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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
View on ClinicalTrials.gov →
NCT05115474
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
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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
View on ClinicalTrials.gov →
NCT05115474