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
Purpose
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.
Condition
- Breast Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 - 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 Criteria
- 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
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Arm A: Placebo + Trastuzumab Emtansine |
Participants will receive an intravenous (IV) infusion of placebo prior to the IV infusion of trastuzumab emtansine on Day 1 of each 21-day cycle for a total of 14 cycles. |
|
Experimental Arm B: Atezolizumab + Trastuzumab Emtansine |
Participants will receive an IV infusion of atezolizumab prior to the IV infusion of trastuzumab emtansine on Day 1 of each 21-day cycle for a total of 14 cycles. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Hoffmann-La Roche
Study Contact
Reference Study ID Number: WO42633 https://forpatients.roche.com/888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com