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A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy
This is a randomised, double-blind trial for people with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes. There is one Active Comparator Arm and one Experimental Arm. Participants in the Active Comparator arm will receive Placebo + Trastuzumab Emtansine. The placebo will be administered via intravenous (IV) infusion at a dose of 1200mg Q3W for 14 cycles. Participants will then receive Trastuzumab Emtansine (vi IV infusion) at a dose of 3.6 mg/kg for 14 weeks. Participants in the Experimental Arm will receive Atezolizumab + Trastuzumab Emtansine. Atezolizumab will be administered via IV infusion at a dose of 1200mg Q3W for 14 weeks. Participants will then receive Trastuzumab Emtansine (via IV infusion) at a dose of 3.6 mg/kg Q3W for 14 weeks.
For both cohorts, Trastuzumab will be used to complete 14 cycles of study treatment if trastuzumab emtansine is discontinued for toxicity not considered to be related to the trastuzumab component of the drug.