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Trials & Filings

AbbVie Begins Triple-Negative Breast Cancer Trial

Veliparib to be added to carboplatin in Ph III trial

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

AbbVie has begun a Phase III trial evaluating the safety and efficacy of its investigational compound, veliparib (ABT-888) when added to carboplatin chemotherapy, in women with early-stage, triple-negative breast cancer. The three-arm trial will compare the addition of veliparib plus carboplatin or placebo plus carboplatin to standard neoadjuvant chemotherapy.

The randomized, placebo-controlled, double-blind trial will recruit approximately 620 patients who will be randomized to one of three arms of the trial. The primary efficacy outcome of the trial is pathological complete response (pCR), which is achieved when there is no evidence of residual, invasive cancer in the breast tissue and lymph node tissue, following treatment. The secondary outcome of the trial will determine the rate of eligibility for breast conservation after therapy. Other pre-specified outcome measures include event-free survival (EFS), overall survival (OS), and complete response rate (CRR). The safety of veliparib will also be evaluated in the trial.

Veliparib is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor being evaluated in multiple tumor types.

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