About this trial
In a prospective study, the influence of adjuvant radiotherapy in patients with non-metastatic breast carcinoma on the epithelial tumor cells (CETCs) circulating in the blood and their immunohistochemical characteristics depending on age will be investigated. In addition to a histopathological assignment of the CETCs as cells of the primary tumor, major trigger points of the immune system will be exploratively analyzed.
For this purpose, blood samples are taken from the patients at different time points after tumor resection and during adjuvant radiotherapy. In addition to the detection, isolation and genetic characterization of the CETCs, the determination of immunological biomarkers by immunophenotyping, among other methods, is planned. Furthermore, analyses of tissue from the primary tumor with respect to immunohistochemical features as well as tumor-infiltrating lymphocytes (TILs) are planned. The results will be classified and correlated especially with regard to patient age.
As there are insufficient data available for breast carcinoma regarding radiotherapeutic effects on the immune system depending on patient age, it is of great interest to better understand these molecular biological basics in order to identify potential prognostic biomarkers.
Eligibility criteria
Qualifiers
Primary diagnosis histologically confirmed invasive breast carcinoma pT1-4 pN0 or pN+ cM0
curative-intended breast-conserving therapy (BET) ± (neo-) adj. system therapy with subsequent adjuvant radiotherapy of the breast ± lymphatic drainage system planned
informed consent of the patient
Disqualifiers
DCIS, Inflammatory breast carcinoma
Recurrence situation
Presence of distant metastases
Second malignancies < 10 years prior to diagnosis of breast carcinoma
Trial design
Treatments tested in this trial
- Adjuvant radiotherapy
- neoadjuvant and adjuvant chemotherapy
Treatment groups
Sponsors and collaborators
University of Jena
Lead sponsor
University Hospital Erlangen
Collaborator
Labor Prof. Pachmann
Collaborator