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.
- drug : trastuzumab
- drug : trastuzumab emtansine
Phase: Phase 3
Ages Eligible For Study:
- Adult patient, >/= 18 years of age - HER2-positive breast cancer - Histologically confirmed invasive breast carcinoma - Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible) - Completion of preoperative systemic treatment consisting of at least 6 cycles with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy - Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol - Pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy - An interval of no more than 12 weeks between the date of surgery and the date of randomization - Known hormone-receptor status - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Adequate hematologic, renal and liver function - Left ventricular ejection fraction (LVEF) >/= 50% at screening and no decrease in LVEF by more than 15% absolute points from pre-chemotherapy - Women of childbearing potential and men with partners of childbearing potential must be willing to use effective contraception as defined by protocol for the duration of study treatment and for at least 6 months after the last dose of study treatment - Documentation of hepatitis B virus and hepatitis C virus serology is required