Evaluating the addition of veliparib to platinum-based chemotherapy for BRCA-positive advanced breast cancer.

This trial was carried out to assess the effectiveness and safety of veliparib (ABT-888) in combination with carboplatin (Paraplatin) and paclitaxel (Taxol) in BRCA-mutated advanced breast cancer (BC). The authors found that the addition of veliparib to platinum-based chemotherapy resulted in an improved survival without disease progression. 

BC is one of the most common cancers found in women. BRCA1 and BRCA2 are gene mutations (abnormalities) that are found in patients who are at high risk of developing BC. Patients with BRCA1 or BRCA2 mutated BC is often found in young patients and can be very resistant to current treatment options. 

Veliparib is a PARP (proteins involved in DNA repair) inhibitor. BRCA1 and BRCA2 mutated cancers have been shown to be responsive to PARP-inhibitors. Carboplatin and paclitaxel are chemotherapy medications. Up to this point, trials have not established the effectiveness and safety of adding veliparib to chemotherapy in patients with BRCA mutated advanced BC.

This trial involved 509 patients with advanced BC. The trial had 2 groups. Group 1 received veliparib plus carboplatin and paclitaxel (337 patients). Group 2 received carboplatin and paclitaxel with a placebo instead of veliparib (172). The average follow-up was 35.7 months (group 1) and 35.5 months (group 2). 

The average survival without cancer worsening was 14.5 months in group 1 compared to 12.6 months in group 1. Group 1 had a 29% higher chance of a longer survival without cancer worsening compared to group 2. The average overall survival was 33.5 months in group 1 compared to 28.2 months in group 2. 

Serious side effects occurred more commonly in group 1 (34%) compared to group 2 (29%). The most common severe side effects were low blood cell counts.

The authors concluded that adding veliparib to a paclitaxel and carboplatin chemotherapy improved survival without cancer worsening in patients with BRCA-positive advanced BC.

This trial was sponsored by AbbVie, the manufacturer of veliparib.