A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes. As of June 4, 2024, this study is no longer accepting any newly screened participants.

Inclusion Criteria: * Histologically confirmed invasive breast carcinoma * Centrally-confirmed human epidermal growth factor receptor 2 (HER2)-positive invasive breast cancer * Centrally confirmed PD-L1 and hormone receptor status * Clinical stage at disease presentation (prior to neoadjuvant therapy): cT4/anyN/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (participants with cT1mi/T1a/T1b/N0 are not eligible) * Completion of pre-operative systemic chemotherapy including at least 9 weeks of taxane and 9 weeks of trastuzumab (anthracycline and/or additional HER2-targeted agents are permitted) * \<=12 weeks between primary surgery and randomization * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Screening left ventricular ejection fraction (LVEF) \>= 50% and no decrease in LVEF by \>15% from the pre-chemotherapy LVEF. If no pre-chemotherapy LVEF, screening LVEF \>= 55% * Life expectancy \>= 6 months * Adequate hematologic and end organ function Exclusion Criteria: * Stage IV breast cancer * An overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy * Prior treatment with T-DM1, or atezolizumab, or other immune checkpoint inhibitors * History of exposure to various cumulative doses of anthracyclines * History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or ductal carcinoma in situ (DCIS) * Current grade \>=2 peripheral neuropathy * History of idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis * History of or active autoimmune disease or immune deficiency * Treatment with immunostimulatory or immunosuppressive agents * Cardiopulmonary dysfunction * Any known active liver disease