HER2+ CNS Surveillance

Conditions studied

Her 2 Positive Breast Cancer, Cancer, CNS

About this study

A multi-centre, randomised study, to determine the feasibility of recruiting men and women with metastatic HER2 positive breast cancer to a study with a baseline MRI scan followed by randomising to surveillance by two further six-monthly MRI scans versus no further surveillance of the brain. Qualitative research (focus groups and/or interviews) and monitoring of approach and consent with SEAR framework will be embedded within the trial to achieve the primary endpoint and explore challenges with study implementation and delivery.

Interventions

• Diagnostic Test: Intervention for Arm 2: Brain MRI Surveillance — Contrast-enhanced magnetic resonance imaging (MRI) of the brain performed at baseline and, for participants assigned to the surveillance arm, repeated at 6 and 12 months to detect asymptomatic CNS metastases

Primary outcomes

• Proportion of eligible participants agreeing to undergo screening and randomisation to surveillance versus no surveillance brain MRI. (Up to 24 months (from first participant approach until recruitment completion, defined as 69 participants consented or 193 participants approached, whichever occurs first))