US-based biopharmaceutical firm AbbVie has started a Phase III clinical trial assessing the safety and efficacy of its investigational compound, veliparib (ABT-888), in combination with carboplatin and paclitaxel, two chemotherapeutic medicines, in patients with advanced breast cancer.
Veliparib is an investigational oral poly (adenosine diphosphate [ADP]-ribose) polymerases (PARP) inhibitor currently being assessed in multiple tumour types.
In the trial, the combination of veliparib, carboplatin and paclitaxel will be compared with treatment with carboplatin, paclitaxel and placebo in these patients with human epidermal growth factor receptor 2-(HER2) negative metastatic or locally-advanced breast cancer, containing BRCA1 and/or BRCA2 gene mutations.
AbbVie executive vice president of research and development and chief scientific officer Michael Severino said: "By adding veliparib to DNA-damaging therapies, such as carboplatin and paclitaxel, we can evaluate its potential to provide incremental benefit to existing treatments.
"This is the third Phase III trial evaluating the efficacy and safety of veliparib, and the second evaluating the addition of veliparib to chemotherapy for the treatment of patients with difficult-to-treat forms of breast cancer."
Approximately 270 patients with human epidermal growth factor receptor 2-(HER2) negative metastatic or locally advanced breast cancer, containing BRCA1 and/or BRCA2 gene mutations, will be enrolled in the randomised, double-blind, Phase III trial.
The trial's primary efficacy outcome is progression-free survival (PFS), while the secondary pre-specified outcome measures include overall survival (OS), clinical benefit rate (CBR), objective response rate (ORR) and duration of response (DOR).
Discovered by AbbVie researchers, Veliparib is being developed to help prevent DNA repair in cancer cells and increase the effectiveness of common DNA-damaging therapies such as chemotherapy or radiation.
Veliparib is currently being evaluated in more than a dozen cancers and tumour types, including Phase III trials in non-small cell lung cancer and breast cancer.
Image: AbbVie's Phase III trial of veliparib will enrol 270 patients with advanced breast cancer. Photo: courtesy of jscreationzs/ freedigitalphotos.net.