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Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer

StatusRecruiting
PhasePhase 3
Started2026-02-25
View on ClinicalTrials.gov ↗

Amendment history

2026-05-14
notable
Study Status, Contacts/Locations v1
Recruitment opened
Start dateestimated 2026-02→confirmed 2026-02-25
Study sitesdetails revised at 2 of 2 sites
2026-01-12
minor
Original filing
This randomized, multi-institutional phase III trial evaluates whether routine surveillance brain MRI every 6 months improves detection and treatment characteristics of brain metastases in neurologically asymptomatic patients with stage IV breast cancer. Patients are stratified by receptor subtype, age, prior therapy, and study site, then randomized 1:1 to either scheduled surveillance MRIs or standard-of-care symptom-triggered imaging. The study aims to determine whether earlier detection leads to differences in treatment modality, frequency of brain metastases, leptomeningeal disease incidence, quality of life, and survival outcomes.
Trial Details
NCT Number NCT07357298
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Florida Department of Health, Florida Biomedical Research Program - Bankhead Coley
Conditions Breast Cancer
Enrollment 156 participants
Start Date 2026-02-25
Primary Completion 2030-02 (estimated)
Study Completion 2030-02 (estimated)
Updated on ClinicalTrials.gov 2026-05-15