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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05406232
• Other study ID #: 2021-0669
• Secondary ID: NCI-2021-0977320
• Status: Recruiting
• Start date: September 15, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Simona F Shaitelman, MD
• Phone: (713) 563-8491
• Email: sfshaitelman[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Invasive Breast Carcinoma

Intervention

Procedure:
• Biopsy
Undergo tumor punch biopsy
• Biospecimen Collection
Undergo blood sample collection

Radiation:
• Radiation Therapy
Undergo RT

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   MD Anderson Cancer Center