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.
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
DCIS, Inflammatory breast carcinoma
Recurrence situation
Presence of distant metastases
Second malignancies < 10 years prior to diagnosis of breast carcinoma
Only female patients with non-metastatic breast carcinoma undergoing breast-conserving surgery (± neoadjuvant or adjuvant system therapy) at the Department of Gynecology and Reproductive Medicine Jena followed by adjuvant radiation therapy at the Department of Radiation Oncology and Radiotherapy Jena between June 1, 2021 and June 1, 2023 (recruitment period) will be studied.
Cohort
Prospective
Adjuvant radiotherapy
RadiationGuideline-based therapy of primary non-metastatic early breast carcinoma
neoadjuvant and adjuvant chemotherapy
DrugGuideline-based therapy of primary non-metastatic early breast carcinoma
Age-dependent influence of radiotherapy on circulating epithelial tumor cell counts (CETC) and immunophenotype (PBMC).
Measurement of CETC count / µl blood in the course of therapy and correlation with patient age.
Longitudinal quantification of CETCs as well as immunophenotype at specific time points during the course of therapy.
Measurement of CETC count / µl blood in the course of therapy and correlation with the cell count of detected T and B cells / µl blood.
Comparison of immunohistochemical parameters of the primary tumor with the immunohistochemical and cytological parameters of CETC
Comparison of PD-L1 expression of primary tumor cells with CETC in percent. Comparison of hormone receptor status (estrogen, progesterone) values of primary tumor and CETC in percent.
Recurrence-free survival (RFS)
Recurrences as a function of time (analysis using Kaplan-Meier curves, log-rank test, and Cox regression).
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University of Jena
Lead sponsor
University Hospital Erlangen
Collaborator
Labor Prof. Pachmann
Collaborator
