Phase III trial of brain MRI surveillance in stage IV breast cancer.

Abstract

TPS1160 Background: The incidence and prevalence of breast cancer patients who develop brain metastasis is increasing. Intracranial surveillance of asymptomatic stage IV breast cancer patients with brain MRIs is not currently recommended by the National Comprehensive Cancer Network (NCCN) Guidelines. In a previously conducted phase II brain MRI surveillance trial, approximately 25% of patients with stage IV breast cancer, independent of tumor subtype, were found to have newly detected brain metastases on the 6-month follow-up MRI from study entry. Methods: The study is designed as a randomized phase III, multi-institutional prospective trial evaluating the role of surveillance brain MRIs in neurologically asymptomatic patients with metastatic breast cancer, based on subtypes (triple negative (TN), HER2+, and hormone receptor (HR)+ breast cancer). Following study enrollment, patients will be randomized in a 1:1 fashion to surveillance brain MRIs at baseline and q6 months for 24 months compared to a baseline MRI followed by standard-of-care brain MRI surveillance for symptomatic presentation. Newly diagnosed stage IV patients (within ≤ 60 days of starting systemic therapy for HER2+ or TN or within ≤ 60 days of initiating 1 st or 2 nd line therapy for HR+/HER2- disease) with an ECOG ≤ 2 and life expectancy ≥ 6 months are eligible. The primary objective is to evaluate the treatment characteristics of brain metastases diagnosed via brain MRI surveillance or standard of care imaging. Secondary objectives include the frequency of asymptomatic brain metastases and leptomeningeal disease, the number and size of brain metastases at diagnosis, quality of life, and overall and brain metastases specific survival following brain metastasis diagnosis in patients randomized to brain MRI surveillance compared to standard of care imaging. A total of 156 patients will be enrolled with an equal distribution of TN, HER2+, and HR+/HER2- subtypes, respectively. Funding: Florida Department of Health. Clinical trial information: NCT07357298 .