A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer

About the trial

Sponsor

AbbVie

Tested

Veliparib Placebo (drug), Veliparib (drug), Carboplatin (drug), Paclitaxel (drug)

Dates

Started 2014-04-08; completion 2024-01-25

Results posted

Yes

The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (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) through the end of Week 24, objective response rate (ORR) and PFS on subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P versus placebo in combination with C/P.

From ClinicalTrials.gov, last updated 2025-02-19. Full record, eligibility and contacts (opens in a new tab)

Industry funding

AbbVie Inc. reported $276,413 in research payments for this study in 2025 (6 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.