Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04902937

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Tumor Cell, Circulating Neoplasm Metastasis Neoplasms Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Radiooncology, Jena

Jena, 07743, Germany

Location status: Recruiting

Location contact

Matthias A Mäurer, MD

CONTACT

[email protected]

+4936419328401

Matthias Mäurer, MD

PRINCIPAL_INVESTIGATOR

About this study

The primary aim of this prospective-explorative phase 0 study is to investigate the influence of adjuvant radiotherapy in patients with non-metastatic breast cancer on the circulating epithelial tumor cells (CETCs) in the peripheral blood and their immunohistochemical characteristics in younger high risk (premenopausal) versus older low risk (postmenopausal) patients. In addition, the immunophenotype will be determined using peripheral venous blood mononuclear cells (PBMCs) at different time points during the course of therapy and correlated with the results of CETC analysis. The aim of the study is to identify prognostic and predictive biomarkers for early stage breast cancer patients. No therapeutic consequences will be derived.

For this purpose, the phenotype and molecular biological profile of CETC will be investigated and compared with the corresponding characteristics of the primary tumor in order to assign the tumor cells detected in the peripheral blood to the primary tumor. In this context, the number of tumor-infiltrating lymphocytes (TILs) will be correlated with circulating tumor cells and immunophenotype.

Another goal is the characterization of individually isolated CETC by RT-PCR. The expression of selected marker genes involved in metastatic processes will be investigated during the course of therapy and compared with that of the primary tumor to identify therapy-associated changes. The in vitro cultivation of so-called tumor spheres and their characterization as a sign of a therapy-resistant phenotype is a secondary objective of the study.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adjuvant radiotherapy

Radiation

Guideline-based therapy of primary non-metastatic early breast carcinoma

Other names: breast-conserving therapy

neoadjuvant and adjuvant chemotherapy

Drug

Guideline-based therapy of primary non-metastatic early breast carcinoma

Primary outcomes

  1. Age-dependent influence of radiotherapy on circulating epithelial tumor cell counts (CETC) and immunophenotype (PBMC).

    Time frame: observation period 2 years

    Measurement of CETC count / µl blood in the course of therapy and correlation with patient age.

  2. Longitudinal quantification of CETCs as well as immunophenotype at specific time points during the course of therapy.

    Time frame: 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.

  3. Comparison of immunohistochemical parameters of the primary tumor with the immunohistochemical and cytological parameters of CETC

    Time frame: 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.

Secondary outcomes

  1. Recurrence-free survival (RFS)

    Time frame: observation period 3 years follow up

    Recurrences as a function of time (analysis using Kaplan-Meier curves, log-rank test, and Cox regression).

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Collaborators

  • Labor Prof. Pachmann
  • University Hospital Erlangen

Registry information

Acronym: CETC

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 26, 2021
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.