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[ "Outcome Measurement: ", " Overall Survival", " The main endpoint of this study is overall survival defined as the time from randomisation to the date of death or last follow-up. For patients who have not died, survival duration will be censored at the date of last contact or last follow-up or the date of last news.", " Time frame: From baseline up to 3 years 1 month", "Results 1: ", " Arm/Group Title: Vinflunine", " Arm/Group Description: Patients randomised in the test arm (arm A) received VFL at the dose of 280 mg/m on day 1 of each cycle every 3 weeks, over a 20-minute intravenous (IV) infusion. Cycles were repeated every 3 weeks.", " vinflunine: 280 mg/m2 on day 1 of each cycle every 3 weeks", " Overall Number of Participants Analyzed: 298", " Median (95% Confidence Interval)", " Unit of Measure: Months 9.1 (7.7 to 10.4)", "Results 2: ", " Arm/Group Title: Alkylating Agent", " Arm/Group Description: Patients randomised in the control arm (arm B) received an alkylating agent used as a single agent which was available in the investigational center and was approved for the treatment of cancer in the country.", " Alkylating agent of physician choice registered in cancer: cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin", " Overall Number of Participants Analyzed: 296", " Median (95% Confidence Interval)", " Unit of Measure: Months 9.3 (7.5 to 10.9)" ]

[ "INTERVENTION 1: ", " Treatment Gel + Oral Placebo", " 4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.", " oral placebo: Oral placebo taken daily for 4-10 weeks.", " afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.", "INTERVENTION 2: ", " Placebo Gel + Oral Treatment", " Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).", " tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.", " placebo gel: Placebo gel applied to breasts daily for 4-10 weeks." ]

[ "INTERVENTION 1: ", " Flaxseed", " Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.", "INTERVENTION 2: ", " Placebo", " Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily." ]

[ "Adverse Events 1:", " Total: 59/373 (15.82%)", " Neutropenia 14/373 (3.75%)", " Febrile neutropenia 10/373 (2.68%)", " Leukopenia 1/373 (0.27%)", " Anaemia 2/373 (0.54%)", " Lymphadenopathy 0/373 (0.00%)", " cardiac failure 2/373 (0.54%)", " Atrial fibrillation 1/373 (0.27%)", " Pericardial effusion 2/373 (0.54%)", " Cardiac failure congestive 1/373 (0.27%)", " Cardiomyopathy 0/373 (0.00%)", "Adverse Events 2:", " Total: 69/377 (18.30%)", " Neutropenia 17/377 (4.51%)", " Febrile neutropenia 10/377 (2.65%)", " Leukopenia 4/377 (1.06%)", " Anaemia 2/377 (0.53%)", " Lymphadenopathy 1/377 (0.27%)", " cardiac failure 1/377 (0.27%)", " Atrial fibrillation 1/377 (0.27%)", " Pericardial effusion 0/377 (0.00%)", " Cardiac failure congestive 0/377 (0.00%)", " Cardiomyopathy 1/377 (0.27%)" ]

[ "Inclusion Criteria:", " Participant is willing and able to give informed consent for participation in the study;", " Female, aged 18 years or above;", " Diagnosed with breast cancer (invasive or dcis);", " Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study;", " Undergoing mastectomy breast surgery.", "Exclusion Criteria:", " Patients with a Pacemaker or implanted device;", " Patients requiring an MRI scan prior to surgery;", " Patients with known coagulopathy or receiving anticoagulant medication including warfarin, heparin, clopidogrel or rivaroxaban;", " Patients receiving Neoadjuvant chemotherapy;", " Patients who are pregnant or lactating;", " Patients scheduled for immediate breast reconstruction;", " Patients who have received Sienna (iron oxide) injection in the previous six months;", " Patients with an existing breast haematoma close to the target lesion." ]

[ "Outcome Measurement: ", " Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 3 (V3)", " Mean total MRI FTV change from baseline to month 3 (V3): For patients with more than one measureable lesion on the MRI, the sum over all measureable lesions on the MRI was calculated at each time point. V3 was calculated by subtracting the total MRI FTV measured (i.e. the sum over all lesions present with MRI FTV measurements) at 3 months from the total MRI FTV measured at baseline. For V3 the raw change in the volume will be calculated for each patient and a mean and 95% confidence interval will be constructed using two-sided t-tests.", " Time frame: up to 3 months from start of treatment", "Results 1: ", " Arm/Group Title: Letrozole + MRI", " Arm/Group Description: Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.", " Overall Number of Participants Analyzed: 68", " Mean (95% Confidence Interval)", " Unit of Measure: cubic centimeters -1.93 (-2.87 to -0.98)" ]

[ "Inclusion Criteria:", " Histologic Documentation of invasive breast cancer by core needle or incisional biopsy. Excess baseline biopsy tumor tissue sufficient to make three 5-micron sections must be available for molecular analyses as part of this study.", " The invasive cancer must be estrogen receptor alpha (ER)-positive, with ER staining present in greater than 50% staining of invasive cancer cells by IHC.", " The invasive cancer must be human epidermal growth factor receptor 2 (HER2) negative (IHC 0-1+, or with a fluorescence in situ hybridization (FISH) ratio of <1.8 if IHC is 2+ or if IHC has not been done).", " Clinical stage I-III invasive breast cancer with the intent to treat with surgical resection of the primary tumor. Tumor must be 2cm to provide adequate tissue.", " Patients with multi-centric or bilateral disease are eligible if the target lesions meet the other eligibility criteria. Samples from all available tumors are requested for research purposes.", " Women age 18, for whom adjuvant treatment with an aromatase inhibitor would be clinically indicated. Women must be either post-menopausal, or pre-menopausal having undergone oophorectomy.", " Patients must meet the following clinical laboratory criteria:", " Absolute neutrophil count (ANC) 1000/mm3 and platelet count 75,000/mm3. Total bilirubin 1.5 X the upper limit of normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 x ULN.", " - Ability to give informed consent.", "Exclusion Criteria:", " Prior endocrine therapy for any histologically confirmed cancer is not allowed. Prior endocrine therapy that was administered 5 years ago for the prevention of breast cancer in patients with no history of breast cancer is allowed.", " Systemic drug treatment to induce ovarian suppression if woman is pre-menopausal.", " Any other neoadjuvant therapy for breast cancer (i.e., treatment with any other anti-cancer agent besides Letrozole (10-21)days before surgical resection of the primary tumor)." ]

[ "Outcome Measurement: ", " Change From Baseline in Mean Duration of the QTc Interval", " The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The corrected QT interval was calculated using Fridericia's correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QTcF intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QTcF interval was subtracted from the average QTcF intervals to create a baseline-adjusted average QTcF interval.", " Time frame: Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.", "Results 1: ", " Arm/Group Title: T-DM1", " Arm/Group Description: Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.", " Overall Number of Participants Analyzed: 51", " Mean (Standard Deviation)", " Unit of Measure: milliseconds Cycle 1, Day 1, 15 minutes post-dose [N=44]: 1.2 (8.3)", " Cycle 1, Day 1, 60 minutes post-dose [N=45]: -1.0 (6.3)", " Cycle 1, Day 8 [N=43]: -4.0 (13.4)", " Cycle 3, Day 1, 15 minutes pre-dose [N=35]: -0.1 (10.1)", " Cycle 3, Day 1, 15 minutes post-dose [N=37]: 4.7 (9.6)", " Cycle 3, Day 1, 60 minutes post-dose [N=37]: 4.7 (10.9)" ]

[ "Adverse Events 1:", " Total: 23/436 (5.28%)", " Neutropenia G 3; Leucopenia G2 1/436 (0.23%)", " Hyperbilirrubinemia [1]1/436 (0.23%)", " Supraventricular arrhythmia NOS [2]1/436 (0.23%)", " Heart failure [2]0/436 (0.00%)", " Infarction and cardiac arrest 0/436 (0.00%)", " Ischemia cardiac/Infarction [3]1/436 (0.23%)", " Coronary vasospam [3]1/436 (0.23%)", " Gastroenteritis and renal insuficience 1/436 (0.23%)", "Adverse Events 2:", " Total: 6/425 (1.41%)", " Neutropenia G 3; Leucopenia G2 0/425 (0.00%)", " Hyperbilirrubinemia [1]0/425 (0.00%)", " Supraventricular arrhythmia NOS [2]0/425 (0.00%)", " Heart failure [2]1/425 (0.24%)", " Infarction and cardiac arrest 1/425 (0.24%)", " Ischemia cardiac/Infarction [3]0/425 (0.00%)", " Coronary vasospam [3]0/425 (0.00%)", " Gastroenteritis and renal insuficience 0/425 (0.00%)" ]

[ "DISEASE CHARACTERISTICS:", " Current random fine needle breast aspiration (FNA) evidence of 1 of the following:", " Hyperplasia with atypia", " Hyperplasia without atypia but with a 10-year modified Gail risk of at least 4%", " Hyperplasia without atypia but with a BRCAPRO risk of at least 25%", " Hyperplasia without atypia but with a known mutation in BRCA1 or BRCA2", " Hyperplasia without atypia but with a history of contralateral ductal carcinoma in situ or invasive breast cancer", " FNA must have been taken during days 1-14 of the menstrual cycle for premenopausal women", " Classified as ACR class I-III on mammogram with stepwedge within past 6 months If intact uterus and/or ovaries, must have color doppler transvaginal pelvic sonogram within past 6 months showing endometrial thickening no greater than 13 mm premenopausal or no greater than 8 mm postmenopausal", " No ovarian cysts felt to be possibly or probably non-physiologic that have not resolved to gynecologist's satisfaction on repeat sonogram", " Must agree to have or have had genetic counseling and genetic testing performed for BRCA1 and BRCA2", " No active cancer (e.g., detectable disease)", " Hormone receptor status:", " Not specified", " PATIENT CHARACTERISTICS:", " Age:", " 18 and over", " Sex:", " Female", " Menopausal status:", " Any", "Performance status:", " Not specified", " Life expectancy:", " At least 12 months", " Hematopoietic:", " Hemoglobin greater than 10 g/dL", " Granulocyte count greater than 1,000/mm^3", " No deficiencies in protein C, protein S, or antithrombin III", " No activated protein C resistance", " Hepatic:", " Albumin greater than 3.0 g/dL", " Bilirubin less than 1.5 mg/dL", " AST less than 100 U/L", " Alkaline phosphatase less than 200 U/L", " Renal:", " Creatinine less than 1.5 mg/dL", " Cardiovascular:", " No history of deep venous thrombosis not related to trauma or pregnancy", " No severe coronary artery disease", " No history of prior stroke", " Other:", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception during and for 3 months after study", " No other active cancer", " No retinal vein thrombosis", " No concurrent severe poorly controlled migraine", " No factor V Leiden mutation carrier", " PRIOR CONCURRENT THERAPY:", " Biologic therapy:", " At least 12 months since prior immunotherapy", " Chemotherapy:", " At least 3 months between completion of prior KUMC phase II difluoromethylornithine (DFMO) study and baseline aspiration", " At least 12 months since prior chemotherapy", " Endocrine therapy:", " Must not have started or stopped hormone replacement therapy or oral contraceptives within 6 months of baseline aspiration", " Must continue all hormone replacement therapy and/or oral contraceptives that were being taken at time of baseline aspiration", " At least 12 months since prior tamoxifen, raloxifene, or other antihormonal therapy", " Radiotherapy:", " At least 3 months since prior radiotherapy", " Surgery:", " At least 6 months between prior oophorectomy and baseline aspiration", " Other:", " At least 2 weeks since the start of other new medication that would be ingested for 1 or more months" ]

[ "DISEASE CHARACTERISTICS:", " Confirmed diagnosis of prior operable, noninflammatory breast cancer meeting the following criteria:", " Steroid hormone receptor-positive tumors (estrogen receptor and/or progesterone receptor), determined by immunohistochemistry, after primary surgery and before commencement of prior endocrine therapy", " Prior local treatment including surgery with or without radiotherapy for primary breast cancer with no known clinical residual loco-regional disease", " Following primary surgery, eligible patients must have had evidence of lymph node involvement either in the axillary or internal mammary nodes, but not supraclavicular nodes", " Clinically disease-free", " Must have completed 4-6 years of prior adjuvant selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs), or a sequential combination of both", " When calculating 4-6 years, neoadjuvant endocrine therapy should not be included", " No evidence of recurrent disease or distant metastatic disease", " No prior bilateral breast cancer", " PATIENT CHARACTERISTICS:", " Female", " Must be postmenopausal by any of the following criteria:", " Patients of any age who have had a bilateral oophorectomy (including radiation castration AND amenorrheic for > 3 months)", " Patients 56 years old or older with any evidence of ovarian function must have biochemical evidence of definite postmenopausal status (defined as estradiol, luteinizing hormone [LH], and follicle-stimulating hormone [FSH] in the postmenopausal range)", " Patients 55 years old or younger must have biochemical evidence of definite postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal range)", " Patients who have received prior luteinizing-hormone releasing-hormone (LHRH) analogues within the last year are eligible if they have definite evidence of postmenopausal status as defined above", " Clinically adequate hepatic function", " No bone fracture due to osteoporosis at any time during the 4-6 years of prior therapy", " No prior or current malignancy except adequately treated basal cell or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, or contra- or ipsilateral in situ breast carcinoma", " No other nonmalignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up", " No psychiatric, addictive, or any other disorder that compromises compliance with protocol requirements", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " More than 12 months since prior and no other concurrent endocrine SERM/AI therapy", " Any type of prior adjuvant therapy allowed including, but not limited to, any of the following:", " Neoadjuvant chemotherapy", " Neoadjuvant endocrine therapy", " Adjuvant chemotherapy", " Trastuzumab (Herceptin®)", " Ovarian ablation", " Gonadotropin releasing hormone analogues", " Lapatinib ditosylate", " No concurrent hormone-replacement therapy, bisphosphonates (except for treatment of bone loss), or any other investigational agent" ]

[ "Inclusion Criteria:", " Female 18 + years of age", " Confirmed diagnosis of DCIS on core or excisional/incisional biopsy and scheduled for definitive surgery", " Pre or Post menopausal women reporting no use of hormone replacement therapy, tamoxifen or raloxifene within the prior 6 months to eligibility screening", " Agree to avoid cruciferous vegetable/condiment intake for 14 days", " Agree to sign an informed consent and allow use of some tissue (slides) from biopsy and definitive surgery for research purposes", "Exclusion Criteria:", " Prior cancer diagnosis other than non-melanomatous skin cancer or cervical carcinoma in-situ", " Used hormone replacement therapy, tamoxifen or raloxifene within the past 6 months prior to eligibility screening", " Used antibiotics within 10 days prior to beginning cruciferous free diet (day -14 prior to surgery)", " Smoked within the past 12 months prior to eligibility screening;", " Active infection or inflammation of the breast at time of eligibility screening", " Has baseline comprehensive metabolic panel (CMP) [Glucose, Calcium, Albumin, Serum total protein (TP), Sodium, Potassium, Carbon dioxide, Chloride, Blood urea nitrogen (BUN), Creatinine, Alkaline phosphatase (ALP), Alanine amino transferase (AST), Aspartate amino transferase (SGOT), and Bilirubin], prothrombin time (PT) and , complete blood count (CBC) values that are 1.5 times in either direction the reported normal range" ]

[ "INTERVENTION 1: ", " AeroForm Tissue Expansion", " AeroForm Tissue Expansion inflation with carbon dioxide by remote control", " AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.", "INTERVENTION 2: ", " Saline Tissue Expansion", " Saline Tissue Expansion inflated by needle injections of saline", " Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline." ]

[ "INTERVENTION 1: ", " FFDM and DBT", " FFDM exam and DBT scan on Siemens MAMMOMAT Inspiration", "INTERVENTION 2: ", " FFDM Only", "FFDM exam only" ]

[ "INTERVENTION 1: ", " ChemoRT", " Concurrent Carboplatin and Radiotherapy", " Carboplatin: IV, weekly for 6 weeks, AUC of 2.0", " 3D-RT or IMRT: From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy" ]

[ "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." ]

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

[ "Inclusion Criteria:", " 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" ]

[ "INTERVENTION 1: ", " One-port", " intervention is placement of one-port tissue expander at time of reconstruction", " Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction", "INTERVENTION 2: ", " Two-port", " intervention is placement of two-port tissue expander at time of reconstruction", " AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction" ]

[ "INTERVENTION 1: ", " IUS Alone", "IUS alone imaging", "INTERVENTION 2: ", " Imagio (IUS+OA)", "IUS+OA imaging" ]

[ "Outcome Measurement: ", " Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years", " Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.", " Time frame: Baseline (Month 0) up to 2.75 years", "Results 1: ", " Arm/Group Title: Exemestane", " Arm/Group Description: Exemestane (Aromasin ) 25 mg QD for 5 years.", " Overall Number of Participants Analyzed: 4898", " Measure Type: Number", " Unit of Measure: Events (disease relapse or death) 352", "Results 2: ", " Arm/Group Title: Tamoxifen Followed by Exemestane", " Arm/Group Description: Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.", " Overall Number of Participants Analyzed: 4868", " Measure Type: Number", " Unit of Measure: Events (disease relapse or death) 388" ]

[ "Outcome Measurement: ", " Ruxolitinib Maximum Tolerated Dose (MTD) [Phase I]", " Ruxolitinib MTD in combination with paclitaxel 80 mg/m2 intravenously (IV) weekly is determined by the number of patients who have dose limiting toxicity (DLT). See DLT primary outcome measure for definition", " If a DLT was observed in 0 of 3 patients in a cohort, then 3 patients were enrolled to the next cohort using a 5mg higher dose of ruxolitinib.", " If a DLT was observed in 1 of 3 patients in a cohort, then 3 additional patients were added, and then if no further DLTs were observed, 3 patients were enrolled to the next cohort using a 5mg higher dose of ruxolitinib.", " The MTD is identified as the level BELOW the cohort where DLT occurred in less than one third of patients within the cohort.", " If no DLT's are observed, the MTD is not reached.", " Time frame: Participants were assessed prior to each dose of paclitaxel with ruxolitinib; The observation period for MTD evaluation was the first 2 cycles of treatment. (Up to 8 weeks).", "Results 1: ", " Arm/Group Title: All Phase I Participants", " Arm/Group Description: Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib orally twice daily according to the established dose escalation schedule for 4 cycles", " 1 cycle = 21 days Participants with stable disease or better will have the opportunity to continue on single agent Ruxolitinib at the established dose until disease progression, unacceptable toxicity or patient withdrawal.", " Overall Number of Participants Analyzed: 18", " Measure Type: Number", " Unit of Measure: mg 15" ]

[ "Outcome Measurement: ", " Maximum Tolerated Dose Determined by Dose-limiting Toxicities", " 1st 3 pts will be treated on arm 2. If 0/3 DLTs observed, the dose will be escalated to arm 3. If 1/3 DLTs onserved on arm 2, 3 more pts will be treated on arm 2. If no additional DLTs are observed on arm 2, the dose will be escalated to arm 3. If at most 1/6 DLTs observed on arm 3, arm 3 will be considered the MTD. If more than 1/6 DLTs observed on arm 3, the dose will be de-escalated to arm 2. If at most 1/6 DLTs observed on arm 2, arm 2 will be considered the MTD. If more than 1/6 pts on arm 2 experience a DLT, the dose will be de-escalated to arm 1. The remaining pts will be treated on arm 1 as the MTD, unless more than 1/6 DLTs, in which case the study will stop. DLT is defined as any grade III or IV non-hematologic toxicity (incl. diarrhea w\\ adequate antidiarrheal treatment & hydration & nausea/vomiting w\\ maximal antiemetic prophylaxis, as per protocol) or grade IV hematologic toxicity. DLT will be based on the 1st course of treatment according to the revised NCI CTC v 2.0", " Time frame: 21 days", "Results 1: ", " Arm/Group Title: Arm 1", " Arm/Group Description: Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,", " Overall Number of Participants Analyzed: 0", " Measure Type: Number", " Unit of Measure: Patients experiencing DLT ", "Results 2: ", " Arm/Group Title: Arm 2", " Arm/Group Description: Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,", " Overall Number of Participants Analyzed: 3", " Measure Type: Number", " Unit of Measure: Patients experiencing DLT 0" ]

[ "Inclusion Criteria:", " Age 18 years.", " Histologically or cytologically confirmed breast cancer diagnosis", " with metastatic disease. Patients without pathologic or cytologic", " confirmation of metastatic disease should have unequivocal", " evidence of metastasis.", " 3. Measurable disease, as per RECIST criteria (Therasse et al.", " 2000). Measurable disease cannot be previously irradiated", " unless progression was documented. Measurable disease is", " defined as: at least one lesion that can be accurately measured in", " at least one dimension [longest diameter to be recorded] as", " >20 mm with conventional techniques, or as >10 mm with spiral", " computed tomography (CT) scan. Disease must be measurable,", " i.e., bone-only disease or evaluable-only disease is not eligible.", " 4. Patients with brain metastasis may participate if they:", " have undergone appropriate treatment,", " are at least 1 month post-treatment,", " have no neurologic symptoms,", " are not on steroids,", " have a follow-up magnetic resonance imaging (MRI) scan that", " demonstrates no residual active lesions, and", " have no new untreated lesions.", " 5 The following prior therapies are allowed:", " No prior chemotherapy in the metastatic setting. However,", " patients must have received prior adjuvant or neo-adjuvant", " chemotherapy.", " Prior radiation therapy in either the metastatic or early-stage", " setting, as long as <25% of the bone marrow has been", " treated. Radiation therapy must be completed at least", " 14 days prior to study registration, and all radiation-related", " toxicities must be resolved to grade 1 before the patient is", " eligible for study inclusion.", " Any number of hormonal therapies in the neo-adjuvant,", " adjuvant, or metastatic setting is allowed. Patients must", " discontinue hormonal therapy at least 1 week prior to starting", " study treatment.", "Prior bevacizumab administered >4 weeks before initiation of", " study treatment is allowed.", " 6 HER2-negative status. Documentation of HER2 results must be", " available at the time of study enrollment. HER2-negative is", " defined as:", " Immunohistochemical (IHC) 0 or IHC 1+ OR", " Fluorescence in situ hybridization (FISH) negative (defined by", " FISH ratio <2.2) OR", " Silver in-situ hybridization (SISH) negative (defined by SISH", " ratio <2.2).", " Patients with an IHC 2+ will need to be validated as HER2-negative", " by FISH.", " 7 An Eastern Cooperative Oncology Group (ECOG) performance", " status of < or = to 2.", " 8. Normal bone marrow function as defined by:", " absolute neutrophil count (ANC) >1,500/μL;", " platelets >100,000/μL;", " hemoglobin >9 g/dL.", " 9 Normal hepatic function as defined by:", " total bilirubin within normal institutional limits;", " aspartate aminotransferase (AST) and alanine", " aminotransferase (ALT) <2.5 × the institutional upper limit of", " normal (ULN) for patients without liver metastasis; <5.0 × ULN", " for patients with liver metastasis.", " 10. Normal renal function as defined by creatinine <1.5 × ULN.", " 11. Left ventricular ejection fraction (LVEF) within institutional limits of", " normal.", " 12. International normalized ratio (INR) <1.5 or a prothrombin", " time/partial thromboplastin time (PT/PTT) within normal limits.", " Patients receiving anti-coagulation treatment with an agent such", " as warfarin or heparin may be allowed to participate. The INR", " should be measured prior to initiation of sorafenib, and for", " patients on warfarin, INR should be monitored at least weekly", " following initiation of protocol treatment, until the INR is stable and", " therapeutic.", " 13. Life expectancy of >6 months.", " 14. For women of childbearing potential, negative serum pregnancy", " test within 7 days prior to starting treatment.", " 15. For women of childbearing potential and men, agreement to use a", " method of contraception that is acceptable to their physician from", " time of first signing the informed consent and for the study", " duration. Men should use adequate birth control for at least three", " months after the last administration of sorafenib. If a woman", " becomes pregnant or suspects she is pregnant while participating", " in this study, she must agree to inform her treating physician", " immediately. As applicable, patients must agree to discontinue", " breast-feeding until at least 3 weeks after their last dose of study", " drug.", " 16. Recovery to < grade 1 toxicity due to prior therapy.", " 17. Ability to understand and willingness to sign a written informed", " consent document.", " Exclusion Criteria", " More than one (>1) prior chemotherapy regimen.", " Treatment with chemotherapy, biologic agents, or targeted agents", " within the previous 4 weeks.", " Previous treatment with sorafenib or ixabepilone.", " Women who are pregnant or breastfeeding.", " Neuropathy (motor or sensory) greater than grade 1.", " Uncontrolled intercurrent illness including (but not limited to)", " ongoing or active infection >grade 2.", " Known history of human immunodeficiency virus (HIV), Hepatitis", " B, or Hepatitis C infection.", " History of other non-breast cancer malignancy treated with", " curative intent within the 5 years preceding study enrollment with", " the exception of carcinoma in situ of the cervix, non-melanoma", " skin cancer, or follicular thyroid cancer.", " Concurrent hormonal therapy, chemotherapy other than", " ixabepilone, or radiation treatments while on study as well as", " treatment with other investigational agents while on study.", " Cardiac disease:", "Congestive heart failure (CHF) greater than New York Heart Association", " (NYHA) Class II (see Appendix B).", " Unstable angina (anginal symptoms at rest) or new onset angina", " (i.e., began within the last 3 months).", " Myocardial infarction within the past 6 months.", " Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.", " Uncontrolled hypertension (systolic blood pressure >150 mmHg", " or diastolic pressure >100 mmHg despite optimal medical", " management).", " Thrombolic or embolic events such as cerebrovascular accident,", " including transient ischemic attacks, within the past 6 months.", " Pulmonary hemorrhage or bleeding event grade 2 within", " 4 weeks of the first dose of study treatment, or any other", " hemorrhage or bleeding event grade 3 within 4 weeks of the", " first dose of study treatment.", " 14. Serious non-healing wound, ulcer, or bone fracture.", " 15. Evidence or history of bleeding diathesis or coagulopathy.", " 16. Major surgery, open biopsy or significant traumatic injury within", " 4 weeks of the first dose of study drugs or anticipation of the need", " for major surgical procedure.", " 17. Chronic use of CYP3A4 inducers and use of the following strong", " CYP3A4 inhibitors: ketoconazole, itraconazole, clarithromycin,", " atazanavir, nefazodone, saquinavir, telithromycin, ritonavir,", " amprenavir, indinavir, nelfinavir, delavirdine, and voriconazole.", " Use of these agents should be discontinued at least 72 hours", " prior to initiation of study treatment.", " 18. Use of St. John's Wort or rifampin (rifampicin).", " 19. Any condition that impairs patient's ability to swallow whole pills or", " gastrointestinal (GI) tract disease that involves an inability to take", " oral medication, malabsorption syndrome, a requirement for", " intravenous (IV) alimentation, prior surgical procedures affecting", " absorption, or uncontrolled inflammatory GI disease (e.g., Crohn's", " disease or ulcerative colitis).", " 20. Psychiatric illness/social situations that would limit compliance", " with study requirements.", " 21. Known or suspected allergy to sorafenib, Cremophor EL", " (polyoxyethylated castor oil) or a drug formulated in", " Cremophor EL such as paclitaxel or any other agent given in the", " course of this trial.", "Exclusion Criteria:" ]

[ "INTERVENTION 1: ", " Collective Placebo", " Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.", "INTERVENTION 2: ", " Pilocarpine 2 Times Per Day", " Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks." ]

[ "INTERVENTION 1: ", " Itraconazole", " oral itraconazole 200mg a day until disease progression or unacceptable toxicities." ]

[ "Adverse Events 1:", " Total: 8/86 (9.30%)", " Hypersensitivity reaction to Cisplatin 1/86 (1.16%)", " Infection with normal ANC 4/86 (4.65%)", " Neutrophil Count 1/86 (1.16%)", " Hyperglycemia 1/86 (1.16%)", " Hypertension 1/86 (1.16%)" ]

[ "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%)" ]

[ "INTERVENTION 1: ", " Breast Cancer Patients", " Tomosynthesis Breast Scanning is done and breast CT Scanning is done." ]

[ "INTERVENTION 1: ", " Pralatrexate", " Study drug 190 mg/m^2 for 2 to 4 weeks." ]

[ "Inclusion Criteria:", " Histologically proven advanced solid cancer for which curative therapy is not available (Part 1 only)", " Histologically proven metastatic Her-2-negative breast cancer (Part 2 only)", " Measurable disease by RECIST 1.1 criteria (Part 2 only)", " Willing and able to consent for self to participate in study", " Progressive or recurrent disease after prior systemic chemotherapy regimen", " Age 18 years", " ECOG performance status of 0 or 1", " Resolution of all acute toxic effects of prior therapy to NCI CTCAE Grade 1 or baseline (except alopecia)", " Adequate organ function", "Exclusion Criteria:", " Prior treatment with more than one systemic chemotherapy regimen for metastatic disease.", " Prior treatment with TRC105", " History of hypersensitivity reaction to antimetabolite therapy", " Receipt of an investigational agent within 28 days of starting study treatment", " Prior surgery (including open biopsy), radiation therapy or systemic therapy within 28 days of starting study treatment", " Minor surgical procedures within 14 days prior to first dose of TRC105", " History of brain metastasis, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease", " Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, DVT, PTCA or CABG within the past 6 months", " Uncontrolled chronic hypertension defined as systolic > 140 or diastolic > 90 despite optimal therapy", " Past medical history of acquired or inherited coagulopathy including patients with known hereditary hemorrhagic telangiectasia", " Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first dose with TRC105", " Cardiac dysrhythmias of NCI CTCAE Grade 2 within the last month", " Hemorrhage within 28 days of starting study treatment", " Unhealed wounds within 28 days of starting study treatment", " History of peptic ulcer disease or gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment", " Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness", " Known active viral or nonviral hepatitis", " History of hypersensitivity reaction to human or mouse antibody products", " Lung cancer with central chest lesions", " Pregnancy or breastfeeding" ]

[ "INTERVENTION 1: ", " Prone", "Prone position", "INTERVENTION 2: ", " Supine", "Supine position" ]

[ "INTERVENTION 1: ", " Vorinostat", " Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy)." ]

[ "INTERVENTION 1: ", " Treatment (Chemotherapy With or Without Maintenance Therapy)", " SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.", " MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.", " cyclophosphamide, paclitaxel, trastuzumab: Given IV" ]

[ "Adverse Events 1:", " Total: 4/104 (3.85%)", " Neutropenia 1/104 (0.96%)", " Leukopenia 2/104 (1.92%)", " paranasal sinus reaction 1/104 (0.96%)", " cellulitis 1/104 (0.96%)", "Adverse Events 2:", " " ]

[ "Adverse Events 1:", " Total: 1/4 (25.00%)", " Vertigo 0/4 (0.00%)", " Abdominal adhesions 0/4 (0.00%)", " Abdominal distension 0/4 (0.00%)", " Abdominal pain 0/4 (0.00%)", " Diarrhoea 0/4 (0.00%)", " Nausea 0/4 (0.00%)", " Vomiting 0/4 (0.00%)", " Disease progression 0/4 (0.00%)", " Influenza 0/4 (0.00%)", " Nasopharyngitis 0/4 (0.00%)", " Lumbar vertebral fracture 0/4 (0.00%)", " Hyponatraemia 0/4 (0.00%)", " Ataxia 0/4 (0.00%)" ]

[ "Inclusion Criteria:", " Primary breast cancer without known extension beyond the breast and axillary nodes (i.e. believed to be Tumor Stage 1-3, Nodes 0-2)", " Scheduled for unilateral or bilateral mastectomy with or without implant (isolated \"lumpectomy\" will not qualify)", " Isolated \"lumpectomy\" with axillary node dissection (anticipated removal of at least five nodes)", " Written informed consent, including willingness to be randomized to morphine or regional analgesia", "Exclusion Criteria:", " Previous surgery for breast cancer (except diagnostic biopsies)", " Inflammatory breast cancer", " Age < 18 or > 85 years old", " Scheduled free flap reconstruction", " ASA Physical Status 4", " Any contraindication to epidural or paravertebral anesthesia and analgesia (including coagulopathy, abnormal anatomy)", " Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine", " Other cancer not believed by the attending surgeon to be in long-term remission", " Systemic disease believed by the attending surgeon to present 25% two-year mortality" ]

[ "Outcome Measurement: ", " Maximum Tolerated Dose Determined by Dose-limiting Toxicities", " 1st 3 pts will be treated on arm 2. If 0/3 DLTs observed, the dose will be escalated to arm 3. If 1/3 DLTs onserved on arm 2, 3 more pts will be treated on arm 2. If no additional DLTs are observed on arm 2, the dose will be escalated to arm 3. If at most 1/6 DLTs observed on arm 3, arm 3 will be considered the MTD. If more than 1/6 DLTs observed on arm 3, the dose will be de-escalated to arm 2. If at most 1/6 DLTs observed on arm 2, arm 2 will be considered the MTD. If more than 1/6 pts on arm 2 experience a DLT, the dose will be de-escalated to arm 1. The remaining pts will be treated on arm 1 as the MTD, unless more than 1/6 DLTs, in which case the study will stop. DLT is defined as any grade III or IV non-hematologic toxicity (incl. diarrhea w\\ adequate antidiarrheal treatment & hydration & nausea/vomiting w\\ maximal antiemetic prophylaxis, as per protocol) or grade IV hematologic toxicity. DLT will be based on the 1st course of treatment according to the revised NCI CTC v 2.0", " Time frame: 21 days", "Results 1: ", " Arm/Group Title: Arm 1", " Arm/Group Description: Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,", " Overall Number of Participants Analyzed: 0", " Measure Type: Number", " Unit of Measure: Patients experiencing DLT ", "Results 2: ", " Arm/Group Title: Arm 2", " Arm/Group Description: Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,", " Overall Number of Participants Analyzed: 3", " Measure Type: Number", " Unit of Measure: Patients experiencing DLT 0" ]

[ "Inclusion Criteria:", " Histologically or cytologically confirmed breast carcinoma.", " Early stage breast cancer (stage 1, 2, 3).", " No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.", " 18 years of age or older.", " Final eligibility for a clinical trial is determined by the health professionals conducting the trial.", "Exclusion Criteria:", " Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.", " Major surgery within 28 days of study entry.", " Evidence of central nervous system (CNS) metastases.", " Final eligibility for a clinical trial is determined by the health professionals conducting the trial." ]

[ "Inclusion Criteria:", " Patients with cytologically confirmed breast cancer with biopsy showing invasive or non-invasive (DCIS) at least 1.0 cm greatest diameter on imaging", " Surgical patients undergoing lumpectomy, subtotal or total mastectomy", " 18 years of age or greater", " female", " available tissue blocks from diagnostic biopsy", " negative pregnancy test, medical history of surgical sterilization, or 1 year post menopausal", " must be willing to forego surgery for minimum of 5 days", " ability and willingness to sign written consent", " if hypertensive, on stable dose of medication at least 30 days", " if diabetic, well controlled (HbA1C < 8.5 within past 60 days or documented FPG < 140 mg/dl for 3 consecutive days", " ECOG status < 2 or Karnofsky of 60% or greater", "Exclusion Criteria:", " previous or current malignancy, excluding non-melanomic skin cancer", " evidence of distant metastatic disease", " history of chemotherapy, biologic or radiotherapy with 6 months of biopsy", " usage of herbal supplements or alternative medications not approved by the FDA within 1 week of starting study drug. LEAG or related ginseng products, and combination products containing ginseng, should be discontinued within 6 weeks of starting study drug", " history of allergic reactions attributed to compounds of similar chemical or biologic composition to LEAG", " history of chronic inflammatory process, including, but not limited to, rheumatoid arthritis and lupus. This includes patients on concurrent systemic steroids or anti-inflammatory medications", " active bleeding or a pathological condition that carries a high risk of bleeding", " any swallowing dysfunction", " uncontrolled intercurrent illness", " poorly controlled diabetes (control indicated with HbA1c < 8.5 within past 60 days or documented fasting blood glucose < 140 mg/dl for three consecutive days)", " known diabetics who have experienced episodes of symptomatic hypoglycemia in the last 6 months are also considered poorly controlled and will be excluded from study participation.", " uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHG)", " pregnant or breast feeding women Women must be willing to use birth control throughout study duration.", " current investigational medications or treatment with an investigational agent within 6 weeks prior to biopsy", " current coumadin therapy or who have been treated with coumadin within the 2 weeks prior to biopsy", " current monoamine oxidase inhibitors treatment" ]

[ "Outcome Measurement: ", " Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Intracranial Response Rate (OIRR)", " OIRR is the percentage of participants with a (CR) or (PR) based on the Response Assessment in Neuro-Oncology Brain Metastasis (RANO-BM) response criteria. CR is measurable target lesions, the disappearance of all central nervous system (CNS) target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum longest duration (LD) of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Nontarget lesions requires disappearance CNS non-target lesions and no new CNS lesions. Stable disease (SD) is less than (<)30% decrease relative to baseline but <20% increase in sum LD relative to nadir. Progressive disease (PD) is greater than or equal to ( ) 20% increase in sum LD relative to nadir and a relative increase of 20%, 1 lesion must increase by absolute value of 5 millimeter (mm).", " Time frame: Baseline to Objective Disease Progression (Up to 36 Months)", "Results 1: ", " Arm/Group Title: Part A Abemaciclib: HR+, HER2+ Breast Cancer", " Arm/Group Description: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.", " Overall Number of Participants Analyzed: 23", " Measure Type: Number", " Unit of Measure: percentage of participants 0", "Results 2: ", " Arm/Group Title: Part B Abemaciclib: HR+, HER2- Breast Cancer", " Arm/Group Description: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET).", " Participants may continue to receive treatment until discontinuation criteria are met.", " Overall Number of Participants Analyzed: 52", " Measure Type: Number", " Unit of Measure: percentage of participants 5.8" ]

[ "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: ", " 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" ]

[ "Adverse Events 1:", " Total: 57/57 (100.00%)", " Dry eyes 13/33 (39.39%)", " Heartburn 9/33 (27.27%)", " Nausea after the CT (before day 7) 57/57 (100.00%)", " Herpetic eruption 0/33 (0.00%)", " Dry skin 15/33 (45.45%)", " Alopecia 57/57 (100.00%)", "Adverse Events 2:", " Total: 23/23 (100.00%)", " Dry eyes 2/11 (18.18%)", " Heartburn 2/11 (18.18%)", " Nausea after the CT (before day 7) 23/23 (100.00%)", " Herpetic eruption 3/11 (27.27%)", " Dry skin 9/11 (81.82%)", " Alopecia 23/23 (100.00%)" ]

[ "Adverse Events 1:", " Total: 267/744 (35.89%)", " Neutropenia *2/744 (0.27%)", " Anaemia *1/744 (0.13%)", " Leukopenia *1/744 (0.13%)", " Thrombocytopenia *1/744 (0.13%)", " Thrombotic thrombocytopenic purpura *1/744 (0.13%)", " Atrial flutter *1/744 (0.13%)", " Cardiac arrest *1/744 (0.13%)", " Myocardial ischaemia *1/744 (0.13%)", " Arrhythmia *0/744 (0.00%)", " Cardiac failure congestive *0/744 (0.00%)", "Adverse Events 2:", " Total: 67/736 (9.10%)", " Neutropenia *1/736 (0.14%)", " Anaemia *0/736 (0.00%)", " Leukopenia *0/736 (0.00%)", " Thrombocytopenia *0/736 (0.00%)", " Thrombotic thrombocytopenic purpura *0/736 (0.00%)", " Atrial flutter *0/736 (0.00%)", " Cardiac arrest *0/736 (0.00%)", " Myocardial ischaemia *0/736 (0.00%)", " Arrhythmia *2/736 (0.27%)", " Cardiac failure congestive *1/736 (0.14%)" ]

[ "Adverse Events 1:", " Total: 6", " Atrial fibrillation 1/67 (1.49%)", " Ventricular fibrillation 1/67 (1.49%)", " Gastrointestinal perforation 1/67 (1.49%)", " Periproctitis 1/67 (1.49%)", " General physical health deterioration 1/67 (1.49%)", " Escherichia sepsis 1/67 (1.49%)", " Pneumonia 1/67 (1.49%)", " Tumour pain 1/67 (1.49%)", " Renal failure acute 1/67 (1.49%)", " Pleurisy 1/67 (1.49%)" ]

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

[ "Inclusion Criteria:", " Cases with Stage II-IIIA Breast Cancer that have completed adjuvant treatment with anthracyclines and/or taxanes + or -Radiation therapy within past 6 months(+/- 7 days) (subjects on concurrent endocrine therapy (TAM, Aromatase inhibitors are also eligible to participate as this is standard of care for this patient population)", " Able to understand and sign the informed consent", " Fluent in reading, comprehension and communication in the English language", " No evidence of dementia - Mini Mental State Examination (MMSE) >=23 but some evidence of cognitive impairment", " Must be aware of the nature of his current medical condition and must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts", " Eastern Cooperative Oncology Group (ECOG) performance status of 0- 2 (Karnofsky score >60%)", " Acceptable hemoglobin and hematocrit level based on complete blood count (CBC)", " Must be willing to be monitored for adequacy of nutritional intake during the intervention, as is the current standard of clinical practice", "Exclusion Criteria:", " Use of estrogens (oral, dermal or vaginal), progesterone (oral or topical), androgens, Raloxifene or Tamoxifen during the previous 3 months", " Use of over the counter steroid hormonal supplements including dehydroepiandrosterone (DHEA)", " Patients with advanced or Stage IIIIB or IV breast cancer or other cancers", " Use of n-3 fatty acids or high dose antioxidant supplements other than what is provided in the trial", " History of known allergy to components of the study supplements", " Renal or liver disease", " Concurrent participation in another chemoprevention trial", " Evidence of bleeding diathesis or coagulopathy", " Metabolic abnormalities (e.g. thyroid disorders, insulin dependent diabetes, rheumatologic disease etc.)", " Known claustrophobia, presence of pacemaker and/or ferromagnetic material in their body that would prohibit MRI imaging", " Medical history of concussions", " Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the potential participant inappropriate for entry into this study" ]

[ "Inclusion Criteria:", " Stage 1-2 invasive breast cancer diagnosis,", " DCIS", " Ability to read English", "Exclusion Criteria:", "Male" ]

[ "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: 22/96 (22.92%)", " Anemia 1/96 (1.04%)", " lymphopenia 1/96 (1.04%)", " cardiac ischemia/infarction 1/96 (1.04%)", " sinus tachycardia 2/96 (2.08%)", " Dehydration 5/96 (5.21%)", " colitis 1/96 (1.04%)", " diarrhea 5/96 (5.21%)", " ileus 1/96 (1.04%)", " nausea 2/96 (2.08%)", " vomiting 1/96 (1.04%)", " distal small bowel obstruction 1/96 (1.04%)", " edema 1/96 (1.04%)", " fatigue 2/96 (2.08%)", "Adverse Events 2:", " Total: 6/49 (12.24%)", " Anemia 0/49 (0.00%)", " lymphopenia 0/49 (0.00%)", " cardiac ischemia/infarction 0/49 (0.00%)", " sinus tachycardia 0/49 (0.00%)", " Dehydration 1/49 (2.04%)", " colitis 0/49 (0.00%)", " diarrhea 0/49 (0.00%)", " ileus 0/49 (0.00%)", " nausea 1/49 (2.04%)", " vomiting 1/49 (2.04%)", " distal small bowel obstruction 0/49 (0.00%)", " edema 0/49 (0.00%)", " fatigue 0/49 (0.00%)" ]

[ "Outcome Measurement: ", " Progression-Free Survival (PFS)", " Progression-free survival was defined as the time from randomization to first occurrence of disease progression (either radiographic or clinical), or death from any cause. PFS was determined using radiographic progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) on measurable lesions captured by computed tomography (CT) or magnetic resonance imaging (MRI). Clinical disease progression was considered only when disease progression could not be confirmed by CT or MRI, such as when the disease site is skin, bone marrow, or central nervous system.", " Time frame: Approximately 2 years", "Results 1: ", " Arm/Group Title: Exemestane", " Arm/Group Description: Participants received exemestane tablet as oral dose of 25 milligram (mg) per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).", " Overall Number of Participants Analyzed: 102", " Median (95% Confidence Interval)", " Unit of Measure: Months 3.68 (1.94 to 5.26)", "Results 2: ", " Arm/Group Title: Abiraterone Acetate + Prednisone", " Arm/Group Description: Participants received abiraterone acetate tablet at a total oral dose of 1000 milligram (mg) along with 5 mg capsule of prednisone/prednisolone per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).", " Overall Number of Participants Analyzed: 89", " Median (95% Confidence Interval)", " Unit of Measure: Months 3.65 (2.73 to 5.59)" ]

[ "Adverse Events 1:", " Total: 31/116 (26.72%)", " Neutropenia 1/116 (0.86%)", " Thrombocytopenia 1/116 (0.86%)", " Acute myocardial infarction 1/116 (0.86%)", " Myocardial infarction 0/116 (0.00%)", " Pericardial effusion 0/116 (0.00%)", " Abdominal pain 3/116 (2.59%)", " Ascites 1/116 (0.86%)", " Diarrhoea 3/116 (2.59%)", " Gingival bleeding 1/116 (0.86%)", " Intestinal haemorrhage 1/116 (0.86%)", " Nausea 2/116 (1.72%)", "Adverse Events 2:", " Total: 24/115 (20.87%)", " Neutropenia 1/115 (0.87%)", " Thrombocytopenia 0/115 (0.00%)", " Acute myocardial infarction 0/115 (0.00%)", " Myocardial infarction 1/115 (0.87%)", " Pericardial effusion 1/115 (0.87%)", " Abdominal pain 0/115 (0.00%)", " Ascites 0/115 (0.00%)", " Diarrhoea 4/115 (3.48%)", " Gingival bleeding 0/115 (0.00%)", " Intestinal haemorrhage 0/115 (0.00%)", " Nausea 3/115 (2.61%)" ]

[ "Adverse Events 1:", " Total: 8/54 (14.81%)", " Anaemia 1/54 (1.85%)", " Febrile Neutropenia 1/54 (1.85%)", " Retinopathy Hypertensive 1/54 (1.85%)", " Febrile Infection 1/54 (1.85%)", " Postoperative Wound Complication 1/54 (1.85%)", " Cardiac Imaging Procedure Abnormal 1/54 (1.85%)", " Malignant Melanoma In Situ 1/54 (1.85%)", " Suicide Attempt 1/54 (1.85%)", " Dyspnoea 1/54 (1.85%)" ]

[ "Adverse Events 1:", " Total: 1/3 (33.33%)", " FEBRILE NEUTROPENIA 0/3 (0.00%)", " LYMPH NODE PAIN 0/3 (0.00%)", " NEUTROPHIL COUNT DECREASED 0/3 (0.00%)", " THROMBOCYTOPENIA 0/3 (0.00%)", " CHEST PAIN 0/3 (0.00%)", " DEHYDRATION 0/3 (0.00%)", " PLEURAL EFFUSION 1/3 (33.33%)", " PNEUMONITIS 0/3 (0.00%)", " PULMONARY INFILTERATES 0/3 (0.00%)", " ALOPECIA 0/3 (0.00%)" ]

[ "Inclusion Criteria:", " Histologically proven advanced solid cancer for which curative therapy is not available (Part 1 only)", " Histologically proven metastatic Her-2-negative breast cancer (Part 2 only)", " Measurable disease by RECIST 1.1 criteria (Part 2 only)", " Willing and able to consent for self to participate in study", " Progressive or recurrent disease after prior systemic chemotherapy regimen", " Age 18 years", " ECOG performance status of 0 or 1", " Resolution of all acute toxic effects of prior therapy to NCI CTCAE Grade 1 or baseline (except alopecia)", " Adequate organ function", "Exclusion Criteria:", " Prior treatment with more than one systemic chemotherapy regimen for metastatic disease.", " Prior treatment with TRC105", " History of hypersensitivity reaction to antimetabolite therapy", " Receipt of an investigational agent within 28 days of starting study treatment", " Prior surgery (including open biopsy), radiation therapy or systemic therapy within 28 days of starting study treatment", " Minor surgical procedures within 14 days prior to first dose of TRC105", " History of brain metastasis, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease", " Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, DVT, PTCA or CABG within the past 6 months", " Uncontrolled chronic hypertension defined as systolic > 140 or diastolic > 90 despite optimal therapy", " Past medical history of acquired or inherited coagulopathy including patients with known hereditary hemorrhagic telangiectasia", " Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first dose with TRC105", " Cardiac dysrhythmias of NCI CTCAE Grade 2 within the last month", " Hemorrhage within 28 days of starting study treatment", " Unhealed wounds within 28 days of starting study treatment", " History of peptic ulcer disease or gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment", " Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness", " Known active viral or nonviral hepatitis", " History of hypersensitivity reaction to human or mouse antibody products", " Lung cancer with central chest lesions", " Pregnancy or breastfeeding" ]

[ "Adverse Events 1:", " Total: 82/217 (37.79%)", " Febrile neutropenia 21/217 (9.68%)", " Neutropenia 4/217 (1.84%)", " Leukopenia 0/217 (0.00%)", " Anaemia 1/217 (0.46%)", " Thrombocytopenia 0/217 (0.00%)", " Atrial fibrillation 0/217 (0.00%)", " Arrhythmia 1/217 (0.46%)", " Arteriospasm coronary 0/217 (0.00%)", " Atrioventricular block first degree 0/217 (0.00%)", " Cardiac failure 0/217 (0.00%)", "Adverse Events 2:", " Total: 106/252 (42.06%)", " Febrile neutropenia 29/252 (11.51%)", " Neutropenia 13/252 (5.16%)", " Leukopenia 3/252 (1.19%)", " Anaemia 0/252 (0.00%)", " Thrombocytopenia 1/252 (0.40%)", " Atrial fibrillation 1/252 (0.40%)", " Arrhythmia 0/252 (0.00%)", " Arteriospasm coronary 1/252 (0.40%)", " Atrioventricular block first degree 1/252 (0.40%)", " Cardiac failure 1/252 (0.40%)" ]

[ "Adverse Events 1:", " Total: 6/40 (15.00%)", " Nausea 1/40 (2.50%)", " Vomiting 1/40 (2.50%)", " Chest pain 1/40 (2.50%)", " Hypercalcemia 1/40 (2.50%)", " Thromboembolism 2/40 (5.00%)" ]

[ "Inclusion Criteria:", " HER-2 overexpressing breast cancer", " Clinical stage 2-3B", " Normal ejection fraction", "Exclusion Criteria:", " Metastatic disease", " Low ejection fraction" ]

[ "DISEASE CHARACTERISTICS:", " Previously diagnosed with primary breast cancer", " Must have received 4½ - 6 years of aromatase inhibitor therapy (e.g., letrozole, anastrozole, or exemestane), either as initial therapy or after prior tamoxifen citrate, including treatment received as part of clinical trial CAN-NCIC-MA17", " Completed aromatase inhibitor therapy 2 years ago", " No metastatic or recurrent disease, contralateral breast cancer, or ductal carcinoma in situ in either breast, as determined by the following:", " Clinical examination of the breast area, axillae, and neck within the past 60 days", " Mammogram within the past 12 months*", " Chest x-ray within the past 60 days", " Bone scan, if alkaline phosphatase > 2 times normal and/or there are symptoms of metastatic disease AND confirmatory x-ray, if bone scan results are questionable, within the past 60 days", " Abdominal ultrasound, liver scan, or CT scan of the abdomen within the past 60 days, if ALT, AST, or alkaline phosphatase > 2 times normal NOTE: *A baseline mammogram is not required for patients who have undergone bilateral complete mastectomy", " Hormone-receptor status:", " Estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) primary tumor at the time of diagnosis, defined as a tumor receptor content of > 10 fmol/mg protein or receptor positive by immunocytochemical assay (for patients not previously enrolled on clinical trial CAN-NCIC-MA17)", " ER+ and/or PR+ primary tumor OR hormone receptor status of primary tumor unknown (for patients previously enrolled on clinical trial CAN-NCIC-MA17)", " PATIENT CHARACTERISTICS:", " Menopausal status not specified", " ECOG performance status 0-2", " Life expectancy 5 years", " WBC > 3.0 x 10^9/L OR granulocyte count (polymorphs + bands) 1.5 times 10^9/L", " Platelet count > 100 x 10^9/L", " AST and/or ALT < 2 times upper limit of normal (ULN)*", " Alkaline phosphatase < 2 times ULN*", " Able (i.e. sufficiently fluent) and willing to complete quality-of-life questionnaires in either English or French (NCIC CTG participating centers)", " Inability to complete questionnaires due to illiteracy in English or French, loss of sight, or other equivalent reason allowed", " Accessible for treatment and follow-up", " No other prior or concurrent malignancy except adequately treated, superficial squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or other cancer treated > 5 years ago that is presumed cured NOTE: *Elevated levels allowed provided imaging examinations have ruled out metastatic disease", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " No concurrent selective estrogen receptor modulator (e.g., raloxifene, idoxifene)", " No other concurrent anticancer therapy" ]

[ "Outcome Measurement: ", " Progression Free Survival (PFS)", " To determine whether MM-121 + exemestane was more effective than placebo + exemestane in prolonging progression-free survival. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), \"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\". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).", " Time frame: Time from first dose to date of progression, the longest time frame of 79.1 weeks", "Results 1: ", " Arm/Group Title: MM-121 + Exemestane", " Arm/Group Description: MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day", " Overall Number of Participants Analyzed: 56", " Median (95% Confidence Interval)", " Unit of Measure: weeks 15.9 (9.3 to 30.3)", "Results 2: ", " Arm/Group Title: Placebo + Exemestane", " Arm/Group Description: Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day", " Overall Number of Participants Analyzed: 59", " Median (95% Confidence Interval)", " Unit of Measure: weeks 10.7 (8.1 to 16.1)" ]

[ "Outcome Measurement: ", " Number of Participants With Detected Lymph Nodes", " The proportion of lymph nodes detected intraoperatively by SentiMag and SiennaXP in relation the proportion of lymph nodes detected by the combination of Technetium Sulfur Colloid and Isosulfan blue dye", " Time frame: During surgical procedure <1 hour", "Results 1: ", " Arm/Group Title: SiennaXP Injection", " Arm/Group Description: Single injection of SiennaXP in addition to comparator single dose of radioisotope (Technetium Tc99m Sulfur Colloid) and single dose of isosulfan blue dye.", " Lymph node localization using the SentiMag handheld intraoperative localization system in addition to localization with standard of care handheld gamma probe.", " SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe", " Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)", "Isosulfan blue dye: Injection of a single dose of isosulfan blue dye", " Overall Number of Participants Analyzed: 146", " Measure Type: Count of Participants", " Unit of Measure: Participants 145 99.3%" ]

[ "Outcome Measurement: ", " Number of Participants With Dose Limiting Toxicity (DLT)", " For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.", " Time frame: Up to 3 weeks", "Results 1: ", " Arm/Group Title: E7389 With Weekly Trastuzumab", " Arm/Group Description: Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.", " Overall Number of Participants Analyzed: 6", " Measure Type: Number", " Unit of Measure: Participants 0", "Results 2: ", " Arm/Group Title: E7389 With Tri-weekly Trastuzumab", " Arm/Group Description: Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.", " Overall Number of Participants Analyzed: 6", " Measure Type: Number", " Unit of Measure: Participants 0" ]

[ "Outcome Measurement: ", " Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.", " Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).", " Time frame: Baseline, 12 months", "Results 1: ", " Arm/Group Title: Zoledronic Acid 4 mg Upfront", " Arm/Group Description: Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.", " Overall Number of Participants Analyzed: 423", " Mean (Standard Deviation)", " Unit of Measure: Percentage change in BMD 2.208 (3.4194)", "Results 2: ", " Arm/Group Title: Zoledronic Acid 4 mg Delayed", " Arm/Group Description: Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.", " Overall Number of Participants Analyzed: 418", " Mean (Standard Deviation)", " Unit of Measure: Percentage change in BMD -3.617 (4.2151)" ]

[ "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." ]

[ "Adverse Events 1:", " Total: 3/6 (50.00%)", " Febrile neutropenia 0/6 (0.00%)", " Leukopenia 0/6 (0.00%)", " Neutropenia 0/6 (0.00%)", " Thrombocytopenia 0/6 (0.00%)", " Cardio-respiratory arrest 0/6 (0.00%)", " Cardiopulmonary failure 0/6 (0.00%)", " Vertigo 0/6 (0.00%)", " Visual impairment 0/6 (0.00%)", " Abdominal pain 0/6 (0.00%)", " Diarrhoea 0/6 (0.00%)", " Dysphagia 0/6 (0.00%)", " Gastric ulcer 0/6 (0.00%)", "Adverse Events 2:", " Total: 6/17 (35.29%)", " Febrile neutropenia 0/17 (0.00%)", " Leukopenia 0/17 (0.00%)", " Neutropenia 0/17 (0.00%)", " Thrombocytopenia 0/17 (0.00%)", " Cardio-respiratory arrest 1/17 (5.88%)", " Cardiopulmonary failure 0/17 (0.00%)", " Vertigo 0/17 (0.00%)", " Visual impairment 0/17 (0.00%)", " Abdominal pain 0/17 (0.00%)", " Diarrhoea 1/17 (5.88%)", " Dysphagia 0/17 (0.00%)", " Gastric ulcer 1/17 (5.88%)" ]

[ "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: 30/98 (30.61%)", " Coagulopathy 1/98 (1.02%)", " Febrile neutropenia 7/98 (7.14%)", " Pancytopenia 2/98 (2.04%)", " Cardiac failure 0/98 (0.00%)", " Cardiac failure congestive 0/98 (0.00%)", " Pericardial effusion 0/98 (0.00%)", " Appendicitis perforated 1/98 (1.02%)", " Colitis 1/98 (1.02%)", " Ileus 1/98 (1.02%)", " Abdominal pain upper 1/98 (1.02%)", " Gastrointestinal haemorrhage 0/98 (0.00%)", "Adverse Events 2:", " Total: 21/99 (21.21%)", " Coagulopathy 0/99 (0.00%)", " Febrile neutropenia 5/99 (5.05%)", " Pancytopenia 0/99 (0.00%)", " Cardiac failure 1/99 (1.01%)", " Cardiac failure congestive 4/99 (4.04%)", " Pericardial effusion 1/99 (1.01%)", " Appendicitis perforated 0/99 (0.00%)", " Colitis 0/99 (0.00%)", " Ileus 0/99 (0.00%)", " Abdominal pain upper 0/99 (0.00%)", " Gastrointestinal haemorrhage 1/99 (1.01%)" ]

[ "Adverse Events 1:", " Total: 18/115 (15.65%)", " Febrile neutropenia * 7/115 (6.09%)", " Neutropenia * 1/115 (0.87%)", " Pancytopenia * 1/115 (0.87%)", " Diarrhoea * 0/115 (0.00%)", " Nausea * 0/115 (0.00%)", " Stomatitis * 0/115 (0.00%)", " Vomiting * 1/115 (0.87%)", " Asthenia * 1/115 (0.87%)", " Mucosal inflammation * 0/115 (0.00%)", " Pyrexia * 3/115 (2.61%)", " Gastrointestinal infection * 1/115 (0.87%)", "Adverse Events 2:", " Total: 8/112 (7.14%)", " Febrile neutropenia * 3/112 (2.68%)", " Neutropenia * 2/112 (1.79%)", " Pancytopenia * 0/112 (0.00%)", " Diarrhoea * 2/112 (1.79%)", " Nausea * 2/112 (1.79%)", " Stomatitis * 1/112 (0.89%)", " Vomiting * 1/112 (0.89%)", " Asthenia * 0/112 (0.00%)", " Mucosal inflammation * 1/112 (0.89%)", " Pyrexia * 0/112 (0.00%)", " Gastrointestinal infection * 0/112 (0.00%)" ]

[ "Inclusion Criteria:", " Female or male patient diagnosed with stage I-IV breast cancer", " HER2 positive breast cancer, defined by immunohistochemical staining for HER2 protein of 3+ intensity and/or amplification of the HER2 gene on fluorescence in situ hybridization (FISH) 2.0 on breast specimen or biopsy of a metastatic site", " LVEF < 50% and 40% documented in echocardiogram done within the last 30 days", " HER2 therapy naïve or currently receiving non-lapatinib HER2 targeted therapy", " Patient receiving or planning to receive trastuzumab, trastuzumab with pertuzumab or ado-trastuzumab emtansine, for at least 3 months, alone or in combination with other systemic treatment or radiation", " Age 18 years", " Patient is willing and able to comply with protocol required assessments and procedures", "Exclusion Criteria:", " Previous hospitalization due to documented heart failure in the last 12 months", " Current signs or symptoms of heart failure or ischemia", " History of arrhythmia requiring pharmacological or electrical treatment", " Concomitant use of anthracyclines or use of anthracyclines in the last 50 days", " Pregnant or lactating patients. Patients of childbearing potential must implement contraceptive measures during study treatment and for 7 months after last dose of treatment drug and must have negative urine or serum pregnancy test within 7 days prior to registration.", " History of significant neurologic or psychiatric disorders including psychotic disorders or dementia that would prohibit the understanding and giving of informed consent." ]

[ "Inclusion Criteria:", " Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.", " ECOG performance status of 0 or 1", " For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception", " For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization", "Exclusion Criteria:", " Disease-Specific Exclusions:", " HER2-positive status", " Prior chemotherapy for locally recurrent or metastatic disease", " Prior hormonal therapy < 2 weeks prior to randomization", " Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization", " Investigational therapy within 28 days of randomization", " General Medical Exclusions:", " Life expectancy of < 12 weeks", " Inadequate organ function", " Uncontrolled serious medical or psychiatric illness", " Active infection requiring intravenous (IV) antibiotics at screening", " Pregnancy or lactation", " History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death" ]

[ "Outcome Measurement: ", " Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)", " Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.", " Time frame: Baseline and Week 13", "Results 1: ", " Arm/Group Title: Bisphosphonate IV Q4W", " Arm/Group Description: Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion", " Overall Number of Participants Analyzed: 38", " Mean (Standard Deviation)", " Unit of Measure: Percent change -10.19 (208.84)", "Results 2: ", " Arm/Group Title: Denosumab 30 mg Q4W", " Arm/Group Description: Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)", " Overall Number of Participants Analyzed: 40", " Mean (Standard Deviation)", " Unit of Measure: Percent change -52.87 (95.14)" ]

[ "INTERVENTION 1: ", " Patients Undergoing Mastectomy Surgery", " Number of individuals having mastectomy surgery who were approached for participation in the trial" ]

[ "INTERVENTION 1: ", " Treatment (Tivantinib)", " Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.", " Laboratory Biomarker Analysis: Correlative studies", " Tivantinib: Given PO" ]

[ "INTERVENTION 1: ", " Accelerated Intensity Modulated Radiation Therapy (AIMRT)", " All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.", " Accelerated intensity modulated radiation therapy (AIMRT)" ]

[ "INTERVENTION 1: ", " AeroForm Tissue Expander", " AeroForm Tissue Expansion inflation with carbon dioxide by remote control", " AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander." ]

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

[ "Adverse Events 1:", " Total: 10/14 (71.43%)", " Hemoglobin 2/14 (14.29%)", " Lymphopenia 1/14 (7.14%)", " Cardiac ischemia/infarction 1/14 (7.14%)", " Hypertension 2/14 (14.29%)", " Hypotension 1/14 (7.14%)", " Constipation 1/14 (7.14%)", " Diarrhea 1/14 (7.14%)", " Heartburn/dyspepsia 1/14 (7.14%)", " Fatigue (asthenia, lethargy, malaise) 2/14 (14.29%)", " Rigors/chills 1/14 (7.14%)" ]

[ "Adverse Events 1:", " Total: 96/162 (59.26%)", " Cardiac disorders - Other, specify 2/162 (1.23%)", " Diarrhea 1/162 (0.62%)", " Mucositis oral 2/162 (1.23%)", " Nausea 1/162 (0.62%)", " Fatigue 6/162 (3.70%)", " Breast infection 2/162 (1.23%)", " Soft tissue infection 1/162 (0.62%)", " Lymphocyte count decreased 2/162 (1.23%)", " Neutrophil count decreased 78/162 (48.15%)", " Hypertension 1/162 (0.62%)" ]

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

[ "INTERVENTION 1: ", " Fulvestrant With Enzalutamide", " 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.", " Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment." ]

[ "Inclusion Criteria:", " Females with Stage II invasive breast cancer and documented axillary metastases by core biopsy, clinical examination, or fine-needle aspiration who are scheduled to undergo an ALND.", " Females > 21 years of age", "Exclusion Criteria:", " Prior ipsilateral axillary surgery", " Prior ipsilateral axillary radiation", " Prior ipsilateral breast cancer", " Prior ipsilateral breast radiation", " Allergy to isosulfan blue dye", " History of ipsilateral upper extremity lymphedema", " Prior history of surgical excision of the upper outer quadrant of the ipsilateral breast", " Prior history of neoadjuvant chemotherapy for current breast cancer", " Bulky axillary disease at presentation (N2)" ]

[ "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." ]

[ "Outcome Measurement: ", " Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters", " Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.", " Time frame: 1, 2, 4, 6, 8, 12, 24 hours postdose", "Results 1: ", " Arm/Group Title: Sunitinib in Combination With Docetaxel", " Arm/Group Description: Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.", " Overall Number of Participants Analyzed: 11", " Median (Full Range)", " Unit of Measure: hours SU011248 C1D2: 6.0 (4.0 to 24.0)", " SU011248 C2D3: 6.0 (2.0 to 8.0)", " SU012662 C1D2: 6.0 (2.0 to 24.0)", " SU012662 C2D3: 6.0 (4.0 to 24.0)", " Total drug C1D2: 6.0 (2.0 to 24.0)", " Total drug C2D3: 6.0 (2.0 to 8.0)" ]

[ "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%)" ]

[ "Adverse Events 1:", " Total: 127/368 (34.51%)", " ANAEMIA 3/368 (0.82%)", " LEUKOPENIA 0/368 (0.00%)", " NEUTROPENIA 0/368 (0.00%)", " COAGULOPATHY 3/368 (0.82%)", " LYMPHADENOPATHY 0/368 (0.00%)", " THROMBOCYTOPENIA 2/368 (0.54%)", " BONE MARROW FAILURE 0/368 (0.00%)", " FEBRILE NEUTROPENIA 4/368 (1.09%)", " DISSEMINATED INTRAVASCULAR COAGULATION 0/368 (0.00%)", " ATRIAL FLUTTER 0/368 (0.00%)", " CARDIAC ARREST 0/368 (0.00%)", "Adverse Events 2:", " Total: 151/369 (40.92%)", " ANAEMIA 11/369 (2.98%)", " LEUKOPENIA 6/369 (1.63%)", " NEUTROPENIA 18/369 (4.88%)", " COAGULOPATHY 0/369 (0.00%)", " LYMPHADENOPATHY 1/369 (0.27%)", " THROMBOCYTOPENIA 7/369 (1.90%)", " BONE MARROW FAILURE 1/369 (0.27%)", " FEBRILE NEUTROPENIA 15/369 (4.07%)", " DISSEMINATED INTRAVASCULAR COAGULATION 1/369 (0.27%)", " ATRIAL FLUTTER 1/369 (0.27%)", " CARDIAC ARREST 1/369 (0.27%)" ]

[ "INTERVENTION 1: ", " Pre-diagnosed Breast Cancer - Biopsy Confirmed", " Low-power microwave breast imaging system.", " Core needle biopsy performed 14 days before the microwave breast investigation", " Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump", "INTERVENTION 2: ", " Pre-diagnosed Breast Cyst", " Low-power microwave breast imaging system.", " No prior biopsy", " Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump" ]

[ "INTERVENTION 1: ", " Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)", " 6 mg/kg IMGN853 IV Q3W" ]

[ "Outcome Measurement: ", " Clinical Benefit Rate", " Clinical benefit = complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 6 months, assessed per Response Evaluation Criteria of Solid Tumor (RECIST).CR=disappearance of all target and non-target lesions. PR= disappearance of or at least 30% decrease in the sum of the longest diameters of target lesions, with non-progressive disease in non-target lesions. SD= sum of the longest diameters of target lesions decrease <30% or increase <20%, with non-progressive disease in non-target lesions. 141 eligible, treated patients were included.", " Time frame: assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years", "Results 1: ", " Arm/Group Title: Anastrozole and ZD1839", " Arm/Group Description: [Not Specified]", " Overall Number of Participants Analyzed: 72", " Measure Type: Number", " Unit of Measure: percentage of participants 44 (33 to 57)", "Results 2: ", " Arm/Group Title: Fulvestrant and ZD1839", " Arm/Group Description: [Not Specified]", " Overall Number of Participants Analyzed: 69", " Measure Type: Number", " Unit of Measure: percentage of participants 41 (29 to 53)" ]

[ "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%" ]

[ "Outcome Measurement: ", " Proportion of Patients With Confirmed Tumor Response", " Confirmed tumor response was defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria on 2 consecutive evaluations at least 8 weeks apart.", " Time frame: Up to 5 years", "Results 1: ", " Arm/Group Title: Treatment (Ziv-afibercept)", " Arm/Group Description: Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 21", " Measure Type: Number", " Unit of Measure: Participants Confirmed tumor partial response: 1", " No Confirmed reponse: 20" ]

[ "Outcome Measurement: ", " Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)", " Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.", " Time frame: Baseline and Week 13", "Results 1: ", " Arm/Group Title: Bisphosphonate IV Q4W", " Arm/Group Description: Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion", " Overall Number of Participants Analyzed: 38", " Mean (Standard Deviation)", " Unit of Measure: Percent change -10.19 (208.84)", "Results 2: ", " Arm/Group Title: Denosumab 30 mg Q4W", " Arm/Group Description: Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)", " Overall Number of Participants Analyzed: 40", " Mean (Standard Deviation)", " Unit of Measure: Percent change -52.87 (95.14)" ]

[ "Adverse Events 1:", " Total: 63/206 (30.58%)", " Febrile neutropenia * 14/206 (6.80%)", " Neutropenia * 9/206 (4.37%)", " Anaemia * 1/206 (0.49%)", " Leukopenia * 0/206 (0.00%)", " Thrombocytopenia * 1/206 (0.49%)", " Cardiac failure * 0/206 (0.00%)", " Cardiac failure congestive * 1/206 (0.49%)", " Cardiomyopathy * 0/206 (0.00%)", " Coronary artery occlusion * 1/206 (0.49%)", " Coronary artery thrombosis * 0/206 (0.00%)", "Adverse Events 2:", " Total: 72/215 (33.49%)", " Febrile neutropenia * 18/215 (8.37%)", " Neutropenia * 6/215 (2.79%)", " Anaemia * 1/215 (0.47%)", " Leukopenia * 1/215 (0.47%)", " Thrombocytopenia * 0/215 (0.00%)", " Cardiac failure * 1/215 (0.47%)", " Cardiac failure congestive * 0/215 (0.00%)", " Cardiomyopathy * 1/215 (0.47%)", " Coronary artery occlusion * 0/215 (0.00%)", " Coronary artery thrombosis * 1/215 (0.47%)" ]

[ "Adverse Events 1:", " Total: 1/3 (33.33%)", " Pericardial effusion [1]0/3 (0.00%)", " Abdominal muscle wall hemorrhage [2]0/3 (0.00%)", " Dehydration [3]0/3 (0.00%)", " Gastroenteritis 0/3 (0.00%)", " Dehydration 0/3 (0.00%)", " Vomiting [4]0/3 (0.00%)", " Colonic perforation [5]0/3 (0.00%)", " Abdominal pain 0/3 (0.00%)", " Chemical meningitis 0/3 (0.00%)", " Lung infection 0/3 (0.00%)", " Wound infection 0/3 (0.00%)", "Adverse Events 2:", " Total: 2/3 (66.67%)", " Pericardial effusion [1]0/3 (0.00%)", " Abdominal muscle wall hemorrhage [2]0/3 (0.00%)", " Dehydration [3]0/3 (0.00%)", " Gastroenteritis 0/3 (0.00%)", " Dehydration 0/3 (0.00%)", " Vomiting [4]0/3 (0.00%)", " Colonic perforation [5]0/3 (0.00%)", " Abdominal pain 0/3 (0.00%)", " Chemical meningitis 0/3 (0.00%)", " Lung infection 0/3 (0.00%)", " Wound infection 1/3 (33.33%)" ]

[ "Adverse Events 1:", " Total: 148/1755 (8.43%)", " Anaemia * 1/1755 (0.06%)", " Neutropenia * 0/1755 (0.00%)", " Thrombocytopenia * 0/1755 (0.00%)", " Thrombocytopenic purpura * 1/1755 (0.06%)", " Acute cardiac event * 1/1755 (0.06%)", " Aortic valve incompetence * 1/1755 (0.06%)", " Arrhythmia * 1/1755 (0.06%)", " Atrial fibrillation * 1/1755 (0.06%)", " Cardiac failure * 0/1755 (0.00%)", " Cardiac tamponade * 0/1755 (0.00%)", "Adverse Events 2:", " Total: 64/868 (7.37%)", " Anaemia * 2/868 (0.23%)", " Neutropenia * 2/868 (0.23%)", " Thrombocytopenia * 1/868 (0.12%)", " Thrombocytopenic purpura * 0/868 (0.00%)", " Acute cardiac event * 0/868 (0.00%)", " Aortic valve incompetence * 0/868 (0.00%)", " Arrhythmia * 1/868 (0.12%)", " Atrial fibrillation * 0/868 (0.00%)", " Cardiac failure * 1/868 (0.12%)", " Cardiac tamponade * 1/868 (0.12%)" ]

[ "Adverse Events 1:", " Total: 29/30 (96.67%)", " Febrile neutropenia [1]3/30 (10.00%)", " Lymphatics 1/30 (3.33%)", " Diarrhea (without colostomy) 5/30 (16.67%)", " Abdominal pain or cramping 2/30 (6.67%)", " Colitis 1/30 (3.33%)", " Dehydration 1/30 (3.33%)", " Nausea 1/30 (3.33%)", " Stomatitis/pharyngitis (oral/pharyngeal/mucositis) 1/30 (3.33%)", " Vomiting 1/30 (3.33%)", "Adverse Events 2:", " " ]

[ "Adverse Events 1:", " Total: 88/291 (30.24%)", " Anemia3/291 (1.03%)", " Febrile Neutropenia11/291 (3.78%)", " Leukopenia1/291 (0.34%)", " Neutropenia7/291 (2.41%)", " Thrombocytopenia2/291 (0.69%)", " Cardiac Arrest1/291 (0.34%)", " Pericardial Effusion1/291 (0.34%)", " Pericarditis1/291 (0.34%)", " Tachycardia2/291 (0.69%)", " Diplopia1/291 (0.34%)", " Macular Hole1/291 (0.34%)", " Abdominal Pain3/291 (1.03%)" ]

[ "Adverse Events 1:", " Total: 30/98 (30.61%)", " NEUTROPENIA 1/98 (1.02%)", " ATRIAL FIBRILLATION 1/98 (1.02%)", " CARDIAC FAILURE 1/98 (1.02%)", " TACHYCARDIA 0/98 (0.00%)", " ACUTE VESTIBULAR SYNDROME 1/98 (1.02%)", " VERTIGO 0/98 (0.00%)", " ABDOMINAL PAIN 0/98 (0.00%)", " COLITIS 0/98 (0.00%)", " DIARRHOEA 2/98 (2.04%)", " FEMORAL HERNIA 0/98 (0.00%)", " HAEMATEMESIS 0/98 (0.00%)", " ILEUS 0/98 (0.00%)", " NAUSEA 0/98 (0.00%)", "Adverse Events 2:", " Total: 46/102 (45.10%)", " NEUTROPENIA 0/102 (0.00%)", " ATRIAL FIBRILLATION 0/102 (0.00%)", " CARDIAC FAILURE 0/102 (0.00%)", " TACHYCARDIA 2/102 (1.96%)", " ACUTE VESTIBULAR SYNDROME 0/102 (0.00%)", " VERTIGO 1/102 (0.98%)", " ABDOMINAL PAIN 2/102 (1.96%)", " COLITIS 1/102 (0.98%)", " DIARRHOEA 8/102 (7.84%)", " FEMORAL HERNIA 1/102 (0.98%)", " HAEMATEMESIS 1/102 (0.98%)", " ILEUS 1/102 (0.98%)" ]

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

[ "Outcome Measurement: ", " Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes", " Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline and after 4 months of treatment; The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.", " Time frame: 4 months", "Results 1: ", " Arm/Group Title: Ultra-rapid Metabolizers", " Arm/Group Description: Those with the highest transformation of the CYP2D6 genotype to allelic activity", " Overall Number of Participants Analyzed: 5", " Mean (Standard Deviation)", " Unit of Measure: ng/mL Baseline endoxifen concentration: 5 participants", " 8.4 (4.59)", " 4-Month endoxifen concentration: 4 participants", " 15.35 (5.48)", "Results 2: ", " Arm/Group Title: Extensive Metabolizers", " Arm/Group Description: Those with the most normal transformation of the CYP2D6 genotype to allelic activity", " Overall Number of Participants Analyzed: 119", " Mean (Standard Deviation)", " Unit of Measure: ng/mL Baseline endoxifen concentration: 119 participants", " 10.00 (6.00)", " 4-Month endoxifen concentration: 106 participants", " 9.30 (5.03)" ]

[ "Inclusion Criteria:", " Participants must have histologically confirmed hormone receptor positive (HR+) HER2 negative stage II (except T2N0) or stage III invasive breast cancer. Evaluation for metastatic disease is not required in the absence of symptoms.", " Men and both pre- and postmenopausal women are eligible.", " Prior Treatment:", " Participants may have received (neo)adjuvant chemotherapy, but must be at least 30 days after last dose, with no more than grade 1 residual toxicity at time of screening.", " Participants may have received adjuvant radiotherapy, but must be at least 30 days after last dose , with no more than grade 1 residual toxicity at the time of screening.", " If most recent therapy was surgery, participants must be at least 30 days out from definitive surgery with no active wound healing complications.", " Participants must have demonstrated ability to tolerate endocrine therapy by prior successful completion of at least 1 month of tamoxifen or aromatase inhibitor (AI) therapy without significant adverse events, and in the opinion of the treating physician any ongoing toxicity does not preclude ability to continue on tamoxifen or AI for at least a projected 2 year continuous duration. Ongoing use of any endocrine therapy, including tamoxifen, letrozole, anastrozole, or exemestane, is allowed. Patients may enroll within 2 years of beginning endocrine therapy, as long as there is a plan for at least 2 more years of adjuvant endocrine therapy.", " ECOG performance status 0-1", " Age 18 years.", " Normal organ and marrow function", " Baseline QTc 480 ms", " The effects of palbociclib on the developing human fetus are unknown. Women who might become pregnant must use adequate contraception", " Ability to understand and the willingness to sign a written informed consent document", "Exclusion Criteria:", " Concurrent therapy with other investigational agents.", " Prior therapy with any CDK4/6 inhibitor.", " History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib.", " Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes are ineligible.", " Current use of drugs that are known to prolong the QT interval", " Subjects with organ allograft requiring immunosuppression.", " 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 are excluded from this study. Breastfeeding should be discontinued prior to entry onto the study.", " Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.", " No ongoing combination antiretroviral therapy" ]

[ "Inclusion Criteria:", " Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1", " Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable", " HER2-positive breast cancer", " Known hormone receptor status of the primary tumor", "Adequately excised: participants must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy", " Pathological tumor-node-metastasis staging (Union for International Cancer Control-American Joint Committee on Cancer [UICC/AJCC] 7th edition): eligible participants must have either:", " Node-positive disease (pN more than or equal to [>/=] 1), any tumor size except T0, and any hormonal receptor status; or Node-negative disease (pN0) with pathologic tumor size >2.0 centimeters by standard local assessment and negative for estrogen receptor (ER) and progesterone receptor (PR) determined by a central pathology laboratory", " Participants with synchronous bilateral invasive disease are eligible only if both lesions are HER2-positive", " No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the last surgery if additional resection required for breast cancer) and randomization", " Baseline left ventricular ejection fraction (LVEF) >/=55% measured by echocardiogram (ECHO; preferred) or multiple-gated acquisition (MUGA) scans", " Documentation on hepatitis B virus (HBV) and hepatitis C virus (HCV) serology is required", " Female participants of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception. For male participants with partners of childbearing potential, one highly effective form of contraception or two effective forms of contraception must be used. Contraception must continue for the duration of study treatment and for 6 months after the last dose of study treatment", "Exclusion Criteria:", " History of any prior (ipsilateral and/or contralateral) invasive breast carcinoma", " History of non-breast malignancies within the 5 years prior to randomization, except for carcinoma in situ (CIS) of the cervix, CIS of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin", " Any clinical T4 tumor as defined by tumor-node-metastasis classification in UICC/AJCC 7th edition, including inflammatory breast cancer", " For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (for example, neoadjuvant or adjuvant), including but not limited to, chemotherapy, anti-HER2 therapy (for example, trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR anti-cancer radiation therapy (RT) (intra-operative radiotherapy as a boost at the time of primary surgery is acceptable)", " Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any malignancy", " History of DCIS and/or lobular CIS (LCIS) that was treated with any form of systemic chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developed. Participants who had their DCIS/LCIS treated with surgery only and/or contralateral DCIS treated with radiation are allowed to enter the study", " Participants with contraindication to RT while adjuvant RT is clinically indicated", " Concurrent anti-cancer treatment in another investigational trial", " Cardiopulmonary dysfunction as defined by protocol: angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease, significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia, myocardial infarction within 12 months prior to randomization, uncontrolled hypertension, evidence of transmural infarction on electrocardiogram (ECG), requirement for oxygen therapy", " Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or known infection with HIV", " Any known active liver disease. For participants who are known carriers of HBV/HCV, active hepatitis B/C infection must be ruled out per local guidelines", " Inadequate hematologic, renal or liver function", " Pregnant or lactating women", " Hypersensitivity to any of the study medications or any of the ingredients or excipients of these medications, including hypersensitivity to benzyl alcohol", " Chronic immunosuppressive therapies, including systemic corticosteroids" ]

[ "Inclusion Criteria:", " female", " subject is 25-100 years of age", " subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy", " subject is able to provide informed consent", "Exclusion Criteria:", " subject is pregnant", " subject is actively lactating or discontinued breastfeeding less than 2 months ago", " subject has breast implants", " subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study", " subject has contraindications for core biopsy and other invasive procedures", " subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus", " subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months", " subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of PEM imaging" ]

[ "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: ", " Zoledronic Acid Upfront", " Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.", " Letrozole : Participants received 2.5 mg daily.", " Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.", "INTERVENTION 2: ", " Zoledronic Acid Delayed-start", " In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.", " Letrozole : Participants received 2.5 mg daily.", " Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months." ]

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

[ "INTERVENTION 1: ", " Bevacizumab Plus Paclitaxel", " Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks", "INTERVENTION 2: ", " Bevacizumab Plus Capecitabine", " Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks" ]

[ "Adverse Events 1:", " Total: 4/26 (15.38%)", " Disseminated intravascular coagulation 1/26 (3.85%)", " Cardiac failure congestive 1/26 (3.85%)", " Breast cellulitis 1/26 (3.85%)", " Cellulitis 1/26 (3.85%)", " Acute myeloid leukaemia 1/26 (3.85%)", " Seizure 0/26 (0.00%)", " Pulmonary embolism 1/26 (3.85%)", "Adverse Events 2:", " Total: 2/24 (8.33%)", " Disseminated intravascular coagulation 0/24 (0.00%)", " Cardiac failure congestive 0/24 (0.00%)", " Breast cellulitis 0/24 (0.00%)", " Cellulitis 1/24 (4.17%)", " Acute myeloid leukaemia 0/24 (0.00%)", " Seizure 1/24 (4.17%)", " Pulmonary embolism 0/24 (0.00%)" ]

[ "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." ]

[ "Inclusion Criteria:", " Cases with Stage II-IIIA Breast Cancer that have completed adjuvant treatment with anthracyclines and/or taxanes + or -Radiation therapy within past 6 months(+/- 7 days) (subjects on concurrent endocrine therapy (TAM, Aromatase inhibitors are also eligible to participate as this is standard of care for this patient population)", " Able to understand and sign the informed consent", " Fluent in reading, comprehension and communication in the English language", " No evidence of dementia - Mini Mental State Examination (MMSE) >=23 but some evidence of cognitive impairment", " Must be aware of the nature of his current medical condition and must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts", " Eastern Cooperative Oncology Group (ECOG) performance status of 0- 2 (Karnofsky score >60%)", " Acceptable hemoglobin and hematocrit level based on complete blood count (CBC)", " Must be willing to be monitored for adequacy of nutritional intake during the intervention, as is the current standard of clinical practice", "Exclusion Criteria:", " Use of estrogens (oral, dermal or vaginal), progesterone (oral or topical), androgens, Raloxifene or Tamoxifen during the previous 3 months", " Use of over the counter steroid hormonal supplements including dehydroepiandrosterone (DHEA)", " Patients with advanced or Stage IIIIB or IV breast cancer or other cancers", " Use of n-3 fatty acids or high dose antioxidant supplements other than what is provided in the trial", " History of known allergy to components of the study supplements", " Renal or liver disease", " Concurrent participation in another chemoprevention trial", " Evidence of bleeding diathesis or coagulopathy", " Metabolic abnormalities (e.g. thyroid disorders, insulin dependent diabetes, rheumatologic disease etc.)", " Known claustrophobia, presence of pacemaker and/or ferromagnetic material in their body that would prohibit MRI imaging", " Medical history of concussions", " Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the potential participant inappropriate for entry into this study" ]

[ "Outcome Measurement: ", " Tumor Response Rate (Complete and Partial) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)", " [Not Specified]", " Time frame: 4 weeks", "Results 1: ", " Arm/Group Title: Arm 1", " Arm/Group Description: Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.", " lapatinib ditosylate: Given orally", " tamoxifen citrate: Given orally", " Overall Number of Participants Analyzed: 17", " Measure Type: Number", " Unit of Measure: participants 1 (1 to 27)" ]

[ "Outcome Measurement: ", " Percentage of Patients With a 2 Year Disease-Free Survival (DFS) as a Measure of Efficacy", " The percentage of patients that are without evidence of disease recurrence at the 2 year timepoint, as measured from date of first protocol treatment date to first documented disease progression date or date of death from any cause, whichever comes first. 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.", " Time frame: Up to 2 years", "Results 1: ", " Arm/Group Title: Cohort A: Triple-negative Breast Cancer Patients", " Arm/Group Description: Patients with triple-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.", " Overall Number of Participants Analyzed: 53", " Measure Type: Number", " Unit of Measure: percentage of patients 56 (42 to 69)", "Results 2: ", " Arm/Group Title: Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients", " Arm/Group Description: Patients with hormone receptor positive (ER and/or PR positive), HER negative breast cancer breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.", " Overall Number of Participants Analyzed: 42", " Measure Type: Number", " Unit of Measure: percentage of patients 83 (67 to 91)" ]

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

[ "Inclusion Criteria:", " female", " subject is 25-100 years of age", " subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy", " subject is able to provide informed consent", "Exclusion Criteria:", " subject is pregnant", " subject is actively lactating or discontinued breastfeeding less than 2 months ago", " subject has breast implants", " subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study", " subject has contraindications for core biopsy and other invasive procedures", " subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus", " subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months", " subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of PEM imaging" ]

[ "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." ]

[ "Inclusion Criteria:", " Adult patients 18 years of age.", " Locally advanced, inflammatory, or early stage, unilateral, and histologically confirmed invasive breast cancer documented at a local laboratory (patients with inflammatory breast cancer must be able to have a core needle biopsy).", " Herceptin (HER)2-positive tumor, confirmed by central testing using immunohistochemistry (IHC) and in situ hybridization (ISH) methods.", " Willingness to receive anthracycline-based chemotherapy or have received doxorubicin/cyclophosphamide (AC) OR 5-fluorouracil (FU)/epirubicin/ cyclophosphamide (FEC) in a similar dose and schedule as described in the protocol as part of neoadjuvant or adjuvant treatment.", " For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients should use condoms for the duration of the study. Specific country requirements will be followed.", " Negative results of serum pregnancy test for premenopausal women of reproductive capacity and for women < 12 months after menopause.", " Patients may enroll before or after AC/FEC chemotherapy has completed.", " Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.", " Adequate hematologic, biochemistry, and cardiac assessments.", "Exclusion Criteria:", " Stage IV breast cancer or bilateral breast cancer.", " Pregnant or breastfeeding women.", " History of other malignancy within the previous 5 years, except contralateral breast cancer and ductal carcinoma in situ (DCIS)/lobular carcinoma in situ (LCIS), appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with outcome similar to those mentioned above.", " Radiation therapy, immunotherapy, or biotherapy within 5 years before study enrollment; non-cardiotoxic chemotherapy for malignancy treated > 5 years before study enrollment is allowed. Patients receiving AC/FEC in a similar fashion to the study treatment prescribed for adjuvant or neoadjuvant treatment of breast cancer will be allowed to enroll in the study after the completion of their AC/FEC. No other prior history of cardiotoxic chemotherapy is allowed.", " Active cardiac history.", " Current chronic daily treatment with oral corticosteroids or equivalent.", " Patients with severe dyspnea at rest or requiring supplementary oxygen therapy.", " Active, unresolved infections at screening.", " Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.", " Major surgery within 4 weeks before enrollment that is unrelated to the breast cancer.", " Patients for whom concomitant radiotherapy + T-DM1 may be contraindicated yet radiation therapy is planned.", " Known hypersensitivity to any of the study drugs or derivatives, including murine proteins.", " Grade 2 peripheral neuropathy at Baseline." ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed invasive mammary carcinoma", " Stage IV disease", " Basal-like disease (triple-negative, hormone-refractory, HER2-negative)", " No locally recurrent breast cancer", " No symptomatic brain metastases", " Patients with a history of brain metastases are eligible provided they are clinically stable for > 3 weeks after completion of radiotherapy and are not taking steroids or therapeutic anticonvulsants that are cytochrome P450 3A4 (CYP3A4) modifiers", " Patients with asymptomatic brain metastases are eligible provided they are not taking prophylactic anticonvulsants that are CYP3A4 modifiers", " PATIENT CHARACTERISTICS:", " Pre- or post-menopausal", " European Cooperative Oncology Group (ECOG) performance status 0-1", " Life expectancy 6 months", " Absolute neutrophil count (ANC) 1,000/mm^3", " Platelet count 100,000/mm^3", " Creatinine 1.5 times upper limit of normal (ULN)", " Total bilirubin 1.5 times ULN ( 3 times ULN in the presence of liver metastasis)", " Direct bilirubin will be measured in patients with Gilbert syndrome", " serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) 1.5 times ULN ( 3 times ULN in the presence of liver metastasis)", " Alkaline phosphatase 3 times ULN (in the presence of liver metastasis)", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment", " Able to swallow and retain oral medication", " No malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel", " No concurrent uncontrolled illness including, but not limited to, any of the following:", " Ongoing or active infection requiring parenteral antibiotics", " Impaired lung function (chronic obstructive pulmonary disease or lung conditions requiring oxygen therapy)", " New York Heart Association class III-IV congestive heart failure", " Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within the past 6 months", " Uncontrolled hypertension (systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg, found on 2 consecutive measurements separated by a 1-week period and despite adequate medical support)", " Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [grade 3 according to NCI Common Toxicity Criteria for Adverse Events v3.0])", " Uncontrolled diabetes (hyperosmolar state, ketoacidosis, etc.)", " Psychiatric illness or social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary", " No symptomatic neuropathy grade 2", " No other invasive cancer within the past 5 years except for completely resected basal cell or squamous cell carcinoma of the skin or successfully treated cervical carcinoma in situ", " No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products, or other recombinant human antibodies", " No history of hepatitis B or C", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " Recovered from prior therapy", " Prior total cumulative life-time dose of doxorubicin 360 mg/m^2 or epirubicin 640 mg/m^2", " No more than 4 prior chemotherapy treatments in the metastatic setting (not including endocrine therapy or single-agent biologic therapy)", " At least 2 weeks since prior investigational drugs", " At least 14 days since prior and no concurrent herbal or dietary supplements", " At least 14 days since prior and no concurrent CYP3A4 inducers", " At least 7 days since prior and no concurrent CYP3A4 inhibitors", " Concurrent radiotherapy to painful bone metastases or areas of impending bone fracture allowed provided radiotherapy is initiated before study entry", " No other concurrent anticancer therapy (chemotherapy, radiotherapy, surgery, immunotherapy, hormonal therapy, biologic therapy)" ]

[ "INTERVENTION 1: ", " Flaxseed", " Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.", "INTERVENTION 2: ", " Placebo", " Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily." ]

[ "INTERVENTION 1: ", " Stratum 1: TAC + Bevacizumab", " HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.", "INTERVENTION 2: ", " Stratum 2: TCH + Bevacizumab", " HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks." ]

[ "INTERVENTION 1: ", " Triptorelin Plus Tamoxifen", " Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.", "INTERVENTION 2: ", " Triptorelin Plus Exemestane", " Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years." ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed adenocarcinoma of the breast", " Does not overexpress HER-2/neu, defined as FISH negative or 0, 1+, or 2+ by IHC", " Stage IV disease", " Must not be eligible for therapy of known curative potential for metastatic breast cancer", " Measurable or evaluable disease", " Stable CNS disease allowed provided that it's adequately treated and not under active treatment", " Hormone receptor status not specified", " PATIENT CHARACTERISTICS:", " Menopausal status not specified", " ECOG performance status 0-1", " ANC > 1,000/mm^3", " Platelets > 100,000/mm^3", " Serum bilirubin < 2.0 mg/dL (unless due to Gilbert syndrome)", " AST and ALT < 2 times upper limit of normal (ULN)", " Alkaline phosphatase < 5 times ULN", " Serum creatinine < 2.0 mg/dL", " Ejection fraction normal by MUGA OR 50% by echocardiogram", " Not pregnant or nursing", " Fertile patients must use effective contraception", " HIV negative", " Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids allowed", " No prior or concurrent autoimmune disease requiring management with systemic immunosuppression, including any of the following:", " Inflammatory bowel disease", " Systemic vasculitis", " Scleroderma", " Psoriasis", " Multiple sclerosis", " Hemolytic anemia or immune-mediated thrombocytopenia", " Rheumatoid arthritis", " Systemic lupus erythematosus", " Sjogren syndrome", " Sarcoidosis", " Other rheumatologic disease", " No other malignancies within the past 5 years, except carcinoma in situ of the cervix, superficial nonmelanoma skin cancer, superficial bladder cancer, or tamoxifen-related endometrial cancer that has been adequately treated", " No active major medical or psychosocial problems that could be complicated by study participation", " No symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest", " No uncontrolled medical problems", " No evidence of active acute or chronic infection", " No known severe hypersensitivity to trastuzumab, except mild to moderate infusion reactions that are easily managed and do not recur", " No allergy to corn", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " More than 28 days since prior and no other concurrent chemotherapy, radiation therapy, or biologic therapy (except trastuzumab)", " Concurrent endocrine therapy and supportive therapy with bisphosphonates allowed", " More than 28 days since prior and no other concurrent participation in an investigational new drug trial", " More than 28 days since prior and no other concurrent systemic oral steroids", " Topical, ocular, and nasal steroids allowed", " No prior vaccination with the allogeneic GM-CSF-secreting breast tumor vaccine" ]

[ "Inclusion Criteria:", " Female patients with histologically confirmed adenocarcinoma of the breast or inflammatory breast cancer", " Clinical stage T 1-4, N 0-3, M0", " FISH+ HER2 gene amplified breast cancer", " 18 years or older", " Normal cardiac function", " Performance status 0-2", " Cannot have received any prior chemotherapy for this disease or cannot have received chemotherapy for any other cancer in the past 5 years.", " Previous diagnosis of noninvasive breast cancer is OK.", " Must have adequate bone marrow, renal and liver function.", " Pregnant or lactating females not allowed.", " Preexisting peripheral neuropathy must be equal to or less than grade 1", " Must have archived tumor tissue for tissue testing.", "Exclusion Criteria:", " You cannot be in this study if you any of the following:", " History of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure", " Any heart attack, stroke or TIAs within the last 6 months or serious arrhythmias needing medication; no bleeding diathesis or coagulopathy.", " No prior investigational drug within the last 30 days", " No prior trastuzumab or bevacizumab therapy", " 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." ]

[ "INTERVENTION 1: ", " Exemestane", " exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.", " Exemestane: exemestane 25 mg by mouth (PO) every day for two years", " Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years", " Vitamin D: Vitamin D 400 international units PO every day x 2 years" ]

[ "INTERVENTION 1: ", " Suramin and Paclitaxel", " Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin." ]

[ "Outcome Measurement: ", " Overall Response Rate", " Overall Response Rate (ORR), subjects with CR or PR by independent review in subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.", " Time frame: From first dose date to progression or last tumor assessment, up to four years and six months.", "Results 1: ", " Arm/Group Title: Neratinb 240 mg + Vinorelbine 25 mg/m - No Prior Lapatinib", " Arm/Group Description: Neratinib 240 mg qd + Vinorelbine 25 mg/m IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure", " Overall Number of Participants Analyzed: 64", " Measure Type: Number", " Unit of Measure: percentage of participants 35.9 (24.3 to 48.9)", "Results 2: ", " Arm/Group Title: Neratinib 240 mg + Vinorelbine 25 mg/m - Prior Lapatinib", " Arm/Group Description: Neratinib 240 mg qd + Vinorelbine 25 mg/m IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure", " Overall Number of Participants Analyzed: 15", " Measure Type: Number", " Unit of Measure: percentage of participants 13.3 (1.7 to 40.5)" ]

[ "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)" ]

[ "Inclusion Criteria:", " Metastatic adenocarcinoma of the breast (Stage IV)", " Actively receiving endocrine therapy for at least 6 weeks (with or without HER2 therapy)", " Minimum age 18 years", " ECOG Performance status of 0, 1 or 2", " Normal organ and marrow function as defined in the protocol", "Exclusion Criteria:", " Participants may not be receiving any other study agents", " Actively receiving chemotherapy (exclusive of hormonal or HER2 therapy ) within last 5 weeks", " Any statin therapy within the last 3 weeks", " Asian decent (including Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin)", " Concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors", " Conditions predisposing to renal failure secondary to rhabdomyolysis", " Recent history of heavy alcohol use as judged by the treating physician", " Known to be pregnant (testing not required) or nursing", " History of rhabdomyolysis on statin therapy", " Known history of Hepatitis C or active hepatitis B infection (baseline testing not required)", " Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements" ]

[ "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:(main conditions)", " Female patients 18 to 75 years of age with metastatic breast cancer histologically/cytologically confirmed not amenable to curative surgery or radiotherapy and who have received at least two prior chemotherapy regimens including anthracyclines,taxanes,antimetabolite and vinca-alkaloid and are no longer candidate for these drugs,", " Karnofsky performance score of at least 70 %, adequate haematological, hepatic and renal functions and ECG without clinically relevant abnormality.", "Exclusion Criteria:", " Concurrent serious uncontrolled medical disorder,", " known or clinical evidence of brain metastases or leptomeningeal involvement,", " pulmonary lymphangitis or symptomatic pleural effusion or symptomatic ascites,", " history of second primary malignancy,", " HIV infection, preexisting neuropathy,", " pregnancy or breast feeding." ]

[ "Outcome Measurement: ", " Overall Survival (OS)", " Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.", " Time frame: from date of randomization until death", "Results 1: ", " Arm/Group Title: Ixabepilone + Capecitabine", " Arm/Group Description: Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.", " Overall Number of Participants Analyzed: 609", " Median (95% Confidence Interval)", " Unit of Measure: months 16.39 (14.95 to 17.91)", "Results 2: ", " Arm/Group Title: Capecitabine", " Arm/Group Description: Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.", " Overall Number of Participants Analyzed: 612", " Median (95% Confidence Interval)", " Unit of Measure: months 15.64 (13.86 to 17.02)" ]

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

[ "Inclusion Criteria:", " Pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed oestrogen receptor positive (ER +ve) breast cancer", " World Health Organization (WHO) performance status of 0, 1, or 2", " Provided written informed consent", "Exclusion Criteria:", " Treatment with tamoxifen or other hormonal therapies as early breast cancer (EBC) adjuvant in the previous 24 weeks", " Received radiotherapy within the past 4 weeks", " History of systemic malignancy other than breast cancer within the previous 3 years", " Estimated survival less than 24 weeks" ]

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