Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer
This randomized, multi-institutional phase III trial evaluates whether routine surveillance brain MRI every 6 months improves detection and treatment characteristics of brain metastases in neurologically asymptomatic patients with stage IV breast cancer. Patients are stratified by receptor subtype, age, prior therapy, and study site, then randomized 1:1 to either scheduled surveillance MRIs or standard-of-care symptom-triggered imaging. The study aims to determine whether earlier detection leads to differences in treatment modality, frequency of brain metastases, leptomeningeal disease incidence, quality of life, and survival outcomes.
• 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