Brain MRI surveillance for HER2-positive metastatic breast cancer
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
Run by The Clatterbridge Cancer Centre NHS Foundation Trust · NCT07748598 · Data updated 2026-11-12
This study tests whether adding regular brain MRIs helps detect hidden brain involvement earlier in people with HER2-positive metastatic breast cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 69 (estimated) |
| Sponsor | The Clatterbridge Cancer Centre NHS Foundation Trust Academic / other |
| Locations | 1 site (Liverpool) |
| Status | Recruiting |
| Started | October 3, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT07748598 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (16+) with HER2-positive metastatic breast cancer, receiving HER2-directed therapy, and with ECOG 0-2 who can undergo MRI and provide consent.
✕Probably not a fit
Patients with or at risk of brain metastases at screening, or those unable to tolerate MRI, may not benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter randomized feasibility study compares baseline MRI with either two additional six-monthly brain MRIs or no further brain imaging in adults with HER2-positive metastatic breast cancer. An embedded qualitative sub-study will gather patient and clinician feedback to understand participation decisions and barriers. The trial aims to measure feasibility through the proportion of patients who consent to baseline MRI and to randomization, informing future diagnostic trials. Standard treatments for CNS metastases may be used as clinically appropriate. The study will monitor safety and collect data to guide the design of larger studies on brain surveillance in this patient group.
Why it matters
Potential benefit: If successful, regular brain MRI surveillance could enable earlier detection and management of brain metastases in HER2-positive patients.
How similar studies have gone: Previous work has explored CNS surveillance approaches, but this feasibility design with embedded qualitative components is relatively novel for this specific patient group.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom Recruiting
Study contacts
- Study coordinator: Carlo Palmieri
- Email: c.palmieri@nhs.net
- Phone: 0151 556 5000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.