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nli4ct_semeval2024

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[ "INTERVENTION 1: ", " Arm I (Curcumin-based Gel)", " Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.", "Curcumin-based Gel: Applied topically", " Laboratory Biomarker Analysis: Correlative studies", " Questionnaire Administration: Ancillary studies", "INTERVENTION 2: ", " Arm II (HPR Plus)", " Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.", " Dermatologic Complications Management: Apply HPR Plus topically", " Laboratory Biomarker Analysis: Correlative studies", " Questionnaire Administration: Ancillary studies" ]

[ "Adverse Events 1:", " Total: 4/20 (20.00%)", " Diarrhea 1/20 (5.00%)", " Nausea 1/20 (5.00%)", " Sodium, serum-low (hyponatremia) 1/20 (5.00%)", " Death - Disease progression NOS 1/20 (5.00%)", " Dyspnea (shortness of breath) 1/20 (5.00%)", " Hypoxia 1/20 (5.00%)" ]

[ "Adverse Events 1:", " Total: 39/39 (100.00%)", " Febrile Neutropenia 1/39 (2.56%)", " Heart failure 1/39 (2.56%)", " Diarrhea 3/39 (7.69%)", " Nausea/vomiting 4/39 (10.26%)", " Mucositis 3/39 (7.69%)", " Fatigue 4/39 (10.26%)", " infection 3/39 (7.69%)", " Urinary tract infection 2/39 (5.13%)", " Musculoskeletal pain 6/39 (15.38%)", " Syncope 1/39 (2.56%)", " Insomnia 3/39 (7.69%)", " Anxiety 2/39 (5.13%)" ]

[ "INTERVENTION 1: ", " Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)", " Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.", "INTERVENTION 2: ", " AC Followed by Docetaxel + Herceptin (AC→TH)", " Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose." ]

[ "Inclusion Criteria:", " Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.", " Unresectable, locally recurrent breast cancer or stage IV disease.", " Have at least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.", " Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale", " Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.", "Exclusion Criteria:", " Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.", " Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.", " Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.", " Active infection or other serious condition.", " Pregnant or breastfeeding." ]

[ "INTERVENTION 1: ", " Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2", " Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.", "INTERVENTION 2: ", " Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2", " Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days." ]

[ "Adverse Events 1:", " Total: 0/23 (0.00%)", " LEFT VENTRICULAR SYSTOLIC DYSFUNCTION *0/23 (0.00%)", " NAUSEA *0/23 (0.00%)", " VOMITING *0/23 (0.00%)", " BILIRUBIN (HYPERBILIRUBINEMIA) *0/23 (0.00%)", " INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E *0/23 (0.00%)", " NEUTROPHILS/GRANULOCYTES (ANC/AGC) *0/23 (0.00%)" ]

[ "Adverse Events 1:", " Total: 122/280 (43.57%)", " Agranulocytosis 0/280 (0.00%)", " Anaemia 10/280 (3.57%)", " Febrile neutropenia 30/280 (10.71%)", " Immune thrombocytopenic purpura 1/280 (0.36%)", " Leukopenia 3/280 (1.07%)", " Neutropenia 12/280 (4.29%)", " Thrombocytopenia 4/280 (1.43%)", " Acute myocardial infarction 1/280 (0.36%)", " Cardiac failure 1/280 (0.36%)", " Cataract 2/280 (0.71%)", "Adverse Events 2:", " Total: 58/282 (20.57%)", " Agranulocytosis 1/282 (0.35%)", " Anaemia 2/282 (0.71%)", " Febrile neutropenia 4/282 (1.42%)", " Immune thrombocytopenic purpura 0/282 (0.00%)", " Leukopenia 0/282 (0.00%)", " Neutropenia 3/282 (1.06%)", " Thrombocytopenia 1/282 (0.35%)", " Acute myocardial infarction 0/282 (0.00%)", " Cardiac failure 0/282 (0.00%)", " Cataract 1/282 (0.35%)", " Cataract subcapsular 1/282 (0.35%)" ]

[ "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" ]

[ "Inclusion Criteria:", " Female, 18-100 years old", " Not pregnant or breastfeeding", " Pre-study radiologic documentation of:", " size 5 cm", " unicentric, unilateral", " suspicious mass or calcification", " BIRADS classification IV", " location of abnormality > 1 cm from skin", " Ductal or Infiltrating Ductal Carcinoma", " Grade I-III on final pathology", " Good general health", " Zubrod Performance Status of 0,1, or 2", " No previous chemotherapy", " No palpable axillary or supraclavicular lymph nodes", " If prior non-breast malignancy, must have > 5 year disease-free survival", "Exclusion Criteria:", " Patient < 18 y/o or > 100 y/o", " Pregnant or breastfeeding", " Male", " Breast implants", " Multicentric disease or bilateral disease", " Lesions > 5 cm in diameter", " Lesions < 1.0 cm from the skin", " Previous prior radiation to the breast", " Need for mastectomy", " Diffuse microcalcifications (as determined by the Investigator)" ]

[ "Inclusion Criteria:", " Patients must have histologically or cytologically confirmed primary invasive breast cancer", " Primary tumor is larger than 2 cm in diameter (T2) as measured by caliper or ultrasound", " Overexpression and/or amplification of HER2 is confirmed by immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) + when IHC 2+", " Patients have not received prior therapies for breast cancer", " Patients have Karnofsky >= 70%", " Leukocytes >= 3,000/mcL", " Absolute neutrophil count >= 1,500/mcL", " Hemoglobin >= 9.0 g/dL", " Platelets >= 75,000/mcL", " Total bilirubin =< 1.5 times institutional upper limit of normal", " Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase[SGPT]) =< 2.5 times institutional ULN", " Creatinine =< 1.5 times institutional upper limit of normal (ULN)", " Patients must have left ventricular ejection fraction (LVEF) >= 50% by multi-gated acquisition (MUGA) or echocardiography", " Patients must be able to take oral medications (i.e., no uncontrolled vomiting, inability to swallow, or diagnosis of chronic malabsorption)", " Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation as well as for at least 6 months after the last dose of trastuzumab", " Ability to understand and willingness not only for treatment but also for undergoing serial biopsies and sign a written informed consent document", " Only Japanese women are eligible for the trial", "Exclusion Criteria:", " Patients who have had chemotherapy or radiotherapy", " Patients who are receiving any other investigational agents", " Patients have distal metastasis (stage IV disease)", " Patients with previous (within 10 years) or current history of malignant neoplasm except for curatively treated basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix", " Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or other agents used in study", " Patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) are ineligible", " Patients who have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements", " Pregnant women", " Patients who have family or personal history of congenital long or short QT syndrome, Brugada syndrome, QT/QTc prolongation, or torsade de pointes", " Patients who have chronic gastrointestinal disease presenting with diarrhea (inflammatory bowel disease, malabsorption, or >= grade 2 diarrhea of any etiology at baseline)", " Patients who have neuropathy >= grade 2 of any cause", " Patients are diagnosed with inflammatory breast cancer or bilateral breast cancer" ]

[ "Adverse Events 1:", " Total: 7/15 (46.67%)", " Cardiac arrest * 1/15 (6.67%)", " Chest pain - cardiac * 1/15 (6.67%)", " Diarrhea * 1/15 (6.67%)", " Duodenal hemorrhage * 1/15 (6.67%)", " Fatigue * 1/15 (6.67%)", " Fever * 1/15 (6.67%)", " Sudden death NOS * 1/15 (6.67%)", " Sepsis * 1/15 (6.67%)", " Skin infection * 1/15 (6.67%)", " Neutrophil count decreased * 1/15 (6.67%)", " Platelet count decreased * 1/15 (6.67%)" ]

[ "Adverse Events 1:", " Total: 69/258 (26.74%)", " Anaemia 3/258 (1.16%)", " Febrile neutropenia 13/258 (5.04%)", " Neutropenia 5/258 (1.94%)", " Thrombocytopenia 1/258 (0.39%)", " Atrial fibrillation 0/258 (0.00%)", " Mitral valve incompetence 1/258 (0.39%)", " Pericardial effusion 0/258 (0.00%)", " Sinus tachycardia 0/258 (0.00%)", " Abdominal pain 3/258 (1.16%)", " Abdominal pain upper 1/258 (0.39%)", " Colitis 1/258 (0.39%)", "Adverse Events 2:", " Total: 64/224 (28.57%)", " Anaemia 2/224 (0.89%)", " Febrile neutropenia 4/224 (1.79%)", " Neutropenia 1/224 (0.45%)", " Thrombocytopenia 0/224 (0.00%)", " Atrial fibrillation 1/224 (0.45%)", " Mitral valve incompetence 0/224 (0.00%)", " Pericardial effusion 2/224 (0.89%)", " Sinus tachycardia 1/224 (0.45%)", " Abdominal pain 3/224 (1.34%)", " Abdominal pain upper 0/224 (0.00%)", " Colitis 0/224 (0.00%)" ]

[ "Outcome Measurement: ", " Progression-free Survival", " RECIST progression defined as 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed, unequivocal progression of non-measurable disease, the appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration, development of one or more new bone lesions from baseline, or symptomatic deterioration related to disease progression. Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.", " Time frame: Up to 2 years", "Results 1: ", " Arm/Group Title: Dasatinib, 100 mg, Daily", " Arm/Group Description: Dasatinib, 100 mg PO daily until progression of disease", " Overall Number of Participants Analyzed: 41", " Median (95% Confidence Interval)", " Unit of Measure: weeks 10.3 (8.4 to 16.7)", "Results 2: ", " Arm/Group Title: Dasatinib, 70 mg, Twice Daily", " Arm/Group Description: Dasatinib, 70 mg PO twice daily until progression of disease", " Overall Number of Participants Analyzed: 38", " Median (95% Confidence Interval)", " Unit of Measure: weeks 15.3 (8.7 to 20.1)" ]

[ "Outcome Measurement: ", " Number of Patients With Objective Treatment Response (Complete or Partial) in the CNS", " Imaging was performed at 8-week intervals to assess response to treatment. Patients with known or suspected leptomeningeal disease were deemed to have a complete response if CSF cytology converted to negative (if positive at baseline) and all meningeal enhancement or nodularity of brain and/or spine MRI resolved. A modified RECIST 1.0 criteria was used to assess CNS response for patients with new or progressing brain metastases. In this modified RECIST criteria, CNS lesions <1cm were not considered measurable, but were considered evaluable for response and progression. Progressive disease for patients with lesions <1 cm was defined as follows: growth of a lesion from less than or equal to 5 mm to greater than or equal to 10mm; or, growth of a 6-9 mm lesion by at least 5 mm in the case of non-target parenchymal brain metastases.", " Time frame: Baseline scan prior to study entry was performed within 14 days of cycle 1 day 1, then every 8 weeks from then until disease progression or up to 2 years", "Results 1: ", " Arm/Group Title: Irinotecan and Temozolomide", " Arm/Group Description: irinotecan hydrochloride administered intravenously (IV) at a starting dose of 125 mg/m2 on days 1 and 15 of a 28 day cycle", " temozolomide orally for seven days at a starting dose of 100 mg/m2 on days 1-7 and days 15-21 of a 28 day cycle", " Overall Number of Participants Analyzed: 30", " Measure Type: Count of Participants", " Unit of Measure: Participants 2 6.7%" ]

[ "Adverse Events 1:", " Total: 56/199 (28.14%)", " AGRANULOCYTOSIS 1/199 (0.50%)", " ANAEMIA 1/199 (0.50%)", " BONE MARROW FAILURE 1/199 (0.50%)", " FEBRILE NEUTROPENIA 11/199 (5.53%)", " LEUKOPENIA 1/199 (0.50%)", " NEUTROPENIA 1/199 (0.50%)", " PANCYTOPENIA 1/199 (0.50%)", " ACUTE MYOCARDIAL INFARCTION 1/199 (0.50%)", " ATRIAL FLUTTER 1/199 (0.50%)", " ATRIAL THROMBOSIS 0/199 (0.00%)", " CARDIAC FAILURE 3/199 (1.51%)", "Adverse Events 2:", " Total: 66/198 (33.33%)", " AGRANULOCYTOSIS 0/198 (0.00%)", " ANAEMIA 0/198 (0.00%)", " BONE MARROW FAILURE 0/198 (0.00%)", " FEBRILE NEUTROPENIA 27/198 (13.64%)", " LEUKOPENIA 0/198 (0.00%)", " NEUTROPENIA 2/198 (1.01%)", " PANCYTOPENIA 1/198 (0.51%)", " ACUTE MYOCARDIAL INFARCTION 0/198 (0.00%)", " ATRIAL FLUTTER 0/198 (0.00%)", " ATRIAL THROMBOSIS 1/198 (0.51%)", " CARDIAC FAILURE 4/198 (2.02%)" ]

[ "Adverse Events 1:", " Total: 3/8 (37.50%)", " Anaemia 0/8 (0.00%)", " Febrile neutropenia 0/8 (0.00%)", " Polycythaemia 0/8 (0.00%)", " Acute coronary syndrome 0/8 (0.00%)", " Vertigo 0/8 (0.00%)", " Eyelid oedema 1/8 (12.50%)", " Constipation 0/8 (0.00%)", " Diarrhoea 0/8 (0.00%)", " Nausea 0/8 (0.00%)", " Stomatitis 0/8 (0.00%)", " Upper gastrointestinal haemorrhage 0/8 (0.00%)", " Vomiting 0/8 (0.00%)", " Chest pain 0/8 (0.00%)", "Adverse Events 2:", " Total: 2/6 (33.33%)", " Anaemia 0/6 (0.00%)", " Febrile neutropenia 0/6 (0.00%)", " Polycythaemia 0/6 (0.00%)", " Acute coronary syndrome 0/6 (0.00%)", " Vertigo 0/6 (0.00%)", " Eyelid oedema 0/6 (0.00%)", " Constipation 0/6 (0.00%)", " Diarrhoea 0/6 (0.00%)", " Nausea 0/6 (0.00%)", " Stomatitis 0/6 (0.00%)", " Upper gastrointestinal haemorrhage 0/6 (0.00%)", " Vomiting 0/6 (0.00%)", " Chest pain 1/6 (16.67%)" ]

[ "Outcome Measurement: ", " Progression-free Survival (PFS)", " PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). RECIST is a set of published rules that define when tumors in cancer patients improve (\"respond\"), stay the same (\"stabilize\") or worsen (\"progress\") during treatment.", " Only data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered.", " Progression of disease was determined if at least 1 of the following criteria applied:", " At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm", " Appearance of 1 or more new lesions", " Unequivocal progression of existing non-target lesions", " Time frame: From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months", "Results 1: ", " Arm/Group Title: Afatinib + Vinorelbine (AV)", " Arm/Group Description: Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.", " Overall Number of Participants Analyzed: 339", " Median (Inter-Quartile Range)", " Unit of Measure: Months 5.49 (3.55 to 9.07)", "Results 2: ", " Arm/Group Title: Trastuzumab + Vinorelbine (TV)", " Arm/Group Description: Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.", " Overall Number of Participants Analyzed: 169", " Median (Inter-Quartile Range)", " Unit of Measure: Months 5.55 (3.55 to 10.84)" ]

[ "Inclusion Criteria:", " Previous participation in study 971-ONC-0028-080.", "Exclusion Criteria:", " Subjects who had not previously participated in study 971-ONC-0028-080." ]

[ "DISEASE CHARACTERISTICS:", " Diagnosis of breast cancer at high risk for recurrence, defined by one of the following:", " Stage IV that is free of all known disease after eradication by surgery, radiotherapy, or chemotherapy", " May or may not have elevated CA 15-3 or CEA levels", " Stage I, II, or III previously treated with adjuvant chemotherapy and clinically free of identifiable disease, but have rising CA 15-3 or CEA levels", " Rising CA 15-3 and CEA defined as a prior normal level increased on 2 consecutive occasions at least 2 weeks apart", " For patients with a significant history of smoking who have a chronically elevated CEA (less than 15), CEA must be increased at least 1.5 times the uppermost chronic value on 2 consecutive occasions at least 2 weeks apart", " Stage III and completed adjuvant therapy no more than 24 months ago", " Recurrence in the ipsilateral axilla after lumpectomy and/or axillary dissection or modified radical mastectomy", " Recurrence in the ipsilateral breast after lumpectomy and/or axillary dissection", " Stage II with at least 4 positive axillary nodes and completed adjuvant therapy no more than 24 months ago", " Stage IV that is stable on hormonal therapy", " Hormone receptor status:", " Not specified", " PATIENT CHARACTERISTICS:", " Age:", " 18 and over", " Sex:", " Male or female", " Menopausal status:", " Not specified", "Performance status:", " Karnofsky 80-100%", " Life expectancy:", " Not specified", " Hematopoietic:", " Lymphocyte count at least 500/mm^3", " WBC at least 3,000/mm^3", " Hepatic:", " AST no greater than 1.5 times upper limit of normal (ULN)", " Alkaline phosphatase no greater than 1.5 times ULN", " Renal:", " Creatinine no greater than 1.5 times ULN", " Cardiovascular:", " No clinically significant New York Heart Association class III or IV cardiac disease", " Other:", " Not pregnant", " Negative pregnancy test", " Fertile patients must use effective contraception", " No prior seafood allergy", " No known prior immunodeficiency or autoimmune disease", " No other active cancer except basal cell or squamous cell skin cancer", " PRIOR CONCURRENT THERAPY:", " Biologic therapy:", " At least 6 weeks since prior immunotherapy", " No prior vaccine with any of the antigens in this study", " Chemotherapy:", " See Disease Characteristics", " At least 4 weeks since prior chemotherapy", " No concurrent chemotherapy", " Endocrine therapy:", " See Disease Characteristics", " Radiotherapy:", " See Disease Characteristics", " At least 4 weeks since prior radiotherapy", " No concurrent radiotherapy", " Surgery:", " See Disease Characteristics", " At least 4 weeks since prior surgery", " Concurrent surgery for local recurrence allowed if patient remains disease free" ]

[ "Inclusion Criteria:", " Biopsy-proven breast cancer, metastatic (persistent or recurrent).", " Failed 1 line of therapy (endocrine or chemotherapy) for metastatic disease.", " Min. 3 distinct metastatic sites, at least one measurable lesion which is at least 1 cm or larger in largest diameter.", " Must be 4 weeks since all of the following treatments (recovered from toxicity of prior treatment to Grade 1, excluding alopecia):", " major surgery;", " radiotherapy;", " chemotherapy ( 6 weeks since therapy if a nitrosourea, mitomycin, or monoclonal antibodies such as bevacizumab);", " immunotherapy;", " biotherapy/targeted therapies.", " >18 years of age.", " Life expectancy >6 months.", " Eastern Cooperative Oncology Group (ECOG) status 0 or 1.", " Adequate organ function including:", " Hemoglobin 10.0g/dL, absolute neutrophil count (ANC) 1,500/mm3, and platelets 100,000/mm3.", " Hepatic: Serum total bilirubin 1.5x upper limit of normal (ULN) (Patients with Gilbert's Disease may be included if total bilirubin is 3.0mg/dL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) 2.5xULN. If patient has known liver metastases, ALT and/or AST 5xULN are allowed.", " Renal: creatinine clearance 60mL/min.", " Prothrombin (PT) and partial thromboplastin times (PTT) <ULN.", " Negative for hepatitis viruses B and C unless consistent with prior vaccination or prior infection with full recovery.", " Patients of childbearing potential must agree to use effective contraception while on study, and for 3 months after last treatment.", " Understand and sign written informed consent document. No consent by durable power of attorney.", "Exclusion Criteria:", " Second malignancy - unless following curative intent therapy, has been disease free for 2 years with probability of recurrence <5%. Curatively treated early-stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia (CIN) are allowed.", " Concurrent cancer therapy.", " Uncontrolled central nervous system (CNS) metastases, meningeal carcinomatosis, malignant seizures, or disease that causes or threatens neurologic compromise (e.g. unstable vertebral metastases).", " History of ascites or pleural effusions, unless successfully treated.", " Organ transplant, including allogeneic bone marrow transplant.", " Immunosuppressive therapy including:", " Systemic corticosteroid therapy, including replacement therapy for hypoadrenalism. Inhaled or topical corticosteroids are allowed (if therapy is <5 days and is limited to systemic steroids as antiemetics);", " Cyclosporine A, tacrolimus, or sirolimus.", " Investigational agents within 4 weeks prior to study enrollment ( 6 weeks if treatment was long-acting agent such as monoclonal antibody).", " Significant or uncontrolled medical illness, e.g. congestive heart failure (CHF), myocardial infarction, symptomatic coronary artery disease, significant ventricular arrhythmias within the last 6 months, or significant pulmonary dysfunction. Patients with remote history of asthma or active mild asthma may participate.", " Active infection, including unexplained fever (>38.5°C).", " Systemic autoimmune disease (e.g. systemic lupus erythematosus, active rheumatoid arthritis).", " Known allergy to any component of GC1008.", " Active thrombophlebitis, thromboembolism, hypercoagulability states, bleeding, or anti-coagulation therapy (including anti platelet agents i.e. aspirin, clopidogrel, ticlopidine, dipyridamole, other agents inducing long-acting platelet dysfunction). Patients with history of deep venous thrombosis are allowed if treated, completely resolved, and no treatment for >4months.", " Calcium >11.0mg/dL (2.75mmol/L) unresponsive or uncontrolled in response to standard therapy (e.g. bisphosphonates).", " Patients who, in the opinion of the Investigator, have significant medical or psychosocial problems, including, but not limited to:", " Other serious non-malignancy-associated conditions that may be expected to limit life expectancy or significantly increase the risk of SAEs;", " Conditions, psychiatric, substance abuse, or other, that, in the opinion of the Investigator, would preclude informed consent, consistent follow-up, or compliance with any aspect of the study;", " Pregnant or nursing women." ]

[ "DISEASE CHARACTERISTICS:", " Histologically proven high-risk primary breast cancer with less than 60% chance of progression-free survival of 3 years from diagnosis", " Stage II with at least 10 positive axillary nodes OR", " Stage IIIA or IIIB", " No histologically proven bone marrow metastasis", " No CNS metastasis", " Hormone receptor status:", " Hormone receptor status known", " PATIENT CHARACTERISTICS:", " Age:", " Physiological age 60 or under", " Menopausal status:", " Not specified", "Performance status:", " Karnofsky 80-100%", " Life expectancy:", " See Disease Characteristics", " Hematopoietic:", " Neutrophil count at least 1,500/mm^3", " Platelet count at least 100,000/mm^3", " Hepatic:", " Bilirubin no greater than 1.5 mg/dL", " SGOT or SGPT no greater than 2 times upper limit of normal", " Hepatitis B antigen negative", " Renal:", " Creatinine no greater than 1.2 mg/dL", " Creatinine clearance at least 70 mL/min", " No prior hemorrhagic cystitis", " Cardiovascular:", " Ejection fraction at least 55% by MUGA", " No prior significant valvular heart disease or arrhythmia", " Pulmonary:", " FEV_1 at least 60% of predicted", " pO_2 at least 85 mm Hg on room air", " pCO_2 at least 43 mm Hg on room air", " DLCO at least 60% lower limit of predicted", " Other:", " No other prior malignancy except squamous cell or basal cell skin cancer or stage I or carcinoma in situ of the cervix", " No CNS dysfunction that would preclude compliance", " HIV negative", " No sensitivity to E. coli-derived products", " Not pregnant", " Fertile patients must use effective contraception", " PRIOR CONCURRENT THERAPY:", " Biologic therapy:", " Not specified", " Chemotherapy:", " At least 4 weeks since prior chemotherapy", " No prior doxorubicin of total dose exceeding 240 mg/m^2", " No prior paclitaxel of total dose of at least 750 mg/m^2", " No more than 12 months since prior conventional-dose adjuvant chemotherapy", " Endocrine therapy:", " At least 4 weeks since prior hormonal therapy", " Radiotherapy:", " At least 4 weeks since prior radiotherapy", " No prior radiation to the left chest wall", " Surgery:", "Not specified" ]

[ "INTERVENTION 1: ", " Glutamine", " 10 grams three times a day (orally) for four days and then stop", " glutamine: 10 grams three times a day (orally) for four days and then stop", "INTERVENTION 2: ", " Placebo", " 10 grams three times a day (orally) for four days and then stop", " Placebo: 10 grams three times a day (orally) for four days and then stop" ]

[ "INTERVENTION 1: ", " Mammography Only", " For this reporting arm, the interpretation and analysis was done with mammography only.", "INTERVENTION 2: ", " Gamma Imaging", " For this reporting arm, the interpretation and analysis was done with gamma imaging only." ]

[ "INTERVENTION 1: ", " Electronic Brachytherapy", " Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source." ]

[ "INTERVENTION 1: ", " Initial Cohort", " Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms", " Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule", "INTERVENTION 2: ", " Escalation Cohort", " Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms", " Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule" ]

[ "Inclusion Criteria:", " Subjects with measurable brain metastases of at least 1 cm in any plane based on anatomic imaging.", " Subjects with prior resection of brain metastases with progressions on brain MRI.", " Histologic confirmation of breast cancer.", " Age of study subject must be > 18 years.", " ECOG Performance Status 2.", " Ability to undergo brain MR and PET imaging", " Study subjects must have normal organ and marrow function as defined below:", " WBC >2,000/mmᶟ, platelets >90,000/mmᶟ, total bilirubin <2.0 mg/dl, creatinine <2.0 mg/dl.", " The effects of EF5 on the developing human fetus are unknown. For this reason, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation (1 month). Should a woman become pregnant pr suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test the day of the F18 -EF5 PET scan prior to the F18 -EF5 injection.", " Ability to understand, participate and provide a documented signed informed consent.", " Subjects who are allergic to gadolinium will have MRI scans without gadolinium contrast.", "Exclusion Criteria:", " History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5.", " Pregnant women are excluded because EF5 has an unknown risk for adverse events in fetuses and nursing infants secondary the administration of EF5 to the mother. Breastfeeding should be discontinued if EF5 is administered to the mother.", " Subject has any other condition or personal circumstance that, in the judgement of the investigator, might interfere with the collection of complete good quality data.", " Subjects who are unable to provide informed consent.", " Patients with prior whole brain radiotherapy.", " Patients with moderate to severe renal failure, defined as estimated GFR less than 30 ml/Lmin 1.73m²" ]

[ "Inclusion Criteria:", " Patients", " with unilateral primary cancer pathologically confirmed before neoadjuvant chemotherapy (NAC)", " who received NAC", " with detectable lesion / clip marker on ultrasound", " with cT1-T3 tumors", " clinical and imaging complete or near-complete response on MRI", " with informed consent", "Exclusion Criteria:", " Multifocal cancer", " Residual microcalcification", " Contralateral breast cancer" ]

[ "Inclusion Criteria:", " Unicentric Stage I invasive ductal breast cancer or Grade I or II DCIS measuring less than or equal to 2cm on pathology and/or mammography", " Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen", " Clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery", "Exclusion Criteria:", " No distant metastasis", " Not pregnant or breastfeeding", " No diffuse suspicious microcalcifications", " No prior radiation therapy to the ipsilateral or contralateral breast or thorax", " No histologic evidence of lymphovascular invasion (LVI)", " No histologic evidence of EIC", " No history of cosmetic or reconstructive breast surgery", " No psychiatric illness that would prevent the patient from giving informed consent", " No medical conditions that, in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient", " No other currently active second malignancy other than non-melanoma skin cancers" ]

[ "INTERVENTION 1: ", " SB-715992", " The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent." ]

[ "INTERVENTION 1: ", " Overall Population", " Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population." ]

[ "INTERVENTION 1: ", " Molecular Breast Imaging", " Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 mCi Tc-99m sestamibi." ]

[ "Key Inclusion Criteria:", " - Women with locally advanced, recurrent, or metastatic breast cancer along with confirmation of estrogen-receptor positive (ER+). Measurable disease defined as at least one lesion 10 mm by CT or MRI that can be accurately measured in at least one dimension (CT scan slice thickness 5 mm) OR Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.", " Key Exclusion Criteria:", " - Patients who received more than one chemotherapy line. Patients with only non-measurable lesions other than lytic or mixed (lytic and blastic) bone metastasis.Previous treatment with exemestane, mTOR inhibitors, PI3K inhibitors or AKT inhibitors." ]

[ "Inclusion Criteria:", " Assigned female at birth;", " 18 years and older;", " Confirmed diagnosis (via biopsy) of early stage breast cancer (stages I-IIIA);", " Eligible for both breast-conserving surgery and mastectomy based on medical records and clinician's opinion before surgery;", " Spoken English, Spanish, or Mandarin Chinese.", "Exclusion Criteria:", " Transgender men and women;", " Women who have undergone prophylactic mastectomy;", " Women with visual impairment;", " Women with a diagnosis of severe mental illness or severe dementia;", " Women with inflammatory breast carcinoma." ]

[ "Adverse Events 1:", " Total: 7/26 (26.92%)", " Febrile neutropenia 1/26 (3.85%)", " Neutropenia 0/26 (0.00%)", " Thrombocytopenia 0/26 (0.00%)", " Cardiac failure congestive 0/26 (0.00%)", " Extrasystoles 0/26 (0.00%)", " Nausea 1/26 (3.85%)", " Abdominal pain 0/26 (0.00%)", " Constipation 0/26 (0.00%)", " Gastrointestinal haemorrhage 0/26 (0.00%)", " Death - unknown cause 1/26 (3.85%)", " Thrombosis in device 0/26 (0.00%)", "Adverse Events 2:", " Total: 5/10 (50.00%)", " Febrile neutropenia 0/10 (0.00%)", " Neutropenia 0/10 (0.00%)", " Thrombocytopenia 1/10 (10.00%)", " Cardiac failure congestive 0/10 (0.00%)", " Extrasystoles 0/10 (0.00%)", " Nausea 0/10 (0.00%)", " Abdominal pain 0/10 (0.00%)", " Constipation 0/10 (0.00%)", " Gastrointestinal haemorrhage 0/10 (0.00%)", " Death - unknown cause 0/10 (0.00%)", " Thrombosis in device 0/10 (0.00%)" ]

[ "Adverse Events 1:", " Total: 45/298 (15.10%)", " Febrile neutropenia * 10/298 (3.36%)", " Neutropenia * 9/298 (3.02%)", " Leukopenia * 0/298 (0.00%)", " Thrombocytopenia * 0/298 (0.00%)", " Lymphadenopathy * 1/298 (0.34%)", " Cardiac failure congestive * 0/298 (0.00%)", " Arrhythmia * 0/298 (0.00%)", " Myocardial infarction * 1/298 (0.34%)", " Angina pectoris * 1/298 (0.34%)", " Atrial fibrillation * 0/298 (0.00%)", "Adverse Events 2:", " Total: 65/297 (21.89%)", " Febrile neutropenia * 13/297 (4.38%)", " Neutropenia * 7/297 (2.36%)", " Leukopenia * 1/297 (0.34%)", " Thrombocytopenia * 1/297 (0.34%)", " Lymphadenopathy * 0/297 (0.00%)", " Cardiac failure congestive * 2/297 (0.67%)", " Arrhythmia * 1/297 (0.34%)", " Myocardial infarction * 1/297 (0.34%)", " Angina pectoris * 0/297 (0.00%)", " Atrial fibrillation * 1/297 (0.34%)" ]

[ "Adverse Events 1:", " Total: 2/38 (5.26%)", " Febrile neutropenia 0/38 (0.00%)", " Abdominal pain 1/38 (2.63%)", " Skin infection 0/38 (0.00%)", " Seizure 1/38 (2.63%)" ]

[ "Adverse Events 1:", " Total: 17/94 (18.09%)", " Anaemia 2/94 (2.13%)", " Lymphadenopathy 0/94 (0.00%)", " Angina pectoris 0/94 (0.00%)", " Ischaemic cardiomyopathy 0/94 (0.00%)", " Myocardial infarction 1/94 (1.06%)", " Haemorrhoids 1/94 (1.06%)", " Ileus 1/94 (1.06%)", " Nausea 1/94 (1.06%)", " Vomiting 1/94 (1.06%)", " Asthenia 1/94 (1.06%)", " Disease progression 0/94 (0.00%)", " Oedema peripheral 1/94 (1.06%)", "Adverse Events 2:", " Total: 9/39 (23.08%)", " Anaemia 2/39 (5.13%)", " Lymphadenopathy 0/39 (0.00%)", " Angina pectoris 0/39 (0.00%)", " Ischaemic cardiomyopathy 0/39 (0.00%)", " Myocardial infarction 1/39 (2.56%)", " Haemorrhoids 1/39 (2.56%)", " Ileus 1/39 (2.56%)", " Nausea 1/39 (2.56%)", " Vomiting 1/39 (2.56%)", " Asthenia 1/39 (2.56%)", " Disease progression 0/39 (0.00%)", " Oedema peripheral 1/39 (2.56%)" ]

[ "INTERVENTION 1: ", " Supportive Care (Fluocinonide Cream)", " This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.", " All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks." ]

[ "INTERVENTION 1: ", " Tamoxifen", " Tamoxifen 20mg orally daily for 5 years", "INTERVENTION 2: ", " Ovarian Function Suppression", " Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)", " Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS." ]

[ "INTERVENTION 1: ", " Single Drain", " Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.", " Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.", " Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.", " Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.", "INTERVENTION 2: ", " Double Drain", " Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.", " Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.", " Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.", " Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography." ]

[ "INTERVENTION 1: ", " Fulvestrant & Everolimus", " Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.", " Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).", " If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.", " Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.", " If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.", "INTERVENTION 2: ", " Fulvestrant & Placebo", " Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.", " Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).", " If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.", " Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet." ]

[ "INTERVENTION 1: ", " Arm A: Triptorelin + Letrozol", " Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles", " Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)", " Letrozole: Letrozole 2.5 mg orally every day for 6 cycles", "INTERVENTION 2: ", " Arm B: Degarelix + Letrozol", " Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles", " Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)", " Letrozole: Letrozole 2.5 mg orally every day for 6 cycles" ]

[ "INTERVENTION 1: ", " Fulvestrant 250 mg + Tipifarnib 300 mg", " Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity" ]

[ "Inclusion Criteria:", " Tissue block containing tumor to confirm metastatic breast cancer is required;", " Measurable disease according to RECIST criteria", " \"Triple negative\" disease defined as tumor demonstrating no expression for estrogen, progesterone or human epidermal growth factor receptor 2(HER2)receptors. \"No expression\" is categorized as 10% of cells staining or Allred 2;", " Aged 18 years or older;", " Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0 or 1; life expectancy 3 months;", " Patients may have received 0 - 1 prior therapies (except taxanes in the metastatic setting). An interval of at least 1 week must have elapsed since prior chemotherapy or hormonal therapy for metastatic disease; at least 6 months must have elapsed since prior adjuvant therapy;", " 2 weeks between surgery and study enrollment ( 4 weeks between major surgery (defined as open abdominal/thoracic/cardiac) and study enrollment;", " Laboratory tests performed within 14 days of study entry:", " Granulocytes 1,500/µL;", " Platelets 100,000/µL;", " Hemoglobin 9 gm/dL;", " Total bilirubin institutional upper limit of normal (ULN);", " Aspartate transaminase (AST) and alanine aminotransferase (ALT) 5 times ULN;", " Alkaline phosphatase 2.5 times ULN;", " Estimated creatinine clearance 60 mL/min.", " left ventricular ejection fraction (LVEF) 50% by multigated acquisition (MUGA)/Echocardiogram;", " Informed consent to receive protocol treatment, to provide biologic specimens, and to complete neurotoxicity questionnaires;", " Cognitive and communication skills to comply with study and/or follow-up procedures;", " No reproductive potential:", " If pre-menopausal: Negative serum pregnancy test and patient agreement to use adequate contraceptive method (abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during and for 3 months after completion of treatment.", "If post-menopausal: Amenorrhea for 12 months.", "Exclusion Criteria:", " Pregnant or breast feeding;", " Prior treatment with Abraxane®, carboplatin or bevacizumab, or any taxane for metastatic breast cancer;", " Known hypersensitivity to any component of any study drug;", " Active infection;", " Current neuropathy grade 2;", " central nervous system (CNS) metastases as determined by head CT with contrast;", " History of bleeding within the past 6 months or active bleeding disorder;", " Serious non-healing wound, ulcer or bone fracture;", " Uncontrolled congestive heart failure (CHF), or history of myocardial infarction(MI), unstable angina, stroke, or transient ischemia within previous 6 months;", " Inadequately controlled hypertension (defined as systolic blood pressure < 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications; prior history of hypertensive crisis or hypertensive encephalopathy;", " Proteinuria (defined as urine protein: creatinine (UPC) ratio 1.0 or urine dipstick 2+.", " Significant vascular disease (aortic aneurysm, aortic dissection) or symptomatic peripheral vascular disease;", " History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within previous 6 months;", " Uncontrolled serious contraindicated medical condition or psychiatric illness." ]

[ "Outcome Measurement: ", " Clinical Benefit Rate (CR + PR + SD > 6 Months).", " To determine the clinical benefit rate (Complete Response + Partial Response + Stable Disease > 6 months) per Response Evaluation Criteria in Solid tumors (RECIST version 1.0). of MPA monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer. This will show the percent of patients who had Clinical Benefit and the Exact 95% Confidence Interval.", " Time frame: baseline through end of study, up to 3 years", "Results 1: ", " Arm/Group Title: Cohort I: MPA-Alone", " Arm/Group Description: Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.", " Overall Number of Participants Analyzed: 14", " Measure Type: Number", " Unit of Measure: Percent of Participants 7.1 (0.2 to 33.9)", "Results 2: ", " Arm/Group Title: Cohort 2: MPA+IdoCM", " Arm/Group Description: Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.", " Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week.", " Overall Number of Participants Analyzed: 16", " Measure Type: Number", " Unit of Measure: Percent of Participants 6.3 (0.2 to 30.2)" ]

[ "Outcome Measurement: ", " Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Mutant Cohort", " Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.", " Time frame: After 24 weeks of treatment", "Results 1: ", " Arm/Group Title: Alpelisib + Letrozole", " Arm/Group Description: Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.", " Overall Number of Participants Analyzed: 60", " Measure Type: Number", " Unit of Measure: Percentage of Participants 1.7 (0.2 to 6.3)", "Results 2: ", " Arm/Group Title: Placebo + Letrozole", " Arm/Group Description: Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.", " Overall Number of Participants Analyzed: 67", " Measure Type: Number", " Unit of Measure: Percentage of Participants 3.0 (0.8 to 7.7)" ]

[ "Inclusion Criteria:", " female patients, 18-70years of age;", " histologically-proven invasive breast cancer;", " no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;", " no distant disease/secondary cancer.", "Exclusion Criteria:", " pregnant or lactating women;", " pre-operative local treatment for breast cancer;", " prior or concurrent systemic antitumor therapy;", " clinically significant cardiac disease." ]

[ "Outcome Measurement: ", " Number of Participants With Stomatitis Grade 2", " The incidence of grade 2 stomatitis was reported. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.", " Time frame: 56 days", "Results 1: ", " Arm/Group Title: Dexamethasone Based Mouthwash", " Arm/Group Description: Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.", " Overall Number of Participants Analyzed: 86", " Measure Type: Number", " Unit of Measure: Participants Stomatitis grade >=2: Yes: 2", " Stomatitis grade >=2: No: 83", " Stomatitis grade >=2: Not evaluable: 1" ]

[ "INTERVENTION 1: ", " Participants With Stage 0-III Breast Cancer", " Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.", " Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions." ]

[ "INTERVENTION 1: ", " Arm I (Omega-3-fatty Acid)", " Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity", "INTERVENTION 2: ", " Arm II (Placebo)", " Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity" ]

[ "INTERVENTION 1: ", " Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2", " Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.", "INTERVENTION 2: ", " Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2", " Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days." ]

[ "Outcome Measurement: ", " Number of Participants With Adverse Events (AEs)", " Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab", " Time frame: From first dose to 30 days post last dose (up to 34 months)", "Results 1: ", " Arm/Group Title: Nivolumab + Daratumumab (TNBC)", " Arm/Group Description: Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)", " Overall Number of Participants Analyzed: 41", " Measure Type: Count of Participants", " Unit of Measure: Participants 41 100.0%", "Results 2: ", " Arm/Group Title: Nivolumab + Daratumumab (NSCLC)", " Arm/Group Description: Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)", " Overall Number of Participants Analyzed: 21", " Measure Type: Count of Participants", " Unit of Measure: Participants 21 100.0%" ]

[ "INTERVENTION 1: ", " Molecular Breast Imaging", " Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 mCi Tc-99m sestamibi." ]

[ "INTERVENTION 1: ", " Control Arm", " Mail", " Standard Reminder Postcard", "INTERVENTION 2: ", " Family Physician Reminder Letter Arm", " Mail", " Standard Reminder Postcard", " Family Physician Reminder Letter" ]

[ "Outcome Measurement: ", " Progression-free Survival (PFS)", " Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier survival curves will be used. A 95% confidence interval for the median PFS will be calculated. A lower bound greater than 8 months would be strong evidence that Nab-Paclitaxel- bevacizumab induction therapy followed by bevacizumab-erlotinib hydrochloride maintenance therapy is superior to paclitaxel and bevacizumab. However, a median PFS of 13 months or greater (regardless of whether the 95% confidence interval for the median extends below 8 months) could also indicate promising results.", " Time frame: Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 8 years", "Results 1: ", " Arm/Group Title: Tx (Chemo, MoAb, and Enzyme Inhibitor)", " Arm/Group Description: INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.", " MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.", " paclitaxel albumin-stabilized nanoparticle formulation: Given IV", " bevacizumab: Given IV", " erlotinib hydrochloride: Given PO", " Overall Number of Participants Analyzed: 55", " Median (95% Confidence Interval)", " Unit of Measure: Months 9.1 (7.2 to 11.1)" ]

[ "Inclusion Criteria:", " Women >=18 years of age", " HER2-negative metastatic breast cancer", " Previous adjuvant chemotherapy or hormonal treatment", " >=1 measurable target lesion", "Exclusion Criteria:", " Previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy for advanced or metastatic cancer", " Radiation therapy within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiation therapy", " Central nervous system metastases", " Other malignancy within last 5 years, except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix", " Serious concurrent infection" ]

[ "Eligibility Criteria:", " Patients must be women with a histologically confirmed diagnosis of locally advanced or inflammatory breast carcinoma. Histologic confirmation shall be by either core needle biopsy or incisional biopsy. Punch biopsy is allowed if invasive breast cancer is documented.", " Patients must meet one of the criteria defined below (indicate one):", " a .Selected Stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0) disease judged primarily unresectable by an experienced breast surgeon; or otherwise deemed appropriate candidates for neoadjuvant treatment.", " b. Stage IIIB (T4, Any N, M0) or (Any T, N3, M0) disease.", " Physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration.", " Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible. Patients with hypertension or age > 60 years must have a Multiple Gated Acquisition (MUGA) or echocardiogram scan performed within 90 days prior to registration (indicate not applicable (NA) if no MUGA required) and Left Ventricular Ejection Fraction (LVEF) % must be greater than the institutional lower limit of normal.", " Patients must have a serum creatinine and bilirubin the institutional upper limit of normal, and an Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) 2x the institutional upper limit of normal. These tests must have been performed within 90 days prior to registration.", " Patients must have an Absolute neutrophil count (ANC) of 1,500/μl and a platelet count of 100,000/μl. These tests must have been performed within 90 days prior to registration.", " Patients must have a performance status of 0-2 by Zubrod criteria", " Pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. A urine pregnancy test is required for women of childbearing potential.", " All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines." ]

[ "Outcome Measurement: ", " Progression-free Survival (PFS)", " Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.", " Time frame: From randomization to the earliest date of documentation of disease progression, up to 5 years", "Results 1: ", " Arm/Group Title: Arm A", " Arm/Group Description: 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", " Overall Number of Participants Analyzed: 19", " Median (95% Confidence Interval)", " Unit of Measure: Median survival and CI in months 6.0 (4.3 to 8.6)", "Results 2: ", " Arm/Group Title: Arm B", " Arm/Group Description: Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1 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", " Overall Number of Participants Analyzed: 37", " Median (95% Confidence Interval)", " Unit of Measure: Median survival and CI in months 4.9 (2.9 to 8.5)" ]

[ "Adverse Events 1:", " Total: 20/88 (22.73%)", " Cardiac Failure * 2/88 (2.27%)", " Intracardiac thrombus * 1/88 (1.14%)", " Abdominal pain * 1/88 (1.14%)", " Diarrhoea * 2/88 (2.27%)", " Enteritis * 1/88 (1.14%)", " Intestinal perforation * 1/88 (1.14%)", " Chest pain * 1/88 (1.14%)", " Death * 1/88 (1.14%)", " Erysipelas * 1/88 (1.14%)", " Pneumonia * 1/88 (1.14%)", " Abdominal wound dehiscence * 1/88 (1.14%)" ]

[ "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%)" ]

[ "Adverse Events 1:", " Total: 427/2002 (21.33%)", " ANAEMIA 13/2002 (0.65%)", " BONE MARROW FAILURE 1/2002 (0.05%)", " DISSEMINATED INTRAVASCULAR COAGULATION 1/2002 (0.05%)", " FEBRILE NEUTROPENIA 1/2002 (0.05%)", " THROMBOCYTOPENIA 11/2002 (0.55%)", " ACUTE CORONARY SYNDROME 3/2002 (0.15%)", " ANGINA PECTORIS 1/2002 (0.05%)", " CARDIAC ARREST 1/2002 (0.05%)", " CARDIAC FAILURE 1/2002 (0.05%)", " CARDIAC TAMPONADE 1/2002 (0.05%)", "Adverse Events 2:", " Total: 36/181 (19.89%)", " ANAEMIA 0/181 (0.00%)", " BONE MARROW FAILURE 0/181 (0.00%)", " DISSEMINATED INTRAVASCULAR COAGULATION 0/181 (0.00%)", " FEBRILE NEUTROPENIA 0/181 (0.00%)", " THROMBOCYTOPENIA 10/181 (5.52%)", " ACUTE CORONARY SYNDROME 1/181 (0.55%)", " ANGINA PECTORIS 0/181 (0.00%)", " CARDIAC ARREST 0/181 (0.00%)", " CARDIAC FAILURE 0/181 (0.00%)", " CARDIAC TAMPONADE 0/181 (0.00%)" ]

[ "Adverse Events 1:", " Total: 9/23 (39.13%)", " Anemia 1/23 (4.35%)", " Diarrhea 1/23 (4.35%)", " Nausea 1/23 (4.35%)", " Fracture 1/23 (4.35%)", " ALT 1/23 (4.35%)", " AST 1/23 (4.35%)", " INR 1/23 (4.35%)", " PTT 1/23 (4.35%)", " Glucose, high 1/23 (4.35%)", " Limb Pain 1/23 (4.35%)", " Ataxia 2/23 (8.70%)", " Neurology - Other 1/23 (4.35%)", " Seizure 1/23 (4.35%)", " Syncope 1/23 (4.35%)", " Confusion 1/23 (4.35%)" ]

[ "Adverse Events 1:", " Total: 14/52 (26.92%)", " Febrile neutropenia * 1/52 (1.92%)", " Tachycardia * 1/52 (1.92%)", " Atrial fibrillation * 0/52 (0.00%)", " Duodenal ulcer * 1/52 (1.92%)", " Gastric ulcer * 1/52 (1.92%)", " Nausea * 1/52 (1.92%)", " Abdominal pain * 0/52 (0.00%)", " Asthenia * 1/52 (1.92%)", " Disease progression * 1/52 (1.92%)", " Mucosal inflammation * 1/52 (1.92%)", " Appendicitis * 1/52 (1.92%)", "Adverse Events 2:", " Total: 4/20 (20.00%)", " Febrile neutropenia * 0/20 (0.00%)", " Tachycardia * 0/20 (0.00%)", " Atrial fibrillation * 1/20 (5.00%)", " Duodenal ulcer * 0/20 (0.00%)", " Gastric ulcer * 0/20 (0.00%)", " Nausea * 0/20 (0.00%)", " Abdominal pain * 1/20 (5.00%)", " Asthenia * 0/20 (0.00%)", " Disease progression * 0/20 (0.00%)", " Mucosal inflammation * 0/20 (0.00%)", " Appendicitis * 0/20 (0.00%)" ]

[ "DISEASE CHARACTERISTICS:", " Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast", " Confirmed by biopsy or fine needle aspiration (FNA) within the past 60 days", " Negative or benign mammogram (BI-RADS assessment 1 or 2) and negative or benign clinical breast exam of the contralateral breast within the past 90 days", " Prior biopsy of the contralateral breast (including FNA) is allowed provided it was performed at least 6 months prior to study entry", " Prior magnetic resonance exam of the contralateral breast is allowed provided it was performed at least 1 year prior to study entry", " No remote history of breast cancer", " No new breast symptoms within the past 60 days for which further evaluation is recommended", " Hormone receptor status:", " Not specified", " PATIENT CHARACTERISTICS:", " Age", " 18 and over", " Sex", " Female", " Menopausal status", " Not specified", " Performance status", " Not specified", " Life expectancy", " Not specified", " Hematopoietic", " Not specified", " Hepatic", " Not specified", " Renal", " Not specified", " Cardiovascular", " No pacemaker", " No magnetic aneurysm clips", " Other", " Not pregnant", " No implanted magnetic device", " No severe claustrophobia", " No other contraindications to MRI", " No psychiatric, psychological, or other condition that would preclude informed consent", " PRIOR CONCURRENT THERAPY:", " Biologic therapy", " Not specified", " Chemotherapy", " At least 6 months since prior anticancer chemotherapy", " Endocrine therapy", " No concurrent therapeutic hormonal therapy, tamoxifen, or aromatase inhibitors (preventive therapy allowed)", " Radiotherapy", " Not specified", " Surgery", "Not specified" ]

[ "INTERVENTION 1: ", " Diagnostic (18F-FLT)", " Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.", " Fluorothymidine F-18: Undergo 18F-FLT PET/CT", " Positron Emission Tomography: Undergo 18F-FLT PET/CT", " Computed Tomography: Undergo 18F-FLT PET/CT", " Laboratory Biomarker Analysis: Correlative studies" ]

[ "INTERVENTION 1: ", " Herceptin© + Taxane", " 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 .", "INTERVENTION 2: ", " MYL-1401O Trastuzumab + Taxane", " 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." ]

[ "Inclusion Criteria:", " Patients must be able and willing to give written informed consent prior to any study related procedures", " Ambulatory, female patients with an age 18 years", " Patients with histologically or cytologically proven diagnosis of breast cancer who are eligible for neoadjuvant or adjuvant chemotherapy.", " Patients who are planned and eligible to receive/ receiving myelosuppressive chemotherapy regimen that contains at least one chemotherapeutic agent from docetaxel/ paclitaxel / doxorubicin/ cyclophosphamide/ epirubicin", " Patients who have not received any hematopoietic growth factors (e.g. G-CSF, PegGCSF, erythropoietin) or cytokines (e.g. interleukins, interferons) anytime in the past", " Patients with baseline WBC LLN/ 3.5 x 109/L, ANC of 1.5 x 109/L, platelet count 100 x 109/L and hemoglobin 8.5 g/dL", " Patients with ECOG Performance status of 2", " Patient who have estimated life expectancy of more than six months", " No evidences of hemorrhage", "Exclusion Criteria:", " 1 Male patients", " 2. Hypersensitivity to any of the study drugs or its components like E.coli proteins or similar product", " 3. Patients weighing <45 Kg", " 4. Patients with myeloid malignancies and myelodysplasia or evidence of metastatic disease in bone marrow or brain", " 5. Patients currently receiving radiation therapy or have completed radiation therapy within 4 weeks before study entry or likely to receive radiotherapy during the study", " 6. Patients with prior bone marrow or stem cell transplantation", " 7. Patients with chronic use of oral corticosteroids (Except 20 mg/day dose of prednisolone/ equivalent steroids), immunotherapy, monoclonal antibody therapy and/or biological therapy or use of any other pegylated drug.", " 8. Patients with history of systemic antibiotic use within 72 hours prior to chemotherapy", " 9. Patients with any active infection which may require systemic antimicrobial therapy. Patients with inadequate hepatic and renal function [defined as Alkaline Phosphatase > 2.5 X Upper limits of normal (ULN), serum SGOT > 2.5 X ULN, SGPT > 2.5 X ULN, Total bilirubin > 1.5 X ULN and Creatinine > 1.5 X ULN of the reference range at the screening assessment]", " 10. Patients with seropositivity for HIV or HBV or HCV", " 11. Known cases of Sickle Cell Anemia", " 12. Patients with radiographic evidence of active pulmonary infections and/or recent history of pneumonia within 1 month of screening", " 13. Patients with clinically evident splenomegaly confirmed subsequently by ultrasonography", " 14. Patients with any other clinically significant disease(s) which, in the opinion of the investigator, could compromise the patient's involvement in the study or overall interpretation of the data. [for e.g. uncontrolled hematologic, renal, hepatic, endocrine, neurologic, psychiatric, metabolic, pulmonary, cardiovascular disease/impaired functioning or history of any autoimmune disease]", " 15. Patients who have participated in another therapeutic clinical study within the past 30 days prior to screening, or are likely to simultaneously participate in another therapeutic clinical study", " 16. Patients who are doubtful to comply with study procedures for mental, psychological or social reasons.", " 17. Women of child-bearing potential who are not willing to follow a reliable & effective contraceptive measure during the course of the study & at least 3 months after the last dose of study drug.", " 18. Pregnant and Breast feeding women." ]

[ "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%)" ]

[ "Adverse Events 1:", " Total: 14/69 (20.29%)", " Febrile neutropenia 0/69 (0.00%)", " Anaemia 0/69 (0.00%)", " Atrial fibrillation 1/69 (1.45%)", " Cardiopulmonary failure 0/69 (0.00%)", " Supraventricular extrasystoles 1/69 (1.45%)", " Abdominal pain 1/69 (1.45%)", " Intestinal obstruction 0/69 (0.00%)", " Vomiting 1/69 (1.45%)", " Chills 1/69 (1.45%)", " Oedema peripheral 0/69 (0.00%)", " Pyrexia 1/69 (1.45%)", "Adverse Events 2:", " Total: 17/66 (25.76%)", " Febrile neutropenia 6/66 (9.09%)", " Anaemia 1/66 (1.52%)", " Atrial fibrillation 1/66 (1.52%)", " Cardiopulmonary failure 1/66 (1.52%)", " Supraventricular extrasystoles 0/66 (0.00%)", " Abdominal pain 0/66 (0.00%)", " Intestinal obstruction 1/66 (1.52%)", " Vomiting 0/66 (0.00%)", " Chills 0/66 (0.00%)", " Oedema peripheral 1/66 (1.52%)", " Pyrexia 0/66 (0.00%)" ]

[ "Adverse Events 1:", " Total: 0/244 (0.00%)", " Pregnancy *0/244 (0.00%)", " Endocervical cancer *0/244 (0.00%)", " Nosocomial pneumonia *0/244 (0.00%)", " Venous thrombosis *0/244 (0.00%)", "Adverse Events 2:", " Total: 5/255 (1.96%)", " Pregnancy *1/255 (0.39%)", " Endocervical cancer *1/255 (0.39%)", " Nosocomial pneumonia *2/255 (0.78%)", " Venous thrombosis *1/255 (0.39%)" ]

[ "Inclusion Criteria:", " Inoperable estrogen receptor positive and HER2 negative breast cancer.", " Postmenopausal status.", " Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2 - CCND1 amplification and/or loss of p16 as determined by the central laboratory.", " Acceptable bone marrow, liver and kidney function.", "Exclusion Criteria:", " Prior or concomitant treatment for advanced breast cancer.", " Other major cancer in the past 3 years.", " Important cardiovascular events in the past 6 months." ]

[ "Inclusion Criteria:", " Patients with newly diagnosed stage I (T>1cm), II or III triple negative breast cancer who have not had definitive breast surgery or received systemic chemotherapy", " The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor and progesterone receptor staining present in 10% of invasive cancer cells by Immunohistochemistry.", " HER- 2 negativity will be based on the current ASCO-CAP guidelines for HER testing", " No prior chemotherapy, endocrine therapy or radiation therapy with therapeutic intent for this cancer", " Female subjects age 18 - 70 years", " ECOG Performance Status of 0-1", " Adequate organ and marrow function as defined below:", " Leukocytes 3,000/uL", " Absolute neutrophil count 1500/uL", " Platelets 100,000/uL", " Total bilirubin 1.5mg/dL", " AST(SGOT)/ALT(SPGT) 2 x institutional upper limit of normal", " Creatinine 1.5mg/dl and/or Creatinine Clearance 60mL/min", " Serum albumin 3.0 g/dL", " Women of child-bearing potential must agree to use adequate contraception", " Pretreatment lab values must be performed within 14 days of treatment initiation, and other baseline studies performed within 30 days prior to registration", " Subjects should have LVEF 50% by echocardiogram or MUGA scan performed within 4 weeks prior to treatment initiation", " Subjects should have breast and axillary imaging with breast MRI or breast and axillary ultrasound within 4 weeks prior to treatment initiation", " Subjects with clinically/radiologically abnormal axillary lymph nodes should have pathological confirmation of disease with image guided biopsy/fine needle aspiration.", " Subjects must be already enrolled in P.R.O.G.E.C.T observational registry", " Staging to rule out metastatic disease is recommended for subjects with clinical stage III disease", " Subjects with bilateral disease are eligible if they meet other eligibility criteria.", " Neuropathy: No baseline neuropathy grade > 2", "Exclusion Criteria:", " Current or anticipated use of other investigational agents", " Subject has received chemotherapy, radiotherapy or surgery for the treatment of breast cancer", " Subject with metastatic disease", " History of allergic reactions to compounds of similar chemical or biologic composition to carboplatin, docetaxel, doxorubicin, cyclophosphamide, paclitaxel, or other agents used in the study", " Subjects with inflammatory breast cancer", " Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements", " Subject is pregnant or nursing", " Subjects with concomitant or previous malignancies within the last 5 years. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).", " Ejection Fraction <50% on ECHO or MUGA", " Cardiac function: Subjects with congestive heart failure, myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia attack within the past 12 months, uncontrolled hypertension (Systolic BP>160 or Diastolic BP>90), uncontrolled or symptomatic arrhythmia, or grade 2 peripheral vascular disease" ]

[ "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." ]

[ "INTERVENTION 1: ", " Alpelisib + Letrozole", " Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.", "INTERVENTION 2: ", " Placebo + Letrozole", " Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily." ]

[ "INTERVENTION 1: ", " FFDM Plus DBT", " Breast Images with FFDM and DBT FFDM Plus DBT: FujiFilm Aspire Cristalle System.", " This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).", "INTERVENTION 2: ", " Full-Field Digital Mammography (FFDM)", " Breast Images with FFDM alone FFDM: FujiFilm Aspire Cristalle System.", " This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate)." ]

[ "INTERVENTION 1: ", " Active Control Group", " Health Education Active Control Group", "INTERVENTION 2: ", " My Surgical Success Treatment Group", " My Surgical Success Intervention Group" ]

[ "Inclusion Criteria:", " Females with histologic or cytologic diagnosis of advanced breast cancer. Lesions should not be amenable to surgery or radiation of curative intent.", " Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale.", " One prior chemotherapy containing anthracyclines as (neo)adjuvant or palliative 1st-line treatment.", " One prior chemotherapy containing taxanes as (neo) adjuvant or palliative 1st-line treatment.", " Prior radiation therapy is allowed to less than 25% of the bone marrow. Participants must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry. Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.", " At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Positron emission tomography [PET] scans and ultrasounds may not be used.", " Antitumoral hormonal treatment must be discontinued prior to enrollment.", " Estimated life expectancy of at least 3 months.", " Participant compliance and geographic proximity that allow adequate follow-up.", " Adequate organ function", " Female participants of childbearing potential must test negative for pregnancy within 7 days of enrollment based on a urine and/or serum pregnancy test and agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.", " Participants must sign an informed consent document.", " Female participants must be at least 18 years of age.", "Exclusion Criteria:", " Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.", " Have previously completed or withdrawn from this study or any other study investigating Pemetrexed, Gemcitabine, Carboplatin or Vinorelbine", " Have received more than one line of chemotherapy in Metastatic Breast Cancer. Participants having received more than one combination of anthracycline plus taxane.", " Are pregnant or breast-feeding.", " Have serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to complete the study.", " Have a prior malignancy other than breast cancer, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.", " Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam), unless the Creatinine Clearance is greater than or equal to 80 ml/min.", " Have central nervous system (CNS) metastases.", " Have clinically relevant (by physical exam) third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study entry.", " Are unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.", " Concurrent administration of any other antitumor therapy." ]

[ "Inclusion Criteria:", " Patients with newly diagnosed stage I (T>1cm), II or III triple negative breast cancer who have not had definitive breast surgery or received systemic chemotherapy", " The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor and progesterone receptor staining present in 10% of invasive cancer cells by Immunohistochemistry.", " HER- 2 negativity will be based on the current ASCO-CAP guidelines for HER testing", " No prior chemotherapy, endocrine therapy or radiation therapy with therapeutic intent for this cancer", " Female subjects age 18 - 70 years", " ECOG Performance Status of 0-1", " Adequate organ and marrow function as defined below:", " Leukocytes 3,000/uL", " Absolute neutrophil count 1500/uL", " Platelets 100,000/uL", " Total bilirubin 1.5mg/dL", " AST(SGOT)/ALT(SPGT) 2 x institutional upper limit of normal", " Creatinine 1.5mg/dl and/or Creatinine Clearance 60mL/min", " Serum albumin 3.0 g/dL", " Women of child-bearing potential must agree to use adequate contraception", " Pretreatment lab values must be performed within 14 days of treatment initiation, and other baseline studies performed within 30 days prior to registration", " Subjects should have LVEF 50% by echocardiogram or MUGA scan performed within 4 weeks prior to treatment initiation", " Subjects should have breast and axillary imaging with breast MRI or breast and axillary ultrasound within 4 weeks prior to treatment initiation", " Subjects with clinically/radiologically abnormal axillary lymph nodes should have pathological confirmation of disease with image guided biopsy/fine needle aspiration.", " Subjects must be already enrolled in P.R.O.G.E.C.T observational registry", " Staging to rule out metastatic disease is recommended for subjects with clinical stage III disease", " Subjects with bilateral disease are eligible if they meet other eligibility criteria.", " Neuropathy: No baseline neuropathy grade > 2", "Exclusion Criteria:", " Current or anticipated use of other investigational agents", " Subject has received chemotherapy, radiotherapy or surgery for the treatment of breast cancer", " Subject with metastatic disease", " History of allergic reactions to compounds of similar chemical or biologic composition to carboplatin, docetaxel, doxorubicin, cyclophosphamide, paclitaxel, or other agents used in the study", " Subjects with inflammatory breast cancer", " Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements", " Subject is pregnant or nursing", " Subjects with concomitant or previous malignancies within the last 5 years. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).", " Ejection Fraction <50% on ECHO or MUGA", " Cardiac function: Subjects with congestive heart failure, myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia attack within the past 12 months, uncontrolled hypertension (Systolic BP>160 or Diastolic BP>90), uncontrolled or symptomatic arrhythmia, or grade 2 peripheral vascular disease" ]

[ "INTERVENTION 1: ", " Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)", " Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.", "INTERVENTION 2: ", " AC Followed by Docetaxel + Herceptin (AC→TH)", " Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose." ]

[ "Outcome Measurement: ", " Progression-free Survival (PFS)", " PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). RECIST is a set of published rules that define when tumors in cancer patients improve (\"respond\"), stay the same (\"stabilize\") or worsen (\"progress\") during treatment.", " Only data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered.", " Progression of disease was determined if at least 1 of the following criteria applied:", " At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm", " Appearance of 1 or more new lesions", " Unequivocal progression of existing non-target lesions", " Time frame: From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months", "Results 1: ", " Arm/Group Title: Afatinib + Vinorelbine (AV)", " Arm/Group Description: Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.", " Overall Number of Participants Analyzed: 339", " Median (Inter-Quartile Range)", " Unit of Measure: Months 5.49 (3.55 to 9.07)", "Results 2: ", " Arm/Group Title: Trastuzumab + Vinorelbine (TV)", " Arm/Group Description: Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.", " Overall Number of Participants Analyzed: 169", " Median (Inter-Quartile Range)", " Unit of Measure: Months 5.55 (3.55 to 10.84)" ]

[ "- Inclusion Criteria:", " A patient will be considered for enrollment in this study if all of the following criteria are met:", " Female patients 18 years of age.", " Have either:", " locally advanced TNBC defined as invasive ductal cancer; ER- tumors with <10% of tumor nuclei immunoreactive; PR- tumors with <10% of tumor nuclei immunoreactive; T3 or T4 disease, regardless of nodal status (T2 disease is eligible if there are positive lymph nodes present by physical exam or imaging evaluation or histological evaluation, OR", " High-risk ER+ breast cancer defined as grade 3 invasive ductal or mixed ductal/lobular cancers, or grade 2 with Ki67 20%; node positive as evidenced by physical exam or imaging evaluation or histological evaluation.", " HER2- negative breast cancer. If HER2-, it is defined as follows:", " FISH-negative (FISH ratio <2.0), or", " IHC 0-1+, or", " IHC 2+ AND FISH-negative (FISH ratio<2.0)", " Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1", " Adequate hematologic function, defined by:", " Absolute neutrophil count (ANC) >1500/mm3", " Platelet count 100,000/mm3", " Hemoglobin >9 g/dL (in the absence of red blood cell transfusion)", " Adequate liver function, defined by:", " AST and ALT 2.5 x the upper limit of normal (ULN)", " Total bilirubin 1.5 x ULN", " Adequate renal function, defined by:", " a. Serum creatinine 1.5 x ULN or calculated creatinine clearance of 60 ml/min", " Patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.", " Eligible for treatment with paclitaxel, doxorubicin, cyclophosphamide and carboplatine.", " Patient must be accessible for treatment and follow-up.", " Patients must be willing to undergo research biopsies to obtain breast cancer tissue for whole exome sequencing and evaluation of tumor immune microenvironment.", " All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.", "Exclusion Criteria:", " A patient will be ineligible for inclusion in this study any of the following criteria are met:", " Evidence of metastatic disease on bone scan and CT scan of chest/abdomen (or PET CT scan). Patients with intrathoracic metastatic adenopathy are eligible.", " Active infection or unexplained fever >38.5°C during screening.", " Active infections including viral hepatitis and HIV.", " Active asthma or other condition requiring steroid therapy.", " Autoimmune disease including lupus erythematosus or rheumatoid arthritis. Topical or inhaled corticosteroids are allowed.", " Patients who are currently receiving or who have received previous systemic therapy for breast cancer (eg, chemotherapy, antibody therapy, targeted agents).The use of an LHRH agonist during chemotherapy in premenopausal women who wish to preserve ovarian function is allowed, but is not required.", " Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.", " Have a NYHA Class III or IV CHF or LVEF <55%. Patients with significant cardiac disease history within 1 year or ventricular arrhythmias requiring medication are also excluded.", " Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:", " severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air", " uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN", " liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).", " History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the patient at high risk for treatment complications.", " Any other investigational or anti-cancer treatments while participating in this study.", "Any other cancer" ]

[ "Inclusion Criteria:", " Tissue diagnosis of a breast carcinoma", " The oncologist must have prescribed doxorubicin as part of the planned chemotherapy regimen", " Have acceptable organ function within 14 days of enrollment defined as:", " liver function: total bilirubin, AST and ALT within normal institutional limits", " kidney function: estimated Creatinine Clearance > 60 ml/min calculated creatinine clearance (for females) - formula: (140 - age) x weight x .85 divided by (sCr x 72)", " At least 18 years old", " Patient must have given written informed consent indicating an understanding of the investigational nature of the study", " Agrees not to consume grapefruit juice while on the study", "Exclusion Criteria:", " Known allergy to enalapril", " Taking any known P450 cytochrome inducers or inhibitors", " Taking any herbal supplements while on the study or the week prior to receiving doxorubicin", " Taking an ace-inhibitor or angiotensin receptor blocker", " Pregnant or lactating. Enalapril is Pregnancy Categories C (first trimester) and D (second and third trimesters)" ]

[ "Inclusion Criteria:", " Age greater than or equal to 18 years", " Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ", " Patient desire to undergo breast surgery", " Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted", " The cancer enhances on breast MRI imaging.", "Exclusion Criteria:", " Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes", " Severe claustrophobia", " Contraindication to use of gadolinium-based intravenous contrast, including life-threatening allergy or compromised renal function (creatinine > 2.0)", " History of median sternotomy", " Pregnancy. Patient attestation that they are not pregnant will be acceptable as per standard policy for MRIs at DHMC." ]

[ "Outcome Measurement: ", " Clinical Benefit Rate (CR + PR + SD > 6 Months).", " To determine the clinical benefit rate (Complete Response + Partial Response + Stable Disease > 6 months) per Response Evaluation Criteria in Solid tumors (RECIST version 1.0). of MPA monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer. This will show the percent of patients who had Clinical Benefit and the Exact 95% Confidence Interval.", " Time frame: baseline through end of study, up to 3 years", "Results 1: ", " Arm/Group Title: Cohort I: MPA-Alone", " Arm/Group Description: Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.", " Overall Number of Participants Analyzed: 14", " Measure Type: Number", " Unit of Measure: Percent of Participants 7.1 (0.2 to 33.9)", "Results 2: ", " Arm/Group Title: Cohort 2: MPA+IdoCM", " Arm/Group Description: Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.", " Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week.", " Overall Number of Participants Analyzed: 16", " Measure Type: Number", " Unit of Measure: Percent of Participants 6.3 (0.2 to 30.2)" ]

[ "Outcome Measurement: ", " Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Mutant Cohort", " Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.", " Time frame: After 24 weeks of treatment", "Results 1: ", " Arm/Group Title: Alpelisib + Letrozole", " Arm/Group Description: Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.", " Overall Number of Participants Analyzed: 60", " Measure Type: Number", " Unit of Measure: Percentage of Participants 1.7 (0.2 to 6.3)", "Results 2: ", " Arm/Group Title: Placebo + Letrozole", " Arm/Group Description: Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.", " Overall Number of Participants Analyzed: 67", " Measure Type: Number", " Unit of Measure: Percentage of Participants 3.0 (0.8 to 7.7)" ]

[ "Inclusion Criteria:", " Patient had provided a signed study ICF prior to any screening procedure", " Patient was a female 18 years of age", " Patient has an ECOG performance status of 0-1", " Patient has a unilateral (multifocal or multicentric disease allowed), histologically confirmed, newly diagnosed early breast cancer >2cm by clinical examination and/or >1.5 cm confirmed by ultrasound or by MRI", " Patient has tumor tissue available for central review of ER, HER2 and PI3K status with centrally confirmed HER2-positive disease and known PI3KCA mutation status", " Patient has adequate bone marrow, renal and liver function", " Patient is able to swallow and retain oral medication", "Exclusion Criteria:", " Patient has received prior systemic treatment for currently diagnosed disease", " Patient has a known contraindications, hypersensitivity or intolerance to trastuzumab, paclitaxel or products containing cremophor", " Patient has bilateral breast cancer or metastatic disease or inflammatory breast cancer", " LVEF below 50% as determined by MUGA scan or ECHO", " Patient has active cardiac disease or a history of cardiac abnormalities as defined in the protocol", " Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120", " Patient is currently receiving warfarin or other coumarin derived anti-coagulants", " Patient is currently receiving chronic treatment with corticosteroids or another immunosuppressive agents (standard premedication for paclitaxel and local applications allowed)", " Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of CYP3A", " Patient has certain scores on an anxiety and depression mood questionnaires", " Pregnant or nursing (lactating) women or patients not willing to apply apply highly effective contraception as defined in the protocol" ]

[ "Inclusion Criteria:", " Survivors: Latina, has been diagnosed with breast cancer, speaks English or Spanish, has a Caregiver who is willing to participate.", " Caregivers: a primary caregiver for a Latina breast cancer survivor, speak English or Spanish", "Exclusion Criteria:", " Inability to understand spoken English and/or Spanish and/or", " Cognitive impairment that precludes informed consent (determined by the PIs or Co-Investigators who are mental health professionals)." ]

[ "INTERVENTION 1: ", " Usual Care", " Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.", "INTERVENTION 2: ", " BreastCARE Intervention", " Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.", " Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.", " BreastCARE : The physician will receive a physician report that contains information similar to the patient report." ]

[ "INTERVENTION 1: ", " Placebo", " Patients receive oral placebo once daily for 12 months.", "INTERVENTION 2: ", " Vitamin D", " Patients receive oral vitamin D (2000 IU) once daily for 12 months." ]

[ "Adverse Events 1:", " Total: 24/101 (23.76%)", " LYMPHADENOPATHY 0/101 (0.00%)", " FEBRILE NEUTROPENIA 20/101 (0.00%)", " ATRIAL FIBRILLATION 1/101 (0.99%)", " ARRHYTHMIA 20/101 (0.00%)", " CARDIAC FAILURE 22/101 (1.98%)", " CARDIAC FAILURE CONGESTIVE 20/101 (0.00%)", " CORONARY OSTIAL STENOSIS 20/101 (0.00%)", " LACRIMAL DISORDER 0/101 (0.00%)", " BLINDNESS 21/101 (0.99%)", " GASTRIC ULCER 1/101 (0.99%)", " NAUSEA 1/101 (0.99%)", "Adverse Events 2:", " Total: 22/103 (21.36%)", " LYMPHADENOPATHY 1/103 (0.97%)", " FEBRILE NEUTROPENIA 21/103 (0.97%)", " ATRIAL FIBRILLATION 1/103 (0.97%)", " ARRHYTHMIA 21/103 (0.97%)", " CARDIAC FAILURE 20/103 (0.00%)", " CARDIAC FAILURE CONGESTIVE 21/103 (0.97%)", " CORONARY OSTIAL STENOSIS 21/103 (0.97%)", " LACRIMAL DISORDER 1/103 (0.97%)", " BLINDNESS 20/103 (0.00%)", " GASTRIC ULCER 0/103 (0.00%)", " NAUSEA 0/103 (0.00%)" ]

[ "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%)" ]

[ "Adverse Events 1:", " Total: 18/50 (36.00%)", " Hypotension 0/50 (0.00%)", " Bradycardia 0/50 (0.00%)", " Cardiac Arrest 1/50 (2.00%)", " Diarrhea 2/50 (4.00%)", " Pain - Abdominal 1/50 (2.00%)", " Hemorrhage - GI 1/50 (2.00%)", " Vomiting 0/50 (0.00%)", " Nausea 0/50 (0.00%)", " Dehydration 0/50 (0.00%)", " Diverticular Abscess 1/50 (2.00%)", " Failure to Thrive 1/50 (2.00%)", " Fever 0/50 (0.00%)", "Adverse Events 2:", " Total: 22/52 (42.31%)", " Hypotension 1/52 (1.92%)", " Bradycardia 1/52 (1.92%)", " Cardiac Arrest 0/52 (0.00%)", " Diarrhea 0/52 (0.00%)", " Pain - Abdominal 0/52 (0.00%)", " Hemorrhage - GI 1/52 (1.92%)", " Vomiting 1/52 (1.92%)", " Nausea 1/52 (1.92%)", " Dehydration 1/52 (1.92%)", " Diverticular Abscess 0/52 (0.00%)", " Failure to Thrive 0/52 (0.00%)", " Fever 1/52 (1.92%)" ]

[ "Inclusion Criteria:", " breast cancer survivors over 20 years-old", " premenopausal at the time of diagnosis", " treated with operation and chemotherapy", " newly developed dyspareunia after cancer treatment", "Exclusion Criteria:", " recent (< 2 months) start or cessation of hormonal treatment (tamoxifen etc.)", " depression or other psychological problems", " active vaginal infection", " evidence of cancer recurrence", " previously use of lactate-containing lubricants", " other chronic diseases which severely disturb the sexual life" ]

[ "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: ", " Healthy Volunteers", " Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.", " Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:", " an IV line is placed by nurse,", " patient is placed in the 4 T MRI scanner at CMRR,", " initial scout images and manual linear shims are adjusted,", " Pre-contrast SWIFT T1 weighted images and T1 map are obtained,", " continuous SWIFT acquisition begins immediately before contrast injection,", " contrast injection,", " continuous SWIFT acquisition continues for 12 min after contrast,", " late enhancement images may also be obtained.", " 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods.", "INTERVENTION 2: ", " Breast Cancer Patients", " Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.", " Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:", " an IV line is placed by nurse,", " patient is placed in the 4 T MRI scanner at CMRR,", " initial scout images and manual linear shims are adjusted,", " Pre-contrast SWIFT T1 weighted images and T1 map are obtained,", " continuous SWIFT acquisition begins immediately before contrast injection,", " contrast injection,", " continuous SWIFT acquisition continues for 12 min after contrast,", " late enhancement images may also be obtained.", " 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar" ]

[ "Inclusion Criteria:", " Histologically-confirmed operable ER+ and/or PR+ invasive breast cancer or ductal carcinoma in situ (DCIS), who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment", " Postmenopausal status defined as cessation of menses for >1 year or FSH > 20 mIU/mL (within the past month)", " Age 21 years", " No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry", " Signed informed consent", "Exclusion Criteria:", " Treatment with other investigational drugs within 6 months of study entry", " Other serious intercurrent medical illness" ]

[ "Inclusion Criteria:", " Patients must have histologically confirmed adenocarcinoma with HER2/neu immunohistochemistry 3+ or FISH-amplified breast cancer with a ratio of 2.0", " Tumor size of 3 cm and node-negative disease. Nodes with single cells or tumor clusters < 0.2 mm by H&E or IHC are considered node-negative. Patients with micrometastasis (nodes with tumor clusters between 0.02 and 0.2 cm) are allowed. Further axillary dissection will be determined by the patient's surgeon as per standard of care.", " Patients must be 18 years of age.", " Patients must have an ECOG performance status of 0 or 1.", " Treatment should be started within 90 days of the final surgical procedure for breast cancer.", " Patients may have bilateral synchronous breast tumors. Patients may have received hormonal therapy for the purpose of chemoprevention but must be willing to discontinue prior to enrollment and while participating in this trial.", " If patients have peripheral neuropathy, it must be grade 1.", " Patients must be willing to discontinue sex hormonal therapy e.g., birth control pills, ovarian hormonal replacement therapy, etc., prior to enrollment. Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.", " Hematologic parameters: absolute neutrophil count (ANC) 1500/μL and platelet count 100,000/μL.", " Non-hematologic parameters: total bilirubin must be 1.5 X institutional upper limit of normal (ULN), transaminases (SGOT or SGPT) 3.0 x ULN.", " Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause. LVEF by ECHO (with strain if possible) with LVEF of 50%. If an ECHO cannot be done, a MUGA may be performed.", " Patients must give written, informed consent indicating their understanding of and willingness to participate in the study.", "Exclusion Criteria:", " Patients with stage IV breast cancer or undergoing chemotherapy, radiation therapy, immunotherapy, or biotherapy for current breast cancer.", " Pregnant or breastfeeding patients.", " Patients with a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer.", " Patients with unstable angina, congestive heart failure, or with a history of a myocardial infarction within 12 months. Patients with high-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV block, supraventricular arrhythmias which are not adequately rate-controlled). Patients are excluded if they have grade 3 QT prolongation (Appendix F) (>500 ms) or require drugs that may prolong the QT.", " Subjects who have current active hepatic (including hepatitis B or C) or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones).", " Patients with active, unresolved infections.", " Patients with a sensitivity to E. coli derived proteins." ]

[ "INTERVENTION 1: ", " All Study Participants, PA Compression Image Sets", " All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.", "INTERVENTION 2: ", " All Study Participants, TC Compression Image Sets", " All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers." ]

[ "INTERVENTION 1: ", " Overall Population", " Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population." ]

[ "INTERVENTION 1: ", " Lapatinib Plus Capecitabine", " Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.", "INTERVENTION 2: ", " Trastuzumab Plus Capecitabine", " Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal." ]

[ "INTERVENTION 1: ", " Behavioral Dietary Intervention", " Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.", " Behavioral dietary intervention: Receive caloric restricted dietary intervention", " Therapeutic conventional surgery: Undergo definitive lumpectomy", " Radiation therapy: Undergo radiation therapy", " Counseling intervention: Receive dietary counseling", " Quality-of-life assessment: Ancillary studies" ]

[ "Outcome Measurement: ", " Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period", " Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.", " Time frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)", "Results 1: ", " Arm/Group Title: Cohort A: SC Herceptin by Needle/Syringe", " Arm/Group Description: Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.", " Overall Number of Participants Analyzed: 1864", " Measure Type: Number", " Unit of Measure: percentage of participants 88.6", "Results 2: ", " Arm/Group Title: Cohort B: SC Herceptin by SID", " Arm/Group Description: Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.", " Overall Number of Participants Analyzed: 709", " Measure Type: Number", " Unit of Measure: percentage of participants 89.0" ]

[ "Adverse Events 1:", " Total: 59/199 (29.65%)", " Anaemia 7/199 (3.52%)", " Thrombocytopenia 2/199 (1.01%)", " Acute myocardial infarction 0/199 (0.00%)", " Atrial fibrillation 1/199 (0.50%)", " Cardiac arrest 1/199 (0.50%)", " Cardiac failure 1/199 (0.50%)", " Cardiopulmonary failure 1/199 (0.50%)", " Left ventricular failure 1/199 (0.50%)", " Supraventricular tachycardia 0/199 (0.00%)", " Ventricular tachycardia 1/199 (0.50%)", "Adverse Events 2:", " Total: 16/36 (44.44%)", " Anaemia 2/36 (5.56%)", " Thrombocytopenia 1/36 (2.78%)", " Acute myocardial infarction 1/36 (2.78%)", " Atrial fibrillation 0/36 (0.00%)", " Cardiac arrest 0/36 (0.00%)", " Cardiac failure 0/36 (0.00%)", " Cardiopulmonary failure 0/36 (0.00%)", " Left ventricular failure 0/36 (0.00%)", " Supraventricular tachycardia 1/36 (2.78%)", " Ventricular tachycardia 0/36 (0.00%)" ]

[ "Adverse Events 1:", " Total: 6/8 (75.00%)", " Thrombocytopenia 1/8 (12.50%)", " Hypertension 1/8 (12.50%)", " Hepatotoxicity 3/8 (37.50%)", " Pancreatectomy * 1/8 (12.50%)" ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed breast cancer", " Clinical stage I-III disease", " Measurable disease defined as 1 unidimensionally measurable lesion 20 mm by conventional techniques OR 10 mm with spiral CT scan", " HER2/neu 3+ by immunohistochemistry or positive by fluorescent in situ hybridization", " No known brain metastases", " Hormone receptor status unspecified", " PATIENT CHARACTERISTICS:", " Menopausal status not specified", " Male or female", " Life expectancy > 12 weeks", " ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%", " WBC 3,000/mm^3", " Absolute neutrophil count 1,500 mm^3", " Platelet count 100,000/mm^3", " Total bilirubin normal", " AST and ALT 2.5 times upper limit of normal", " Creatinine normal OR creatinine clearance 60 mL/min", " LVEF 50% as measured by echocardiogram or MUGA scan", " No other malignancy within the past year", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception", " Able to swallow and retain oral medication", " No history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib", " No ongoing or active infection", " No symptomatic congestive heart failure", " No unstable angina pectoris", " No cardiac arrhythmia", " No psychiatric illness or social situation that would preclude study compliance", " No other uncontrolled illness", " No gastrointestinal (GI) tract disease that would preclude ability to take oral medication", " No malabsorption syndrome", " No requirement for IV alimentation", " No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)", " PRIOR CONCURRENT THERAPY:", " No prior chemotherapy, immunotherapy, radiotherapy, or hormonal therapy for breast cancer", " No prior treatment with epidermal growth factor receptor targeting therapies", " No prior surgical procedures affecting absorption", " No prior surgery for breast cancer", " At least 14 days since prior and no concurrent CYP3A4 inducers, including any of the following:", " Dexamethasone or dexamethasone equivalent dose 1.5 mg/day, including any of the following:", " Cortisone ( 50 mg/day)", " Hydrocortisone ( 40 mg/day)", " Prednisone ( 10 mg/day)", " Methylprednisolone ( 8 mg/day)", " Phenytoin", " Carbamazepine", " Phenobarbital", " Efavirenz", " Nevirapine", " Rifampin", " Rifabutin", " Rifapentine", " Hypericum perforatum (St. John's wort)", " Modafinil", " At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:", " Clarithromycin", " Erythromycin", " Troleandomycin", " Delavirdine", " Ritonavir", " Indinavir", " Saquinavir", " Nelfinavir", " Amprenavir", " Lopinavir", " Itraconazole", " Ketoconazole", " Voriconazole", " Fluconazole (doses up to 150 mg/day are permitted)", " Nefazodone", " Fluvoxamine", " Verapamil", " Diltiazem", " Cimetidine", " Aprepitant", " Grapefruit or its juice", " At least 6 months since prior and no concurrent amiodarone", " At least 2 days since prior and no concurrent gastric pH modifiers*, including any of the following:", " Cimetidine", " Ranitidine", " Nizatidine", " Famotidine", " Omeprazole", " Esomeprazole", " Rabeprazole", " Pantoprazole", " Lansoprazole", " NOTE: *Antacids are allowed within 1 hour before and after administration of study drug", " No other concurrent investigational agents", " No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or antitumor hormonal therapy", " No concurrent herbal (alternative) medicines", " No concurrent combination antiretroviral therapy for HIV-positive patients", " Concurrent bisphosphonates allowed" ]

[ "Adverse Events 1:", " Total: 39/2240 (1.74%)", " Supraven.arrhyth. Atrial fibrillation 1/2240 (0.04%)", " Cardiac ischemia/infarction 2/2240 (0.09%)", " Valvular heart disease 1/2240 (0.04%)", " Cardiac General - Other 2/2240 (0.09%)", " Endocrine - Other 1/2240 (0.04%)", " Ocular - Other 1/2240 (0.04%)", " Colitis 2/2240 (0.09%)", " Diarrhea 1/2240 (0.04%)", " Dysphagia 1/2240 (0.04%)", " Gastritis 1/2240 (0.04%)" ]

[ "Adverse Events 1:", " Total: 6", " Agranulocytosis 0/42 (0.00%)", " Anaemia 2/42 (4.76%)", " Febrile neutropenia 1/42 (2.38%)", " Leukopenia 0/42 (0.00%)", " Neutropenia 1/42 (2.38%)", " Thrombocytopenia 1/42 (2.38%)", " Cardio-respiratory arrest 0/42 (0.00%)", " Pericardial effusion 1/42 (2.38%)", " Gastric ulcer haemorrhage 0/42 (0.00%)", " Melaena 0/42 (0.00%)", " Fatigue 1/42 (2.38%)", " Multi-organ failure 0/42 (0.00%)", "Adverse Events 2:", " Total: 13", " Agranulocytosis 1/61 (1.64%)", " Anaemia 1/61 (1.64%)", " Febrile neutropenia 0/61 (0.00%)", " Leukopenia 2/61 (3.28%)", " Neutropenia 2/61 (3.28%)", " Thrombocytopenia 1/61 (1.64%)", " Cardio-respiratory arrest 1/61 (1.64%)", " Pericardial effusion 0/61 (0.00%)", " Gastric ulcer haemorrhage 1/61 (1.64%)", " Melaena 1/61 (1.64%)", " Fatigue 1/61 (1.64%)", " Multi-organ failure 1/61 (1.64%)" ]

[ "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." ]

[ "Inclusion Criteria:", " female patients, 18-70years of age;", " histologically-proven invasive breast cancer;", " no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;", " no distant disease/secondary cancer.", "Exclusion Criteria:", " pregnant or lactating women;", " pre-operative local treatment for breast cancer;", " prior or concurrent systemic antitumor therapy;", " clinically significant cardiac disease." ]

[ "Adverse Events 1:", " Total: 21/107 (19.63%)", " Febrile neutropenia * 10/107 (9.35%)", " Neutropenia * 1/107 (0.93%)", " Left ventricular dysfunction * 0/107 (0.00%)", " Angina pectoris * 0/107 (0.00%)", " Cardiac failure congestive * 0/107 (0.00%)", " Diarrhoea * 2/107 (1.87%)", " Abdominal strangulated hernia * 0/107 (0.00%)", " Duodenal ulcer haemorrhage * 0/107 (0.00%)", " Pyrexia * 1/107 (0.93%)", "Adverse Events 2:", " Total: 22/107 (20.56%)", " Febrile neutropenia * 8/107 (7.48%)", " Neutropenia * 6/107 (5.61%)", " Left ventricular dysfunction * 3/107 (2.80%)", " Angina pectoris * 1/107 (0.93%)", " Cardiac failure congestive * 0/107 (0.00%)", " Diarrhoea * 0/107 (0.00%)", " Abdominal strangulated hernia * 1/107 (0.93%)", " Duodenal ulcer haemorrhage * 0/107 (0.00%)", " Pyrexia * 1/107 (0.93%)" ]

[ "Inclusion Criteria:", " Patients must have histologically or cytologically confirmed early stage, ER-positive (Allred score 3), invasive breast cancer that is not either locally advanced by criteria other than size or inflammatory, and is not metastatic. - Patients must be candidates for surgical removal of the tumor by lumpectomy or mastectomy.", " Patients must not have bilateral tumors. Tumor must be amenable to core biopsy in midstudy.", " Patients must be >18 years of age.", " Patients must have a performance status 1 by Zubrod criteria.", " Patients must have a life expectancy of greater than three months.", " Patients must have normal organ and marrow function within 28 days of registration as defined below:", " absolute neutrophil count >1,500/μL", " platelets >100,000/μL", " total bilirubin 1.5 x the institutional upper limit of normal", " AST(SGOT)/ALT(SGPT) <2 X institutional upper limit of normal", " creatinine within normal institutional limits OR", " creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal", " Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. A negative serum pregnancy test must be obtained within 72 hours of receiving the first dose of the hormonal therapy as well as within 72 hours of the first dose of the MK-0752 GSI medication for women of child-bearing potential. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.", "Exclusion Criteria:", " Patients may not have received any prior chemotherapy or endocrine therapy (tamoxifen, raloxifene, or an aromatase inhibitor) and may not have received prior therapy with a gamma-secretase inhibitor or other investigational agents. - Patients may not have received previous radiation therapy.", " Patients may not be currently participating or have participated in a study with an investigational compound or device within 30 days.", " Patients must not have known brain or CNS disease, evidence of brain or CNS metastases, or carcinomatous meningitis.", " Patients must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.", " Patients may not have known hypersensitivity to the components of MK-0752 or it analogs.", " Patients will be excluded if there is a known history of human immunodeficiency (HIV) virus infection, or a known history of hepatitis B or C infection.", " Patients must not have a previous history of inflammatory bowel disease or uncontrolled irritable bowel syndrome.", " Patients must not have a history of greater than one basal cell carcinoma of the skin within the past five years or a history of Gorlin syndrome." ]

[ "INTERVENTION 1: ", " Urea/Lactic Acid Cream", " Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.", "INTERVENTION 2: ", " Placebo Cream", " Patients receive placebo cream applied to palms and soles twice daily." ]

[ "Inclusion Criteria:", " Age 21", " Diagnosis of breast cancer, Stage III, IV, or Stage I or II with metastasis or recurrence", " Able to perform basic ADLs", " Undergoing chemotherapy and/or hormonal therapy for breast cancer", " Able to speak and understand English", " Have access to a telephone", " Able to hear normal conversation", " Cognitively oriented to time, place, and person (determined via nurse recruiter)", "Exclusion Criteria:", " Diagnosis of major mental illness on the medical record and verified by the recruiter", " Residing in a nursing home", " Bedridden", " Currently receiving regular reflexology", " Diagnosis of symptoms of deep vein thrombosis or painful foot neuropathy, which will require medical approval" ]

[ "Adverse Events 1:", " Total: 20/52 (38.46%)", " Febrile bone marrow aplasia * 5/52 (9.62%)", " Febrile neutropenia * 6/52 (11.54%)", " Leukopenia * 6/52 (11.54%)", " Atrial tachycardia * 1/52 (1.92%)", " Vomiting * 1/52 (1.92%)", " Tooth loss * 1/52 (1.92%)", " Hyperthermia * 1/52 (1.92%)", " Malaise * 1/52 (1.92%)", " Pyrexia * 1/52 (1.92%)", " Impaired healing * 3/52 (5.77%)", " Inflammation * 1/52 (1.92%)" ]

[ "INTERVENTION 1: ", " Group I (SparkPeople Program)", " Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.", " Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.", " Behavioral Dietary Intervention: Use SparkPeople web-based program", " Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program", " Activity Monitoring Device: Wear Fitbit activity monitoring device", "INTERVENTION 2: ", " Group II (Wait List)", " Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment.", " Exercise Intervention: Use Fitbit monitor", " Activity Monitoring Device: Wear Fitbit activity monitoring device" ]

[ "INTERVENTION 1: ", " Arm 1: Yoga Intervention", " Yoga Intervention", " Yoga: Yoga sessions", "INTERVENTION 2: ", " Arm 2: Educational Wellness Group", " Educational Wellness Group", " Education: Educational Wellness Group" ]

[ "INTERVENTION 1: ", " Definity Infusion", " Infusion of Definity (Perflutren Lipid Microspheres)", " Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min" ]

[ "INTERVENTION 1: ", " Meso BioMatrix Acellular Peritoneum Matrix", " All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction." ]

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

[ "Adverse Events 1:", " Total: 16/149 (10.74%)", " Anaemia 0/149 (0.00%)", " Febrile neutropenia 7/149 (4.70%)", " Neutropenia 1/149 (0.67%)", " Pancytopenia 1/149 (0.67%)", " Atrial fibrillation 2/149 (1.34%)", " Cardiac failure congestive 0/149 (0.00%)", " Abdominal pain 0/149 (0.00%)", " Diarrhoea 2/149 (1.34%)", " Dyspepsia 0/149 (0.00%)", " Gastritis haemorrhagic 0/149 (0.00%)", " Nausea 2/149 (1.34%)", "Adverse Events 2:", " Total: 20/151 (13.25%)", " Anaemia 1/151 (0.66%)", " Febrile neutropenia 4/151 (2.65%)", " Neutropenia 2/151 (1.32%)", " Pancytopenia 0/151 (0.00%)", " Atrial fibrillation 0/151 (0.00%)", " Cardiac failure congestive 1/151 (0.66%)", " Abdominal pain 1/151 (0.66%)", " Diarrhoea 3/151 (1.99%)", " Dyspepsia 1/151 (0.66%)", " Gastritis haemorrhagic 1/151 (0.66%)", " Nausea 1/151 (0.66%)" ]

[ "Adverse Events 1:", " Total: 5/95 (5.26%)", " Febrile neutropenia 0/95 (0.00%)", " Neutropenia 0/95 (0.00%)", " Atrial fibrillation 0/95 (0.00%)", " Pleuropericarditis 0/95 (0.00%)", " Vomiting 0/95 (0.00%)", " Pryexia 0/95 (0.00%)", " Anaphylactic shock 1/95 (1.05%)", " Gastroenteritis 0/95 (0.00%)", " Fibula fracture 1/95 (1.05%)", " Tibia fracture 1/95 (1.05%)", " Intervertebral disc protrusion 0/95 (0.00%)", "Adverse Events 2:", " Total: 3/20 (15.00%)", " Febrile neutropenia 0/20 (0.00%)", " Neutropenia 0/20 (0.00%)", " Atrial fibrillation 1/20 (5.00%)", " Pleuropericarditis 1/20 (5.00%)", " Vomiting 0/20 (0.00%)", " Pryexia 0/20 (0.00%)", " Anaphylactic shock 0/20 (0.00%)", " Gastroenteritis 1/20 (5.00%)", " Fibula fracture 0/20 (0.00%)", " Tibia fracture 0/20 (0.00%)", " Intervertebral disc protrusion 1/20 (5.00%)" ]

[ "Inclusion Criteria:", " Written informed consent", " Operable breast cancer patients (T1-T3) with negative axillary lymph nodes (10 axillary nodes dissection) and high risk criteria according to St. Gallen consensus criteria.", " Histologically proven breast cancer. Interval between surgery and registration is less than 60 days.", " Definitive surgical treatment must be either mastectomy, or breast conservative surgery. Margins of resected specimen from surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ is not considered as positive margin.", " Patients without proven metastatic disease.", " Estrogen and progesterone receptors performed on the primary tumour prior to randomization.", " Age between 18 years and 70 years.", " Karnofsky performance status index > 80 %.", " Adequate hepatic, renal and heart functions.", " Adequate hematology levels.", " Negative pregnancy test", "Exclusion Criteria:", " Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).", " Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.", " Prior radiation therapy for breast cancer.", " Bilateral invasive breast cancer.", " Pregnant, or lactating patients.", " Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment .", " Any T4 or N1-3 or M1 breast cancer.", " Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI criteria.", " Other serious illness or medical condition", " Past or current history of neoplasm other than breast carcinoma.", " Ipsilateral ductal carcinoma in-situ (DCIS) of the breast.", " Lobular carcinoma in-situ (LCIS) of the breast.", " Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose", " Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry.", " Definite contraindications for the use of corticosteroids.", " Concurrent treatment with other experimental drugs.", " Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.", " Concurrent treatment with any other anti-cancer therapy.", "Male patients." ]

[ "Outcome Measurement: ", " Recurrence-free Survival", " 2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)", " Time frame: 5 years", "Results 1: ", " Arm/Group Title: Ketorolac 30 mg", " Arm/Group Description: Active drug to be compared with placebo", " Ketorolac 30 mg IV", " Overall Number of Participants Analyzed: 96", " Measure Type: Count of Participants", " Unit of Measure: Participants 80 83.3%", "Results 2: ", " Arm/Group Title: NaCl 0.9% 3mL", " Arm/Group Description: Ketorolac 30 mg IV", " Overall Number of Participants Analyzed: 107", " Measure Type: Count of Participants", " Unit of Measure: Participants 96 89.7%" ]

[ "Inclusion Criteria:", " Female or male patients >=18 years of age.", " Histologically confirmed invasive breast cancer, locally unresectable or metastatic.", " No prior chemotherapy for MBC. Patients may have received adjuvant or", " neoadjuvant chemotherapy (including taxanes and/or bevacizumab) as long as", " treated was completed >12 months prior to relapse. Prior hormonal therapy in the", " adjuvant or metastatic setting will be permitted.", " Prior hormonal therapy in the adjuvant or metastatic setting is permitted. Estrogen receptor positive patients should be considered candidates for chemotherapy.", " HER2-negative breast cancer, defined as follows:", " FISH-negative (FISH ratio <2.2), or", " IHC 0-1+, or", " IHC 2-3+ AND FISH-negative (FISH ratio <2.2).", " Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.", " Adequate hematologic function, defined by:", " · Absolute neutrophil count (ANC) >1500/mm3", " Platelet count >=100,000/mm3", " Hemoglobin >9 g/dL", " Adequate liver function, defined by:", " · AST and ALT <=2.5 x the upper limit of normal (ULN) or <=5 x ULN in", " presence of liver metastases", " Total bilirubin <=1.5 x ULN", " Adequate renal function, defined by:", " · Serum creatinine <=1.5 x ULN or calculated creatinine clearance of", " >=40 ml/min", " International normalized ratio (INR) <=1.5 or prothrombin time (PT)/partial", " thromboplastin time (PTT) within normal limits (WNL) of the institution (if patient is not on anti-coagulation therapy). Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin are eligible if the INR is stable and within the therapeutic range prior to study treatment initiation.", " Adequate lipid profile: total cholesterol <=300 mg/dL OR <=7.75 mmol/L and fasting triglyceride 2.5 x ULN. Note: In case one or both of these thresholds are exceeded,the patient can only be included after initiation of appropriate lipid lowering medication.", " Patients with proteinuria at screening as demonstrated by either:", " · Urine protein creatinine (UPC) ration >1.0 at screening", " or", " Urine dipstick for proteinuria >=2+ (patients discovered to have", " >=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour", " urine collection and must demonstrate <1 g of protein in 24 hours to be", " eligible).", " Measurable disease by RECIST criteria.", " Life expectancy >=12 weeks.", " Ability to swallow oral medications.", " Adequate cardiac function, defined by baseline left ventricular ejection fraction (LVEF) value >= normal per institutional guidelines by MUGA scan or", " echocardiogram (ECHO).", " Adequate recovery from recent surgery.", " Major surgical procedure >28 days from study entry", " Minor surgical procedure >7 days from study entry (Portacath placement", " excepted - patients can start treatment <7 days after portacath placement.)", " Patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.", " Patient must be accessible for treatment and follow-up.", " All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.", " -", "Exclusion Criteria:", " Patients with active brain metastases or meningeal metastases. Patients who have had brain metastases resected, or have received brain radiation therapy >4 weeks prior to study entry are eligible, if they meet all of the following criteria: 1) residual symptoms < grade 2, 2) no dexamethasone requirement, and 3) follow-up MRI shows regression of lesions after treatment and no new lesions appearing.", " Previous treatment with an m-TOR inhibitor (sirolimus, temsirolimus, everolimus) or anti-angiogenesis agent unless:", " in the adjuvant setting, and", " >=12 months prior to recurrence.", " Previous radiotherapy for metastatic disease completed <2 weeks prior to study treatment initiation.", " Patients who are current receiving systemic cancer therapy or have received", " previous systemic therapy within 4 weeks of the start of study drug (e.g.", " chemotherapy, antibody therapy, targeted agents).", " Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.", " Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or", " diastolic pressure >100 mmHg, despite optimal medical management.", " Concurrent use of CYP3A4 inhibitors and inducers from 72 hours prior to initiation of study treatment until the end of treatment with everolimus.", " Cardiac disease, including: congestive heart failure (CHF) > Class II per New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.", " History of stroke or transient ischemic attack within 6 months prior to first", " bevacizumab dose.", " Patients with any non-healing wound, ulcer, or long-bone fracture.", " Patients with clinical history of hemoptysis or hematemesis.", " Patients with any history of a bleeding diathesis or coagulopathy.", " Patients with a PEG or G tube cannot be enrolled into this trial.", " History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning bevacizumab.", " Patients with an impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).", " Patients who have any severe and/or uncontrolled medical conditions or other", " conditions that could affect their participation such as:", " severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air", " uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN.", " History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the subject at high risk for treatment complications.", " History of hypersensitivity to Cremophor EL (polyoxyethylated castor oil) or a drug formulated in Cremophor EL, such as paclitaxel.", " Patients may not receive any other investigational or anti-cancer treatments while participating in this study.", " Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.", " Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period.", " Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.", " Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or its excipients.", " Patients with a known HIV seropositivity.", "-" ]

[ "Inclusion Criteria:", " Female subjects participating in FMSU004A protocol with known clinical status", "Exclusion Criteria:", " Subjects with unknown clinical status not participating in FMSU004A protocol." ]

[ "Adverse Events 1:", " Total: 12/538 (2.23%)", " Hypertension 0/538 (0.00%)", " Acoustic Neuroma 1/538 (0.19%)", " Diarrhea 0/538 (0.00%)", " Colitis 1/538 (0.19%)", " Elevated ALT or AST enzyme 7/538 (1.30%)", " Diagnosis of Uterine Cancer 0/538 (0.00%)", " Motorcycle accident 0/538 (0.00%)", " Fall 0/538 (0.00%)", " Surgery 3/538 (0.56%)", "Adverse Events 2:", " Total: 8/537 (1.49%)", " Hypertension 1/537 (0.19%)", " Acoustic Neuroma 0/537 (0.00%)", " Diarrhea 1/537 (0.19%)", " Colitis 0/537 (0.00%)", " Elevated ALT or AST enzyme 0/537 (0.00%)", " Diagnosis of Uterine Cancer 2/537 (0.37%)", " Motorcycle accident 1/537 (0.19%)", " Fall 1/537 (0.19%)", " Surgery 2/537 (0.37%)" ]

[ "Adverse Events 1:", " Total: 2/15 (13.33%)", " Sinus Tachycardia * 0/15 (0.00%)", " Acute coronary syndrome * 0/15 (0.00%)", " Obstruction Gastric * 0/15 (0.00%)", " Vomiting * 0/15 (0.00%)", " Hemorrhoids * 0/15 (0.00%)", " Nausea * 0/15 (0.00%)", " Duodenal ulcer * 0/15 (0.00%)", " Hepatic pain * 0/15 (0.00%)", " Infections and infestations-other * [1]0/15 (0.00%)", " Lipase Increased * 0/15 (0.00%)", "Adverse Events 2:", " Total: 11/35 (31.43%)", " Sinus Tachycardia * 1/35 (2.86%)", " Acute coronary syndrome * 1/35 (2.86%)", " Obstruction Gastric * 1/35 (2.86%)", " Vomiting * 3/35 (8.57%)", " Hemorrhoids * 1/35 (2.86%)", " Nausea * 3/35 (8.57%)", " Duodenal ulcer * 1/35 (2.86%)", " Hepatic pain * 1/35 (2.86%)", " Infections and infestations-other * [1]1/35 (2.86%)", " Lipase Increased * 1/35 (2.86%)" ]

[ "Adverse Events 1:", " Total: 15/41 (36.59%)", " Febrile neutropenia * 0/41 (0.00%)", " Diarrhea * 1/41 (2.44%)", " Stomach pain * 1/41 (2.44%)", " Fever * 2/41 (4.88%)", " Cytokine release syndrome * 1/41 (2.44%)", " Infection * 1/41 (2.44%)", " Skin infection * 2/41 (4.88%)", " Urinary tract infection * 1/41 (2.44%)", " Coagulopathy * 0/41 (0.00%)", " INR increased * 0/41 (0.00%)", " Lipase increased * 1/41 (2.44%)", "Adverse Events 2:", " Total: 2/5 (40.00%)", " Febrile neutropenia * 1/5 (20.00%)", " Diarrhea * 0/5 (0.00%)", " Stomach pain * 0/5 (0.00%)", " Fever * 0/5 (0.00%)", " Cytokine release syndrome * 0/5 (0.00%)", " Infection * 0/5 (0.00%)", " Skin infection * 0/5 (0.00%)", " Urinary tract infection * 0/5 (0.00%)", " Coagulopathy * 1/5 (20.00%)", " INR increased * 1/5 (20.00%)", " Lipase increased * 0/5 (0.00%)" ]

[ "Outcome Measurement: ", " Clinical Benefit Response (Independent Reviewer-assessed)", " CBR is defined as the percentage of participants receiving at least one dose of study medication who achieved a best overall response classified as a complete or partial (confirmed) tumor response or stable disease for at least 6 months (24 weeks). A \"complete response\" is defined as the disappearance of all target or non-target lesions, \"partial response\" and \"disease progression\" as at least a 30% decrease and at least a 20% increase, respectively, in the sum of the longest diameter of target lesions, and \"stable disease\" as neither \"partial response\" nor \"disease progression.\"", " Time frame: Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression (up to Week 119)", "Results 1: ", " Arm/Group Title: Lapatinib 1250 mg and Capecitabine 2000 mg/m^2", " Arm/Group Description: Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.", " Overall Number of Participants Analyzed: 51", " Measure Type: Number", " Unit of Measure: percentage of participants 59" ]

[ "Adverse Events 1:", " Total: 1/6 (16.67%)", " Angina pectoris 0/6 (0.00%)", " Pericardial effusion 0/6 (0.00%)", " Diplopia 0/6 (0.00%)", " Abdominal pain 0/6 (0.00%)", " Colitis 0/6 (0.00%)", " Gastritis 0/6 (0.00%)", " Nausea 0/6 (0.00%)", " Vomiting 0/6 (0.00%)", " Fatigue 0/6 (0.00%)", " General physical health deterioration 0/6 (0.00%)", " Generalised oedema 0/6 (0.00%)", " Hepatic failure [1]0/6 (0.00%)", "Adverse Events 2:", " Total: 2/6 (33.33%)", " Angina pectoris 0/6 (0.00%)", " Pericardial effusion 0/6 (0.00%)", " Diplopia 0/6 (0.00%)", " Abdominal pain 0/6 (0.00%)", " Colitis 0/6 (0.00%)", " Gastritis 0/6 (0.00%)", " Nausea 0/6 (0.00%)", " Vomiting 0/6 (0.00%)", " Fatigue 0/6 (0.00%)", " General physical health deterioration 0/6 (0.00%)", " Generalised oedema 0/6 (0.00%)", " Hepatic failure [1]0/6 (0.00%)" ]

[ "Adverse Events 1:", " Total: 0/2 (0.00%)", " ANAEMIA 0/2 (0.00%)", " FEBRILE NEUTROPENIA 0/2 (0.00%)", " LYMPHADENOPATHY 0/2 (0.00%)", " NEUTROPENIA 0/2 (0.00%)", " PANCYTOPENIA 0/2 (0.00%)", " THROMBOCYTOPENIA 0/2 (0.00%)", " ATRIAL FIBRILLATION 0/2 (0.00%)", " CARDIAC TAMPONADE 0/2 (0.00%)", " PERICARDIAL EFFUSION 0/2 (0.00%)", " TACHYCARDIA 0/2 (0.00%)", " ABDOMINAL PAIN 0/2 (0.00%)", " ABDOMINAL PAIN UPPER 0/2 (0.00%)", "Adverse Events 2:", " Total: 0/1 (0.00%)", " ANAEMIA 0/1 (0.00%)", " FEBRILE NEUTROPENIA 0/1 (0.00%)", " LYMPHADENOPATHY 0/1 (0.00%)", " NEUTROPENIA 0/1 (0.00%)", " PANCYTOPENIA 0/1 (0.00%)", " THROMBOCYTOPENIA 0/1 (0.00%)", " ATRIAL FIBRILLATION 0/1 (0.00%)", " CARDIAC TAMPONADE 0/1 (0.00%)", " PERICARDIAL EFFUSION 0/1 (0.00%)", " TACHYCARDIA 0/1 (0.00%)", " ABDOMINAL PAIN 0/1 (0.00%)", " ABDOMINAL PAIN UPPER 0/1 (0.00%)" ]

[ "Outcome Measurement: ", " Systemic Tumor Response Rates (Complete Response+Partial Response)", " The systemic tumor response refers to the response at the time of best overall response. The response criteria are specially adapted from Response Evaluation Criteria in Solid Tumor for Immunotherapies (Wolchok, et al., 2009).", " Time frame: 9 weeks from the start of the treatment of RT", "Results 1: ", " Arm/Group Title: IMQ+RT", " Arm/Group Description: This arm has been closed as of 6/4/2014.", " Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)", " Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.", " Week 9: response assessment", " Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.", " Radiation", " Imiquimod", " Overall Number of Participants Analyzed: 12", " Measure Type: Number", " Unit of Measure: proportion of tumors .25 (.06 to .57)", "Results 2: ", " Arm/Group Title: CTX/IMQ/RT", " Arm/Group Description: Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion", " Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)", " Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.", " Week 9: response assessment", " Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.", " Radiation", " Imiquimod", " Cyclophosphamide", " Overall Number of Participants Analyzed: 12", " Measure Type: Number", " Unit of Measure: proportion of tumors .083 (.002 to .38)" ]

[ "Inclusion Criteria:", " Postmenopausal breast cancer (adenocarcinoma) estrogen (ER)and/or progesterone (PR) receptor positive that is locally advanced or locally recurrent and not able to be surgically removed OR with measurable and/or disease that is able to be assessed including isolated bone metastasis", " Female patients 18 years or older", " Documentation of ER+ and/or PR+", " No prior chemotherapy or hormone therapy for metastatic breast cancer or inoperable breast cancer that is locally recurrent or locally advanced", " Measurable or evaluable disease", " Radiation therapy to painful bone lesions or impending fractures is allowed as long as there is measurable or evaluable disease outside the radiated area.", " Must have adequate bone marrow, renal and liver function", " Patients receiving prior treatment with an anthracycline based chemotherapy must have a normal left ventricle ejection fraction", "Exclusion Criteria:", " No metastatic disease to the Central Nervous System", " No history of myocardial infarction (MI), stroke or transient ischemic attacks in the last 6 months", " No symptoms of peripheral vascular disease", " No history of abdominal fistula, gastrointestinal perforation or intrabdominal abscess in the past 6 months", " No known hypersensitivity to phosphate, trehalose or polysorbate", " No serious non-healing wound, ulcer or bone fracture", " No uncontrolled high blood pressure or history of hypertensive crisis", " No New York Hear Association class II congestive heart failure", " No extensive cancer involvement of the liver or lungs", " No history of significant psychiatric disorders", " No significant vascular disease", " There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate." ]

[ "INTERVENTION 1: ", " Lapatinib,Whole Brain Radiation,Herceptin", " Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly" ]

[ "Outcome Measurement: ", " Clinical Benefit Rate, in Centrally Confirmed Androgen Receptor (AR)+ Subjects", " To estimate the clinical benefit rate (defined as complete response, partial response, or stable disease) according to RECIST 1.1, in subjects with estrogen receptor positive/androgen receptor positive (ER+/AR+) BC who have centrally confirmed AR+ status. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Clinical Benefit Rate (CBR)= CR + PR + SD.", " Time frame: 24 weeks", "Results 1: ", " Arm/Group Title: GTx-024 9 mg", " Arm/Group Description: Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 9 mg", " GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate.", " Overall Number of Participants Analyzed: 50", " Measure Type: Number", " Unit of Measure: participants 16", "Results 2: ", " Arm/Group Title: GTx-024 18 mg", " Arm/Group Description: Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 18 mg", " GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate.", " Overall Number of Participants Analyzed: 52", " Measure Type: Number", " Unit of Measure: participants 15" ]

[ "INTERVENTION 1: ", " Mometasone", " Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.", "INTERVENTION 2: ", " Placebo", " Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A." ]

[ "INTERVENTION 1: ", " Afatinib Monotherapy", " Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.", "INTERVENTION 2: ", " Afatinib and Paclitaxel or Vinorelbine Combination Therapy", " Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy" ]

[ "Outcome Measurement: ", " Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)", " Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.", " Time frame: Baseline, 24 months", "Results 1: ", " Arm/Group Title: Letrozole", " Arm/Group Description: 2.5 mg once daily (q.d.)orally for 5 years", " Overall Number of Participants Analyzed: 63", " Median (Full Range)", " Unit of Measure: Percent Change -4.63 (-14.21 to 4.32)", "Results 2: ", " Arm/Group Title: Tam-Let", " Arm/Group Description: 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.", " Overall Number of Participants Analyzed: 68", " Median (Full Range)", " Unit of Measure: Percent Change 0.37 (-6.98 to 15.21)" ]