Early detection of breast cancer in women with a familial or genetic predisposition of developing breast cancer using biomarkers in serum

The purpose of a screening program is to identify breast cancer at an early stage before (regional) metastatic spread with the aim of improving the survival time of patients. However, currently, still a lot of cancer cases are missed. Especially in the high-risk group, mammography has a low performance and high numbers of interval cancers are being reported. The use of MRI next to mammography may improve the sensitivity in this group, but the specificity is variable, the technique is time-consuming and costs are high. Thus, there is a need to improve the screening for the early detection of breast cancer.
A specific and more sensitive addition to these imaging-based techniques could be the use of proteomic biomarkers. Therefore, in this study, the aim is to identify prediagnostic changes in protein biomarker levels between serial samples from the same study subject and between study subjects (cases and controls) and to identify a panel of protein-based biomarkers for the early detection of breast cancer in high-risk women. This will be studied by obtaining serum blood samples from high-risk women who visit the outpatient clinic for regular screening. On average, two samples will be collected every year, depending on the regular screening appointments. Protein profiles in serum will be analyzed using LC-MS.

We expect that from a panel of possible protein-based biomarkers for the early detection of breast cancer, a small number of markers will be highly distinctive and able to detect breast cancer 1-2 years before diagnosis.

Every 6 months (during regular screening appointments) until disease onset and at the moment of cancer discovery

Blood draw once every 6 months