Assessing immune changes in breast cancer patients after radiation therapy
Official title: Breast Radiation-induced Immunologic Genomic Hypofractionated Temporal Radiation Alterations DNA Damage (BRIGHT-RAD) Study.
Run by M.D. Anderson Cancer Center · NCT05406232 · Data updated 2026-11-12
This study is testing how radiation therapy affects the immune system in breast cancer patients by looking at changes in immune cells and DNA damage before and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | September 15, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT05406232 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with biopsy-proven invasive breast cancer who are receiving palliative radiation therapy.
✕Probably not a fit
Patients with a history of prior radiation to the treatment area or those currently receiving immunotherapy or chemotherapy may 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 evaluates the changes in immune cell levels in breast cancer patients following hypofractionated radiation therapy. The primary objective is to measure the percent change in immune infiltration at specific time points after radiation treatment. Secondary objectives include assessing DNA damage and examining immune signaling in cancer cells post-therapy. Patients will undergo tumor biopsies and blood sample collection before and after radiation to gather comprehensive data on immune responses and DNA damage.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how radiation therapy influences immune responses in breast cancer, potentially leading to improved treatment strategies.
How similar studies have gone: While the approach of examining immune changes post-radiation is not entirely novel, the specific focus on hypofractionated radiation and its effects on immune infiltration is relatively underexplored.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients \>= 18 years of age with biopsy proven invasive breast cancer * Breast cancer that appears to be superficially accessible to a tumor punch biopsy * Patients thought to derive clinical benefit from palliative RT to the breast/chestwall * In discussions with the medical oncologist, if clinically reasonable, systemic therapy will be held during RT Exclusion Criteria: * A history of prior radiation to the area requiring radiation for which the attending physician believes reirradiation could not be safely delivered * Pregnancy * Active usage of anticoagulant medications that are considered to pose an increased risk of tumor punch biopsies * Receipt of immunotherapy or chemotherapy 7 days prior to start of RT
Where it's running
-
M D Anderson Cancer Center
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Simona F Shaitelman, MD — M.D. Anderson Cancer Center
- Study coordinator: Simona F Shaitelman, MD
- Email: sfshaitelman@mdanderson.org
- Phone: (713) 563-8491
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.