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

NCT05406232 | Recruiting

• 2 other identifiers: 2021-0669NCI-2021-09773
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma; Invasive Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• Percent change of CD8+ T cells

  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 8

• Percent change of CD4+ T cells

  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 8

Study Arms (1)

Observational (RT, biopsy)

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.

Procedure: Biopsy; Procedure: Biospecimen Collection; Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

Undergo RT

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Observational (RT, biopsy)

Biopsy PROCEDURE

Undergo tumor punch biopsy

Also known as: BIOPSY_TYPE, Bx

Observational (RT, biopsy)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected

Observational (RT, biopsy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer that appears to be superficially accessible to a tumor punch biopsy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Artidis: collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Therapeutics; Physical Phenomena

Study Officials

• Simona F Shaitelman, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simona F Shaitelman, MD

CONTACT

(713) 563-8491; sfshaitelman@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 6, 2022
• Study Start: September 15, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (1)