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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT04891068
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    5-Azacitidine is a pyrimidine nucleoside analog in which nitrogen replaces carbon at position 5

Study Details

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.

Key Dates

Start date
Jan 10, 2022
Status verified
Jan 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm with previously untreated high risk early stage breast cancer
    All participants will receive azacitidine 50mg/m2 SC daily for five consecutive days.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois Cancer CenterChicagoIllinois60612
VK Gadi, MD
[email protected]
312-996-1581
Michelle Karan
[email protected]
224-563-7137

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By research site
University of Illinois Cancer Center· Chicago, IL

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