A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer

Inclusion Criteria:

• Those voluntarily signing the informed consent form, understanding the study andwilling to follow all testing procedures;
• Females aged ≥ 18 years and ≤ 75 years (at the date of signing the informed consentform);
• Patients diagnosed with early (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3,M0) invasive breast cancer histologically;
• Patients with HER2-positive breast cancer: HER2 detection is based on the ChineseBreast Cancer HER2 Detection Guidelines (2019 Edition), the immunohistochemistry (IHC)method is used to detect the expression level of HER2 protein, and the in situhybridization (ISH) method is used to detect the HER2 gene amplification level. ISHincludes fluorescence in situ hybridization (FISH) and bright-field in situhybridization. The common bright-field in situ hybridization method includeschromogenic in situ hybridization (CISH) and silver-enhanced in situ hybridization (SISH);The HER2-positive criterion is: IHC detection +++, or IHC++, and further insitu hybridization confirms that HER2 gene amplification is positive;
• Those planning to receive final surgical resection of breast cancer, i.e.breast-conserving surgery or total mastectomy, sentinel node (SN) biopsy or axillarylymph node dissection (ALND);
• Those planning to receive neoadjuvant chemotherapy;
• Those with the maximum primary tumor diameter of > 2cm determined by the standardevaluation method of study center (MRI);
• Patients with performance status score of 0 or 1 by the US Eastern CooperativeOncology Group (ECOG);
• Those with left ventricular ejection fraction (LVEF) of ≥ 55% within 4 weeks prior torandomized enrollment; 10) Those with suitable organs and hematopoietic functions,without significant abnormality in the following laboratory examinations:
• Absolute neutrophil count (NEUT#) ≥1.5×109/L;
• Absolute white blood cell count (WBC) ≥ 3.0 × 109/L;
• Platelet ≥90×109/L;
• Hemoglobin ≥90g/L;
• Serum creatinine ≤1.5 x upper limit of normal (ULN);
• AST and ALT values ≤ 1.5 x ULN;
• Serum total bilirubin (TBIL) ≤ 1.5 x ULN;
• International normalized ratio (INR) ≤ 1.5 x ULN, or activated partialthromboplastin time (APTT) ≤ 1.5 x ULN (except for subjects undergoinganticoagulation therapy).

(The above laboratory examinations are subject to the normal values of each clinicalresearch center)

• Female patients without menopause or surgical sterilization: they agree to practiceabstinence or effective contraception during treatment and at least 7 months after thelast administration in the study treatment. Women at childbearing age who have undergone surgical sterilization (includinghysterectomy, bilateral oophorectomy or total hysterectomy) or have been menopausal (defined as having no menstruation for more than 12 months without medical reason) areconsidered as having no possibility of pregnancy. Throughout the clinical trial, women with the possibility of pregnancy are willing topractice medically accepted, effective contraception, including intrauterine contraceptivedevice.

Exclusion Criteria:

• Pregnant or lactating women, and patients with positive baseline pregnancy test; womenof childbearing age who do not agree to practice abstinence or effective contraceptionduring the study period and within 7 months after the last administration;
• Those with a clear history of drug allergy, especially those with prior severeallergic reaction to macromolecular protein preparation/monoclonal antibody, or to anyof the test drug components (NCI-CTCAE 5.0 greater than grade 3);
• Patients with bilateral breast cancer or inflammatory breast cancer;
• Patients with (metastatic) breast cancer Stage IV;
• Those with a history of congestive heart failure, unstable angina, arrhythmia ormyocardial infarction;
• Those with other invasive tumors (including second primary breast cancer) that mightaffect the result evaluation and protocol compliance; however, subjects who are curedwith a disease-free survival of at least 5 years may be enrolled;
• Patients with breast cancer who have previously received chemotherapy, endocrinetherapy, or anti-HER2 biotherapy, or have received breast surgery (except fordiagnostic biopsy of primary breast cancer);
• Those with known, uncontrolled, active bacterial, viral, fungal, mycobacterial,parasitic or other infections (excluding nail bed fungal infection) or with anysignificant systemic infection event that required intravenous antibiotic treatment orhospitalization (except for neoplastic fever) within 4 weeks prior to enrollment);
• Those with any positive HIV antibody or treponema pallidum antibody;
• Those with active hepatitis B (hepatitis B virus DNA titer is above the lower limit ofnormal);
• Those with existing, sudden lung disease, interstitial lung disease, pneumonia orpulmonary fibrosis, except for local interstitial pneumonia induced by radiotherapy;
• Those with a prior history of drug abuse, alcohol abuse or drug addiction;
• Those with a clear history of neurological or mental disease and with poor compliance,such as epilepsy and dementia;
• Those with a major surgical operation or infusion of blood or blood components 4 weeksprior to the clinical trial;
• Those with blood loss or donation of more than 400 ml within the 2 months prior to theclinical trial;
• Those who have participated in other clinical trials 3 months prior to this clinicaltrial;
• Those with reduced possibility of enrollment (e.g. weakness) or non-compliancetendency during the study period, or with other diseases that might complicateenrollment as judged by the investigator.