Standard Surveillance vs. Intensive Surveillance in Early Breast Cancer

ConditionBreast Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorProf. Wolfgang Janni

About this trial

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.

Eligibility criteria

Qualifiers

Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.

Unilateral or bilateral primary invasive carcinoma of the breast, confirmed histologically.

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

Disqualifiers

in situ carcinoma of the cervix or

adequately treated basal cell carcinoma of the skin or

ipsi- or contralateral non-invasive carcinoma of the breast (DCIS).

Patients in pregnancy or breastfeeding. If a patient gets pregnant during the participation in the interventional phase of the study (Year 1-5), an end of intervention visit will be scheduled and the patient will enter the follow-up phase of the study. Pregnancy during the follow-up phase of the study is to be reported but does not lead to an exclusion of the study.

Trial design

Treatments tested in this trial

Determination of tumormarkers (CA27.29, CEA, CA125)
Determination of CTC levels
Determination of ctDNA levels
Biobanking of blood samples

Treatment groups

3,500 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Prof. Wolfgang Janni

Lead sponsor

University of Ulm

Sponsor institution

German Federal Ministry of Education and Research

Collaborator

Source ClinicalTrials.gov