Breast Carcinoma Clinical Trial
Official title:
Quantifying 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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To estimate the percent change in immune infiltration. | 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 7 |
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