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A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1
Gilead Sciences, Inc.
This trial is for people with locally advanced inoperable or metastatic triple-negative breast cancer expressing PD-L1 who have not received treatment for their advanced disease. People may be eligible if they have received prior treatment for their less advanced cancer. Eligible participants will be randomly allocated to either the Experimental Arm or Active Comparator Arm. In the Experimental Arm, participants will receive Sacituzumab Govitecan-hziy (SG) + Pembrolizumab. SG will be administered intravenously at a dose of 10mg/kg on Days 1 and 8 of 21-day cycles, and pembrolizumab will be administered intravenously at a dose of 200mg on Day 1 of 21-day cycles. In the Active Comparator Arm, participants will Pembrolizumab + Treatment of Physician's Choice (TPC). Pembrolizumab will be administered intravenously at a dose of 200mg on Day 1 of each 21-day cycle, plus TPC determined prior to randomisation from 1 of the 3 following permitted regiments: paclitaxel (90mg/m^2 on Days 1, 8, and 15 of 29-day cycles); nab-paclitaxel (100mg/m^2 on Days 1, 8 and 15 of 28-day cycles), or gemcitabine (1000mg/m^2) + carboplatin area under the curve 2 (on days 1 and 8 of 21-day cycles).