Study to Evaluate the Efficacy and Safety of SYSA1901 vs. Perjeta® of HER2-Positive Breast Cancer

Inclusion Criteria

• •1. Voluntary agreement to provide written informed consent;
• •2. Age ≥ 18 years;
• •3. Histologically confirmed invasive breast carcinoma, and breast cancer staging \[in accordance with the American Joint Committee on Cancer (AJCC) staging system (8th edition)\]: early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2-3, M0; T4, any N, M0);
• •4. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;
• •5. HER2 positive, defined as immunohistochemistry (IHC) 3+, or IHC 2+ with In Situ Hybridization (ISH) positive;
• •6. Estrogen receptor (ER) and progestin receptor (PR) negative; ER and PR negative is defined as \< 1% nuclear staining;
• •7. Agree to receive surgical treatment of breast cancer at the participating unit when the surgical criteria are met after neoadjuvant therapy;
• •8. Primary tumor size of \> 2 cm in diameter;
• •9. Left ventricular ejection fraction (LVEF)≥ 55% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan;
• •10. Adequate major organ function, meeting the following criteria (have not received blood transfusion, EPO,G-CSF, other hematopoietic stimulating factors or medical supportive treatments within 14 days before the first dose of study drug): absolute neutrophil count (ANC) ≥1.5×10\^9 /L; Leukocyte count≥3.0×10\^9 /L, platelet (PLT) ≥100×10\^9 /L; hemoglobin ≥90 g/L; Serum creatinine ≤ 1.5 x the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; total bilirubin ≤1.5×ULN; international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, or activated partial thromboplastin time (APTT) ≤1.5×ULN (not receiving anticoagulation), or patients receiving anticoagulation need to be within treatment target range and at a stable dose;
• •11. Women of childbearing age must have a negative pregnancy test prior to the first dose;
• •12. Female and male patient of childbearing age must agree to take adequate contraceptive measures during the entire study period and through at least 6 months after the last dose of study drug.