TROPiCS-02: A Phase III Study Investigating Sacituzumab Govitecan in the Treatment of HR+/HER2- Metastatic Breast Cancer

Hope S. Rugo(University of California, San Francisco), Aditya Bardia(Harvard University), Sara M. Tolaney(Harvard University), Carlos L. Arteaga(The University of Texas Southwestern Medical Center), Javier Cortés(Vall d'Hebron Institute of Oncology), Joohyuk Sohn(Yonsei University), Frederik Marmé(University Hospital Heidelberg), Quan Hong(Immunomedics (United States)), Rosemary Delaney(Immunomedics (United States)), Amir Hafeez(Immunomedics (United States)), Fabrice André(Institut Gustave Roussy), Peter Schmid(Queen Mary University of London)
Future Oncology
March 30, 2020
10.2217/fon-2020-0163
Cited by 124Open Access
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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.

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