Breast Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

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 is for people with:

Breast Cancer

Estimated Enrollment:

12

Study ID:

NCT05406232

Recruitment Status:

Not yet recruiting

Sponsor:

M.D. Anderson Cancer Center

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There is 1 Location for this study

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M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Simona F. Shaitelman, MD
Contact
713-563-8491
[email protected]
Simona F. Shaitelman, MD
Principal Investigator

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Study is for people with:

Breast Cancer

Estimated Enrollment:

12

Study ID:

NCT05406232

Recruitment Status:

Not yet recruiting

Sponsor:


M.D. Anderson Cancer Center

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