Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer
Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer
This is a prospective, open label, parallel controlled study to evaluate the efficacy and
 safety of neoadjuvant pyrotinib in HER2+ breast cancer patients
Inclusion Criteria:

 1. Female breast cancer patients at the age of >= 18 years and <= 65 years who received
 first treatment；

 2. Pathologically confirmed HER2-positive invasive breast cancer（which is defined as the
 immunohistochemistry score of > 10% immunoreactive cells being 3+ or in situ
 hybridization results showing HER2 gene amplification），regardless of hormone receptor
 status (ER and PR)；

 3. According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard
 for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm；

 4. The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1；

 5. The functional level of the main organs must meet the following requirements ： 1)
 blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10^9/L; platelet
 count (PLT) ≥ 90 × 10^9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper
 limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate
 aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen
 (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular
 ejection fraction (LVEF) ≥ 55%;

 6. Women of childbearing age, tested negative for serum pregnancy test 7 days before
 randomization，and willing to use appropriate methods during the trial and within 8
 weeks after the last administration of the test drug;

 7. A volunteer to participate in the study; provision of written informed consent; good
 compliance and willing to cooperate during the follow-up.

 Exclusion Criteria:

 1. Known history of hypersensitivity to pyrotinib or any of it components;

 2. Patients have previously received antitumor treatment or radiation therapy for any
 malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that
 have been cured);

 3. Patients underwent major breast cancer-free surgery within 4 weeks and have not fully
 recovered;

 4. Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of
 gastrointestinal absorption;

 5. Patients with severe heart disease or discomfort who cannot be treated;

 6. The patient suffers from mental illness or psychotropic substance abuse and cannot
 cooperate;

 7. Pregnant or lactating women;

 8. Less than 4 weeks from the last clinical trial;

 9. Patients participating in other clinical trials at the same time

 10. The researchers think inappropriate.