TROPION-Breast01: Datopotamab deruxtecan vs chemotherapy in pre-treated inoperable or metastatic HR+/HER2– breast cancer

Author:

Bardia Aditya1ORCID,Jhaveri Komal23,Kalinsky Kevin4,Pernas Sonia5ORCID,Tsurutani Junji6,Xu Binghe7,Hamilton Erika8,Im Seock-Ah9,Nowecki Zbigniew10,Sohn Joohyuk11,Laurentiis Michelino De12,Jañez Noelia Martínez13,Adamo Barbara14,Lee Keun Seok15,Jung Kyung Hae16,Rubovszky Gábor17ORCID,Tseng Ling-Ming18,Lu Yen-Shen19,Yuan Yuan20,Maxwell Micah J21,Haddad Vincent22,Khan Sabrina S21,Rugo Hope S23,Pistilli Barbara24

Affiliation:

1. Massachusetts General Hospital Cancer Center, Boston, MA, USA

2. Memorial Sloan Kettering Cancer Center, New York, NY, USA

3. Weill Cornell Medical College, New York, NY, USA

4. Winship Cancer Institute at Emory University, Atlanta, GA, USA

5. Institut Català d'Oncologia, IDIBELL, L'Hospitalet, Barcelona, Spain

6. Showa University Hospital, Tokyo, Japan

7. National Cancer Center / National Clinical Research Center for Cancer / Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China

8. Sarah Cannon Research Institute / Tennessee Oncology, Nashville, TN, USA

9. Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, Seoul, Republic of Korea

10. Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland

11. Yonsei University College of Medicine, Seoul, Republic of Korea

12. Istituto Nazionale Tumori Napoli IRCCS “Fondazione Pascale”, Napoli, Italy

13. Ramón y Cajal University Hospital, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain

14. August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clinic, University of Barcelona, Barcelona, Spain

15. Center for Breast Cancer, National Cancer Center, Goyang, Republic of Korea

16. Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

17. National Institute of Oncology, Budapest, Hungary

18. Comprehensive Breast Health Center, Taipei Veterans General Hospital, Taipei, Taiwan

19. National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan

20. Formerly City of Hope Comprehensive Cancer Center, Duarte, CA, USA; Currently: Cedars-Sinai Cancer Center, Los Angeles, CA, USA

21. AstraZeneca, Gaithersburg, MD, USA

22. AstraZeneca, Cambridge, UK

23. University of California San Francisco Comprehensive Cancer Center, San Francisco, CA, USA

24. Gustave Roussy Cancer Center, Villejuif, France

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 )

Funder

AstraZeneca

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

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