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.
You may not be if
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.
Clareo Health | Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
