The Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide or In Combination With Carboplatin and Paclitaxel Versus Placebo in Subjects With BRCA1 and BRCA2 Mutation and Metastatic Breast Cancer.

Status: Recruiting
Diagnosis: Breast: Metastatic
NCT ID: NCT01506609 (View complete trial on
DFCI Protocol ID: 12-084


The Study Evaluating Efficacy And Tolerability of Veliparib in Combination with Temozolomide or Veliparib/Placebo in Combination with Carboplatin and Paclitaxel in Subjects with Breast Cancer Gene (BRCA1) and (BRCA2) Mutation and Metastatic Breast Cancer.


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Steven Isakoff, MD, PhD, Massachusetts General Hospital

Site-responsible Investigators:
Judy Garber, MD, Dana-Farber Cancer Institute
Nadine Tung, MD, Beth Israel Deaconess Medical Center

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - ≥ 18 years of age, male and female. - Histologically or cytologically confirmed breast cancer with evidence of metastatic disease. - Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation. - If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy. - Subject has measurable disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria. - Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2. - Subject must have adequate bone marrow, renal and hepatic function. - Subject must not be pregnant or plan to conceive a child. Exclusion Criteria: - Received anticancer agent(s), an investigational agent, or radiotherapy within 21 days prior Cycle 1 Day 1 - More than 1 prior line of cytotoxic chemotherapy - Prior therapy with temozolomide, a platinum agent, or a PARP (Poly (ADP-ribose) - Polymerase) inhibitor. - Prior taxane therapy for metastatic disease - A history of or evidence of brain metastases or leptomeningeal disease. - A history of uncontrolled seizure disorder - Pre-existing neuropathy from any cause in excess of Grade 1 - Known history of allergic reaction to cremophor/paclitaxel - Clinical significant uncontrolled conditions - active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance. - Pregnant or breastfeeding
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