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NCT Number: NCT05406232

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Simona F. Shaitelman, MD

CONTACT

[email protected]

713-563-8491

Simona F. Shaitelman, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy

Procedure

Undergo tumor punch biopsy

Other names: BIOPSY_TYPE, Bx

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected

radiation therapy

Radiation

Undergo RT

Other names: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Primary outcomes

  1. Percent change of CD8+ T cells

    Time frame: Baseline up to day 8

    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.

  2. Percent change of CD4+ T cells

    Time frame: Baseline up to day 8

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Simona F Shaitelman, MD

CONTACT

[email protected]

(713) 563-8491

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Artidis

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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