Breast Carcinoma, Invasive Breast Carcinoma
Conditions
Brief 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.
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.
Interventions
PROCEDUREBiopsy
Undergo tumor punch biopsy
PROCEDUREBiospecimen Collection
Undergo blood sample collection
RADIATIONRadiation Therapy
Undergo RT
Sponsors
M.D. Anderson Cancer Center
Artidis
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change of CD8+ T cells | 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. |
| Percent change of CD4+ T cells | 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. |
Countries
United States
Contacts
CONTACTSimona F Shaitelman, MD
PRINCIPAL_INVESTIGATORSimona F Shaitelman, MD
M.D. Anderson Cancer Center
Outcome results
None listed