Breast CancerNCT07725172
Radiation Therapy and Thymus Function in Young Women With Breast Cancer
An observational study of Breast Cancer, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Blood draw for the laboratory assessment
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population includes women age 18-50 with breast cancer seen in the Duke Breast Oncology Program
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke Cancer Center
Durham, North Carolina, 27710
Eileen Duffy, RN OCN, 919-668-3726, eileen.duffy@duke.edu
Linda Kaltenbach, PhD, (919) 668-3726, Linda.Kaltenbach@duke.edu
About this study
Official title: Off-Target Effects of Breast Cancer Adjuvant Radiation Therapy on Thymus Function in Young Women
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.
Read the detailed description
This study includes participants whose plan of care may or may not include radiation therapy.
- Participants whose plan of care includes radiation therapy will have about three teaspoons of research blood collected at the following time points:
- Before the start of radiation therapy
- At the end of radiation therapy
- About six months after completing radiation therapy
- Participants whose plan of care does NOT include radiation therapy will have about three teaspoons of research blood collected at the following timepoints:
- After surgery (up to three months after surgery)
- About 8 months after the first research blood collection
- Conditions
- Breast Cancer
- Being tested
- Blood draw for the laboratory assessment
- Keywords
- breast cancer in young women, blood collection, thymopoesis, thymus, radiation therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw for the laboratory assessmentProcedure or surgery
Blood will be drawn and processed for Peripheral Blood Mononuclear Cells (PBMCs). PBMC biomarkers will be used to assess thymopoiesis .
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy | Up to 100 Breast cancer patients receiving radiation therapy Receives: Procedure: Blood draw for the laboratory assessment | |
| No Radiation Therapy | Up to 25 Breast cancer patients NOT receiving radiation therapy as control Receives: Procedure: Blood draw for the laboratory assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: baseline
Level of CD4+ RTE cells in participant blood samples
As measured by flow cytometry in blood from participants receiving radiotherapy (RT)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months post RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan McDuff, MD PhD, Principal investigator, Duke University Health System (DUHS)Andrew Macintyre, PhD, Principal investigator, Duke Human Vaccine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725172
- Sponsor's protocol ID
- Pro00120784
- Other IDs
- BC250719P1
- Status last verified
- Nov 2026
- First submitted
- 21 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be shared after publication if deidentified.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Off-Target Effects of Breast Cancer Adjuvant Radiation Therapy on Thymus Function in Young Women
- ClinicalTrials.gov ID
- NCT07725172
- Acronym / sponsor ID
- Pro00120784
- Conditions
- Breast Cancer
- Keywords
- breast cancer in young women, blood collection, thymopoesis, thymus, radiation therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study includes participants whose plan of care may or may not include radiation therapy.
- Participants whose plan of care includes radiation therapy will have about three teaspoons of research blood collected at the following time points:
- Before the start of radiation therapy
- At the end of radiation therapy
- About six months after completing radiation therapy
- Participants whose plan of care does NOT include radiation therapy will have about three teaspoons of research blood collected at the following timepoints:
- After surgery (up to three months after surgery)
- About 8 months after the first research blood collection
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy | – | Procedure: Blood draw for the laboratory assessmentUp to 100 Breast cancer patients receiving radiation therapy |
| No Radiation Therapy | – | Procedure: Blood draw for the laboratory assessmentUp to 25 Breast cancer patients NOT receiving radiation therapy as control |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population includes women age 18-50 with breast cancer seen in the Duke Breast Oncology Program
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw for the laboratory assessmentBlood will be drawn and processed for Peripheral Blood Mononuclear Cells (PBMCs). PBMC biomarkers will be used to assess thymopoiesis . | Procedure or surgery | No Radiation Therapy, Radiation Therapy |
Primary outcome
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
Time frame: baseline
As measured by quantitative PCR in participants receiving radiotherapy (RT)
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
Time frame: at the end of RT, about 5 weeks
As measured by quantitative PCR in participants receiving radiotherapy (RT)
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
Time frame: 6 months post-RT
As measured by quantitative PCR in participants receiving radiotherapy (RT)
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
Time frame: within 3 months after breast cancer surgery
As measured by quantitative PCR in participants NOT receiving radiotherapy (RT)
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
Time frame: approximately 8-11 months after breast cancer surgery
As measured by quantitative PCR in participants NOT receiving radiotherapy (RT)
Level of CD4+ recent thymic emigrant (RTE) cells in participant blood samples
Time frame: baseline
As measured by flow cytometry in blood from participants receiving radiotherapy (RT)
Level of CD4+ RTE cells in participant blood samples
Time frame: at the end of RT, about 5 weeks
As measured by flow cytometry in blood from participants receiving radiotherapy (RT)
Level of CD4+ RTE cells in participant blood samples
Time frame: 6 months post RT
As measured by flow cytometry in blood from participants receiving radiotherapy (RT)
Level of CD4+ RTE cells in participant blood samples
Time frame: within 3 months of breast cancer surgery
As measured by flow cytometry in blood from participants NOT receiving radiotherapy (RT)
Level of CD4+ RTE cells in participant blood samples
Time frame: approximately 8-11 months after breast cancer surgery
As measured by flow cytometry in blood from participants NOT receiving radiotherapy (RT)
Effect of adjuvant radiotherapy treatment dose on levels of sjTREC-containing T cells
Time frame: 6 months post RT
using a linear mixed-effect model in participants receiving RT
Effect of adjuvant radiotherapy treatment fractionation on levels of sjTREC-containing T cells
Time frame: 6 months post RT
using a linear mixed-effect model in participants receiving RT
Effect of adjuvant radiotherapy treatment fractionation on levels of CD4+ RTE cells
Time frame: 6 months post RT
using a linear mixed-effect model in participants receiving RT
Effect of adjuvant radiotherapy treatment dose on levels of CD4+ RTE cells
Time frame: 6 months post RT
using a linear mixed-effect model in participants receiving RT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided. IPD may be shared after publication if deidentified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan McDuff, MD PhD principal investigator
Duke University Health System (DUHS)
Andrew Macintyre, PhD principal investigator
Duke Human Vaccine Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duke Radiation Oncology Clinical Trials ((919 668-3726, RadOnc-Clinical_Trials@dm.duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells (time frame: baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.