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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-15

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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 the degree of deoxyribonucleic acid (DNA) damage at approximately 3 and 7 days after radiotherapy compared to baseline.

II. To examine cancer cell intrinsic immune signaling following radiotherapy.

EXPLORATORY OBJECTIVE:

I. To examine the association between DNA damage and micronuclei formation. II. To examine the association between DNA damage and immune infiltration. III. To examine the association between micronuclei formation and immune infiltration.

OUTLINE:

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.

Conditions

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Breast Carcinoma Invasive Breast Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Biopsy

Intervention Type PROCEDURE

Undergo tumor punch biopsy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Radiation Therapy

Intervention Type RADIATION

Undergo RT

Interventions

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Biopsy

Undergo tumor punch biopsy

Intervention Type PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Radiation Therapy

Undergo RT

Intervention Type RADIATION

Other Intervention Names

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BIOPSY_TYPE Bx Biological Sample Collection Biospecimen Collected Cancer Radiotherapy ENERGY_TYPE Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No