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

May, 2021

Scientific title

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

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.

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

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: Double, Subject masked: Yes, Investigator masked: Yes,

Conditions

Breast Cancer

Other study ID numbers

WO42633; 2020-003681-40; 2023-503568-18-00

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