Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

NeoAdjuvant Trastuzumab/ Pyrotinib Plus Weekly Paclitaxel/Cisplatin in HER2-positive Locally Advanced Breast Cancer Patients

This is a prospective, open label study to evaluate the efficacy and safety of neoadjuvant pyrotinib in early breast cancer patients.

Inclusion Criteria:

• Female, Aged ≥18 and ≤70 years
• Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ)
• Subjects with at least one evaluable lesion
• ECOG 0-1
• Adequate organ function

Exclusion Criteria:

• Metastatic disease (Stage IV)
• Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption
• Treated or treating with T-DM1, lapatinib and neratinib before study entry
• History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation
• Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial
• 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