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Study of Screening Brain MRIs in Stage IV Breast Cancer

RECRUITINGSponsored by H. Lee Moffitt Cancer Center and Research Institute
Actively Recruiting
SponsorH. Lee Moffitt Cancer Center and Research Institute
Started2021-12-21
Est. completion2026-04-17
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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