Clinical trial · Observational
Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
Breast Radiation-induced Immunologic Genomic Hypofractionated Temporal Radiation Alterations DNA Damage (BRIGHT-RAD) Study.
NCT05406232CI-TRIAL-00110687recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (RT, biopsy)
- description
- 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.
- interventionNames
- Procedure: Biopsy
- Procedure: Biospecimen Collection
- Radiation: Radiation Therapy
Primary outcomes (2)
- measure
- Percent change of CD8+ T cells
- timeFrame
- Baseline up to day 8
- description
- 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.
- measure
- Percent change of CD4+ T cells
- timeFrame
- Baseline up to day 8
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.