T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases

Summary

TUXEDO-4 is an international, multicentric, single arm, phase II study aiming to gather additional solid evidence of Trastuzumab-Deruxtecan (T-DXd) activity in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-low breast cancer with active brain metastases. This study will analyze the efficacy of T-DXd as determined by overall response rate (ORR) at any timepoint as judged by best CNS response according to RANO-BM criteria.

Timeline

Start

2024-06-05

Primary completion

2026-11

Completion

2026-11

Publications

• Marhold M, Vaz Batista M, Blancas I, Morales C, Saura-Manich C, Saavedra C, Ruiz-Borrego M, Cortez P, Slebe F, Campolier M, Santos JC, Guerrero-Martinez JA, Jimenez-Cortegana C, Rottenmanner B, Forstner H, Bartsch R, Preusser M. TUXEDO-4: phase II study of trastuzumab-deruxtecan in HER2-low breast cancer with new or progressing brain metastases. Future Oncol. 2025 Apr;21(9):1065-1073. doi: 10.1080/14796694.2025.2470604. Epub 2025 Feb 28.

Drugs

Indications