Benefits of Enhanced Follow-Up Care with Additional Testing of Specific Blood Markers Compared to Standard Follow-Up Care

Breast cancer (mammary carcinoma) is a malignant disease of the breast gland tissue characterized by the uncontrolled proliferation of breast gland cells. Treatment of the disease depends on numerous factors; generally, a combination of drug therapies (e.g., chemotherapy), surgery, and radiation therapy is used. Once treatment is complete, patients continue to be monitored regularly as part of follow-up care. One goal of follow-up care is to detect a recurrence of the disease at an early stage. However, aside from a consultation with a physician and various examinations (mammography, ultrasound, physical examination), no blood tests (e.g., tumor markers) have been performed to date. As part of an intensified follow-up program, specific blood parameters are analyzed at each follow-up appointment in addition to the standard examinations (liquid biopsy). These include tumor markers (CA27-29, CA125, CEA), circulating tumor cells (CTCs), and circulating tumor DNA (ctDNA). These parameters can provide early indications of a recurrence.

The aim of this study is to investigate the potential benefits of this enhanced follow-up compared to standard follow-up. Patients will be randomly assigned to 2 groups as part of the study. Group 1 (study arm) will receive the intensified follow-up care, and Group 2 (control arm) will receive standard follow-up care with an additional blood draw; however, tumor markers, CTCs, and ctDNA will not be measured in this group. The blood samples will be stored but not analyzed for the time being. The study is partially double-blind, meaning that neither the medical staff nor the patients know which type of follow-up care the participants are receiving. If abnormalities are detected in the blood tests, the blinding is lifted, and the patients undergo further testing to investigate the suspicion of a recurrence. Follow-up examinations as part of the study will continue for up to 10 years.

Women and men between the ages of 18 and 75 who have completed the complete removal of breast cancer are eligible to participate in the study. Participants must have a moderate to high risk of recurrence (return of the disease), and no more than 24 months may have elapsed since the completion of initial treatment.