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Trastuzumab Deruxtecan + Stereotactic Radiosurgery (SRS) in HER2+ Breast Cancer Brain Metastases

StatusNot Yet Recruiting
PhasePhase 1
Started2027-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jul 2028 → Feb 2029
See other at-risk trials from Baptist Health South Florida

Amendment history

2026-10-02
critical
Primary completion pushed: 2028-07 → 2029-02
Completion pushed: 2029-07 → 2030-02
A phase I clinical trial (a type of research study) for people with human epidermal growth factor receptor 2 (HER-2) positive breast cancer with metastasis to the brain. This research study will evaluate how well brain metastases can be controlled using a type of radiation therapy known as stereotactic radiosurgery (SRS) when combined with the therapeutic agent Trastuzumab Deruxtecan (T-DXd). The combined use of SRS with T-DXd is considered investigational.
Trial Details
NCT Number NCT07454668
Lead Sponsor Baptist Health South Florida
Collaborators: National Brain Tumor Society
Conditions Breast Cancer, HER2-positive Breast Cancer, Brain Metastases, Cancer, Cancer Metastatic
Enrollment 20 participants
Start Date 2027-01
Primary Completion 2029-02 (estimated)
Study Completion 2030-02 (estimated)
Updated on ClinicalTrials.gov 2026-10-01