Veliparib: Phase III started
AbbVie began a double-blind, placebo-controlled, U.S. Phase III trial to compare veliparib or placebo in combination with carboplatin as an add-on to standard neoadjuvant chemotherapy vs. standard neoadjuvant chemotherapy alone in about 620 patients with early stage TNBC. Standard neoadjuvant chemotherapy consists of paclitaxel followed by doxorubicin and cyclophosphamide.
In December, researchers at the University of California, San Francisco, and colleagues said a veliparib-containing regimen "graduated" from the open-label Phase II I-SPY 2 trial based on having a high probability of success in patients with TNBC in a Phase III trial. The I-SPY 2 trial is designed to rapidly and inexpensively develop data to support small Phase III trials of new neoadjuvant therapies for locally advanced breast cancer or to help companies quickly kill ineffective candidates (see BioCentury, Dec. 16, 2013). ...