A Randomized Open-label Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician s Choice in Patients with Triple Negative Breast Cancer That Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy
Brief description of study
This is an international, multicenter, open-label, randomized, Phase 3 study in patients with TNBC who have received neoadjuvant chemotherapy with or without checkpoint inhibitor (CPI) therapy, with a finding of invasive disease in the breast or axillary lymph nodes after surgery. Patients must have had adequate excision and surgical removal of all clinical evidence of disease in the breast and/or lymph nodes as well as radiotherapy as indicated in the eligibility criteria prior to screening. Approximately 1514 patients will be enrolled at approximately 300 sites globally. Triple negative breast cancer status must be confirmed per current American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines for humanepidermal growth factor receptor 2 (HER2) testing. Estrogen receptor (ER) and progesterone receptor (PgR) expression must be < 10%. Patients who have known ER-positive (= 10%), PgR-positive (= 10%), HER2-positive breast cancer—as defined by current ASCO/CAP guidelines, or germline breast cancer gene (BRCA) mutation—are not eligible to participate in the study. TNBC diagnosis from postsurgical tissue sample is preferred and will be used for eligibility determination in case of discordant expression results from pretreatment diagnostic biopsy. A tumor tissue block (preferably) from diagnostic pretreatment core biopsy or at least 10-15 freshly sectioned unstained slides will be required. Tumor specimen from the surgical resection will also be mandatory (tumor tissue block preferable, or at least 20-25 freshly sectioned unstained slides). Tumor PD-L1 status will be assessed retrospectively in a central laboratory using the PD-L1 immunohistochemistry (IHC) 22C3 assay. Tumor tissues will also be analyzed retrospectively for Trop-2 levels and other potential exploratory biomarkers. Eligible patients will be randomly assigned (1:1) to one of the following 2 arms for treatment: Arm A: SG 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles for 8 cycles and pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles Arm B: TPC; TPC will be limited to one of the following treatment regimens determined prior to randomization: Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles and capecitabine 1000 mg/m2 orally twice daily on Days 1 through 14 of 21-day cycles for up to 8 cycles No other treatment regimen is allowed and no crossover to SG is permitted. Treatment in both arms will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death. Randomized patients will be stratified according to the following factors: Prior anti–programmed cell death ligand 1 [aPD-(L)1] therapy (yes versus no) Prior anthracycline-based therapy (yes versus no) Pathologic nodal status at time of surgery (ypN0 versus ypN+) Geographic region (US versus East Asia versus Rest of World) The study will be conducted in 3 parts: screening, treatment period, and long-term follow-up.
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