Association of Adjuvant Radiotherapy of Non-metastatic Breast Carcinoma With Immunomodulation and Circulating Tumor Cell Phenotype in Relation to Patient Age.

Condition(s) studied

Investigational drug(s) / intervention(s)

Adjuvant radiotherapy: Guideline-based therapy of primary non-metastatic early breast carcinoma

neoadjuvant and adjuvant chemotherapy: Guideline-based therapy of primary non-metastatic early breast carcinoma

Study summary

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

Primary outcome measure(s)

• Age-dependent influence of radiotherapy on circulating epithelial tumor cell counts (CETC) and immunophenotype (PBMC). — observation period 2 years
  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. — observation period 2 years
  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 — observation period 2 years
  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.

Trial sites (1)

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