Chief Investigator - Prof Carlo Palmieri
Chief Investigator - Dr Sara Meade
Co-Investigator - Dr Helena Harder
Co-Investigator - Prof Val Jenkins
Funder: Make 2nds Count
HER2+ CNS Surveillance
The development of brain metastases in HER2 positive secondary breast cancer is associated with a worse overall survival. There is a need to test and explore surveillance strategies that enable early detection of asymptomatic CNS disease.
This study will investigate if it is acceptable to women and men with HER2 positive secondary breast cancer with no history of brain metastases to be randomised to surveillance via MRI scanning versus no surveillance (the current standard of care). All participants will have an initial MRI scan at baseline, to see if brain metastases are present, and will then be randomised. MRI surveillance will comprise of 6-monthly scans for 1 year.
SHORE-C is responsible for the embedded qualitative sub-study. We will interview a sample of participants to explore their views and decisions around study participation, such as being randomly allocated to screening and possible implications for every-day life. We will also interview healthcare professionals involved in this study to identify potential challenges with study implementation and delivery. This information is important when designing and running a larger randomised trial in the future.
A total of 69 patients will be recruited from 6 different cancer centres across the UK (Liverpool, Birmingham, London, Manchester, Edinburgh and Cardiff) and The Republic of Ireland (Dublin). The study is anticipated to run for 36 months, with recruitment starting in Spring 2025.
Current Stage:
In setup