TROPiCS-02: A Phase III Study Investigating Sacituzumab Govitecan in the Treatment of HR+/HER2- Metastatic Breast Cancer
Hope S. Rugo, Aditya Bardia, Sara M. Tolaney, Carlos L. Arteaga, Javier Cortés, Joohyuk Sohn, Frederik Marmé, Quan Hong, Rosemary Delaney, Amir Hafeez, Fabrice André, Peter Schmid
Abstract
Patients with HR+/HER2- metastatic breast cancer (MBC) whose cancers have progressed despite conventional therapies represent an unmet clinical need. Trop-2, a transmembrane calcium signal transducer, is highly expressed in MBC and plays a role in tumor growth and progression. Sacituzumab govitecan (SG) is a novel antibody-drug conjugate comprising an Trop-2 antibody coupled to SN-38, the active metabolite of irinotecan, via a unique hydrolyzable linker. SG has demonstrated promising activity in a Phase I/II IMMU-132-01 basket study in heavily pretreated solid tumors, including HR+/HER2- MBC. We describe the registrational Phase III TROPiCS-02 study (NCT03901339), evaluating SG versus treatment of physician's choice in HR+/HER2- MBC. Trial registration number: NCT03901339.