H. Lee Moffitt Cancer Center and Research Institute
With
Florida Department of Health
Florida Biomedical Research Program - Bankhead Coley
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status
Radiographic evidence of stage IV extracranial disease enrolled within 60 days of diagnosis or starting first line therapy. HR+/HER2- patients may be enrolled within 60 days of starting 2nd line therapy as well.
HR+ will be defined as ER and/or PR \> 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO / CAP Guidelines41. Triple negative will be classified as ER and PR \<10% and HER2-.
Age ≥ 18
Life expectancy ≥ 6 months
Eastern Cooperative Oncology Group performance status ≤ 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
You may not be if
Prior diagnosis or treatment of brain metastases or leptomeningeal disease
History of other non-breast malignancy requiring treatment with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of \> 90%), such as but not limited to, non-melanoma skin cancers, stage I endometrioid uterine cancer, and others at the discretion of the PI
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 (including multiple sclerosis, stroke, traumatic brain injuries, epilepsy, hydrocephalus and pituitary gland disorders)
Contraindication towards MRI with contrast
Chronic kidney disease stage IV or V or end stage renal disease (CrCl \<30 ml/min)
Clareo Health | Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer
