Investigating the effects of radiotherapy on circulating tumor cells in breast cancer patients
Association of Adjuvant Radiotherapy of Non-metastatic Breast Carcinoma With Immunomodulation and Circulating Tumor Cell Phenotype in Relation to Patient Age.
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Jena Academic / other |
| Locations | 1 site (Jena) |
| Trial ID | NCT04902937 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed invasive breast carcinoma who are undergoing curative-intended breast-conserving therapy followed by adjuvant radiotherapy.
Not a fit: Patients with ductal carcinoma in situ (DCIS), inflammatory breast carcinoma, or those with distant metastases will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Jena
- Department of Radiooncology, Jena — Jena, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.