Saci-IO TNBC: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC)
Dana-Farber Cancer Institute
Summary
This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative. The names of the study interventions involved in this study are: * Sacituzumab govitecan (Trodelvy™;IMMU-132) * Pembrolizumab (Keytruda®; MK-3475)
Description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug or a combination of investigational drugs to learn whether the drug or drug combination works in treating a specific disease. "Investigational" means that the drug or drug combination is being studied. The U.S. Food and Drug Administration (FDA) has approved Sacituzumab Govitecan for metastatic triple-negative breast cancer, but it is currently approved only for patients who have had 2 or more prior regimens for metastatic disease. The U.S. Food and Drug Admi…