Breast CarcinomaNCT05406232
Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
An observational study of Breast Carcinoma and Invasive Breast Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Invasive Breast Carcinoma
- What is being tested?
- Biopsy, Biospecimen Collection and Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer that appears to be superficially accessible to a tumor punch biopsy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Simona F. Shaitelman, MD, 713-563-8491, sfshaitelman@mdanderson.org
Simona F. Shaitelman, MD
About this study
Official title: Breast Radiation-induced Immunologic Genomic Hypofractionated Temporal Radiation Alterations DNA Damage (BRIGHT-RAD) Study.
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To estimate the percent change in immune infiltration at day 3 and day 7 of radiotherapy (RT) relative to baseline (before radiotherapy).
SECONDARY OBJECTIVE:
- 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:
- 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
- Breast Carcinoma, Invasive Breast Carcinoma
- Being tested
- Biopsy, Biospecimen Collection, Radiation Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called BIOPSY_TYPE, Bx
Undergo tumor punch biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected
Undergo blood sample collection
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation
Undergo RT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change of CD8+ T cells
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.
Measured: Baseline up to day 8
Percent change of CD4+ T cells
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.
Measured: Baseline up to day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start15 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Artidis
- Responsible party
- Sponsor
- Investigators
- Simona F Shaitelman, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406232
- Sponsor's protocol ID
- 2021-0669
- Other IDs
- NCI-2021-09773, 2021-0669
- Status last verified
- Apr 2026
- First submitted
- 1 Jun 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Radiation-induced Immunologic Genomic Hypofractionated Temporal Radiation Alterations DNA Damage (BRIGHT-RAD) Study.
- ClinicalTrials.gov ID
- NCT05406232
- Acronym / sponsor ID
- 2021-0669
- Conditions
- Breast Carcinoma, Invasive Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Artidis
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To estimate the percent change in immune infiltration at day 3 and day 7 of radiotherapy (RT) relative to baseline (before radiotherapy).
SECONDARY OBJECTIVE:
- 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (RT, biopsy) | – | Procedure: Biopsy, Procedure: Biospecimen Collection, Radiation: Radiation TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer that appears to be superficially accessible to a tumor punch biopsy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyAlso: BIOPSY_TYPE, BxUndergo tumor punch biopsy | Procedure or surgery | Observational (RT, biopsy) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen CollectedUndergo blood sample collection | Procedure or surgery | Observational (RT, biopsy) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, Irradiated, IrradiationUndergo RT | Radiation | Observational (RT, biopsy) |
Primary outcome
Percent change of CD8+ T cells
Time frame: Baseline 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 cells
Time frame: Baseline 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simona F Shaitelman, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma and Invasive Breast Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simona F Shaitelman, MD ((713) 563-8491, sfshaitelman@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change of CD8+ T cells (time frame: Baseline up to day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.