Study ID: S1416
Phase 2 randomized placebo-controlled trial of cisplatin with or without ABT-888 (Veliparib) in metastatic triple-negative breast cancer and/or (any ER/PR if) BRCA mutation-associated breast cancer
This treatment trial is studying outcomes of breast cancer patients administered the chemotherapy drug cisplatin either alone or in conjunction with veliparib, a potential anti-cancer drug that acts as an inhibitor of a protein called PARP. Participants will be randomly placed in one of two study arms. Those in Arm 1 will receive cisplatin intravenously and a placebo, while those in Arm 2 will receive cisplatin intravenously and veliparib orally.
- Metastatic triple negative diagnosis, BRCA mutation, measurable or non-measurable disease
- Chest/abdominal CT scan and bone scan within 28 days prior to registration
- Adequate tissue available for germline DNA sequencing and other correlative studies
- =< 1 prior cytotoxic regimen for metastatic disease
- Completed any prior radiation therapy and hormonal therapy at least 14 days prior to registration
- No prior cisplatin or PARP inhibitors; prior carboplatin iniparib is allowed if completed more than 6 months prior to study entry
- No chemotherapy within 14 days prior to registration; no immunotherapy, biologic or investigational drug within 28 days prior to registration; no bevacizumab within 42 days prior to registration
*See protocol for complete eligibility requirements, including specifics to the Brain Met cohort.
- Must have been diagnosed with metastatic triple-negative breast cancer and/or BRCA mutation-associated breast cancer
- Must not have been treated with immunotherapy, or a biologic or investigational drug within 28 days prior to registration in the study, and no bevacizumab within 42 days