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

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.

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