ERBB2 and breast cancer: Based on the above phase 1 or 1/2 data, an open-label, multicenter, phase 2 trial was launched to assess the clinical activity of neratinib in two cohorts of patients with advanced HER2-positive BC (66 with prior trastuzumab treatment, and 70 with no prior trastuzumab treatment)(Burstein et al. 2010).