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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Jena

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

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Jena

Lead sponsor

University Hospital Erlangen

Collaborator

Labor Prof. Pachmann

Collaborator