Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-25 @ 3:10 PM
Study NCT ID:
NCT04891068
Status:
RECRUITING
Last Update Posted:
2025-06-10
First Post:
2021-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Sponsor:
University of Illinois at Chicago
Organization:
Study Overview
Official Title:
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRE-04
Brief 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.
Detailed 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 βhCG 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
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 βhCG 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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: