Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer

Inclusion Criteria

• •1. Histologically or cytologically proven adenocarcinoma of the breast stages II-III, according to the AJCC Staging Manual, 7th Edition, 2009
• •2. The following receptor status:
• •Expansion: Triple negative (ER\<1%, PR\<1%, and Her-2/neu negative Phase 1 (closed): Negative Her-2/neu status
• •3. ECOG performance status 0 or 1
• •4. Negative pregnancy test
• •5. Normal cardiac function (ejection fraction \> lower limit of normal) as determined by MUGA or echocardiogram
• •6. ANC greater than or equal to 1,500/mm3; platelet greater than or equal to 100,000/mm3; hemoglobin greater than or equal to 9 gm/dL
• •7. Serum bilirubin levels less than or equal to 1.5 mg/dL
• •8. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 X upper limit of normal, alkaline phosphatase less than or equal to 2.5 X upper limit of normal.
• •9. Serum creatinine levels less than or equal to 1.5 mg/dL
• •10. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with nab-paclitaxel through 28 days after the last dose. Men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel. Appropriate methods of birth controls for women include oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner and also based on the judgment of the investigator.
• •11. Female, greater than or equal to 19 years of age and any race.