Abstract OT3-19-01: Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer
Authors: Ahmed Kamran A. , Kim Youngchul , Armaghani Avan , Arrington John , Costa Ricardo , Czerniecki Brian J. , Diaz Roberto , Forsyth Peter A. , Khong Hung , Lee Kimberley , Loftus Loretta , Rosa Marilin , Soliman Hatem H. , Washington Iman , Soyano Aixa , Han Hyo S. 
Published: March 2023

Abstract
Background: As systemic therapy improves, there has been an increasing number of breast cancer patients who develop brain metastasis. Screening of asymptomatic stage IV breast cancer patients with brain MRIs is not currently recommended by the National Comprehensive Cancer Network (NCCN) Guidelines. Retrospective reports suggest breast cancer patients are more likely to present with more advanced central nervous system disease at the time of brain metastasis diagnosis compared to melanoma and non-small cell lung cancer (NSCLC) patients. This may be in part due to routine screening recommendations in melanoma and NSCLC. Early detection and treatment of brain metastases may improve outcomes for breast cancer patients. Trial Design: The study is designed as a single arm, nonrandomized phase II study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer. Breast cancer patients will be allocated based on receptor subtypes into triple negative (TN), HER2+, and hormone receptor (HR)+/HER2- breast cancer. Following study enrollment, patients will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner. Eligibility: Asymptomatic, stage IV breast cancer patients that have progressed past first line therapy in the metastatic setting with an ECOG/= 6 months are eligible. Specific Aims: The primary objective is to determine the incidence of asymptomatic brain metastasis in metastatic breast cancer by subtype. Secondary objectives include determining the incidence of asymptomatic leptomeningeal disease, the number and size of brain metastases at diagnosis, the number of patients requiring whole brain radiation therapy vs. stereotactic radiation following diagnosis and overall survival and brain metastasis specific survival following brain metastasis diagnosis in metastatic breast cancer by subtype. Statistical Methods: A total of 30, 30, and 40 TN, HER2+, and HR+/HER2-, breast cancer patients will be enrolled, respectively. Using an incidence rate of 17%, the 95% CI by subtype will be (0.06,0.351), (0.06,0.351), and (0.07,0.322). Patient Accrual: This study is open with 30 patients enrolled at the time of submission. A total of 100 patients will be enrolled. Contact Information: Kamran A. Ahmed MD, Moffitt Cancer Center, email: kamran.ahmed@moffitt.org, Clinical trial information: NCT05115474. Funding: Florida Breast Cancer Foundation.
Citation Format: Kamran A. Ahmed, Youngchul Kim, Avan Armaghani, John Arrington, Ricardo Costa, Brian J. Czerniecki, Roberto Diaz, Peter A. Forsyth, Hung Khong, Kimberley Lee, Loretta Loftus, Marilin Rosa, Hatem H. Soliman, Iman Washington, Aixa Soyano, Hyo S. Han. Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT3-19-01.