Randomized Controlled Clinical Study of Efficacy and Safety of Initumab Combined with Pyrrotinib and Chemotherapeutic Agents in Neoadjuvant Therapy for HER2-positive Breast Cancer with Different Treatment Cycles

Exclusion Criteria

• •1. Previous history of invasive breast cancer
• •2. Bilateral breast cancer, inflammatory breast cancer (e.g., erythema and/or skin involvement, and/or pathological findings of tumor cells in the dermal lymphatic vessels), or clinical stage T1c, N0, M0
• •3. Prior biopsy of primary tumor and/or axillary lymph node excision and/or excision
• •4. Previous systemic treatment for breast cancer;
• •5. A history of life-threatening hypersensitivity, or a known history of allergy to any component of the investigational drug;
• •6. Participated in clinical trials of other drugs or medical devices within 4 weeks before the first drug use, and received treatment with experimental drugs or devices
• •7. Patients who had undergone major surgery within 28 days prior to the first dose or planned to undergo major surgery during the study period
• •8. Other malignant tumors (excluding cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ) within the previous 5 years
• •9. Active hepatitis, active tuberculosis or other serious infectious diseases, including but not limited to: Active hepatitis C virus (HCV) infection (HCV antibody positive but not RNA negative), or hepatitis B virus (HBV) infection (HBV surface antigen positive and HBV-DNA copy number \>2000 IU/mL) or other serious infections requiring systemic treatment such as bacteremia, severe infectious pneumonia
• •10. A history of immunodeficiency or other autoimmune diseases, including but not limited to human immunodeficiency virus (HIV) infection (HIV-positive), systemic lupus erythematosus, rheumatoid arthritis, or a history of organ transplantation
• •11. Patients with a history of cardiovascular and cerebrovascular diseases, including: (1) unstable angina pectoris; (2) medically treatable or clinically significant arrhythmias; (3) myocardial infarction occurring within 6 months; (4) Heart failure, degree II and above atrioventricular block; (5) Cerebral infarction (except lacunar cerebral infarction), cerebral hemorrhage and other diseases occurring within 6 months
• •12. Patients with poorly controlled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg under regular medication), or with a prior history of hypertensive crisis or hypertensive encephalopathy
• •13. Pregnant and lactating female patients; Pregnant women of childbearing age who were positive in screening pregnancy test; Patients who are unwilling to use effective contraception throughout the trial period and for 6 months after the end of medication
• •14. Other circumstances deemed inappropriate by the investigator to participate in the study