HER2+ CNS Surveillance Study
Research type
Research Study
Full title
A Study of the feasibility of randomising women and men with HER2 Positive metastatic breast cancer to Central Nervous System surveillance versus no surveillance
IRAS ID
341272
Contact name
Carlo Palmieri
Contact email
Sponsor organisation
The Clatterbridge Cancer Centre NHS Foundation Trust
Clinicaltrials.gov Identifier
CCR6034, Royal Marsden CTU internal reference
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Patients with metastatic breast cancer who are HER2+ (i.e. their cancer cells show an abnormally high level of HER2 proteins when tested) are at high risk of cancer spreading to the brain and central nervous system (CNS). The current standard of care is to monitor patients for symptoms indicative of such cancer spread. The motivation of the researchers is to investigate if surveillance through MRI scans of the brain with standard MRI contrast agents would allow detection of asymptomatic spread to the brain and CNS, and then earlier management of such spread. Metastatic lesions in the brain and CNS can be treated or managed, including by neurosurgery, stereotactic radiosurgery (radiotherapy highly focussed on the observed volume of lesions) or other radiotherapy treatment plans. The investigators are interested in surveillance plans of either a single MRI scan, or repeated MRI scans every 6 months for a year. The purpose of this research protocol is to look at the feasibility of running trials into the diagnostic value of such brain MRI scans. In order to assess the feasibility of such trials the primary research endpoint will be the proportion of patients agreeing to register to a study with baseline MRI and then randomisation to further MRIs or not. The proportion that agree and the feedback from patients about the reasons to participate or not will feed into the design and planning of future research protocols. There will be an embedded qualitative sub-study with interviews and/or focus groups discussing recruiting to and running such studies with patients and staff. The investigators also plan to collect data on diagnosis, management and clinical outcomes (given as secondary endpoints in the protocol) that will allow the outcomes for the patients on this study to be included in combined analyses with those of future studies.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
24/SC/0396
Date of REC Opinion
12 Feb 2025
REC opinion
Further Information Favourable Opinion