Personalised Disease Monitoring in Metastatic Breast Cancer (PDM-MBC)
Research type
Research Study
Full title
Personalised disease monitoring during treatment with an aromatase inhibitor + CDK4/6 inhibitor as 1st line endocrine therapy in patients with ER-positive/HER2-negative metastatic breast cancer
IRAS ID
254239
Contact name
Sacha Howell
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 11 months, 28 days
Research summary
When breast cancer spreads to other organs such as the bones, liver or lungs it is called metastatic breast cancer (MBC). Unfortunately MBC cannot be cured. However, drug treatments can be very successful in controlling MBC, sometimes for many years. The standard approach to monitoring patient progress on drug treatments involves CT (computer tomography) scans. These scans are very labour intensive, may be unpleasant for the individual and deliver a dose of ionising radiation which could induce a second cancer years later. The purpose of this study is to try and identify markers in the blood that would determine whether an individual’s cancer was controlled or not and, therefore, whether a scan was really required. Patients with MBC starting their first therapy with a hormone therapy and additional drug called a cyclin dependent kinase 4/6 inhibitor will be asked whether they wish to take part. If so they will receive their drug treatments entirely as normal, according to existing guidelines. CT scans will be performed every 3-4 months as is standard practice. However, additional blood tests will be taken before treatment starts, after 2 and 4 weeks and then at every scan. The blood tests will be analysed by a specialized laboratory in Sweden using an assay called TK1 (thymidine kinase 1) which show promise in identifying those responding well to this kind of treatment. By collecting samples rigorously at every time point we will work out whether the change in blood levels of the TK1 biomarker can predict the outcome of each scan and ultimately when the cancer becomes active after a period of control. Hopefully, we can show that unnecessary scans can be safely avoided by using disease monitoring based on blood tests alone. Samples will also be stored such that novel biomarkers can be analysed on this cohort in the future, without having to repeat the whole study.
REC name
West of Scotland REC 3
REC reference
19/WS/0012
Date of REC Opinion
15 Feb 2019
REC opinion
Further Information Favourable Opinion