• Future oncology · Apr 2020

    Randomized Controlled Trial Multicenter Study

    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 Arteaga, Javier Cortes, Joohyuk Sohn, Frederik Marmé, Quan Hong, Rosemary J Delaney, Amir Hafeez, Fabrice André, and Peter Schmid.
    • Department of Medicine (Hematology/Oncology), University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA 94115, USA.
    • Future Oncol. 2020 Apr 1; 16 (12): 705-715.

    AbstractPatients 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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