A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy

This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab
emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer
who have residual tumor present in the breast or axillary lymph nodes following preoperative
therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6
mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or
hormone therapy will be given in addition if indicated.