• 5-year DFS [ Time Frame: 5 years ]
  5-year disease-free survival rate
• 5-year OS [ Time Frame: 5 years ]
  5-year overall survival rate
• Adverse events (AE) [ Time Frame: 5 years ]
  Incidence and Severity of adverse events according to the CTC AE V4.03

Subjects will receive one of two treatment regimens:

Group A: intravenous infusion of pegylated liposomal doxorubicin（PLD） 35 mg/m2, d1; cyclophosphamide 600 mg/m2, intravenous infusion, d1; once every 21days, for 4 cycles. Sequential docetaxel 100 mg/m2, intravenous infusion, d1, or paclitaxel 80mg/m2,intravenous infusion, d1,8,15, once every 21 days, for 4 cycles.

Group B: intravenous infusion of doxorubicin 60 mg/m2, d1; cyclophosphamide 600 mg/m2, intravenous infusion, d1; sequential docetaxel 100 mg/m2, intravenous infusion, d1, or paclitaxel 80mg/m2,intravenous infusion, d1,8,15, once every 21days, for 4 cycles. The primary endpoint is cardiotoxity,the secondary endpoint is 5-year disease-free survival (DFS), 5-year overall survival (OS), and safety: hematology and non hematological toxicity.

• Drug: PLD
  pegylated liposomal doxorubicin is 35 mg/m2 intravenously on Days 1 of each 21-day cycle followed by cyclophosphamide.
  Other Name: duomeisu
• Drug: CTX
  cyclophosphamide is 600 mg/m2 intravenously on Days 1 of each 21-day cycle, followed by docetaxel or paclitaxel.
  Other Name: huanlinxianan
• Drug: Docetaxel
  docetaxel is 100 mg/m2 intravenously on Days 1 of each 21-day cycle.
  Other Name: taisudi
• Drug: Paclitaxel
  paclitaxel is 80mg/m2 intravenously on Days 1, 8 and 15 of each 21-day cycle.
  Other Name: taisu
• Drug: Doxorubicin
  doxorubicin is 60 mg/m2 intravenously on Days 1 of each 21-day cycle followed by cyclophosphamide.
  Other Name: ameisu

• Experimental: PLD plus CTX sequential docetaxel or PTX
  pegylated liposomal doxorubicin 35 mg/m2,i.v.,d1, plus cyclophosphamide（CTX） 600 mg/m2,i.v.,d1, sequential docetaxel 100 mg/m2,i.v.,d1, or paclitaxel（PTX） 80mg/m2,i.v.,d1,8,15, once every 21days, for 4 cycles.
  Interventions:

  • Drug: PLD
  • Drug: CTX
  • Drug: Docetaxel
  • Drug: Paclitaxel
• Active Comparator: DOX plus CTX sequential docetaxel or PTX
  doxorubicin（DOX） 60 mg/m2,i.v.,d1, plus cyclophosphamide 600 mg/m2,i.v.,d1, sequential docetaxel 100 mg/m2,i.v.,d1, or paclitaxel 80mg/m2,i.v.,d1,8,15, once every 21days, for 4 cycles.
  Interventions:

  • Drug: CTX
  • Drug: Docetaxel
  • Drug: Paclitaxel
  • Drug: Doxorubicin

Inclusion Criteria:

• 1.Subjects had histopathologically confirmed early stage breast cancer with adjuvant chemotherapy treatment evidence;
• 2.Age :18-75years old female;
• 3.High risk of recurrence: axillary lymph node-positive, or axillary lymph node negative with at least one of the following risk factors: triple negative breast cancer, histological grade III, the maximum tumor diameter> 5cm, Ki 67 ≥ 50%, vascular thrombosis positive;
• 4.ECOG score 0-1;
• 5.Expected survival time ≥ 12 months;
• 6.LVEF ≥ 55%;
• 7.Normal ECG, ST segment depression in patients such as coronary angiography, confirm <50% stenosis or incidental premature beats are acceptable;
• 8.Bone Marrow Function: ANC：≥1.5×109/L； PLT：≥100×109/L；Hb: ≥90g/L;
• 9.Liver and renal function:Serum creatinine ≤ normal upper limit (ULN) 1.5times; aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ULN 2.5times; total bilirubin (TBil) level:≤ ULN 1.5 times, or ≤ ULN 2.5times if Gilbert's syndrome are present;
• 10.Subjects are well-behaved, able to undergo treatment and follow-up, and voluntarily comply with this study and understood the study's research process and signed the informed consent.

Exclusion Criteria:

• 1.New York Heart Association (NYHA) Class II or greater heart failure;
• 2.Severe heart disease or discomfort, including but not limited to: High-risk uncontrolled arrhythmias, atrial tachycardia (heart rate>100/min at rest), significant ventricular arrhythmias (ventricular arrhythmias) or higher, atrioventricular block ([Mobitz 2] or third-degree atrioventricular block); Angina pectoris that needs to be treated with anti-anginal medicine; Valvular heart disease with clinical significance; Electrocardiogram shows transmural myocardial infarction; Uncontrolled high blood pressure(eg: Systolic blood pressure> 180 mmHg or diastolic blood pressure> 100 mmHg);
• 3.Prior received neoadjuvant chemotherapy;
• 4.Severe systemic infection or other serious disease;
• 5.Allergies to chemotherapeutic drugs or their excipients or intolerant patients;
• 6.Other malignant tumors have been found in the past 5 years,except for cured cervical carcinoma in situ, non melanoma of the skin;
• 7.Childbearing age patients who are pregnant or lactation and refusing to take effective contraceptive measures during the trial;
• 8.Received any other test drug treatment or participated in other clinical trials at the same time;
• 9.Other conditions considered to be inappropriate to be enrolled by the investigator.