Oral neratinib: Phase II data

The open-label, international Phase II FB-7 trial in 126 locally advanced stage IIB-IIIC HER2-positive invasive breast cancer patients showed that 2 regimens of oral neratinib -- once-daily 240 mg oral neratinib plus paclitaxel and once-daily 200 mg oral neratinib plus paclitaxel and Herceptin trastuzumab -- both for four 28-day cycles followed by standard doxorubicin and cyclophosphamide chemotherapy administered prior to surgery led to pCR rates of 33.3% and 50%, respectively, vs. 38.1% for Herceptin plus paclitaxel for four 28-day cycles followed by standard doxorubicin and cyclophosphamide chemotherapy administered prior to surgery. In hormone receptor-positive patients, neratinib plus paclitaxel and neratinib plus paclitaxel and Herceptin led to pCR rates of 27.6% and 30.4%, respectively, vs. 29.6% for Herceptin plus paclitaxel. In hormone receptor-negative patients, neratinib plus paclitaxel and neratinib plus paclitaxel and Herceptin led to pCR rates of 46.2% and 73.7%, respectively, vs. 57.1% for Herceptin plus paclitaxel. ...