Actively Recruiting
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Led by University of Illinois at Chicago · Updated on 2026-01-14
40
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- ECOG performance status of 0, 1, or 2
- Histologically confirmed invasive breast carcinoma by biopsy with clinical stage T1a-T3/N0-N1/M0
- Disease characteristics include either Triple Negative Breast Cancer (TNBC) with HER2-negative status or ER positive with high risk features such as HER2 positive, node positive, high-risk expression profiles, or PR negative
- Adequate organ function as defined by specific hematological, renal, and hepatic laboratory values within 30 days prior to registration
- No evidence of distant metastases (M0)
- Written informed consent and HIPAA authorization provided
- Women of childbearing potential must have a negative serum or urine pregnancy test
- Ability to understand and comply with study procedures as determined by the enrolling physician or designee
You will not qualify if you...
- Previous anti-cancer treatment including chemotherapy, immunotherapy, biologic therapy, radiotherapy, or investigational agents for current breast cancer
- Presence of any type of breast implants
- Active infection requiring systemic therapy
- Uncontrolled HIV/AIDS or active viral hepatitis
- Pregnant or nursing
- Prior or concurrent malignancy interfering with study safety or efficacy assessment
- Mental or medical conditions preventing informed consent or participation without a legal representative
- Other major comorbidities as determined by the study principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
V
VK Gadi, MD, PhD
CONTACT
M
Michelle Karan, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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