NCT04891068 BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
| NCT ID | NCT04891068 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Illinois at Chicago |
| Condition | Breast Cancer Invasive |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-01-10 |
| Primary Completion | 2026-05 |
Trial Parameters
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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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years of age at time of consent 2. ECOG 0, 1, or 2 3. Histologically confirmed invasive breast carcinoma documented by biopsy. AJCC 8th edition clinical stage T1a-T3/N0-N1/M0 by physical exam or radiologic studies 4. 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: 1. HER2 positive (IHC or FISH) 2. Node positive 3. Any clinical high-risk expression profile (mammaprint, oncotype, endopredict) 4. 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 Neutro
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