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Screening Brain MRIs in Stage IV Breast Cancer

This study is looking at whether screening brain MRIs (Magnetic Resonance Imaging) can help find brain metastases (cancer that has spread to the brain) in people with stage IV breast cancer. You might be able to join if you have triple negative, HER2-positive, or hormone receptor-positive breast cancer that has spread, and you are at least 18 years old. You should also have a life expectancy of at least 6 months and a good performance status (meaning you can do most daily activities). The study will measure how many people have brain metastases at the beginning and up to 6 months later. The current recruitment status is unclear.

Study design
This is a single-arm, non-randomized phase II study, meaning all participants will receive the same intervention. It plans to enroll 170 participants.
What's involved
Participants will undergo MRI imaging with and without contrast. The study will measure brain metastasis at baseline and up to 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for brain metastasis up to 6 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.

NCT05115474

Study of Screening Brain MRIs in Stage IV Breast Cancer

Recruiting
PHASE2Ages 18+InterventionalScreening
H. Lee Moffitt Cancer Center and Research Institute
~170 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:Magnetic Resonance 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
Rate of Brain Metastasis
Measured over at Baseline
+1 more outcome measured

Conditions

Triple Negative Breast Cancer
HER2-positive Breast Cancer
Hormone Receptor-positive Breast Cancer

Explore related trials

HER2-Positive Breast CarcinomaHormone Receptor-Positive Breast CarcinomaTriple-negative breast cancer

Where it's being run

2 sites across 1 states
Florida2

Study leadership

  • Kamran A Ahmed, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Robin Dowell
[email protected]
813-745-0393
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 diease having progressed past first line therapy in HR+/HER2- patients
Radiographic evidence of stage IV extracranial disease in TN and HER2+ patients
Age ≥ 18
Life expectancy ≥ 6 months
Eastern Cooperative Oncology Group performance status 0 to 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
Patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years
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
Contraindication towards MRI imaging with contrast
Chronic kidney disease stage IV or V or end stage renal disease

What this trial measures

  • Rate of Brain Metastasisat Baseline

    Rate of brain metastasis by breast cancer subtype at baseline using MRI images.

  • Rate of Brain Metastasisup to 6 months

    Rate of brain metastasis by breast cancer subtype at 6 months or first systemic progression using MRI images.