Clinical Trials

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physicianâ??s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or

ClinicalTrials.gov Identifier

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Principal Investigator

Virginia Kaklamani, MD

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About This Study

This is an international, multicenter, open-label, randomized, Phase 3 study in patients withlocally advanced, inoperable or metastatic triple-negative breast cancer (TNBC) who have not received previous therapy for advanced disease and whose tumors are either: PD-L1 negative at screening (defined using the PD-L1 IHC 22C3 assay as tumors with a combined positive score (CPS) < 10), OR PD-L1 positive at screening (defined using the PD-L1 IHC 22C3 assay as tumors with a CPS ≥ 10) if they previously received a checkpoint inhibitor in the adjuvant or neoadjuvant setting.