PACTR202201721209443Not yet recruitingPhase 3
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
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Hoffmann La Roche
- Enrollment
- 1,700
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 19 Year(s) to 44 Year(s) (—)
- Sex
- All
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: 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
Investigators
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