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:
Chemotherapy, Immunotherapy
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: 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

Stage IV breast cancerAn 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

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

Choose trial site (519)

National University Hospital 119074
National University Hospital 119074 Not yet recruiting
Singapore 119074
National Cancer Centre Singapore
National Cancer Centre Singapore Recruiting
11 Hospital Crescent, Singapore 169610