidence of disease at time of enrollment AND no history of cancer directed treatment in the 2 years preceding enrollment.", "EXCLUSION CRITERIA:", " Current or recent chronic use (within 3 months) of hormonal medications, e.g. oral contraceptive pills, hormone replacement therapy, tamoxifen, raloxifene, IUD with progestins or corticosteroids. (Subjects on chronic topical or inhaled steroids will be eligible for the study.) Current use of phenytoin, carbamazepine, rifampin due to increased estrogen metabolism.", " History of clotting or bleeding disorder.", " History of allergic reactions attributed to compounds of similar chemical or biologic composition to exemestane (e.g. anastrozole, letrozole, formestane).", " Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements." ]

[ "Adverse Events 1:", " Total: 9/157 (5.73%)", " Blood disorder 1/157 (0.64%)", " Hemoglobin decreased 1/157 (0.64%)", " Hemolysis 0/157 (0.00%)", " Arrhythmia 0/157 (0.00%)", " Cardiac disorder 0/157 (0.00%)", " Myocardial ischemia 1/157 (0.64%)", " Hearing impaired 0/157 (0.00%)", " Tinnitus 0/157 (0.00%)", " Cataract 0/157 (0.00%)", " Diplopia 0/157 (0.00%)", " Glaucoma 0/157 (0.00%)", " Vision blurred 0/157 (0.00%)", "Adverse Events 2:", " Total: 14/157 (8.92%)", " Blood disorder 0/157 (0.00%)", " Hemoglobin decreased 2/157 (1.27%)", " Hemolysis 1/157 (0.64%)", " Arrhythmia 0/157 (0.00%)", " Cardiac disorder 0/157 (0.00%)", " Myocardial ischemia 0/157 (0.00%)", " Hearing impaired 2/157 (1.27%)", " Tinnitus 1/157 (0.64%)", " Cataract 1/157 (0.64%)", " Diplopia 0/157 (0.00%)", " Glaucoma 1/157 (0.64%)", " Vision blurred 1/157 (0.64%)" ]

[ "Adverse Events 1:", " Total: 6/168 (3.57%)", " FEBRILE NEUTROPENIA 3/168 (1.79%)", " ENTERITIS 1/168 (0.60%)", " PERIPHERAL NEUROPATHY 2/168 (1.19%)", " DEPRESSION 1/168 (0.60%)" ]

[ "Adverse Events 1:", " Total: 8/101 (7.92%)", " Vertigo * 1/101 (0.99%)", " Infected lymphocele * 1/101 (0.99%)", " Ejection fraction decreased * 5/101 (4.95%)", " Lymphoedema * 1/101 (0.99%)" ]

[ "Adverse Events 1:", " Total: 3/30 (10.00%)", " Cholecystitis * [1]1/30 (3.33%)", " Increase in diarrhea * [2]1/30 (3.33%)", " Flank pain * [3]1/30 (3.33%)" ]

[ "Inclusion Criteria:", " Histologically or cytologically confirmed invasive breast carcinoma.", " Early stage breast cancer - stage I (tumor size greater than 1 cm), II and IIA.", " 3+ HER2 overexpression by IHC or 2+ HER2 overexpression and FISH positivity.", " Patients must have measurable disease as defined by palpable lesion with both diameters greater than or equal to 1 cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension greater than or equal to 1 cm. Bilateral mammogram and clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the patient registration form. To be valid for baseline, the measurements must have been made within the 14 days (4-6 weeks for x-rays and scans) immediately preceding patient's entry in study.", " ECOG performance status 0 to 2 within 14 days of study entry.", " Normal (greater than 50%) left ventricular ejection fraction (LVEF) by MUGA scan or echocardiography.", " Must be 18 years of age or older.", " Women or men of childbearing potential must use a reliable and appropriate contraceptive method. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.", " Final eligibility for a clinical trial is determined by the health professionals conducting the trial.", "Exclusion Criteria:", " Evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.", " Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer. Patients with history of DCIS are eligible if they were treated with surgery alone.", " Medical, psychological, or surgical condition which the investigator feels might compromise study participation.", " Pregnant or lactating women are not eligible.", " Patients with history of previous or current malignancy at other sites with the exception of adequately treated carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies who remain disease free for greater than five years are eligible.", " Evidence of sensory and/or peripheral neuropathy.", " Serious, uncontrolled, concurrent infections.", " Major surgery within 4 weeks of the start of study treatment without complete recovery.", " Final eligibility for a clinical trial is determined by the health professionals conducting the trial." ]

[ "Inclusion Criteria:", " Early invasive breast cancer (T1-4N1-3M0) confirmed by histology or cytology.", " ER positive.", " The patient must be postmenopausal woman.", " The patient has received adjuvant Tamoxifen therapy for up to 2-3 years and will switch to receive Aromasin® treatment (The decision to prescribe Aromasin® will necessarily precede and will be independent of the decision to enroll patients in the study).", "Exclusion Criteria:", " Following the adjuvant Tamoxifen therapy for 2-3 years and prior to receiving Aromasin® treatment, there is evidence of a local relapse or distant metastasis of breast cancer, or a second primary cancer.", " Following the adjuvant Tamoxifen therapy for 2-3 years and received other aromatase inhibitors (not Aromasin®)." ]

[ "INCLUSION CRITERIA", " Histologically-confirmed, bi-dimensionally measurable, recurrent or metastatic carcinoma of the breast that is progressive", " Premenopausal, defined as any of:", " Last menstrual period within 3 months, or", " Post-hysterectomy without bilateral oophorectomy and with follicle-stimulating hormone (FSH) in the premenopausal range, or,", " If tamoxifen administered within the past 3 months, plasma estradiol must be in the premenopausal range", " Either positive estrogen and/or progesterone receptor determination by Immunohistochemistry (IHC) or competitive binding assay on metastatic disease, or if not performed on their metastatic disease a positive result on their primary breast cancer specimen.", " Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2", " Granulocytes > 1500/mm^3", " Platelets > 100,000/mm^3", " Serum glutamic oxaloacetic transaminase (SGOT) < 2.5 x upper limit of normal", " Total bilirubin < 1.5 mg/dL", " May have received irradiation to bony sites of disease for pain control or for prevention of fracture. The irradiated site(s) will NOT be evaluable for disease response.", " Must be using effective contraception or not be of childbearing potential", " Signed written informed consent", " INCLUSION CRITERIA", " Active, unresolved infection", " Active malignancy other than breast cancer, in situ carcinoma of the cervix, or non-melanomatous skin cancers in the past 5 years", " Prior treatment with an aromatase inhibitor or inactivator", " Prior treatment with an luteinizing hormone-releasing hormone (LH/RH) agonist/antagonist", " Adjuvant chemotherapy within 6 months of study entry.", " Received chemotherapy or hormonal therapy in the 3 weeks prior to enrollment", " Central nervous system metastasis", " Lymphangitic pulmonary metastasis", " Pregnant or lactating" ]

[ "Inclusion Criteria:", " Histologically confirmed, measurable, invasive breast carcinoma T >2cm, Nany, M0.", " Patients with node-negative, ER or PR-positive tumors 4 cm in size whose tumors are low risk (defined as a score of 0-17) on an Oncotype DX profile are not eligible.", " 19 years of age or greater", " Known ER, PR and HER-2 status (FISH assay to be done on specimens with 2+ or 3+ immunohistochemical staining for HER-2): patients with gene amplification on FISH study will be considered to be HER-2 positive. Patients for this study must be FISH negative if immunohistochemical stain is 2+ or 3+ positive; patients with negative, 0 or 1+ immunohistochemical stain for HER-2 are eligible.", " Known axillary nodal status: aspiration cytology or biopsy", " Documented menopausal status premenopausal (having menstrual periods or FSH <35) or postmenopausal ( 12 months since last menstrual period with intact uterus and at least one ovary or FSH 35 or previous bilateral oophorectomy", " Non-pregnant if premenopausal (negative serum or urine pregnancy test within 7 days of starting chemotherapy) and not breast feeding", " Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment.", " Life expectancy of less than 12 weeks", " Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study", " Pregnant or lactating women.", " History of cardiac disease, with New York Heart Association Grade II or greater or clinical evidence of congestive heart failure.", " Serious comorbid medical conditions which would impair the ability to receive chemotherapy on time", " Previous invasive cancer within the last 5 years", " Altered mental status or dementia which would interfere with understanding of informed consent and ability to comply with study and follow-up procedures.", " Hypersensitivity to Doxil, doxorubicin, cyclophosphamide, cremophore (contained in teniposide, cyclosporine, and vitamin K), or to any component of Avastin", " Inadequately controlled hypertension (defined as blood pressure of >150/100 mmHg on antihypertensive medication)", " Unstable angina pectoris", " History of myocardial infarction or unstable angina within 12 months prior to beginning therapy", " History of stroke or TIA at any time", " Clinically significant vascular (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis, aortic dissection) or peripheral vascular disease with 6 months prior to beginning therapy", " History of hemoptysis (greater than or equal to 1/2 teaspoon of bright red blood per episode) within 1 month prior to beginning therapy", " Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)", " Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to beginning therapy or anticipation of need for major surgical procedure during the course of the study", " Patients must have a 2-d echocardiogram indicating an ejection fraction of > 50% within 42 days prior to first dose of study drug. The method used at baseline must be used for later monitoring.", " No distant metastases on bone scan and on CT scans of chest and abdomen (no metastasis on optional PET scan is an acceptable alternative; if PET scan is done for any reason it must show no evidence of distant metastasis). Baseline PET scan is recommended but not required for all patients.", " No CNS metastasis", " Hbg 9 gm, platelets 100,000, granulocytes 1000, total or direct bilirubin 1.2, creatinine 2.0 and urine protein:creatinine ratio <1.0", " No prior chemotherapy or radiotherapy and 4 weeks of prior antiestrogen or aromatase inhibitor therapy", " No concomitant hormone replacement (i.e. estrogen or progestin) therapy", " PS less than or equal to one", "Exclusion Criteria:", " Minor surgical procedure (excluding placement of a vascular access device) such as fine needle aspiration or core needle biopsy within 7 days of beginning therapy", " Urine protein:creatinine ratio 1.0 at initial screening", " Known hypersensitivity to any component of Avastin", " History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of beginning therapy", " Serious, non-healing wound, active ulcer, or untreated bone fracture", " Any prior history of hypertensive crisis or hypertensive encephalopathy", " Known CNS metastasis, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded." ]

[ "INTERVENTION 1: ", " A: Exemestane", " ARM A: Patients will be treated with exemestane.", " Exemestane: 25 mg daily by mouth for 6 to 12 months.", "INTERVENTION 2: ", " B: Docetaxel and Cytoxan", " ARM B: Patients will be treated with docetaxel and cytoxan.", " Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).", " Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)." ]

[ "Adverse Events 1:", " Total: 32/106 (30.19%)", " Febrile neutropenia * 6/106 (5.66%)", " Leukopenia * 1/106 (0.94%)", " Neutropenia * 1/106 (0.94%)", " Arrhythmia * 1/106 (0.94%)", " Atrial fibrillation * 0/106 (0.00%)", " Cardiac failure * 0/106 (0.00%)", " Left ventricular dysfunction * 1/106 (0.94%)", " Myocardial infarction * 1/106 (0.94%)", " Supraventricular tachycardia * 0/106 (0.00%)", " Tachycardia * 0/106 (0.00%)", "Adverse Events 2:", " Total: 44/107 (41.12%)", " Febrile neutropenia * 3/107 (2.80%)", " Leukopenia * 0/107 (0.00%)", " Neutropenia * 3/107 (2.80%)", " Arrhythmia * 0/107 (0.00%)", " Atrial fibrillation * 1/107 (0.93%)", " Cardiac failure * 1/107 (0.93%)", " Left ventricular dysfunction * 0/107 (0.00%)", " Myocardial infarction * 0/107 (0.00%)", " Supraventricular tachycardia * 1/107 (0.93%)", " Tachycardia * 1/107 (0.93%)" ]

[ "Inclusion Criteria:", " Pathologically and radiologically confirmed metastatic triple negative breast cancer", " Up to two prior lines of chemotherapy for metastatic breast cancer", " Availability of a representative tumor specimen", " At least one measurable lesion", "Exclusion Criteria:", " Have received previous treatment with PI3K inhibitors", " Symptomatic central nervous system (CNS) metastases (controlled and asymptomatic CNS metastases are acceptable)", " Concurrent malignancy or has a malignancy within 3 years of study enrollment", " Any of the following mood disorders: active major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, history of suicidal attempt or ideation, homicidal ideation, greater than or equal to Common Toxicity Criteria for Adverse Events (CTCAE) grade 3 anxiety", " Concurrently using other approved or investigational antineoplastic agent and/or chemotherapy within 21 days prior to enrollment in this study", " Has received radiation therapy within 28 days prior to enrollment in this study or has not recovered from side effects of such therapy", " Major surgery within 28 days of starting therapy or has not recovered from major side effects of a previous surgery", " Poorly controlled diabetes mellitus", " History of cardiac dysfunction", " Currently receiving treatment with QT prolonging medication and the treatment cannot be discontinued or switched to a different medication", " Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120", " Receiving chronic treatment with steroids or another immunosuppressive agent", " Other concurrent severe and/or uncontrolled medical condition that would contraindicate participation in this study", " History of non-compliance to a medical regimen", " Currently being treated with drugs known to be moderate or strong inhibitors or inducers of isoenzyme Cytochrome P450, family 3, subfamily A (CYP3A)", " Known history of human immunodeficiency virus (HIV)", " Pregnant or breastfeeding", " Unwilling to observe total abstinence or to use double barrier method for birth control throughout trial" ]

[ "INTERVENTION 1: ", " Post-menopausal Women Using Adjuvant Letrozole", " Part A Routine Care Letrozole; Part B Double Dose Letrozole in overweight/obese participants", " Letrozole: Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period." ]

[ "INTERVENTION 1: ", " Neratinib 40 mg", "Neratinb 40 mg qd", "INTERVENTION 2: ", " Neratinib 80 mg", "Neratinib 80 mg qd" ]

[ "Adverse Events 1:", " Total: 3/9 (33.33%)", " Fatigue * 1/9 (11.11%)", " Non-cardiac chest pain * 1/9 (11.11%)", " Sepsis * 1/9 (11.11%)", " Urinary tract infection * 1/9 (11.11%)", " Syncope * 1/9 (11.11%)", " Anxiety * 1/9 (11.11%)", " Thromboembolic event * 1/9 (11.11%)" ]

[ "INTERVENTION 1: ", " Zoledronic Acid 5 mg IV", " Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx)." ]

[ "INTERVENTION 1: ", " Cohort -1 (250mg BYL719, 3.6mg/kg T-DM1)", " Patients receive 250 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.", " PI3K inhibitor BYL719: Given PO", " Ado-trastuzumab emtansine: Given IV", " Pharmacological study: Correlative studies", " Laboratory biomarker analysis: Optional correlative studies", "INTERVENTION 2: ", " Cohort 1 (300mg BYL719, 3.6mg/kg T-DM1)", " Patients receive 300 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.", " PI3K inhibitor BYL719: Given PO", " Ado-trastuzumab emtansine: Given IV", " Pharmacological study: Correlative studies", " Laboratory biomarker analysis: Optional correlative studies" ]

[ "Outcome Measurement: ", " Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment", " [Not Specified]", " Time frame: 6 months", "Results 1: ", " Arm/Group Title: AC/PTL", " Arm/Group Description: Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.", " Overall Number of Participants Analyzed: 109", " Measure Type: Number", " Unit of Measure: participants 0" ]

[ "Adverse Events 1:", " Total: 103/1408 (7.32%)", " Anaemia 1/1408 (0.07%)", " Angina pectoris 1/1408 (0.07%)", " Myocardial infarction 1/1408 (0.07%)", " Atrial fibrillation 0/1408 (0.00%)", " Sinus tachycardia 0/1408 (0.00%)", " Tachycardia 0/1408 (0.00%)", " Vertigo 0/1408 (0.00%)", " Diarrhoea 22/1408 (1.56%)", " Vomiting 12/1408 (0.85%)", " Nausea 4/1408 (0.28%)", " Abdominal pain 2/1408 (0.14%)", " Pancreatitis 2/1408 (0.14%)", "Adverse Events 2:", " Total: 85/1408 (6.04%)", " Anaemia 1/1408 (0.07%)", " Angina pectoris 0/1408 (0.00%)", " Myocardial infarction 1/1408 (0.07%)", " Atrial fibrillation 1/1408 (0.07%)", " Sinus tachycardia 1/1408 (0.07%)", " Tachycardia 1/1408 (0.07%)", " Vertigo 1/1408 (0.07%)", " Diarrhoea 1/1408 (0.07%)", " Vomiting 1/1408 (0.07%)", " Nausea 1/1408 (0.07%)", " Abdominal pain 0/1408 (0.00%)", " Pancreatitis 1/1408 (0.07%)" ]

[ "Adverse Events 1:", " Total: 46/170 (27.06%)", " Anaemia 1/170 (0.59%)", " Febrile neutropenia 1/170 (0.59%)", " Cardiac tamponade 1/170 (0.59%)", " Myocarditis 1/170 (0.59%)", " Pericardial effusion 2/170 (1.18%)", " Pericarditis 1/170 (0.59%)", " Colitis 1/170 (0.59%)", " Constipation 1/170 (0.59%)", " Diarrhoea 0/170 (0.00%)", " Gastroenteritis eosinophilic 0/170 (0.00%)", " Intestinal obstruction 0/170 (0.00%)", "Adverse Events 2:", " Total: 0/1 (0.00%)", " Anaemia 0/1 (0.00%)", " Febrile neutropenia 0/1 (0.00%)", " Cardiac tamponade 0/1 (0.00%)", " Myocarditis 0/1 (0.00%)", " Pericardial effusion 0/1 (0.00%)", " Pericarditis 0/1 (0.00%)", " Colitis 0/1 (0.00%)", " Constipation 0/1 (0.00%)", " Diarrhoea 0/1 (0.00%)", " Gastroenteritis eosinophilic 0/1 (0.00%)", " Intestinal obstruction 0/1 (0.00%)", " Nausea 0/1 (0.00%)" ]

[ "INTERVENTION 1: ", " High-dose Chemotherapy", " Carboplatin + Cyclophosphamide + Thiotepa", " Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.", " Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.", " Stem Cell Transplant : Stem Cell Transplant on Day 0.", " Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion." ]

[ "INTERVENTION 1: ", " Samarium 153-EDTMP + Stem Cell Transplant", " Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP." ]

[ "Adverse Events 1:", " Total: 672/2264 (29.68%)", " Febrile neutropenia * 117/2264 (5.17%)", " Neutropenia * 98/2264 (4.33%)", " Febrile bone marrow aplasia * 14/2264 (0.62%)", " Anaemia * 8/2264 (0.35%)", " Leukopenia * 8/2264 (0.35%)", " Thrombocytopenia * 6/2264 (0.27%)", " Disseminated intravascular coagulation * 3/2264 (0.13%)", " Agranulocytosis * 1/2264 (0.04%)", " Bone marrow failure * 1/2264 (0.04%)" ]

[ "Inclusion Criteria:", " Signed written informed consent", " Histologically confirmed primary invasive adenocarcinoma of the breast.", " Clinical stage breast cancer T2-3, N0-3, M0", " Negative HER-2/neu expression as determined by local hospital laboratory using Fluorescence In Situ Hybridization (FISH), or is less or equal to 1+ using Immunohistochemistry (IHC).", " No prior treatment for primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy or surgery. Subjects receiving hormone replacement treatment (HRT) are eligible if this therapy is discontinued at least 2 weeks before starting study treatment. Treatment for DCIS is allowed, such as surgery, hormonal therapy and radiotherapy.", " Karnofsky performance status (KPS) of 80 - 100", " The ability and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.", " Baseline MUGA or echocardiogram scans with LVEF of > 50%.", " Normal PTT and either INR or PT < 1.5 x ULN.", " Men or women 18 years of age or older.", " Women of childbearing potential (WOCBP) must agree to use a medically acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drugs.", " Willingness to have core biopsies and/or FNA performed before the start of study treatment and at the end of 12 week on treatment.", "Exclusion Criteria:", " Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast-feeding.", " Disease free of prior malignancy for < 5 years with the exception of DCIS, curatively treated basal carcinoma of the skin, local skin squamous cell carcinoma, or carcinoma in situ of the cervix.", " Absolute neutrophils count (ANC) < 1500/mm^3", " Total bilirubin > 1.5 times the upper limit of normal (ULN)", " AST or ALT > 2.5 times the upper limit of normal (ULN)", " Platelets < 100,000/mm^3.", " Serum creatinine > 1.5 x ULN or creatinine clearance < 60 mL/min (measured or calculated by Cockcroft-Galt method)", " Evidence of metastatic breast cancer following a standard tumor staging work-up", " Evidence of inflammatory breast cancer.", " Evidence of any grade 2 sensory or motor neuropathy.", " Known human immunodeficiency viral (HIV) infection", " Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy.", " Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocols." ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed breast cancer meeting 1 of the following criteria:", " Unresectable stage IIIB or IIIC disease", " Stage IV disease", " Must be negative for all of the following:", " Estrogen receptor (< 10%)", " Progesterone receptor (<10%)", " HER-2 (negative FISH, IHC 0 - 1+, or IHC +2 with negative FISH)", " Measurable or evaluable disease", " No symptomatic or progressive CNS (central nervous system) metastases", " Previously treated CNS metastases allowed provided all of the following criteria are met:", " At least 8 weeks since prior radiation to brain or CNS metastases", " No concurrent steroids", " No leptomeningeal disease", " PATIENT CHARACTERISTICS:", " Menopausal status not specified", " ECOG (Eastern Cooperative Oncology Group) performance status 0-2", " Life expectancy 6 months", " WBC > 1,500/mm³", " Platelet count > 100,000/mm³", " Creatinine clearance > 40 mL/min", " Normal electrolytes (i.e., Na, K, and Ca normal; minor deviations are allowed if they do not impact on patient safety in the clinical judgment of the treating physician)", " Bilirubin 1.5 times upper limit of normal (ULN)", " ALT and AST 2.5 times ULN ( 5 times ULN in the presence of documented liver metastases)", " Alkaline phosphatase 2.5 times ULN ( 5 times ULN in the presence of liver or bone metastases)", " Not pregnant or nursing", " Fertile patients must use effective barrier contraception", " No uncontrolled intercurrent illness", " No active infection requiring systemic therapy", " Able to swallow oral medications and with no medical problems or prior surgeries that may interfere with the absorption of oral medications including the following:", " Uncontrolled nausea, vomiting, or diarrhea", " Lack of the physical integrity of the upper gastrointestinal tract", " Malabsorption syndrome", " No known hypersensitivity to bendamustine hydrochloride, mannitol, or erlotinib hydrochloride", " No prior malignancy in the past 5 years except for adequately treated basal cell or squamous cell skin carcinoma, or adequately treated stage I-II cancer for which the patient is in complete remission", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " Prior adjuvant or neoadjuvant chemotherapy and 1 prior chemotherapy regimen in the metastatic setting allowed provided recovered from all acute toxicities", " No prior bendamustine hydrochloride or EGFR-directed therapy", " No other concurrent antineoplastic treatments, including radiotherapy, chemotherapy, biological therapy, hormonal therapy, immunotherapy, gene therapy, and surgery", " Intravenous bisphosphonates allowed", " No concurrent antiretroviral therapy for HIV-positive patients", " No other concurrent investigational agents" ]

[ "Outcome Measurement: ", " Changes in QTcF After Treatment With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer", " The number of participants with notable electrocardiogram changes meeting predefined criteria is being reported.", " Time frame: Screening (within 7 days before enrollment) up to Cycle 3 Day 15 (each cycle is 21 days)", "Results 1: ", " Arm/Group Title: DS-8201a", " Arm/Group Description: Participants who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks on Day 1 of each 21-day cycle.", " Overall Number of Participants Analyzed: 49", " Measure Type: Count of Participants", " Unit of Measure: Participants Maximum change from baseline in QTcF: >30 ms: 3 6.1%", " Maximum change from baseline in QTcF: >60 ms: 0 0.0%" ]

[ "Outcome Measurement: ", " Phase I Portion: Maximum Tolerated Dose/MTD of Dasatinib When Administered in Combination With a Fixed Dose of Weekly Paclitaxel.", " [Not Specified]", " Time frame: Through completion of Phase I, up to 1 year", "Results 1: ", " Arm/Group Title: Dasatinib and Paclitaxel", " Arm/Group Description: The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel.", " The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel.", " Dasatinib and Paclitaxel: A treatment cycle will consist of 28 days, according to the following schedule:", " Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.", " The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel.", " Overall Number of Participants Analyzed: 15", " Measure Type: Number", " Unit of Measure: mg of dasatinib 120" ]

[ "Inclusion Criteria:", " Adult women with proven diagnosis of advanced adenocarcinoma of the breast (locoregional recurrent or metastatic disease).", " Women who are not of childbearing potential.", " ER-positive and/or Progesterone receptor (PgR)-positive tumor based on local laboratory results (test as per local practice).", " HER2-negative breast cancer based on local laboratory results (test as per local practice or local guidelines).", " Patients must be appropriate candidates for letrozole therapy.", " Eastern Cooperative Oncology Group (ECOG) performance status 0-2.", " Adequate bone marrow function.", " Adequate liver function", " Adequate renal function.", "Exclusion Criteria:", " Known hypersensitivity to letrozole, or any of its excipients, or to any palbociclib excipients.", " Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4 isoenzymes within 7 days prior to study entry.", " Prior treatment with any CDK inhibitor.", " Previous participation in a palbociclib clinical study.", " Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation.", " QTc >480 msec; history of QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.", " High cardiovascular risk, including, but not limited to recent myocardial infarction, severe/unstable angina and severe cardiac dysrhythmias in the past 6 months prior to enrollment.", " Diagnosis of any second invasive malignancy within the last 3 years prior to enrollment. Note: patients with adequately treated basal cell or squamous cell skin cancer, a history of intraepithelial neoplasia or in situ disease (eg, carcinoma in situ of the cervix or melanoma in situ) may enter.", " Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, brain metastases are permitted.", " Other severe acute or chronic medical or psychiatric conditions.", " Patients who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees directly involved in the conduct of the study." ]

[ "INTERVENTION 1: ", " Hypnotherapy", " Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.", "INTERVENTION 2: ", " Gabapentin", " Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily)." ]

[ "INTERVENTION 1: ", " Digital Breast Tomosynthesis", " Digital Breast Tomosynthesis + Synthetic Mammography (DBT)", " The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.", " Women selected for further assessment (positive screening exam) was recalled.", " Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis.", "INTERVENTION 2: ", " Digital Mammography", " The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.", " Women selected for further assessment (positive screening exam) was recalled.", " Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis." ]

[ "Adverse Events 1:", " Total: 112/458 (24.45%)", " Febrile neutropenia 8/458 (1.75%)", " Neutropenia 6/458 (1.31%)", " Anaemia 3/458 (0.66%)", " Thrombocytopenia 3/458 (0.66%)", " Pancytopenia 2/458 (0.44%)", " Myocardial infarction 0/458 (0.00%)", " Pericardial effusion 0/458 (0.00%)", " Tachycardia 0/458 (0.00%)", " Acute myocardial infarction 1/458 (0.22%)", " Atrial fibrillation 0/458 (0.00%)", "Adverse Events 2:", " Total: 39/221 (17.65%)", " Febrile neutropenia 5/221 (2.26%)", " Neutropenia 1/221 (0.45%)", " Anaemia 2/221 (0.90%)", " Thrombocytopenia 0/221 (0.00%)", " Pancytopenia 0/221 (0.00%)", " Myocardial infarction 2/221 (0.90%)", " Pericardial effusion 2/221 (0.90%)", " Tachycardia 2/221 (0.90%)", " Acute myocardial infarction 0/221 (0.00%)", " Atrial fibrillation 1/221 (0.45%)" ]

[ "Adverse Events 1:", " Total: 13/74 (17.57%)", " neutropenia 1/74 (1.35%)", " left ventricular dysfunction 1/74 (1.35%)", " fistula enterovesical 1/74 (1.35%)", " constipation and hypokalemia 1/74 (1.35%)", " nausea, vomiting and burning abdominal pain 2/74 (2.70%)", " Infection 1/74 (1.35%)", " febrile neutropenia 3/74 (4.05%)", " speech impairment 1/74 (1.35%)", " dyspnea, pain 1/74 (1.35%)", " hemorrhage/bleeding 2/74 (2.70%)" ]

[ "Adverse Events 1:", " Total: 11/50 (22.00%)", " Anemia 3/50 (6.00%)", " Febrile neutropenia 1/50 (2.00%)", " Arrythmia 1/50 (2.00%)", " Ileus 1/50 (2.00%)", " Nausea 1/50 (2.00%)", " Pain-Abdominal 1/50 (2.00%)", " Vomiting 1/50 (2.00%)", " Bronchial infection 1/50 (2.00%)", " Sepsis 1/50 (2.00%)", " Neutropenia 2/50 (4.00%)", " Platelet count decreased 1/50 (2.00%)", " Dehydration 1/50 (2.00%)", " Arthralgia 1/50 (2.00%)" ]

[ "INTERVENTION 1: ", " Lidocaine Patch", " Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.", "INTERVENTION 2: ", " Placebo Patch", " Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day." ]

[ "INTERVENTION 1: ", " Letrozole, Breast Enhancement, Safety", " Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI." ]

[ "INTERVENTION 1: ", " Fulvestrant + Anastrozole", " Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg", "INTERVENTION 2: ", " Anastrozole", "Anastrozole 1 mg" ]

[ "INTERVENTION 1: ", " Prone to Supine MRI Evaluated by Radiologist A", " Radiologist A, number of participants successfully segmented", "INTERVENTION 2: ", " Prone to Supine MRI Evaluated by Radiologist B", " Radiologist B, number of participants successfully segmented" ]

[ "INTERVENTION 1: ", " Treatment (Pazopanib Hydrochloride)", " Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.", " pazopanib hydrochloride: Given orally", " pharmacological study: Correlative studies", " laboratory biomarker analysis: Correlative studies" ]

[ "Adverse Events 1:", " Total: 12/32 (37.50%)", " Anaemia 0/32 (0.00%)", " Neutropenia 1/32 (3.13%)", " Thrombocytopenia 4/32 (12.50%)", " Atrial fibrillation 1/32 (3.13%)", " Cardiac failure congestive 1/32 (3.13%)", " Myocardial ischaemia 1/32 (3.13%)", " Abdominal discomfort 0/32 (0.00%)", " Ascites 1/32 (3.13%)", " Constipation 0/32 (0.00%)", " Rectal haemorrhage 1/32 (3.13%)", " Vomiting 1/32 (3.13%)", " Fatigue 1/32 (3.13%)", "Adverse Events 2:", " Total: 8/20 (40.00%)", " Anaemia 1/20 (5.00%)", " Neutropenia 0/20 (0.00%)", " Thrombocytopenia 1/20 (5.00%)", " Atrial fibrillation 0/20 (0.00%)", " Cardiac failure congestive 0/20 (0.00%)", " Myocardial ischaemia 0/20 (0.00%)", " Abdominal discomfort 1/20 (5.00%)", " Ascites 0/20 (0.00%)", " Constipation 2/20 (10.00%)", " Rectal haemorrhage 0/20 (0.00%)", " Vomiting 0/20 (0.00%)", " Fatigue 0/20 (0.00%)" ]

[ "Adverse Events 1:", " Total: 28/36 (77.78%)", " Lymphocytopenia 210/36 (27.78%)", " Neutropenia 29/36 (25.00%)", " Anemia 26/36 (16.67%)", " Thrombocytopenia 24/36 (11.11%)", " Hyperglycemia 27/36 (19.44%)", " Nausea 213/36 (36.11%)", " Diarrhea 211/36 (30.56%)", " Fatigue 215/36 (41.67%)", " Flu-like symptoms 26/36 (16.67%)", " Hot Flashes 25/36 (13.89%)", " AST/ALT elevation 211/36 (30.56%)", " Arthralgia 24/36 (11.11%)" ]

[ "Adverse Events 1:", " Total: 1/22 (4.55%)", " Blood bilirubin increased 1/22 (4.55%)", " Alkaline phosphatase increased 1/22 (4.55%)" ]

[ "Adverse Events 1:", " Total: 53/218 (24.31%)", " Febrile Neutropenia 2/218 (0.92%)", " Neutropenia 2/218 (0.92%)", " Anaemia 1/218 (0.46%)", " Thrombocytopenia 1/218 (0.46%)", " Pancytopenia 0/218 (0.00%)", " Left Ventricular Dysfunction 4/218 (1.83%)", " Atrial Fibrillation 0/218 (0.00%)", " Angina Unstable 0/218 (0.00%)", " Arteriospasm Coronary 1/218 (0.46%)", " Cardiac Arrest 1/218 (0.46%)", "Adverse Events 2:", " Total: 58/228 (25.44%)", " Febrile Neutropenia 1/228 (0.44%)", " Neutropenia 1/228 (0.44%)", " Anaemia 0/228 (0.00%)", " Thrombocytopenia 1/228 (0.44%)", " Pancytopenia 1/228 (0.44%)", " Left Ventricular Dysfunction 13/228 (5.70%)", " Atrial Fibrillation 2/228 (0.88%)", " Angina Unstable 1/228 (0.44%)", " Arteriospasm Coronary 0/228 (0.00%)", " Cardiac Arrest 0/228 (0.00%)" ]

[ "Adverse Events 1:", " Total: 21/82 (25.61%)", " Neutrophils count decreased 1/82 (1.22%)", " Cardiac ischemia/infarction 1/82 (1.22%)", " Left ventricular systolic dysfunction 1/82 (1.22%)", " Hypertension 1/82 (1.22%)", " Supraventricular and nodal arrhythmia 1/82 (1.22%)", " Anorexia 1/82 (1.22%)", " Gastrointestinal perforation 1/82 (1.22%)", " Vomiting 1/82 (1.22%)", " Dehydration 1/82 (1.22%)", " Diarrhoea 1/82 (1.22%)" ]

[ "INTERVENTION 1: ", " Afatinib 50 mg", " Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.", "INTERVENTION 2: ", " Lapatinib 1500 mg", " Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial." ]

[ "Outcome Measurement: ", " Percentage of Progression Free Participants After 16 Weeks of Treatment", " Progression was defined according to 1 of the following criteria: New bone lesion(s) on bone scan or on magnetic resonance imaging; Progression or occurrence of new lesion(s) according to the Response Evaluation Criteria In Solid Tumours version 1.0 (RECIST); an increase in tumour marker CA 15.3 of more than 20 percent,compared with baseline, at 2 consecutive examinations; occurrence of disease-related skeletal events. If a patient did not fulfil any criteria and was withdrawn because of clinical deterioration amounting to PD according to the Investigator, they were considered as having PD.", " Time frame: 16 weeks", "Results 1: ", " Arm/Group Title: Afatinib 50 mg With Letrozole", " Arm/Group Description: Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.", " Overall Number of Participants Analyzed: 7", " Measure Type: Number", " Unit of Measure: Percentage of participants 28.57 (3.67 to 70.96)", "Results 2: ", " Arm/Group Title: Afatinib 40 mg With Letrozole", " Arm/Group Description: Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.", " Overall Number of Participants Analyzed: 13", " Measure Type: Number", " Unit of Measure: Percentage of participants 0.00 (0.00 to 24.71)" ]