Prospective, Single-center, Observational Clinical Study of Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer
This study is a prospective, single-center, observational clinical study, The objection was to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III breast cancer and observation of the efficacy of step-down neoadjuvant therapy for HER2-positive stage T1cN0M0 breast cancer.
• Female patients aged 18-75 years;
• Her2-positive breast cancer confirmed by pathology;
• invasive breast cancer confirmed by histology, Tumor stage: early stage (T1c-3, N0-1, M0) or locally advanced stage (T2-4, N2, N3, M0);
• ECOG PS: 0-1 score;
• Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND)
• Normal function of major organs means that the following criteria are met:
⁃ (1) Blood test neutrophil (ANC) \>=1.5x10\^9/L; Platelet count (PLT) \>=90x10\^9/L; Hemoglobin (Hb) \>=90g/L; (2) Total bilirubin (TBIL) \<=1.5 upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<=1.5xULN; Alkaline phosphatase \<=2.5xULN; Urea nitrogen (BUN) and creatinine (Cr) \<=1.5xULN; (3) Left ventricular ejection fraction (LVEF) \>=55%; (4) The QT interval (QTcF) corrected by Fridericia method was less than 470msec in 12-lead ECG; 7. For women who have not undergone menopause or surgical sterilization: consent to abstinence or use an effective contraceptive method (during treatment and for at least 7 months after the last dose in the study treatment); 8. Volunteer to participate in this study, sign the informed consent, have good compliance and be willing to cooperate with follow-up.