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.

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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05406232.

United States

Texas

Houston

M D Anderson Cancer Center

Status: Active

Contact: Simona F. Shaitelman

Phone: 832-829-0363

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).

OUTLINE: This is an observational study.

Patients undergo RT on day 1. Patients also undergo tumor punch biopsies prior to the first fraction and on days 1, 3, and 7.

Trial PhaseNo phase specified

Trial TypeNot provided by clinicaltrials.gov

Lead OrganizationM D Anderson Cancer Center

Principal InvestigatorSimona F. Shaitelman

Primary ID2021-0669
Secondary IDsNCI-2021-09773
ClinicalTrials.gov IDNCT05406232

Breast Radiation-Induced Immunologic Genomic Hypofractionated Temporal Radiation Alterations DNA damage, BRIGHT-RAD Study

Inclusion Criteria

Exclusion Criteria

United States

Texas

Houston

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Breast Radiation-Induced Immunologic Genomic Hypofractionated Temporal Radiation Alterations DNA damage, BRIGHT-RAD Study

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Eligibility Criteria

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Trial Objectives and Outline

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