Trastuzumab deruxtecan in HER2-low metastatic breast cancer: long-term survival analysis of the randomized, phase 3 DESTINY-Breast04 trial

Shanu Modi; William Jacot; Hiroji Iwata; Yeon Hee Park; Maria Vidal Losada; Wei Li; Junji Tsurutani; Naoto T Ueno; Khalil Zaman; Aleix Prat; Konstantinos Papazisis; Hope S Rugo; Toshinari Yamashita; Nadia Harbeck; Seock-Ah Im; Michelino De Laurentiis; Jean-Yves Pierga; Xiaojia Wang; Andrea Gombos; Eriko Tokunaga; Cecilia Orbegoso Aguilar; Lotus Yung; Feng Xiao; Yingkai Cheng; David Cameron

doi:10.1038/s41591-025-03981-4

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Trastuzumab deruxtecan in HER2-low metastatic breast cancer: long-term survival analysis of the randomized, phase 3 DESTINY-Breast04 trial

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Trastuzumab deruxtecan in HER2-low metastatic breast cancer: long-term survival analysis of the randomized, phase 3 DESTINY-Breast04 trial

Shanu Modi, William Jacot, Hiroji Iwata, Yeon Hee Park, Maria Vidal Losada, Wei Li, Junji Tsurutani, Naoto T Ueno, Khalil Zaman, Aleix Prat, …

Nature medicine

08/10/2025

DOI: https://doi.org/10.1038/s41591-025-03981-4

PMID: 41062831

Résumé

In DESTINY-Breast04 ( NCT03734029 ), trastuzumab deruxtecan (T-DXd) significantly improved overall survival (OS) and progression-free survival compared with treatment of physician's choice of chemotherapy (TPC) for patients with human epidermal growth factor receptor 2-low (HER2-low) (immunohistochemistry (IHC) 1+ or IHC 2+/in situ hybridization-negative) metastatic breast cancer. After an extended median follow-up of 32.0 months, median OS in the overall cohort was 22.9 months for T-DXd and 16.8 months for TPC (hazard ratio 0.69; 95% confidence interval 0.55-0.86). For the hormone receptor-positive cohort, median OS was 23.9 and 17.6 months for T-DXd and TPC, respectively (hazard ratio 0.69; 95% confidence interval 0.55-0.87). Median OS also favored T-DXd in exploratory analyses of hormone receptor-negative, estrogen receptor IHC 1%-10% and estrogen receptor IHC >10% cohorts. The overall safety profile of T-DXd was acceptable and generally manageable. Results confirm T-DXd as standard of care after prior chemotherapy in patients with HER2-low metastatic breast cancer. ClinicalTrials.gov identifier: NCT03734029 .

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Titre: Trastuzumab deruxtecan in HER2-low metastatic breast cancer: long-term survival analysis of the randomized, phase 3 DESTINY-Breast04 trial
Créateurs - sans rôle: Shanu Modi - Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. modis@mskcc.org
William Jacot - Medical Oncology Department, Institut du Cancer de Montpellier, Université de Montpellier, INSERM U1194, Montpellier, France
Hiroji Iwata - Nagoya City University
Yeon Hee Park - Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
Maria Vidal Losada - Department of Medical Oncology, Hospital Clinic of Barcelona, Translational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain
Wei Li - First Hospital of Jilin University, Changchun, China
Junji Tsurutani - Showa University
Naoto T Ueno - University of Hawaiʻi at Mānoa
Khalil Zaman - Department of Oncology, Lausanne University Hospital CHUV, Lausanne, Switzerland
Aleix Prat - Clinic Barcelona Comprehensive Cancer Center, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain
Konstantinos Papazisis - Euromedica General Clinic, Thessaloniki, Greece
Hope S Rugo - Department of Medicine, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA
Toshinari Yamashita - Department of Breast Surgery and Oncology, Kanagawa Cancer Center, Yokohama, Japan
Nadia Harbeck - Breast Center, Department of Obstetrics and Gynecology and CCC Munich, LMU University Hospital, Munich, Germany
Seock-Ah Im - Seoul National University Hospital
Michelino De Laurentiis - Department of Breast and Thoracic Oncology, Istituto Nazionale Tumori IRCCS 'Fondazione G. Pascale', Naples, Italy
Jean-Yves Pierga - Department of Medical Oncology, Institut Curie, Paris and Université Paris Cité, Paris, France
Xiaojia Wang - Zhejiang Cancer Hospital, Hangzhou, China
Andrea Gombos - Medical Oncology Department, Institut Jules Bordet, Brussels, Belgium
Eriko Tokunaga - Department of Breast Oncology, NHO Kyushu Cancer Center, Fukuoka, Japan
Cecilia Orbegoso Aguilar - Global Oncology R&D, Daiichi Sankyo France SAS, Rueil-Malmaison, France
Lotus Yung - Clinical Development, Daiichi Sankyo Inc., Basking Ridge, NJ, USA
Feng Xiao - Biostatistics, Daiichi Sankyo, Inc., Basking Ridge, NJ, USA
Yingkai Cheng - Clinical Safety and Pharmacovigilance, Daiichi Sankyo Inc., Basking Ridge, NJ, USA
David Cameron - University of Edinburgh
Détails de publication: Nature medicine
Identifiants: 99140174909311
Unité académique: Institut de Recherche en Cancérologie de Montpellier - IRCM
Langue: English
Type de ressource: Journal article