Neoadjuvant Inetetamab Combined With Pertuzumab and Paclitaxel/Carboplatin for Breast Cancer

Inclusion Criteria:

* Age of minimum of 18 years to a maximum of 70 years; males or females
* diagnosed as invasive breast carcinoma by preoperative needle core biopsy; patients with clinical stage of T1c to T4, N0-3, and M0, as defined by the American Joint Committee on Cancer AJCC Staging Manual, 8th Edition staging criteria
* HER2-positive: an immunohistochemistry (IHC) score of 3+ or IHC 2+ and in situ hybridization ISH+/fluorescence in situ hybridization FISH+.
* Left ventricular ejection fraction (LVEF) ≥50%；
* Eastern Cooperative Oncology Group (ECOG) performance score was 0/1；
* In the absence of blood transfusion or pharmacological treatment (granulocyte colony-stimulating factor/erythropoietin (EPO)/interleukin-11, etc.) within 14 days prior to the first treatment, and organ function must meet the following requirements: absolute neutrophil count (ANC) ≥ 1.5×109/L; platelets (PLT) ≥ 100×109/L; hemoglobin (Hb) ≥ 90g/L. Blood biochemistry: total bilirubin (TBIL) ≤1.5×ULN; ALT and AST ≤1.5×ULN; BUN and Cr ≤1.5×ULN; creatinine clearance ≥50mL/min (Cockcroft-Gault formula); total bilirubin (TBIL) ≤1.5×ULN; ALT and AST ≤1.5×ULN; BUN and Cr ≤1.5×ULN; creatinine clearance ≥50mL/min (Cockcroft-Gault formula);
* Volunteered to participate in this study and signed informed consent.

Exclusion Criteria:

* had a previous history of invasive breast cancer;
* Bilateral breast cancer, inflammatory breast cancer (eg, erythema and/or skin involvement, and/or pathological findings of neoplastic cells in dermal lymphatic vessels);
* Previous excisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes;
* Previous systemic therapy for breast cancer；
* History of previous life-threatening hypersensitivity reactions, or known hypersensitivity to any component of the study drug；
* Participated in clinical trials of other drugs or medical devices within 4 weeks before the first medication, and received treatment with experimental drugs or devices；
* Patients who have undergone major surgery within 28 days before the first dose, or plan to have major surgery during the study period；
* Other malignancies within the past 5 years (except cervical cancer in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ)；
* Active hepatitis, active tuberculosis or other serious infectious diseases, etc., including but not limited to: active hepatitis C virus (HCV) infection (except for HCV antibody positive but RNA negative), or active hepatitis B virus (HBV) infection (hepatitis B Surface antigen positive and HBV-DNA copy number \>2000 IU/mL) or bacteremia, severe infectious pneumonia and other serious infections requiring systemic treatment
* History of immunodeficiency or other autoimmune diseases, including but not limited to human immunodeficiency virus (HIV) infection (HIV antibody positive), systemic lupus erythematosus, rheumatoid arthritis, or history of organ transplantation；
* Those with the following history of cardiovascular and cerebrovascular diseases, including: (1) unstable angina; (2) arrhythmia requiring drug treatment or clinically significant; (3) myocardial infarction within 6 months; (4) cardiac arrhythmia Failure, second-degree and above atrioventricular block; (5) cerebral infarction (except lacunar infarction), cerebral hemorrhage and other diseases within 6 months；
* Patients with poorly controlled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg under regular drug control), or a history of hypertensive crisis or hypertensive encephalopathy；
* Pregnant and breastfeeding female patients; women of childbearing age who have a positive pregnancy test during the screening period; patients who are unwilling to take effective contraceptive measures during the entire test period and within 6 months after the end of the medication；
* Other conditions that the investigator considers inappropriate to participate in this trial.