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

NCT07357298 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-05-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Florida Department of Health

    collaborator OTHER_GOV

  • Florida Biomedical Research Program - Bankhead Coley

    collaborator UNKNOWN

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Kamran Ahmed, MD · Moffitt Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-25
Primary Completion
2030-02-28
Completion
2030-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07357298 on ClinicalTrials.gov