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

NCT07357298 | Not Yet Recruiting Phase 3

• 1 other identifier: MCC-24030
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Treatment Characteristics of Brain Metastases

  Proportion of patients receiving surgery or whole-brain radiation therapy for brain metastases.

  Up to 24 Months

Secondary Outcomes (6)

• Frequency of Brain Metastases

  Up to 24 Months

• Leptomeningeal Disease Incidence

  Up to 24 Months

• Brain Metastases at Diagnosis

  Up to 24 Months

• Size of Largest Brain Metastasis

  Up to 24 Months

• Overall Survival After Brain Metastasis Diagnosis

  Up to 48 Months

Study Arms (2)

Surveillance Brain MRI

OTHER

Participants receive a baseline brain MRI followed by surveillance brain MRI every 6 months for 24 months.

Diagnostic Test: Surveillance Brain MRI

Standard of Care Brain Imaging

OTHER

Participants receive a baseline brain MRI followed by standard-of-care imaging only if neurologic symptoms develop.

Diagnostic Test: Standard of Care Brain Imaging

Interventions

Surveillance Brain MRI DIAGNOSTIC_TEST

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

Surveillance Brain MRI

Standard of Care Brain Imaging DIAGNOSTIC_TEST

Imaging performed only when clinically indicated.

Standard of Care Brain Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Florida Department of Health: collaborator
• Florida Biomedical Research Program - Bankhead Coley: collaborator

Study Sites (2)

Baptist Health South Florida

Miami, Florida, 33176, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kamran Ahmed, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rheese McNab

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 22, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (2)