Neoadjuvant Chemotherapy Plus Pyrotinib and Trastuzumab for HER2-positive Breast Cancer (NEOTORCH-BREAST05): A Prospective, Single-arm, Multi-center Clinical Study
This study is a prospective, single arm, multi-center clinical trial. The primary study objective is to evaluate the pathologic complete response (pCR)and clinical complete response(cCR) of neodjuvant treatment of HER2-positive breast cancer with pyrotinib and trastumab combined with neoadjuvant chemotherapy. The secondary study objective is to observe and evaluate the disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response Rate(ORR). The study also observes the incidence and types of adverse events.
‣ 1\. Female patients aged 18-75 years old; 2. ECOG score is 0-1 points; 3. Histologically confirmed invasive cancer meets the following standards:
• T1N1-3M0 or T2-4N0M0
• All patients were pathohistologically confirmed as HER2+ breast cancer. HER2 positivity was determined locally and defned as 3+ staining intensity by immunohistochemistry or HER2 gene amplifcation by fuorescence in situ hybridization according to the 2013 American Society of Clinical Oncology/College of American Pathologists guidelines.
• 4\. The functional level of major organs must meet the following requirements (no blood transfusion, no use of leukocyte and platelet boosting drugs within 2 weeks before screening):
⁃ Blood routine: Absolute neutrophil count (ANC) greater than 1.5 × 109/L; platelet count (PLT) greater than 75 × 109/L; Hemoglobin (Hb) is greater than 90g/L; Lymphocyte count ≥ 1.5 × 109/L
⁃ Blood biochemistry: Total bilirubin (TBIL) is less than 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate (AST) levels are less than 1.5 × ULN; Alkaline phosphatase is less than 2.5 × ULN; Urea nitrogen/Urea (BUN/UREA) and creatinine (Cr) are less than 1.5 × ULN.
⁃ Cardiac ultrasound: Left ventricular ejection fraction (LVEF) greater than 55%.
⁃ 12 lead electrocardiogram: The Fridericia corrected QT interval (QTcF) is less than 470 milliseconds 5. For female patients who have not yet reached menopause or undergone surgical sterilization: during the treatment period and in the study treatment, the final use effective contraceptive methods for at least 6 months after a single administration.
• 6\. Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.