AbbVie, a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott, announced the initiation of a Phase 3 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 3 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 MD, 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.” [Pat’s note: Some forms are aggressive, but not all. I wish experts would not make such blanket statements. Research needs to show us which ones are fast growing and which are not. Again, most women survive TNBC, especially those with early stage.]
The randomized, placebo-controlled, double-blind, Phase 3 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.
More information on the trial is available at www.clinicaltrials.gov (NCT02032277). The trial will be conducted in collaboration with cooperative groups: Alliance Oncology, German Breast Group (GBG), German Gynecological Oncology Working Group-Breast (AGO-B), National Surgical Adjuvant Breast and Bowel Project (NSABP), and U.S. Oncology Research.
About Veliparib (ABT-888) Veliparib (ABT-888) is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor being evaluated in multiple tumor types. PARP is a naturally occurring enzyme in the body that repairs damage to DNA, and contributes to chemotherapy resistance in cancer cells. Discovered and developed by AbbVie researchers, veliparib is being developed to increase the effectiveness of common DNA-damaging therapies like chemotherapy or radiation. Veliparib is currently being studied in more than a dozen cancers and tumor types, including Phase 2 studies in a variety of cancers, including breast, ovarian, and non-small cell lung cancers.
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