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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 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

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

NCT04873362•Hoffmann-La Roche

View on ClinicalTrials.gov

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. As of June 4, 2024, this study is no longer accepting any newly screened participants.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Exclusion Criteria

•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
+7 more criteria

Locations (238)

Alabama Oncology

Birmingham, Alabama, United States

Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center

Buena, California, United States

UCLA Medical Center

Santa Monica, California, United States

Innovation Clinical Research Institute

Whittier, California, United States

Florida Cancer Specialists

West Palm Beach, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Carrollton, Georgia, United States

University of Iowa

Iowa City, Iowa, United States

New England Cancer Specialists

Westbrook, Maine, United States

The Valley Hospital

Paramus, New Jersey, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Key Dates

Start Date

May 4, 2021

Primary Completion Date

August 31, 2028

Completion Date

October 2, 2034

Last Updated

March 4, 2026

Enrollment

1,188

ACTUAL participants

Conditions

Breast Cancer

Interventions

Atezolizumab

DRUG

Trastuzumab Emtansine

DRUG

Placebo

DRUG

Trastuzumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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