A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection for Patients With Breast Cancer

Inclusion Criteria:

• Female patients newly diagnosed breast cancer≥18 and ≤70 years of age;
• Karnofsky performance status≥70 and measurable or evaluable;
• Stages Ⅲa-ⅢC;
• Baseline left ventricular ejection fraction (LVEF) ≥ 50%;
• Adequate marrow function (WBC count> 4.0×10(9)/L, neutrophil> 2.0×10(9)/L, platelet count > 100×10(9)/L，hemoglobin > 90g/L );
• AST and ALT ≤1.5× institutional upper limit of normal, alkaline phosphatase
• ≤2.5×institutional upper limit of normal，bilirubin ≤institutional upper limit of normal;
• Serum creatinine ≥ 44µmol/L and ≤ 133 µmol/L;
• Expected lifetime ≥ 12 months;
• Pregnancy tests of reproductive age women is negative;
• All patients provided written informed consent.

Exclusion Criteria:

• Distant metastasis;
• Severe heart failure (NYHA grade II or higher);
• Active and uncontrolled severe infection;
• Hypersensitivity to anthracycline therapy or a history of severe hypersensitivity reactions to products containing liposomal doxorubicin and docetaxel;
• Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride liposome or doxorubicin;
• Pregnancy or breast feeding;
• Other situations that investigators consider as contra-indication for this study