DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease

Summary

This is a multicenter, international, open-label, single-arm, multicohort, two-stage optimal Simon's design, phase II clinical trial

Timeline

Start

2020-05-25

Primary completion

2021-09-30

Completion

2023-04-04

Outcome

Met primary endpoint

paper The median OS was 13.3 months (95% confidence interval [CI], 5.7-NA, p < 0.001), meeting the primary endpoint. PMID 39265579 ↗

Publications

• Vaz Batista M, Perez-Garcia JM, Garrigos L, Garcia-Saenz JA, Cortez P, Racca F, Blanch S, Ruiz-Borrego M, Fernandez-Ortega A, Fernandez-Abad M, Iranzo V, Gion M, Martrat G, Alcala-Lopez D, Perez-Escuredo J, Sampayo-Cordero M, Llombart-Cussac A, Braga S, Cortes J. The DEBBRAH trial: Trastuzumab deruxtecan in HER2-positive and HER2-low breast cancer patients with leptomeningeal carcinomatosis. Med. 2025 Jan 10;6(1):100502. doi: 10.1016/j.medj.2024.08.001. Epub 2024 Sep 11.
• Vaz Batista M, Perez-Garcia JM, Cortez P, Garrigos L, Fernandez-Abad M, Gion M, Martinez-Bueno A, Saavedra C, Teruel I, Fernandez-Ortega A, Servitja S, Ruiz-Borrego M, de la Haba-Rodriguez J, Martrat G, Perez-Escuredo J, Alcala-Lopez D, Sampayo-Cordero M, Braga S, Cortes J, Llombart-Cussac A. Trastuzumab deruxtecan in patients with previously treated HER2-low advanced breast cancer and active brain metastases: the DEBBRAH trial. ESMO Open. 2024 Sep;9(9):103699. doi: 10.1016/j.esmoop.2024.103699. Epub 2024 Sep 9.

Drugs

Indications