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Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2026-02
Completion Date
2030-02
Last Updated
2026-01-22
Healthy Volunteers
No
Conditions
Interventions
Surveillance Brain MRI
Routine scheduled MRI imaging at baseline and at 6-month intervals.
Standard of Care Brain Imaging
Imaging performed only when clinically indicated.
Locations (2)
Baptist Health South Florida
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States