ClinicaliQ Trial Snapshot
- HER2+ CNS Surveillance — Recruiting • Non-phase study • Oncology • NCT07748598.
- What is being tested: The feasibility of implementing regular brain MRI surveillance (baseline plus two six-monthly scans) versus no surveillance in patients with metastatic HER2-positive breast cancer to detect central nervous system (CNS) involvement and assess whether early detection improves outcomes.
- Patient eligibility overview: Men and women with metastatic HER2-positive breast cancer are eligible for randomisation after a baseline MRI scan, though specific inclusion/exclusion criteria regarding stage, prior CNS disease, and treatment history would determine final suitability.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.