Study of Screening Brain MRIs in Stage IV Breast Cancer

  • End date
    Aug 31, 2023
  • participants needed
  • sponsor
    H. Lee Moffitt Cancer Center and Research Institute
Updated on 6 May 2022
stage iv breast cancer


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.

Condition Triple Negative Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-positive Breast Cancer
Treatment magnetic resonance imaging
Clinical Study IdentifierNCT05115474
SponsorH. Lee Moffitt Cancer Center and Research Institute
Last Modified on6 May 2022


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Inclusion Criteria

Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status
Radiographic evidence of stage IV extracranial disease having progressed past first line therapy
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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