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

• Status: Recruiting
• Trial end date: 2034-10-26
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ado-Trastuzumab Emtansine; Atezolizumab; Maytansine; Trastuzumab

Criteria

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: 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