Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer

- Aged ≥18 and ≤70 years;

- Histologically confirmed invasive HER2 positive breast cancer;

- Duration from random time to the last use of trastuzumab or T-DM1 ≤3 years;

- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;

- Adequate organ functions.

- Metastatic disease (Stage IV);

- Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;

- Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;

- Treated or treating with anti-HER2 tyrosine kinase inhibitor;

- Less than 4 weeks from the last clinical trial;

- History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;

- Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test; Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period;

- Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.