US drug-maker AbbVie has started a Phase III clinical trial designed to assess 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 company said that the three-arm trial will compare the addition of veliparib plus carboplatin or placebo, plus carboplatin to standard neoadjuvant chemotherapy.
AbbVie vice-president of pharmaceutical development Scott Brun said: "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."
Around 620 patients will be enrolled in the randomised, placebo-controlled, double-blind, Phase III trial and they will be randomised to one of three arms of the trial.
In the trial, primary efficacy outcome is pathological complete response (pCR), while the secondary outcome will determine the rate of eligibility for breast conservation after therapy.
pCR is achieved when there is no evidence of residual, invasive cancer in the breast tissue and lymph node tissue, following treatment.
Other pre-specified outcome measures in the trial will include event-free survival (EFS), overall survival (OS), and complete response rate (CRR).
Safety of veliparib will also be assessed in the trial, which will be carried out 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 US Oncology Research.
AbbVie is developing Veliparib, an investigational oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, to increase the effectiveness of common DNA-damaging therapies like chemotherapy or radiation.
It is currently being studied in a number of cancers and tumour types, including Phase II studies in a variety of cancers, including breast, ovarian, and non-small cell lung cancers.
Image: Veliparib is being developed to increase the effectiveness of common DNA-damaging therapies. Photo: courtesy of freedigitalphotos.net.