HER2+ CNS Surveillance
Recruiting · NCT07748598 · Interventional (participants receive a specific treatment) · Lead sponsor: The Clatterbridge Cancer Centre NHS Foundation Trust
View the official record on ClinicalTrials.gov →Interventions studied
Intervention for Arm 2: Brain MRI Surveillance
What this trial is about
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.
Who can take part
Age range
16 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- The Clatterbridge Cancer Centre NHS Foundation Trust - Liverpool, United Kingdom