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

  • STATUS
    Recruiting
  • End date
    May 5, 2023
  • participants needed
    40
  • sponsor
    University of Illinois at Chicago
Updated on 5 September 2021

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.

Description

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. Median TIL counts will be compared between the pre- and post-treatment specimens with the Wilcoxon signed-rank test if TIL count does not follow normal distribution. General linear model (GLM) or kruskal wallis test will be used in the multivariate analyses to estimate the effect of low dose azacitidine therapy on TILs after adjusting for other clinical factors and patients characteristics, including the heterogeneity of tumors.

Screening Evaluation Visit All screening procedures will take place within 30 days of the first treatment visit unless otherwise noted.

  • Informed consent, HIPAA authorization
  • Medical history including prior and concurrent therapies and pathology
  • Physical exam, height, weight
  • Vital signs (blood pressure, heart rate, temperature)
  • Review of concomitant medications
  • ECOG performance status
  • Blood chemistries (sodium, potassium, serum creatinine [or GFR], calcium, albumin, ALT, AST, total bilirubin, alkaline phosphatase, total protein)
  • CBC with differential
  • Hepatitis B screening (hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), total Ig or IgG, and antibody to hepatitis B surface antigen (anti-HBs))
  • Diagnostic Mammogram (NOTE: can be performed up to 60 days prior to study enrollment) Tumor and axillary assessment
  • Surgical assessment
  • Serum pregnancy test for women of childbearing potential (NOTE: serum hCG within 14 days prior to study registration).
  • Archival tumor tissue assessment

Azacitidine Treatment Visits Day 1

  • Pre-treated with ondansetron 8mg PO once 30 minutes prior to azacitidine administration.
  • Urine pregnancy test for women of childbearing-potential (NOTE: if >7days since screening)
  • Research blood draw
  • Azacitidine administration
  • AE assessment

Days 2-5

  • Premedicate with ondansetron 8mg PO once 30 minutes prior to azacitidine administration.
  • Azacitidine administration

Pre study biopsy visit

  • Physical exam, weight
  • Vital signs (blood pressure, heart rate, temperature)
  • Review of concomitant medications
  • ECOG performance status
  • Blood chemistries (sodium, potassium, serum creatinine [or GFR], calcium, albumin, ALT, AST, total bilirubin, alkaline phosphatase, total protein)
  • CBC with differential
  • Research blood draw
  • AE assessment

Post Study Biopsy Follow-Up visit

  • Physical exam, weight
  • Vital signs (blood pressure, heart rate, temperature)
  • Review of concomitant medications
  • ECOG performance status
  • Research blood draw
  • Archival tumor tissue assessment
  • AE assessment

Details
Condition Breast Cancer Female, Invasive Breast Cancer, Breast Cancer Invasive
Treatment Azacitidine
Clinical Study IdentifierNCT04891068
SponsorUniversity of Illinois at Chicago
Last Modified on5 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years of age at time of consent
ECOG 0, 1, or 2
Histologically confirmed invasive breast carcinoma documented by biopsy. AJCC 8th edition clinical stage T1c-T2/N0-N1/M0 by physical exam or radiologic studies
Primary breast tumor > 1cm
Disease characteristics I. TNBC (Less than or equal to 10% of tumor cells staining for ER and for PR by immunohistochemistry (IHC). HER2-negative, as defined by ASCO/CAP guidelines)
OR
II. ER positive (as determined by immunohistochemistry (IHC)) and any of the
following high risk characteristics
HER2 positive (IHC or FISH)
Node positive
Any clinical high-risk expression profile (mammaprint, oncotype, endopredict)
PR negative (IHC) OR III. HER 2 positive (as defined by ASCO/ACP guidelines)
Demonstrates adequate organ function as defined in table below. All screening labs to be obtained within 30 days prior to registration
System Laboratory Value Hematological Leukocytes 3,000/mm3 Platelet count
000/mm3 Absolute Neutrophil Count (ANC) 1,500/mm3 Hemoglobin (Hgb) 9.0
g/dL Renal Creatinine/Calculated creatinine clearance (CrCl) Cr < 1.5 x upper
limit of normal (ULN) or CrCl 50 mL/min using the Cockcroft-Gault formula
Hepatic Bilirubin Bilirubin 1.5 ULN. Subjects with Gilbert's syndrome may have
a bilirubin > 1.5 ULN, if no evidence of biliary obstruction exists Aspartate
aminotransferase (AST) 2.5 ULN Alanine aminotransferase (ALT) 2.5 ULN
\. No evidence of distant metastases (M0 per AJCC staging guidelines)
\. Provided written informed consent and HIPAA authorization for release of
personal health information, via an approved UIC Institutional Review Board
(IRB) informed consent form and HIPAA authorization
\. Women of childbearing potential must not be pregnant or breast-feeding. A
negative serum or urine pregnancy test is required per institutional practice
guidelines
\. As determined at the discretion of the enrolling physician or protocol
designee, ability of the subject to understand and comply with study
procedures for the entire length of the study

Exclusion Criteria

Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and/or ipsilateral axillary lymph nodes or investigational agents) with therapeutic intent for the current breast cancer
Any type of breast implants
Active infection requiring systemic therapy
Uncontrolled HIV/AIDS or active viral hepatitis
Pregnant or nursing
Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist
Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
Other major comorbidity, as determined by study PI
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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