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
- Trial number:
- NCT04873362
- Trial phase:
- 3
- Study type:
- Local/Regional therapies, Immunotherapy, Targeted therapy, Chemotherapy
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
Histologically confirmed invasive breast carcinomaCentrally-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