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HER2+ CNS Surveillance

RecruitingNAAges 16 Years - anyAllThe Clatterbridge Cancer Centre NHS Foundation Tr…
NCT07748598 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria Age 16 years or older. Male or female. Histologically or cytologically confirmed HER2-positive breast cancer with evidence of metastatic breast cancer. Estrogen receptor (ER) positive or negative disease. Visceral disease present. Receiving active HER2-directed therapy. ECOG Performance Status 0-2. Life expectancy greater than 6 months. Written informed consent and ability to comply with study procedures and follow-up. Exclusion Criteria History of brain metastases. History or evidence of leptomeningeal carcinomatosis. Symptoms suggestive of brain metastases. Inability to tolerate or undergo MRI scans. Bone-only metastatic disease. Significant medical condition or laboratory finding that would make study participation undesirable. Inability to provide informed consent.
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What it tests

  • Intervention for Arm 2: Brain MRI Surveillance
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Where

1 site
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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