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

NCT07357298•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status
•Radiographic evidence of stage IV extracranial disease enrolled within 60 days of diagnosis or starting first line therapy. HR+/HER2- patients may be enrolled within 60 days of starting 2nd line therapy as well.
•HR+ will be defined as ER and/or PR \> 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO / CAP Guidelines41. Triple negative will be classified as ER and PR \<10% and HER2-.
•Age ≥ 18
•Life expectancy ≥ 6 months
•Eastern Cooperative Oncology Group performance status ≤ 2
•Patients must be able to understand and the willingness to sign an informed consent for study procedures
•Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

•Prior diagnosis or treatment of brain metastases or leptomeningeal disease
•History of other non-breast malignancy requiring treatment with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of \> 90%), such as but not limited to, non-melanoma skin cancers, stage I endometrioid uterine cancer, and others at the discretion of the PI
•Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment
•Indications warranting brain MRI for other neurologic conditions at time of study entry (including multiple sclerosis, stroke, traumatic brain injuries, epilepsy, hydrocephalus and pituitary gland disorders)
•Contraindication towards MRI with contrast
•Chronic kidney disease stage IV or V or end stage renal disease (CrCl \<30 ml/min)

Locations (2)

Baptist Health South Florida

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Key Dates

Start Date

February 1, 2026

Primary Completion Date

February 1, 2030

Completion Date

February 1, 2030

Last Updated

January 22, 2026

Enrollment

156

ESTIMATED participants

Conditions

Breast Cancer

Interventions

Surveillance Brain MRI

DIAGNOSTIC_TEST

Standard of Care Brain Imaging

DIAGNOSTIC_TEST

Contacts

Rheese McNab

CONTACT

813-745-1780 Rheese.McNab@moffitt.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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