RecruitingNot ApplicableNCT07748598

HER2+ CNS Surveillance

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


Sponsor

The Clatterbridge Cancer Centre NHS Foundation Trust

Enrollment

69 participants

Start Date

Oct 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Intervention for Arm 2: Brain MRI Surveillance for people with cns, cancer, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 16 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTIntervention 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

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NCT07748598


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