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Study of Screening Brain MRIs in Stage IV Breast Cancer

RecruitingPhase 2

Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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

About the study

The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.

What is being tested

Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Participants: 170 · Started: Dec 21, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT05115474

Locations in the U.S.

FloridaMorton Plant Mease- Baycare, Clearwater

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.