Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

Investigating the effects of radiotherapy on circulating tumor cells in breast cancer patients

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

Run by University of Jena · NCT04902937 · Data updated 2026-11-12

This study is testing how radiation treatment affects certain cancer cells in the blood of younger and older women with early-stage breast cancer to help improve future treatment plans.

More Circulating Tumor DNA trials

Quick facts

Study typeObservational
Ages18 Years and up
SexWomen only
Enrollment200 (estimated)
SponsorUniversity of Jena
Academic / other
Locations1 site (Jena)
StatusRecruiting
StartedJuly 1, 2021
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedNovember 28, 2023
Trial IDNCT04902937 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with histologically confirmed invasive breast carcinoma who are undergoing curative-intended breast-conserving therapy followed by adjuvant radiotherapy.

Probably not a fit

Patients with ductal carcinoma in situ (DCIS), inflammatory breast carcinoma, or those with distant metastases will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore how adjuvant radiotherapy affects circulating epithelial tumor cells (CETCs) in patients with non-metastatic breast carcinoma, focusing on differences based on patient age. Blood samples will be collected at various time points after tumor resection and during radiotherapy to analyze the immunohistochemical characteristics of CETCs and their correlation with tumor-infiltrating lymphocytes. The study seeks to identify prognostic and predictive biomarkers that could inform treatment strategies for early-stage breast cancer patients.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding of tumor biology and better personalized treatment strategies for breast cancer patients.

How similar studies have gone: While similar studies have explored the relationship between radiotherapy and circulating tumor cells, this specific approach focusing on age-related differences in immunomodulation is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Department of Radiooncology, Jena
    Jena, Germany
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.