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Study of Screening Brain MRIs in Stage IV Breast Cancer

Study of Screening Brain MRIs in Stage IV Breast Cancer

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

Study details
    Triple Negative Breast Cancer
    HER2-positive Breast Cancer
    Hormone Receptor-positive Breast Cancer

NCT05115474

H. Lee Moffitt Cancer Center and Research Institute

14 October 2025

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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