Actively Recruiting
Standard Surveillance vs. Intensive Surveillance in Early Breast Cancer
Led by Prof. Wolfgang Janni · Updated on 2025-05-02
3500
Participants Needed
1
Research Sites
677 weeks
Total Duration
On this page
Sponsors
P
Prof. Wolfgang Janni
Lead Sponsor
G
German Federal Ministry of Education and Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 either marker will trigger diagnostic imaging to search for possible metastases. The blood samples of the standard surveillance arm will solely be biobanked for future research purposes.
CONDITIONS
Official Title
Standard Surveillance vs. Intensive Surveillance in Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent for all study procedures before starting
- Diagnosed with unilateral or bilateral primary invasive breast cancer confirmed by tissue analysis
- Have medium- to high-risk early breast cancer defined by any of: indication for (neo-)adjuvant chemotherapy, tumor larger than 50 mm, positive lymph nodes, or high tumor grade (G3 or above)
- Primary tumor completely removed with no invasive cancer at the margins
- Completed primary anti-tumor therapy (chemotherapy, surgery, or radiotherapy) at least 4 weeks and no more than 24 months ago
- Available primary tumor tissue sample from biopsy or surgery with required size and tumor content
- No current clinical signs of distant metastases
- Female or male aged between 18 and 75 years
- Performance status of 1 or less on the ECOG scale
- Willing and able to follow scheduled visits, treatments, lab tests, and other study procedures
You will not qualify if you...
- History of any secondary primary cancer except for in situ cervical carcinoma, treated basal cell skin cancer, or non-invasive breast carcinoma (DCIS)
- Pregnant or breastfeeding at study entry; pregnancy during intervention phase leads to end of intervention but continued follow-up
- History of significant neurological or psychiatric disorders that prevent informed consent
- Severe kidney impairment with glomerular filtration rate below 30 mL/min
- Previous or current systemic antineoplastic treatment not intended for primary breast cancer
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Trial Site Locations
Total: 1 location
1
University Hospital Ulm Gynecology/Obstetrics
Ulm, Germany, 89075
Actively Recruiting
Research Team
S
Sophia Huesmann, Dr.
CONTACT
F
Forca Mehmeti, M.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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