NCT05406232

Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Carcinoma
• Invasive Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo tumor punch biopsy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
RADIATION	Radiation Therapy	Undergo RT

Timeline

• Start date: 2023-09-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-06-06
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States