Datopotamab Deruxtecan Versus Chemotherapy in Previously Treated Inoperable/Metastatic Hormone Receptor–Positive Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer: Primary Results From TROPION-Breast01

• DOI: 10.1200/jco.24.00920
• Publication Date: 2024-09-12T19:59:35Z
• Authors: Aditya Bardia; Komal Jhaveri; Seock-Ah Im; Sonia Pernas; Michelino De Laur...; Shusen Wang; Noelia Martínez J...; Giuliano Borges; David W. Cescon; Masaya Hattori; Yen-Shen Lu; Erika Hamilton; Qingyuan Zhang; Junji Tsurutani; Kevin Kalinsky; Pedro Emanuel Rub...; Lu Xu; Rick M. Fairhurst; Sabrina Khan; Neelima Denduluri; Hope S. Rugo; Binghe Xu; Barbara Pistilli; ; Betiana Romitelli; Ernesto Korbenfeld; Cristian Buono; Arturo Barbero; Geronimo Rosselli; Sergio Daniele; Sandra Anabel Ost...; Hans Wildiers; Kevin Punie; Joëlle Collignon; Guy Jerusalem; Andrea Gombos; Giuliano Borges; Pedro Emanuel Rub...; Marcelle Cesca; Patricia Beato; Laura Testa; Helio Pinczowski; Liane Rapatoni; Debora Jardim; José Bines; David W. Cescon; Jamil Asselah; Andre Blais; Joanne Yu; Jennifer Friedmann; Cristiano Ferrario; Binghe Xu; Shusen Wang; Qingyuan Zhang; ZeFei Jiang; Zhongsheng Tong; Quchang Ouyang; Jingfen Wang; Tingjing Yao; Yongsheng Wang; Xiaojia Wang; Meili Sun; Hui Li; Shu Wang; Yuan Sheng; Aimin Zang; Zhanmin Zhang; Wenyan Chen; Xian Wang; Zhong Ouyang; Wei Li; Barbara Pistilli; Thomas Bachelot; Mony Ung; Cristian Villanueva; Delphine Garbay; Anne-Claire Hardy...; Audrey Mailliez; Stéphanie Becourt; William Mina; Thomas Decker; Julia Radosa; Andreas Schneeweiß; Michael Braun; Bahriye Aktas; Gábor Rubovszky; Zsuzsanna Pápai; Tibor Csőszi; Yousuf Al-Farhat; Ankit Patel; Vineet Gupta; Richu Sharma; Chandrakanth Mosa...; Shailesh Bondarde; Somnath Roy; Nikhil Ghadyalpatil; Lalit Sharma; Rajani Yedla; Michelino De Laur...; Ida Paris; Claudio Zamagni; Valentina Guarneri; Icro Meattini; Marco Colleoni; Giampaolo Bianchini; Ugo De Giorgi; Filippo Montemurro; Elena Geuna; Laura Biganzoli; Junji Tsurutani; Masaya Hattori; Yukinori Ozaki; Akihiko Shimomura; Naoki Niikura; Mitsuya Itoh; Tetsuhiko Taira; Toru Mukohara; Kenjiro Aogi; Tsutomu Iwasa; Eriko Tokunaga; Shigehira Saji; Nobuko Kawaguchi; Toshinari Yamashita; Kenichi Inoue; Takahiro Nakayama; Kenichi Watanabe; Masayuki Nagahashi; Kan Yonemori; Jan Drooger; Inge Konings; Agnès van de Wouw; Zbigniew Nowecki; Ewa Chmielowska; Iwona Danielewicz; Jacek Jassem; Ewa Kalinka; Bogumiła Czartory...; Bogusława Karasze...; Mariusz Kwiatkowski; Seock-Ah Im; Joo Hyuk Sohn; Yeon Hee Park; Keun Seok Lee; Kyung Hae Jung; Kyong Hwa Park; Jee Hung Kim; Daniil Stroyakovskiy; Elena Artamonova; Martha Mekebeb-Re...; Bernardo Rapoport; Elizabeth Schoeman; Maria Coccia-Port...; Rofhiwa Mathiba; Sonia Pernas; Noelia Martínez J...; Barbara Adamo; Begoña Bermejo de...; José Ángel García...; Manuel Ruiz Borrego; María Emilia Domí...; Begoña Jiménez Ro...; Silvia Antolín Novoa; Elena Galve Calvo; Javier Cortés Castán; Juan Lucas Bayo C...; Shin-Cheh Chen; Ling-Ming Tseng; Yen-Shen Lu; Wei-Pang Chung; Yuan-Ching Chang; Chien-Ting Liu; Hwei-Chung Wang; Kun-Ming Rau; Charles Comins; Jeremy Braybrooke; Annabel Borley; Ciara O'Brien; Caroline Michie; Peter Schmid; Sophie McGrath; Duncan Wheatley; Mukesh Mukesh; Sachin Trivedi; Syed Karim; Pavel Bezecny; Aditya Bardia; Hope S. Rugo; Kevin Kalinsky; Erika Hamilton; Komal Jhaveri; Yuan Yuan; Niki Patel; Joanne Mortimer; Sara Tolaney; Amy Vander Woude; Gail Wright; Fauzia Riaz; Apurva Pandey; Halle Moore; Masey Ross; Kelly McCann
• Keywords: Vinorelbine; Eribulin

PURPOSE The global, phase 3, open-label, randomized TROPION-Breast01 study assessed the trophoblast cell surface antigen 2–directed antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) versus investigator's choice of chemotherapy (ICC) in hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2–) breast cancer. METHODS Adult patients with inoperable/metastatic HR+/HER2‒ cancer, who had disease progression on endocrine therapy, for whom therapy was unsuitable, and received one to two previous lines setting, were randomly assigned 1:1 Dato-DXd (6 mg/kg once every 3 weeks) or ICC (eribulin/vinorelbine/capecitabine/gemcitabine). Dual primary end points progression-free survival (PFS) by blinded independent central review (BICR) overall (OS). RESULTS Patients (n = 365) 367). significantly reduced risk death (PFS BICR hazard ratio [HR], 0.63 [95% CI, 0.52 0.76]; P < .0001). Consistent PFS benefit observed across subgroups. Although OS data not mature, a trend favoring (HR, 0.84 0.62 1.14]). rate grade ≥3 treatment-related adverse events (TRAEs) lower than (20.8% v 44.7%). most common TRAEs (any grade; ≥3) nausea (51.1%; 1.4%) stomatitis (50%; 6.4%) neutropenia (grouped term, 42.5%; 30.8%) ICC. CONCLUSION receiving statistically significant clinically meaningful improvement favorable manageable safety profile, compared Results support as novel treatment option cancer have this setting.