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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05406232
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo tumor punch biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Radiation Therapy — RADIATION
    Undergo RT

Study Details

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.

Key Dates

Start date
Sep 15, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
36 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Percent change of CD8+ T cells [ Time Frame: Baseline up to day 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Simona F. Shaitelman, MD
713-563-8491
Simona F. Shaitelman, MD (PRINCIPAL_INVESTIGATOR)

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