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NOT YET RECRUITING
NCT07357298
PHASE3

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

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

Surveillance Brain MRI

Routine scheduled MRI imaging at baseline and at 6-month intervals.

DIAGNOSTIC_TEST

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