Radiation therapy and the thymus in young women with breast cancer

Is this trial a fit for you?

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 follows young women with breast cancer who are planning mastectomy or breast-conserving surgery. For those receiving radiation therapy, researchers will draw about three teaspoons of blood before, at the end of radiation, and about six months later to study thymus function. If radiation is not part of the plan, blood will be collected after surgery and again about eight months after the first collection to examine thymus-related biomarkers. The project is sponsored by Duke University and is conducted at Duke Cancer Center in Durham, NC. Blood samples will be used for laboratory analyses related to thymopoiesis and thymus activity, with data integrated as covariates alongside standard treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Duke Cancer Center
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Susan McDuff, MD PhD — Duke University Health System (DUHS)
• Study coordinator: Duke Radiation Oncology Clinical Trials
• Email: RadOnc-Clinical_Trials@dm.duke.edu
• Phone: (919 668-3726

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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.