Pyrotinib in HER2-positive Early Breast Cancer

This is a Multi-cohort, Phase II Clinical Study of Neoadjuvant - Adjuvant Pyrotinib in the Treatment of HER2-positive Early Breast Cancer, To evaluate the efficacy and safety of the pyrotinib-containing study regimen in patients with early HER2-positive early breast cancer with neoadjuvant and postoperative different Residual tumor burden scores.

Inclusion criteria

• Women aged ≥18 years and ≤75 years with newly treated breast cancer;
• Pathological examination confirmed HER2 positive (immunohistochemistry staining +++ or immunohistochemistry staining ++ and Fluorescence in situ hybridization positive);
• Patients with invasive breast cancer diagnosed histologically plus imaging as early (T1c-3, N0-1, M0) or locally advanced (T2-3, N2, or N3, M0);
• Eastern Cooperative Oncology Group score 0~1;
• 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);
• If the major organs function normally, the following criteria are met:

(1) The standard of blood routine examination should meet: absolute neutrophil count(ANC) ≥1.5×109/L; blood platelet (PLT) ≥90×109/L; Hb ≥90g/L; (2) Biochemical examination should meet the following criteria: total bilirubin(TBIL)≤ upper limit of normal value (ULN); alanine aminotransferase(ALT) and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); blood urea nitrogen(BUN)and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (CockcroftGault formula); (3) Color Doppler ultrasonography and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) Fridericia calibrated QT interval (QTcF) for 18-lead ECG <470 ms; 7. For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment; 8. Volunteer to join the study and sign the informed consent.

Exclusion criteria

• Known allergic history of the drug components of this protocol;
• Previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);
• Has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery;
• Stage IV (metastatic) breast cancer patients;
• Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug;
• Serious heart disease or discomfort that cannot be treated;
• Suffering from mental illness or psychotropic substance abuse, unable to cooperate;
• Pregnant or lactating women;
• Patients with severe liver and kidney function diseases and blood system diseases;
• Those who were not considered suitable for inclusion by the researchers included: history of drug abuse, history of use of blood products, anticoagulant drugs and immunological drugs within the past year; Patients with poor compliance and refusal to cooperate with treatment; Patients with severe high blood pressure, diabetes and other doctors deemed unsuitable for joining the study.