Status:

RECRUITING

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

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborating Sponsors:

Artidis

Conditions:

Breast Carcinoma

Invasive Breast Carcinoma

Eligibility:

All Genders

18+ years

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 c...

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 t...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 15 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT05406232

Start Date

September 15 2023

End Date

December 31 2026

Last Update

August 14 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030