RecruitingPhase 2NCT04891068

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


Sponsor

University of Illinois at Chicago

Enrollment

40 participants

Start Date

Jan 10, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a low dose of a drug called azacitidine (which can reactivate silenced genes) given before surgery can improve the immune response to breast cancer. This is a 'window of opportunity' study, meaning the drug is given for a brief period before the tumor is surgically removed so researchers can study its effects on the tumor. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of invasive breast cancer (early stage, not yet spread) - Your cancer is one of: triple-negative breast cancer (TNBC), HER2-positive, or estrogen receptor-positive with high-risk features (node-positive, HER2-positive, poor prognosis profile, or PR-negative) - You have not yet received any treatment for this breast cancer diagnosis - You have adequate blood counts and organ function - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You have already received any chemotherapy, immunotherapy, or radiation for this breast cancer - You have breast implants - You have an active serious infection, uncontrolled HIV/AIDS, or active viral hepatitis - You are pregnant or nursing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzacitidine

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


Locations(1)

University of Illinois Cancer Center

Chicago, Illinois, United States

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NCT04891068


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