Clinical trial · Observational
Association of Adjuvant Radiotherapy of Non-metastatic Breast Carcinoma With Immunomodulation and Circulating Tumor Cell Phenotype in Relation to Patient Age.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor Cell, Circulating | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant radiotherapy | Radiation | — | UNRESOLVED |
| neoadjuvant and adjuvant chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- premenopausal patients
- interventionNames
- Radiation: Adjuvant radiotherapy
- Drug: neoadjuvant and adjuvant chemotherapy
- label
- postmenopausal patients
- interventionNames
- Radiation: Adjuvant radiotherapy
- Drug: neoadjuvant and adjuvant chemotherapy
Primary outcomes (3)
- measure
- Age-dependent influence of radiotherapy on circulating epithelial tumor cell counts (CETC) and immunophenotype (PBMC).
- timeFrame
- observation period 2 years
- description
- Measurement of CETC count / µl blood in the course of therapy and correlation with patient age.
- measure
- Longitudinal quantification of CETCs as well as immunophenotype at specific time points during the course of therapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * DCIS, Inflammatory breast carcinoma * Recurrence situation * Presence of distant metastases * Second malignancies \< 10 years prior to diagnosis of breast carcinoma * Prior exposure to radiotherapy
References
Publications (0)
Data not yet available