Doxorubicin Hydrochloride Liposome Injection Combination With Cyclophosphamide vs Pirarubicin Combination With Cyclophosphamide in Patients With Locally Advanced Breast Cancer

The Efficacy and Safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer ：a Randomised Multicentre, Open-label Trial

Evaluate the efficacy and safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer Patients

Inclusion Criteria:

• Female patients with age between 18 and 70 years.
• Newly diagnosed breast cancer, stages IIb-IIIc.
• KPS performance status≥70.
• Measurable disease according to RECIST version 1.1.
• Normal cardiac function confirmed by baseline left ventricular ejection fraction (LVEF)≥50%.
• Adequate bone marrow reserve (WBC≥4.0×10(9)/L, neutrophils≥2.0×10(9)/L, platelets≥100×10(9)/L,and hemoglobin≥90g/L).
• Adequate hepatic and renal function.
• AST and ALT ≤ 2×institutional upper limit of normal；alkaline phosphatase ≤ 2×institutional upper limit of normal；bilirubin ≤ institutional upper limit of normal.
• Serum creatinine≥44 µmol/L and ≤133 µmol/L.
• Written informed consent are acquired.
• Not in pregnancy or the pregnancy tests of females is negative.

Exclusion Criteria:

• Severe heart failure (NYHA grade II or higher).
• Active and uncontrolled severe infection.
• Have accepted any other anti-tumor drug within 30 days before the first dose or
• received radiation treatment.
• Other situations that investigators consider as contra-indication for this study.