BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer

To determine the effect of low dose azacitidine therapy on tumor infiltrating lymphocytes (TILs) in primary tumors from patients with high-risk early stage breast cancer, paired t-tests will be first used to compare TIL count in pre- and post-treatment specimens.

NCT Number	NCT04891068
Lead Sponsor	University of Illinois at Chicago
Conditions	Breast Cancer Invasive, Early-stage Breast Cancer, High Risk Breast Carcinoma
Enrollment	40 participants
Start Date	2022-01-10
Primary Completion	2027-05 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2026-06-23