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

Eligibility 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 T1c-T2/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)
• 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.
• 1. 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.
• 2. Any type of breast implants
• 3. Active infection requiring systemic therapy
• 4. Uncontrolled HIV/AIDS or active viral hepatitis
• 5. Pregnant or nursing
• 6. 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.
• 7. 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.
• 8. Other major comorbidity, as determined by study PI