ERBB2 and breast cancer: The open-label randomized controlled phase 2 NEfERT-T trial compared neratinib (240 mg/d orally) plus paclitaxel (80 mg/m2 on days 1, 8, and 15 every 28 days) with trastuzumab (4 mg/kg followed by 2 mg/kg weekly) plus paclitaxel in 479 previously-treated patients (242 receiving neratinib-paclitaxel and 237 trastuzumab-paclitaxel) with recurrent and/or metastatic HER2-positive BC; women with asymptomatic CNS involvement were eligible, and the randomization was stratified by prior trastuzumab and lapatinib exposure, HR status, and region.