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

NCT04902937 | Recruiting

• 1 other identifier: CETC 002
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tumor Cell, Circulating

Keywords

Early Stage Breast cancer; Circulating Tumor Cells; Tumor-infiltrating lymphocytes; Radiotherapy; Immunophenotyping

Outcome Measures

Primary Outcomes (3)

• 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.

  observation period 2 years

• 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.

  observation period 2 years

• 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.

  observation period 2 years

Secondary Outcomes (1)

• Recurrence-free survival (RFS)

  observation period 3 years follow up

Study Arms (2)

premenopausal patients

Radiation: Adjuvant radiotherapy; Drug: neoadjuvant and adjuvant chemotherapy

postmenopausal patients

Radiation: Adjuvant radiotherapy; Drug: neoadjuvant and adjuvant chemotherapy

Interventions

Adjuvant radiotherapy RADIATION

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

Also known as: breast-conserving therapy

postmenopausal patients; premenopausal patients

neoadjuvant and adjuvant chemotherapy DRUG

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

postmenopausal patients; premenopausal patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female Breast cancer
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• DCIS, Inflammatory breast carcinoma
• Recurrence situation
• Presence of distant metastases
• Second malignancies \< 10 years prior to diagnosis of breast carcinoma
• Prior exposure to radiotherapy

Sponsors & Collaborators

• University of Jena: lead
• University Hospital Erlangen: collaborator
• Labor Prof. Pachmann: collaborator

Study Sites (1)

Department of Radiooncology, Jena

Jena, 07743, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Single-cell analyses using qRT-PCR

MeSH Terms

Conditions

Neoplastic Cells, Circulating

Interventions

Radiotherapy, Adjuvant; Mastectomy, Segmental; Neoadjuvant Therapy; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Radiotherapy; Mastectomy; Surgical Procedures, Operative; Drug Therapy

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 26, 2021
• Study Start: July 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

DE (1)