NCT07357298

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2030-02-01
• Completion: 2030-02-01
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

2 sites across 1 country: United States