Feasibility Study of CNS MRI Surveillance Versus No Routine Surveillance in Adults with HER2-Positive Metastatic Breast Cancer

What this Trial Is About

HER2-positive metastatic breast cancer has a high risk of spreading to the brain, which can cause serious symptoms like headaches, seizures, and cognitive changes. Although treatments targeting HER2 have improved control of cancer outside the brain, brain involvement remains a major concern. This study evaluates whether it is possible and acceptable to recruit patients and randomly assign them to routine brain MRI surveillance or standard care without routine brain imaging. Participants will receive a baseline contrast-enhanced brain MRI. Those without brain metastases on this scan will be randomly assigned to one of two groups one undergoes brain MRI surveillance at 6 and 12 months, and the other receives no routine brain imaging unless symptoms develop. If brain metastases are found at any time, treatment follows standard clinical practice. The study will follow participants for 14 months from the baseline scan. During the study, participants will be monitored for the development of brain metastases, symptoms related to brain involvement, treatments directed at brain metastases like surgery or radiotherapy, changes in systemic cancer therapy, and survival. Researchers will assess how many eligible patients agree to participate and be randomized. This information will help decide if a larger trial on brain surveillance in this patient group is feasible.

SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveillance