OncoMatch/Clinical Trials/NCT04891068
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Is NCT04891068 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Azacitidine for breast cancer invasive.
Treatment: Azacitidine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression ≤10% (≤10% of tumor cells staining for ER by IHC)
TNBC (Less than or equal to 10% of tumor cells staining for ER and for PR by immunohistochemistry (IHC))
Required: PR (PGR) expression ≤10% (≤10% of tumor cells staining for PR by IHC)
TNBC (Less than or equal to 10% of tumor cells staining for ER and for PR by immunohistochemistry (IHC))
Required: HER2 (ERBB2) wild-type (HER2-negative, as defined by ASCO/CAP guidelines)
HER2-negative, as defined by ASCO/CAP guidelines
Required: ESR1 expression >10% (ER positive (as determined by immunohistochemistry (IHC)))
ER positive (as determined by immunohistochemistry (IHC))
Required: HER2 (ERBB2) amplification (HER2 positive (IHC or FISH))
HER2 positive (IHC or FISH)
Required: PR (PGR) wild-type (PR negative (IHC))
PR negative (IHC)
Required: HER2 (ERBB2) amplification (HER2 positive (as defined by ASCO/ACP guidelines))
HER2 positive (as defined by ASCO/ACP guidelines)
Disease stage
Required: Stage T1A-T3, N0-N1 (AJCC 8th edition)
AJCC 8th edition clinical stage T1a-T3/N0-N1/M0 by physical exam or radiologic studies
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: cytotoxic chemotherapy
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.
Cannot have received: immunotherapy
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.
Cannot have received: biologic therapy
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.
Cannot have received: radiation therapy
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.
Cannot have received: investigational agents
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.
Lab requirements
Blood counts
Leukocytes ≥3,000/mm3; Platelet count ≥ 100,000/mm3; ANC ≥ 1,500/mm3; Hemoglobin ≥ 9.0 g/dL
Kidney function
Creatinine < 1.5 x ULN or CrCl ≥ 50 mL/min using Cockcroft-Gault formula
Liver function
Bilirubin ≤ 1.5 × ULN (Gilbert's syndrome allowed if no biliary obstruction); AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Illinois Cancer Center · Chicago, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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