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