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
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT04873362
- Run by
- Hoffmann-La Roche
- People needed
- 1188
- Starts
- 2021-05-04
- Expected to finish
- 2034-10-02
- Last updated by the study team
- 2026-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 (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
You may not qualify if…
- 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
Where it is running
- 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
- Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit — Philadelphia, Pennsylvania, United States
- The West Clinic — Germantown, Tennessee, United States
- Thompson Cancer Survival Center — Knoxville, Tennessee, United States
- Mays Cancer Center at UT Health San Antonio MD Anderson Cancer — San Antonio, Texas, United States
- Hematology Oncology Associates of Fredericksburg, Inc. — Fredericksburg, Virginia, United States
- Virginia Oncology Associates - New Port News — Newport News, Virginia, United States
- Virginia Oncology Associates — Norfolk, Virginia, United States
- Virginia Cancer Institute — Richmond, Virginia, United States
- Virginia Oncology Associates - Virginia Beach — Virginia Beach, Virginia, United States
- Providence Regional Cancer Partnership — Everett, Washington, United States
- Kadlec Clinic Hematology and Oncology — Kennewick, Washington, United States
- Northwest Medical Specialties — Tacoma, Washington, United States
- Macarthur Cancer Therapy Centre — Campbelltown, New South Wales, Australia
- Royal North Shore Hospital — St Leonards, New South Wales, Australia
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
- Alabama Oncology — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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