A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab
A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This
 study is a randomized, multi-center, multinational, open-label, active-controlled, parallel
 design study of the combination of pyrotinib plus capecitabine versus the combination of
 lapatinib plus capecitabine in HER2+ MBC patients who have prior received anthracyclin,
 taxane or trastuzumab. Patients will be stratified by weather have prior use of trastuzumab
 and randomized in a 1:1 ratio to one of the following treatment arms:

 -  Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily)

 -  Arm B: lapatinib (1250 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Patients
 will receive either arm of therapy until the occurrence of death, disease progression,
 unacceptable toxicity, or other specified withdrawal criterion.
Inclusion Criteria:

 -  Aged ≥18 and ≤70 years.

 -  ECOG performance status of 0 to 1.

 -  Life expectancy of more than 12 weeks.

 -  At least one measurable lesion exists.(RECIST 1.1).

 -  Histologically or cytologic confirmed HER2 positive advanced breast cancer which
 failed prior therapies.

 -  Required laboratory values including following parameters:

 ANC: ≥ 1.5 x 10^9/L;Platelet count: ≥ 100 x 10^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin:
 ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN;BUN and creatine clearance
 rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: < 470 ms for female and < 450 ms for male.

 -  Signed informed consent

 Exclusion Criteria:

 -  Received previous therapy with lapatinib, neratinib, pyrotinib or any other HER2
 directe tyrosine kinase inhibitor.

 -  Received previous therapy with capecitabine within 3 months.