The results for Phase I after the inclusion of 19 patients with stages II and IIIA HER2-positive breast cancer determined the recommended dose for Phase II to be LD 50 mg/m2 plus docetaxel 60 mg/m2 every three weeks with standard dose trastuzumab when prophylactic pegylated-filgrastim was administered. The gene discussed is ERBB2; the disease is breast cancer.