Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer

Inclusion Criteria:

1. age:18-75 years old, female;
2. HER2 positive advanced breast cancer diagnosed by pathology, cytology or radiology, including inoperable breast cancer with stage IV, or recurrent/metastatic breast cancer.HER-2 positivity was confirmed by histopathological test: immunohistochemistry(IHC) results of 3 + or in situ hybridization (ISH) results of amplification of HER2;
3. Disease progression occurs after treatment with trastuzumab (stopping the drug for more than 12 months) or newly diagnosed IV stage breast cancer patients;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
5. Life expectancy greater than or equal to 6 months;
6. The main organs function well, and the inspection indicators meet the following requirements:

1\) For results of blood routine test HB≥90g/L; ANC≥1.5×109/L; PLT≥90×109/L; 2) For results of blood biochemical test ALT and AST≤2×ULN, but≤5×ULN if the transferanse elevation is due to liver metastases； TBIL≤1.5×ULN； Serum creatinine ≤1.5×ULN; 7. The researchers believed that the subjects were preference to benefit; 8. Participants were willing to join in this study, and written informed consent.

Exclusion Criteria:

1. Patients with brain metastases by CT or MRI;
2. More factors affecting of oral drugs (gastrointestinal surgery history, inability to swallow, chronic diarrhea, intestinal obstruction);
3. Study drug and excipient allergy;
4. History of psychiatric drugs abuse and can't quit or patients with mental disorders;
5. Pregnant or lactating female patients;
6. Less than 4 weeks from the last clinical trial;
7. The researchers think inappropriate.