Trial purpose
Cancer treatment
Tumor type
Breast
Age
18+
Clinical summary
Summary
This is a randomised, double-blind trial for people with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes. There is one Active Comparator Arm and one Experimental Arm. Participants in the Active Comparator arm will receive Placebo + Trastuzumab Emtansine. The placebo will be administered via intravenous (IV) infusion at a dose of 1200mg Q3W for 14 cycles. Participants will then receive Trastuzumab Emtansine (vi IV infusion) at a dose of 3.6 mg/kg for 14 weeks. Participants in the Experimental Arm will receive Atezolizumab + Trastuzumab Emtansine. Atezolizumab will be administered via IV infusion at a dose of 1200mg Q3W for 14 weeks. Participants will then receive Trastuzumab Emtansine (via IV infusion) at a dose of 3.6 mg/kg Q3W for 14 weeks. For both cohorts, Trastuzumab will be used to complete 14 cycles of study treatment if trastuzumab emtansine is discontinued for toxicity not considered to be related to the trastuzumab component of the drug.
Conditions
This trial is treating people with HER2-positive breast cancer
Eligibility
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
Inclusion
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Hoffmann-La Roche
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
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