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Recruiting NCT05115474

Study of Screening Brain MRIs in Stage IV Breast Cancer

Trial Parameters

Condition Triple Negative Breast Cancer
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Study Type OBSERVATIONAL
Phase N/A
Enrollment 170
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-12-21
Completion 2026-04-17
Interventions
Magnetic Resonance Imaging

Brief 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 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 neurol

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