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 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

- 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

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 (314)

National University Hospital; National University Cancer Institute, Singapore (NCIS)

National University Hospital 119074

Not yet recruiting
Singapore 119074
National Cancer Centre; Medical Oncology

National Cancer Centre Singapore

Recruiting
11 Hospital Crescent, Singapore 169610
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