RecruitingNCT07357298Updated May 15, 2026

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

A Phase 3 interventional study of Surveillance Brain MRI and Standard of Care Brain Imaging in Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 3, Interventional, and Screening

From the registry’s dates

Started Feb 2026; still recruiting 7 months later.

Phase: Phase 3
Study type: Interventional
Enrollment: 156
Allocation: Randomized
Ages: 18 Years and older
Sex: All

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 studied

Breast Cancer

Browse trials for

Breast Neoplasms 12,543

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 156 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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)

Study design

Phase: Phase 3
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 156 participants (estimated)

Study arms

Other
Surveillance Brain MRI
Participants receive a baseline brain MRI followed by surveillance brain MRI every 6 months for 24 months.
Diagnostic Test: Surveillance Brain MRI
Other
Standard of Care Brain Imaging
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

Diagnostic testSurveillance Brain MRI
Routine scheduled MRI imaging at baseline and at 6-month intervals.
Diagnostic testStandard of Care Brain Imaging
Imaging performed only when clinically indicated.

What researchers measure

Primary outcomes

Treatment Characteristics of Brain Metastases
Proportion of patients receiving surgery or whole-brain radiation therapy for brain metastases.
Time frame: Up to 24 Months

Secondary outcomes

Frequency of Brain Metastases
The frequency of metastasis detection over the 24-month screening/follow-up period.
Time frame: Up to 24 Months
Leptomeningeal Disease Incidence
Incidence of radiographic detection of leptomeningeal disease.
Time frame: Up to 24 Months
Brain Metastases at Diagnosis
Average number of lesions on diagnostic MRI.
Time frame: Up to 24 Months
Size of Largest Brain Metastasis
Average size of largest brain metastasis.
Time frame: Up to 24 Months
Overall Survival After Brain Metastasis Diagnosis
Time from brain metastasis diagnosis to death from any cause.
Time frame: Up to 48 Months
Brain Metastasis Specific Survival
Time from brain metastasis diagnosis to death attributable to brain metastases.
Time frame: Up to 48 Months

Study locations

1 of 2 sites recruiting

Baptist Health South Florida
Miami, Florida 33176, United States
- Rupesh Kotecha, MD · Principal investigator
- Reshma Mahtani, MD · Principal investigator
Not yet recruiting
Moffitt Cancer Center
Tampa, Florida 33612, United States
- Kamran Ahmed, MD · Principal investigator
Recruiting

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07357298
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Florida Department of Health, Florida Biomedical Research Program - Bankhead Coley
Responsible party: Sponsor
First posted: Jan 22, 2026
Start date: Feb 25, 2026
Primary completion: Feb 2030 (estimated)
Completion: Feb 2030 (estimated)
Last update: May 15, 2026

Study contacts

Rheese McNab

Contact

Rheese.McNab@moffitt.org

813-745-1780

Kamran Ahmed, MD

principal investigator · Moffitt Cancer Center

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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