A Randomized Controlled Trial of HER-2 Positive Breast Cancer Patients Treated With Lapatinib vs Herceptin

Inclusion Criteria: 1. the first diagnosis of invasive breast cancer, confirmed by histology or cytology, and surgical resection of the primary lesions before receiving any anti breast cancer treatment; 2. female patients, aged 18 years and less than 80 years of age; 3. surgical resection of the primary tumor pathological examination, showed HER2 positive (defined as immunohistochemistry \[IHC\] 3+ or fluorescence in situ hybridization (FISH) positive); 4. hormone receptor status is known, lymph node positive or sentinel lymph node negative but high risk factors 5. the eastern oncology cooperative group (ECOG) patients with physical status score was 0 -2; 6. baseline LVEF \>50% 7. the relevant institutional review board (IRB) or independent ethics committee (IEC) written informed consent Exclusion Criteria: 1. the subjects in pregnancy or lactation; 2. pregnant women may be within the first 7 days before pregnancy test positive (urine or serum). 3. received chemotherapy, endocrine or anti HER2 anti-tumor therapy; 4. congestive heart failure, unstable angina, heart failure or myocardial infarction and other diseases; 5. other invasive tumors (including the second primary breast cancer), may affect the outcome of the evaluation and program compliance; but the treatment of patients with disease free survival at least more than 5 years can be selected; 6. with chronic liver disease in patients with liver dysfunction and / or with clinical manifestations: the serum total bilirubin \> 2.5 \* ULN; or INR = 1.5 but no bilirubin. serum ALT or AST\> \* 3 \* ULN; alkaline phosphatase \>2.5 \* ULN; ALT or AST can be gradually increased, but with gradually increasing fatigue, nausea and vomiting, fever, right upper quadrant pain or tenderness 7. hematopoietic dysfunction, defined as follows: neutrophil count (ANC) \<1.5 \* 109/L; platelet \<100 \* 109/L; hemoglobin \<9 g/dL; 8. other serious diseases, including: congestive heart failure (heart function NYHA grade II, III, IV) or occurred within 6 months of congestive heart failure, unstable angina, arrhythmia, myocardial infarction patients can't control or other severe cardiovascular disease; breathing at rest or need oxygen therapy; serious infection; uncontrolled diabetes; 9. there is a serious psychological or mental abnormalities, estimated that the participants to participate in this study is not strong; 10. known to study drug allergy; 11. the past 30 days participated in the study of other drug clinical trials. 1, failed to complete the clinical trial of at least 1 cycles according to the program, can not carry out safety and efficacy evaluation 2, a serious violation of this research program, not in accordance with the prescribed dose, method and course of medication. Patients will receive lapatinib treatment, until a predetermined end end point, or development of unacceptable toxicity, or withdrawal of consent, or illness or death, to appear before the subject.