The purpose of this study is to compare the effects, good or bad, of atezolizumab plus trastuzumab emtansine versus placebo plus trastuzumab emtansine in patients with HER2-positive early breast cancer.
- Conditions
- Cancer
- Registration Number
- PACTR202201721209443
- Lead Sponsor
- Hoffmann La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 1700
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: 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
-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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Invasive Disease-free Survival (IDFS)<br>IDFS event is defined as the time from randomization to the first occurrence of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, contralateral invasive breast cancer, distant recurrence, death from any cause.
- Secondary Outcome Measures
Name Time Method