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Study of Screening Brain MRIs in Stage IV Breast Cancer

RECRUITINGPhase 2Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Actively Recruiting
PhasePhase 2
SponsorH. Lee Moffitt Cancer Center and Research Institute
Started2021-12-21
Est. completion2026-06-16
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions5

Breast CancerCancerHER2-positive Breast CancerHormone Receptor Positive Breast CancerTriple Negative Breast Cancer

Locations2 sites

Morton Plant Mease- Baycare
Clearwater, Florida, 33756
Ronica H. Nanda, MDRonica.Nanda@baycare.org
Moffitt Cancer Center
Tampa, Florida, 33612

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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