Status:
RECRUITING
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Breast Cancer Female
Breast Cancer Invasive
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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) f. 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 ≥ 100,000/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 g. No evidence of distant metastases (M0 per AJCC staging guidelines) h. 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.
- i. Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
- j. 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
- 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 unless a Legal Authorized Representative (LAR) is in place to sign on behalf of the patient.
- Other major comorbidity, as determined by study PI
Key Trial Info
Start Date :
January 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04891068
Start Date
January 10 2022
End Date
May 1 2026
Last Update
June 10 2025
Active Locations (1)
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1
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612