NOV-002, Doxorubicin, Cyclophosphamide, and Docetaxel in Women With Newly Diagnosed Stage II or IIIC Breast Cancer

Exclusion Criteria

• •Prior therapy of any modality for the treatment of breast cancer
• •Any prior therapy with an anthracycline or a taxane for any other indication
• •HER-2 positive breast cancer defined as either gene amplification by Fluorescent In Situ Hybridization (FISH) or 3+ staining by IHC (Hercept™).
• •Women who have a positive pregnancy test, no pregnancy test available, who are pregnant or who are lactating.
• •Women of childbearing potential must agree to use a reliable and appropriate contraceptive method, which could include a double barrier method (condom plus diaphragm), an intrauterine device or oral contraceptives. Women with ER or PR positive breast cancer, should not, however, use oral contraceptives as a method of contraception. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
• •Women with breast cancer that do not have palpable breast tumors at screening.
• •History of another malignancy within the last 5 years except curatively treated basal cell carcinoma of the skin or cervical intraepithelial neoplasia.
• •Clinically significant (i.e. active) cardiac disease (NYHA Grade II or greater congestive heart failure, symptomatic coronary artery disease, unstable angina, and cardiac arrhythmia not well-controlled with medication), myocardial infarction within the last 6 months prior to study start, or screening ejection fraction of \< 50%.
• •Any of the following abnormal laboratory values:
• •* Absolute neutrophil count \< 1.5 x 109/L
• •* Platelet count \< 100 x 109/L
• •* Serum bilirubin \> 1.5 x upper limit of normal (ULN)
• •* Serum alanine transaminase (ALT), aspartate transaminase (AST) \> 2.5 x ULN
• •* Serum creatinine \> 2.0 mg/dL or 177mmol/L or calculated creatinine clearance by the method of Cockcroft and Gault \< 50mL/min).
• •Any severe or poorly controlled systemic disease (e.g., hypertension; clinically significant cardiovascular, pulmonary, or metabolic disease, disorders of wound-healing, ulcer or bone fracture).
• •Patients who have received any investigational treatment within 4 weeks of study start.
• •Known infection with HIV, Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
• •Known hypersensitivity to any of the components of NOV-002 or to any of the study drugs.
• •Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.