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.
Diagnosis: Breast: Metastatic
NCT ID: NCT01506609
(View complete trial on ClinicalTrials.gov)
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.
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, Beth-Israel Deaconess Medical Center
Steven Isakoff, MD, PhD,
Massachusetts General Hospital
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
- ≥ 18 years of age, male and female.
- Histologically or cytologically confirmed breast cancer with evidence of metastatic
- Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline
- 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
- 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.
- 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) -
- 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