Trial Identifiers
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Scientific Title
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
Commercial Sponsor
Gilead Sciences, Inc.
Summary
This trial is for people with locally advanced, inoperable or metastatic triple-negative breast cancer who have not received pervious treatment for their advanced cancer, and whose cancer does not express programmed cell death ligand 1 (PD-L1), or people previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose cancers do express PD-L1. Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. In the Experimental Arm, participants will receive Sacituzumab Govitecan-hziy (10mg/mg) intravenously on Days 1 and 8 of a 21-day cycle. In the Active Comparator Arm, participants will treatment of the physician's choice which will be determined prior to randomisation from 1 of the 3 following regiments: paclitaxel (90mg/m^2 on Days 1, 8, and 15 of a 28-day cycle), nab-paclitaxel (100mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), or gemcitabine (1000mg/m^2) + carboplatin (area under the curve (AUC) 2) on days 1 and 8 of a 21-day cycle.