CRC 13105: A Randomized Phase 2 Study of Veliparib plus Temozolomide or Veliparib plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer
Purpose: The Study Evaluating Efficacy And Tolerability of Veliparib in Combination with Temozolomide or Veliparib/Placebo in Combination with Carboplatin and Paclitaxel in Subjects with locally recurrent Breast Cancer not amenable to therapy with curative intent, or metastatic breast cancer and a documented (BRCA1) and (BRCA2) deleterious germline mutation.
January 01, 1900
Cancer () - Breast
Erin Ellis, M.D.
Swedish Cancer Institute
- Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.
- Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.
- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2
- No more than 2 prior lines of cytotoxic chemotherapy
- No prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor
- No prior taxane therapy for metastatic breast cancer