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.

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Carcinoma; Invasive Breast Carcinoma
• Intervention / Treatment: Radiation: Radiation Therapy; Procedure: Biospecimen Collection; Procedure: Biopsy

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.

• Study Type: Observational
• Enrollment (Estimated): 36

Contacts and Locations

• Study Contact: Name: Simona F Shaitelman, MD; Phone Number: (713) 563-8491; Email: sfshaitelman@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Simona F. Shaitelman, MD; Phone Number: 713-563-8491; Email: sfshaitelman@mdanderson.org
      • Principal Investigator: Simona F. Shaitelman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer that appears to be superficially accessible to a tumor punch biopsy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (RT, biopsy); 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.	Radiation: Radiation Therapy; Undergo RT; Other Names: Cancer Radiotherapy; Irradiate; Irradiated; Irradiation; Radiation; Radiotherapeutics; Radiotherapy; RT; Therapy, Radiation; Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Procedure: Biopsy; Undergo tumor punch biopsy; Other Names: Bx; BIOPSY_TYPE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline up to day 8

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: Artidis
• Investigators: Principal Investigator: Simona F Shaitelman, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Investigative Techniques; Therapeutics; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Cytodiagnosis; Physical Phenomena; Diagnostic Techniques, Surgical; Radiotherapy; Radiation; Biopsy
• Other Study ID Numbers: 2021-0669 (Other Identifier: M D Anderson Cancer Center); NCI-2021-09773 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No