Study on Low Dose Azacitidine Before Surgery for High-Risk Early Stage Breast Cancer

Sponsor: University of Illinois at Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04891068

Provider View

This clinical trial is exploring whether a low dose of the drug azacitidine, given before surgery, can affect immune cells in tumors of patients with high-risk early stage breast cancer.

Patient Parameters

Program Overview

The aim of this study is to see if low dose azacitidine can change the number of immune cells, called tumor infiltrating lymphocytes (TILs), in breast cancer tumors. Researchers will compare the number of these cells before and after treatment to understand the drug's impact.

Description

In this study, patients with high-risk early stage breast cancer will receive low dose azacitidine before surgery. The researchers want to see if this treatment affects the immune cells in the tumor. They will compare the number of these cells in tumor samples taken before and after the treatment.

Before starting the treatment, participants will have a screening visit to check their health and eligibility. This includes signing a consent form, reviewing medical history, and undergoing various tests like blood tests and a mammogram.

During the treatment phase, participants will take azacitidine for five days. They will also take a medication called ondansetron to help prevent nausea.

After the treatment, participants will have follow-up visits to monitor their health and assess any side effects. The study will also involve collecting blood samples and evaluating tumor tissue.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a good performance status, meaning able to carry out daily activities with minimal restrictions.
  • Have a confirmed diagnosis of invasive breast cancer at an early stage.
  • Meet specific disease characteristics, such as certain hormone receptor statuses or high-risk profiles.
  • Have adequate organ function based on blood tests.
  • No evidence of cancer spread beyond the breast and nearby lymph nodes.
  • Must not be pregnant or breastfeeding and agree to use contraception if of childbearing potential.
  • Able to understand and agree to the study procedures.

Exclusion Criteria

  • Have received any previous treatment for the current breast cancer.
  • Have breast implants.
  • Have an active infection requiring treatment.
  • Have uncontrolled HIV/AIDS or active hepatitis.
  • Are pregnant or nursing.
  • Have another cancer that could interfere with the study.
  • Have a mental or medical condition that prevents understanding or participation in the study.

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