NCT07725172

Brief Summary

Breast cancer treatment sometimes includes radiation to the breast or chest wall. There is a small gland, called the thymus, located in the upper chest that may receive a small amount of the radiation aimed at the breast. The goal of this study is to collect blood samples from young women with breast cancer to study the effect of radiation therapy on the thymus gland.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
37mo left

Started Sep 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

July 21, 2026

Last Update Submit

July 21, 2026

Conditions

Breast Cancer

Keywords

breast cancer in young womenblood collectionthymopoesisthymusradiation therapy

Outcome Measures

Primary Outcomes (14)

  • Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells

    As measured by quantitative PCR in participants receiving radiotherapy (RT)

    baseline

  • Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells

    As measured by quantitative PCR in participants receiving radiotherapy (RT)

    at the end of RT, about 5 weeks

  • Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells

    As measured by quantitative PCR in participants receiving radiotherapy (RT)

    6 months post-RT

  • Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells

    As measured by quantitative PCR in participants NOT receiving radiotherapy (RT)

    within 3 months after breast cancer surgery

  • Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells

    As measured by quantitative PCR in participants NOT receiving radiotherapy (RT)

    approximately 8-11 months after breast cancer surgery

  • Level of CD4+ recent thymic emigrant (RTE) cells in participant blood samples

    As measured by flow cytometry in blood from participants receiving radiotherapy (RT)

    baseline

  • Level of CD4+ RTE cells in participant blood samples

    As measured by flow cytometry in blood from participants receiving radiotherapy (RT)

    at the end of RT, about 5 weeks

  • Level of CD4+ RTE cells in participant blood samples

    As measured by flow cytometry in blood from participants receiving radiotherapy (RT)

    6 months post RT

  • Level of CD4+ RTE cells in participant blood samples

    As measured by flow cytometry in blood from participants NOT receiving radiotherapy (RT)

    within 3 months of breast cancer surgery

  • Level of CD4+ RTE cells in participant blood samples

    As measured by flow cytometry in blood from participants NOT receiving radiotherapy (RT)

    approximately 8-11 months after breast cancer surgery

  • Effect of adjuvant radiotherapy treatment dose on levels of sjTREC-containing T cells

    using a linear mixed-effect model in participants receiving RT

    6 months post RT

  • Effect of adjuvant radiotherapy treatment fractionation on levels of sjTREC-containing T cells

    using a linear mixed-effect model in participants receiving RT

    6 months post RT

  • Effect of adjuvant radiotherapy treatment fractionation on levels of CD4+ RTE cells

    using a linear mixed-effect model in participants receiving RT

    6 months post RT

  • Effect of adjuvant radiotherapy treatment dose on levels of CD4+ RTE cells

    using a linear mixed-effect model in participants receiving RT

    6 months post RT

Study Arms (2)

Radiation Therapy

Up to 100 Breast cancer patients receiving radiation therapy

Procedure: Blood draw for the laboratory assessment

No Radiation Therapy

Up to 25 Breast cancer patients NOT receiving radiation therapy as control

Procedure: Blood draw for the laboratory assessment

Interventions

Blood draw for the laboratory assessmentPROCEDURE

Blood will be drawn and processed for Peripheral Blood Mononuclear Cells (PBMCs). PBMC biomarkers will be used to assess thymopoiesis .

No Radiation TherapyRadiation Therapy

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women are eligible to participate due to differences in thymus development in males
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population includes women age 18-50 with breast cancer seen in the Duke Breast Oncology Program

You may qualify if:

  • Women aged 18 to 50 undergoing mastectomy or breast-conserving surgery for breast cancer of any subtype at DUMC and associated satellite centers
  • Histologic documentation of breast cancer based on pathology
  • Systemic therapies including hormone therapy, targeted therapy, chemotherapy and immunotherapy as given for breast cancer treatment at the discretion of the treating medical oncologist are allowed and use of such therapies will be documented and included as a covariate
  • Willing and able to provide written informed consent

You may not qualify if:

  • Prior history of therapeutic high-dose irradiation of the thorax (e.g. for treatment of lung cancer, head/neck cancer, Hodgkin disease, etc., not just radiological imaging alone)
  • History of thymectomy or treatment with immunosuppressive drugs within the past six months
  • Individuals with rheumatoid arthritis or other autoimmune conditions
  • Individuals with Down's syndrome
  • Male patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, PBMCs

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Susan McDuff, MD PhD

    Duke University Health System (DUHS)

    PRINCIPAL INVESTIGATOR

  • Andrew Macintyre, PhD

    Duke Human Vaccine Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Duke Radiation Oncology Clinical Trials

CONTACT

(919 668-3726RadOnc-Clinical_Trials@dm.duke.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 24, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

July 24, 2026

Record last verified: 2026-07

Locations

US(1)