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Phase III Brain MRI Surveillance for Stage IV Breast Cancer

This study is a Phase III trial for people with stage IV breast cancer. It's testing if having regular brain MRI scans (magnetic resonance imaging) every six months, called Surveillance Brain MRI, is better than only getting brain imaging when symptoms appear (Standard of Care Brain Imaging). The goal is to see if finding brain metastases (cancer spread to the brain) earlier changes how they are treated, how often they occur, if leptomeningeal disease (cancer cells in the fluid around the brain and spinal cord) develops, and impacts quality of life and survival. You can join if you are 18 or older, have stage IV breast cancer, and your cancer's ER/PR/HER2 status is known. The study is looking for 156 participants, but its current recruitment status is unclear.

Study design
This is a randomized Phase III study with 156 planned participants. You would be randomly assigned to one of two groups: scheduled brain MRIs or symptom-triggered imaging.
What's involved
If you are in the surveillance group, you would have brain MRI scans at the start and then every six months. The primary endpoint is measured for up to 24 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Treatment Characteristics of Brain Metastases, is measured for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07357298

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

Recruiting
PHASE3Ages 18+InterventionalScreening
H. Lee Moffitt Cancer Center and Research Institute
~156 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Surveillance Brain MRIStandard of Care Brain Imaging

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment Characteristics of Brain Metastases
Measured over Up to 24 Months

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

2 sites across 1 states
Florida2

Study leadership

  • Kamran Ahmed, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Rheese McNab
[email protected]
813-745-1780
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Treatment Characteristics of Brain MetastasesUp to 24 Months

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