Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biopsy, Biospecimen Collection, Radiation Therapy.
- Who it may be relevant to
- Registry conditions: Breast Carcinoma, Invasive Breast Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Breast Radiation-induced Immunologic Genomic Hypofractionated Temporal Radiation Alterations DNA Damage (BRIGHT-RAD) Study.
Overview
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.
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 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.
Interventions
- Procedure Biopsy
Undergo tumor punch biopsy - Procedure Biospecimen Collection
Undergo blood sample collection - Radiation Radiation Therapy
Undergo RT
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT05406232 · 2021-0669 · NCI-2021-09773 · 2021-0669