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HER2+ CNS Surveillance
Sponsor: The Clatterbridge Cancer Centre NHS Foundation Trust
Summary
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.
Official title: HER2-CNS SURVEILLANCE: A Study of the Feasibility of Randomising Women and Men With HER2 Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus no Surveillance
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
69
Start Date
2025-10-03
Completion Date
2027-12-31
Last Updated
2026-08-05
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom