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Observational Study of Immune Changes with Radiation Therapy in Breast Cancer

This study is looking at how radiation therapy (RT) affects the immune system in people with invasive breast cancer. Researchers want to see if RT causes immune cells, like CD8+ and CD4+ T cells, to enter tumors and fight cancer. You would receive RT and have tumor biopsies and blood samples taken before, during, and after treatment to measure these immune cell changes. The goal is to understand if RT can help the body's immune system target cancer cells. This study is currently recruiting 36 participants.

Study design
This is an observational study, meaning researchers will be watching and collecting information without assigning specific treatments. It plans to enroll 36 participants.
What's involved
You would undergo radiation therapy, tumor punch biopsies, and blood sample collections before your first radiation treatment and on days 1, 3, and 7.
Compensation
Not stated in the trial record.
Follow-up
Immune cell changes are measured from baseline up to day 8 after radiation therapy.

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NCT05406232

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

Recruiting
Not specifiedAges 18+Observational
M.D. Anderson Cancer Center
~36 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionRadiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent change of CD8+ T cells
Measured over Baseline up to day 8
+1 more outcome measured

Conditions

Breast Carcinoma
Invasive Breast Carcinoma

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Simona F Shaitelman, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Simona F Shaitelman, MD
[email protected]
(713) 563-8491
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Percent change of CD8+ T cellsBaseline up to day 8

    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.

  • Percent change of CD4+ T cellsBaseline up to day 8

    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.