NCT04891068

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Median TIL counts will be compared between the pre- and post-treatment specimens with the Wilcoxon signed-rank test if TIL count does not follow normal distribution. General linear model (GLM) or kruskal wallis test will be used in the multivariate analyses to estimate the effect of low dose azacitidine therapy on TILs after adjusting for other clinical factors and patients characteristics, including the heterogeneity of tumors. Screening Evaluation Visit All screening procedures will take place within 30 days of the first treatment visit unless otherwise noted. * Informed consent, HIPAA authorization * Medical history including prior and concurrent therapies and pathology * Physical exam, height, weight * Vital signs (blood pressure, heart rate, temperature) * Review of concomitant medications * ECOG performance status * Blood chemistries (sodium, potassium, serum creatinine \[or GFR\], calcium, albumin, ALT, AST, total bilirubin, alkaline phosphatase, total protein) * CBC with differential * Hepatitis B screening (hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), total Ig or IgG, and antibody to hepatitis B surface antigen (anti-HBs)) * Diagnostic Mammogram (NOTE: can be performed up to 60 days prior to study enrollment) Tumor and axillary assessment * Surgical assessment * Serum pregnancy test for women of childbearing potential (NOTE: serum βhCG within 14 days prior to study registration). * Archival tumor tissue assessment Azacitidine Treatment Visits Day 1 * Pre-treated with ondansetron 8mg PO once 30 minutes prior to azacitidine administration. * Urine pregnancy test for women of childbearing-potential (NOTE: if \>7days since screening) * Research blood draw * Azacitidine administration * AE assessment Days 2-5 * Premedicate with ondansetron 8mg PO once 30 minutes prior to azacitidine administration. * Azacitidine administration Pre study biopsy visit * Physical exam, weight * Vital signs (blood pressure, heart rate, temperature) * Review of concomitant medications * ECOG performance status * Blood chemistries (sodium, potassium, serum creatinine \[or GFR\], calcium, albumin, ALT, AST, total bilirubin, alkaline phosphatase, total protein) * CBC with differential * Research blood draw * AE assessment Post Study Biopsy Follow-Up visit * Physical exam, weight * Vital signs (blood pressure, heart rate, temperature) * Review of concomitant medications * ECOG performance status * Research blood draw * Archival tumor tissue assessment * AE assessment

Conditions

• Breast Cancer Invasive
• Early-stage Breast Cancer
• High Risk Breast Carcinoma

Interventions

Type	Name	Description
DRUG	Azacitidine	5-Azacitidine is a pyrimidine nucleoside analog in which nitrogen replaces carbon at position 5

Timeline

• Start date: 2022-01-10
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2021-05-18
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study