NCT05115474PHASE2Recruiting
Study of Screening Brain MRIs in Stage IV Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute
Start Date
12/21/2021
Completion Date
10/1/2026
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
Age Range: 18 years to No maximum
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
Interventions
DIAGNOSTIC_TEST
Magnetic Resonance Imaging
Conditions
Triple Negative Breast CancerHER2-positive Breast CancerHormone Receptor-positive Breast Cancer
Locations
Morton Plant Mease- Baycare
Clearwater, Florida 33756
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States