Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2034
Estimated Enrollment :
1188 Patients enrolled
Trial Details
Trial ID
NCT04873362
Start Date
May 4 2021
End Date
October 2 2034
Last Update
December 5 2025
Active Locations (239)
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1
Alabama Oncology
Birmingham, Alabama, United States, 35205
2
Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center
Buena, California, United States, 91505
3
UCLA Medical Center
Santa Monica, California, United States, 90404
4
Innovation Clinical Research Institute
Whittier, California, United States, 90603