Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
Patients with breast cancer that appears to be superficially accessible to a tumor punch biopsy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biopsy
Procedure/SurgeryUndergo tumor punch biopsy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Radiation Therapy
RadiationUndergo RT
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Observational (RT, biopsy)3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline up to day 82
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.
Time frame
Baseline up to day 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Artidis
Collaborator
Source ClinicalTrials.gov