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
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.
Inclusion Criteria:
Exclusion Criteria:
Long Beach, California 90806, United States
Baltimore, Maryland 21237, United States
Vancouver, British Columbia V5Z 4E6, Canada
Shanghai, 200025, China
Medellin-Antioquia, Colombia
Frankfurt am Main, 60389, Germany
Halle, 06110, Germany
Hanover, 30625, Germany
Lichtenberg, 10367, Germany
Navarra, Navarre 31008, Spain
Edirne, 22770, Turkey (Türkiye)
Malatya, 44280, Turkey (Türkiye)
Birmingham, B15 2TH, United Kingdom
Devon, EX31 4JB, United Kingdom