Recruiting

Hypofractionated Radiation

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05406232

Conditions

Breast Carcinoma

Invasive Breast Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy

Biospecimen Collection

Radiation Therapy

Study Details

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

Study ID

NCT05406232

Start date

Sep 15, 2023

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biopsy

Undergo tumor punch biopsy

Biospecimen Collection

Undergo blood sample collection

Radiation Therapy

Undergo RT

Primary outcome measure

  • Percent change of CD8+ T cells [ Time Frame: Baseline up to day 8 ]
  • Percent change of CD4+ T cells [ Time Frame: Baseline up to day 8 ]

Central Contacts and Locations

Central contacts

Simona F Shaitelman, MD

(713) 563-8491sfshaitelman@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Simona F. Shaitelman, MD

713-563-8491sfshaitelman@mdanderson.org

Principal Investigator:

Simona F. Shaitelman, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-06.