Clinical Trials Search
Clinical Trial 17835
Cancer Type: Breast
Interventions:Not Applicable; Paraplatin (carboplatin); Placebo; Taxol (paclitaxel); Veliparib (ABT-888); carboplatin; paclitaxel
Study Type: Treatment
Phase of Study: Phase III
- Heather Han
A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer
The main purpose of the study is to determine if veliparib in combination with carboplatin and paclitaxel improves the efficacy of chemotherapy alone in participants with a BRCA1 or BRCA2 mutation and HER2-negative metastatic or locally advanced breast cancer.
The primary endpoint is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin (C) and paclitaxel (P) compared to placebo with C/P in subjects with a BRCA1 and/or BRCA2 Mutation and HER2-Negative Metastatic or Locally Advanced Unresectable Breast Cancer. The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR), objective response rate (ORR), PFS2 and duration of overall response (DOR) in subjects treated with veliparib in combination with C/P versus subjects treated with placebo with C/P. The tertiary objectives are to assess change in ECOG performance status, change in Quality of Life (QoL).