| NCT ID | NCT07748598 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Clatterbridge Cancer Centre NHS Foundation Trust |
| Condition | Her 2 Positive Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 69 participants |
| Start Date | 2025-10-03 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 69 participants in total. It began in 2025-10-03 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07748598 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Her 2 Positive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07748598 currently recruiting?
Yes, NCT07748598 is actively recruiting participants. Contact the research team at c.palmieri@nhs.net for enrollment information.
Where is the NCT07748598 trial being conducted?
This trial is being conducted at Liverpool, United Kingdom.
Who is sponsoring the NCT07748598 clinical trial?
NCT07748598 is sponsored by The Clatterbridge Cancer Centre NHS Foundation Trust. The trial plans to enroll 69 participants.
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