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.
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
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
Single group
Magnetic Resonance Imaging
Diagnostic testParticipants will undergo MRI imaging with and without contrast.
Rate of Brain Metastasis
Rate of brain metastasis by breast cancer subtype at baseline using MRI images.
Rate of Brain Metastasis
Rate of brain metastasis by breast cancer subtype at 6 months or first systemic progression using MRI images.
Rate of Asymptomatic Leptomeningeal Disease
Rate of asymptomatic leptomeningeal disease by breast cancer subtype at baseline and at 6 months or first systemic progression, using MRI images.
Number of Brain Metastases
Number of Brain Metastases at Diagnosis by Breast Cancer Subtype, using MRI images.
Overall Survival
Overall Survival (OS) will be measured from the initial on study date to the recorded date of death.
Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation
Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation by breast cancer type.
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H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Florida Breast Cancer Foundation
Collaborator
