Standard Surveillance vs. Intensive Surveillance in Early Breast Cancer
The goal of this clinical study is to evaluate the potential benefits of intensified surveillance versus standard surveillance in medium-risk and high-risk early breast cancer patients. The main questions it aims to answer are: * Comparison of the 5-year ob´verall survival rates between patients in the Standard Surveil
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The goal of this clinical study is to evaluate the potential benefits of intensified surveillance versus standard surveillance in medium-risk and high-risk early breast cancer patients. The main questions it aims to answer are: * Comparison of the 5-year ob´verall survival rates between patients in the Standard Surveillance arm versus patients in the liquid-biopsy guided Intensive Surveillance arm * Determination of the Overall Lead Time Effect generated due to tumor marker/CTC/ctDNA guided Intensive Surveillance compared to Standard Surveillance after primary therapy in early breast cancer patients. Participants will recieve regular blood drawals. Solely the blood samples of the intensive surveillance arm will be analysed for prospective tumor markers/CTCs/ctDNAs. Abnormal findings of eit |
| Who can participate | Inclusion Criteria: 1. Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures. 2. Unilateral or bilateral primary invasive carcinoma of the breast, confirmed histologically. 3. Patients with intermediate- to high-risk early breast cancer defined as either * an indication for (neo-)adjuvant chemotherapy (regardless whether performed or not), and/or * Large tumor (\> 50 mm), and/or * Positive lymph nodes, and/or * High grade (\>= G3). Indication to (neo-)adjuvant chemotherapy is seen as stated in the German S3 guideline for breast cancer as well as stated in the guidelines from the AGO. 4. A complete resection of the primary tumor, with resection margins free of invasive carcinoma. 5. Completion of primary |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Prof. Wolfgang Janni |
| Locations | Ulm, Germany |
| Start date | 2022-12-07 |
| NCT ID | NCT05658172 |
| Official listing | https://clinicaltrials.gov/study/NCT05658172 |