AbbVie, a global, research-based biopharmaceutical company, has initiated a phase III clinical trial evaluating the safety and efficacy of its investigational compound, veliparib (ABT-888) when added to carboplatin, a 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.
"This new phase III trial is an important step in potentially providing women with early-stage triple-negative breast cancer with a new treatment option for use in conjunction with surgical therapy," said Scott Brun M.D., vice president, pharmaceutical development, AbbVie. "While therapies exist to treat many forms of breast cancer, there is still a significant need for effective, targeted therapies for women with early-stage triple-negative breast cancer, which tends to be an aggressive, faster growing form of breast cancer."
The randomized, placebo-controlled, double-blind, phase III 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 also will be evaluated in the trial.