Assessing immune changes in breast cancer patients after radiation therapy
Breast Radiation-induced Immunologic Genomic Hypofractionated Temporal Radiation Alterations DNA Damage (BRIGHT-RAD) Study.
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 |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05406232 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven invasive breast cancer who are receiving palliative radiation therapy.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Houston, Texas
- 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
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.