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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the impact of low-dose azacitidine therapy on tumor infiltrating lymphocytes (TILs) in primary tumors of patients with high-risk early stage breast cancer. The study uses statistical tests to compare TIL counts before and after treatment, considering other clinical factors and tumor differences to better understand azacitidine's effect. It is a phase 2 trial conducted by the University of Illinois at Chicago. Participants will receive azacitidine at a dose of 50 mg/m2 by subcutaneous injection once daily for five consecutive days. Before each dose, ondansetron 8 mg is given orally to reduce nausea. The study includes an initial screening visit, treatment visits over five days, a pre-study biopsy visit, and a post-study biopsy follow-up visit to collect tumor tissue and monitor patient health. During the study, participants undergo physical exams, vital sign checks, blood tests, pregnancy tests for women of childbearing potential, and assessments of adverse events. Researchers measure changes in TIL counts and tumor characteristics two weeks after starting treatment. Safety and tolerability are monitored up to 30 days after the last dose, with long-term follow-up for disease-free and overall survival over two years. The total participation includes screening, treatment, biopsy visits, and extended monitoring.
CONDITIONS
Brief 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, clinical stage T1a-T3/N0-N1/M0
- Disease is triple-negative breast cancer with ER and PR 2; HER2-negative
- OR ER positive with one or more high-risk features: HER2 positive, node positive, high-risk expression profile, or PR negative
- Adequate organ function including leukocytes 6000/mm3, platelets 100,000/mm3, ANC 1,500/mm3, hemoglobin 9.0 g/dL
- Renal function with creatinine <1.5x ULN or creatinine clearance 50 mL/min
- Hepatic function with bilirubin 1.5x ULN (except Gilbert's syndrome) and AST, ALT 2.5x ULN
- No distant metastases (M0)
- Signed informed consent and HIPAA authorization
- Women of childbearing potential must have a negative pregnancy test
- Ability to understand and comply with study procedures
You will not qualify if you...
- Previous anti-cancer treatment with therapeutic intent for current breast cancer
- 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 safety or efficacy assessment
- Any mental or medical condition preventing informed consent or participation unless a Legal Authorized Representative is present
- 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
Your Study Journey
Duration - Up to 30 days before treatment
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive low dose azacitidine therapy administered daily for five consecutive days, with assessments before and during treatment.
5 treatment visits (in-person)
Duration - Up to 30 days after last treatment dose
Participants have a post study biopsy and follow-up assessments including physical exams, blood draws, and adverse event monitoring.
1 follow-up visit (in-person)
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
M
Michelle Karan, BS
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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