TROPION-Breast01: Datopotamab deruxtecan vs chemotherapy in pre-treated inoperable or metastatic HR+/HER2– breast cancer
Aditya Bardia, Komal Jhaveri, Kevin Kalinsky, Sònia Pernas, Junji Tsurutani, Binghe Xu, Erika Hamilton, Seock‐Ah Im, Zbigniew Nowecki, Joohyuk Sohn, Michelino De Laurentiis, Noelia Martínez-Jáñez, Bárbara Adamo, Keun Seok Lee, Kyung Hae Jung, Gábor Rubovszky, Ling-Ming Tseng, Yen‐Shen Lu, Yuan Yuan, Micah J. Maxwell, Vincent Haddad, Sabrina Khan, Hope S. Rugo, Barbara Pistilli
Abstract
Improving the prognosis for patients with metastatic HR+/HER2- breast cancer remains an unmet need. Patients with tumors that have progressed on endocrine therapy and/or are not eligible for endocrine therapy had limited treatment options beyond chemotherapy. Antibody-drug conjugates are a novel and promising treatment class in this setting. Datopotamab deruxtecan (Dato-DXd) consists of a TROP2-directed humanized IgG1 monoclonal antibody attached via a serum-stable cleavable linker to a topoisomerase I inhibitor payload. TROPION-Breast01 is an ongoing phase 3 study that is evaluating the efficacy and safety of Dato-DXd compared with investigator's choice of standard-of-care chemotherapy in patients with inoperable or metastatic HR+/HER2- breast cancer who have received one or two prior lines of systemic chemotherapy in the inoperable or metastatic setting. Clinical Trial Registration: NCT05104866 (ClinicalTrials.gov)