RecruitingObservational

Breast Radiation-induced Immunologic Genomic Hypofractionated Temporal Radiation Alterations DNA Damage (BRIGHT-RAD) Study.

NCT ID: NCT05406232Sponsor: M.D. Anderson Cancer CenterLast updated: 2026-05-06

Summary

This study assesses changes to the immune cells following hypofractionated radiation-induced DNA damage in breast cancer patients. Radiation therapy may cause immune cells to enter tumors and target cancer cells. The goal of this study is to measure the change in the level of immune cells in the tumor before and after radiation therapy.

Detailed description

PRIMARY OBJECTIVE: I. To estimate the percent change in immune infiltration at day 3 and day 7 of radiotherapy (RT) relative to baseline (before radiotherapy). SECONDARY OBJECTIVE: I. To estimate the degree of deoxyribonucleic acid (DNA) damage at approximately 3 and 7 days after radiotherapy compared to baseline. II. To examine cancer cell intrinsic immune signaling following radiotherapy. EXPLORATORY OBJECTIVE: I. To examine the association between DNA damage and micronuclei formation. II. To examine the association between DNA damage and immune infiltration. III. To examine the association between micronuclei formation and immune infiltration. OUTLINE: Patients undergo RT on day 1. Patients also undergo tumor punch biopsies and blood sample collection prior to the first fraction and on days 1, 3, and 7.

Arms & interventions

ProcedureBiopsy
Undergo tumor punch biopsy
ProcedureBiospecimen Collection
Undergo blood sample collection
RadiationRadiation Therapy
Undergo RT

Outcome measures

Primary

Percent change of CD8+ T cells
Will be estimated with corresponding two-sided 80% confidence intervals. Also, marker levels at each time point and unstandardized effect sizes (arithmetic differences from baseline) across time points will be estimated along with 2-sided 80% confidence intervals.
Time frame: Baseline up to day 8
Percent change of CD4+ T cells
Will be estimated with corresponding two-sided 80% confidence intervals. Also, marker levels at each time point and unstandardized effect sizes (arithmetic differences from baseline) across time points will be estimated along with 2-sided 80% confidence intervals.
Time frame: Baseline up to day 8

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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

Study locations (1)

M D Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Simona F. Shaitelman, MD · Contact

713-563-8491 sfshaitelman@mdanderson.org

Simona F. Shaitelman, MD · Principal Investigator