BRE-04: Low-Dose Azacitidine for High-Risk Early Breast Cancer

This study is looking at how a drug called azacitidine affects tumor-infiltrating lymphocytes (TILs) in people with high-risk, early-stage breast cancer. TILs are immune cells that fight cancer. You might be able to join if you are at least 18 years old, have good general health (ECOG 0, 1, or 2), and have early-stage invasive breast cancer that is considered high-risk, specifically triple-negative breast cancer. The main goal is to see if azacitidine changes the number of TILs in your tumor after two weeks of treatment. The study plans to enroll about 40 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 40 participants.
What's involved
You would have screening procedures within 30 days of your first treatment, including medical history, physical exam, vital signs, and blood tests. The primary outcome is measured at 2 weeks from the first dose of azacitidine.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 2 weeks from the first dose of azacitidine. Longer-term follow-up is not specified.

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NCT04891068

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Illinois at Chicago
~40 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Azacitidine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in tumor infiltrating lymphocytes (TILs) count in primary tumors from patients with high-risk early stage breast cancer following low-dose azacitidine therapy.
Measured over 2 weeks from first dose of azacitidine
Breast Cancer Invasive
Early-stage Breast Cancer
High Risk Breast Carcinoma
1 sites across 1 states
Illinois1
  • Vijayakrishna Krishnamurthy Gadi, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago

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  • Change in tumor infiltrating lymphocytes (TILs) count in primary tumors from patients with high-risk early stage breast cancer following low-dose azacitidine therapy.2 weeks from first dose of azacitidine

    Number of participants that show tumor infiltrating lymphocytes (TILs) in primary tumors from patients with high-risk early stage breast cancer