Clinical Trial

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

Study acronym: TUXEDO-4
Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2023-09-20; most recent amendment 2026-05-04.
Status change: Recruiting → Active, Not Recruiting 2026-03-06
Status change: Not Yet Recruiting → Recruiting 2024-06-21
Trial Details
NCT Number NCT06048718
Lead Sponsor MedSIR
Collaborators: Daiichi Sankyo
Conditions Breast Cancer, Metastatic Breast Cancer
Enrollment 28 participants
Start Date 2024-06-05
Primary Completion 2026-11 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2026-05-08