shr-a1811 plus pertuzumab in the neoadjuvant treatment of her2 positive bc

Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Summary: the goal of this clinical trial is to evaluate the efficacy and safety of shr-a1811 plus pertuzumab in combination with or without albumin-paclitaxel neoadjuvant therapy for early or locally advanced her2-positive breast cancer. the main questions it aims to answer are: * does the pcr of shr-a1811 plus pertuzumab with or without albumin-paclitaxel improve compared to the current standard of treatment? * is the safety of shr-a1811 plus pertuzumab with or without albumin-paclitaxel better compared to the current standard of treatment? researchers will compare shr-a1811+pertuzumab or shr-a1811+pertuzumab+albumin-paclitaxel to tcbhp to see if shr-a1811 plus pertuzumab with or without albumin-paclitaxel works to treat early or locally advanced her2-positive breast cancer. subjects will be randomly assigned 1:1:1 to： * cohort 1：shr-a1811 combined with pertuzumab for 6 cycles; * cohort 2：shr-a1811 combined with pertuzumab and albumin-paclitaxel for 6 cycles; * cohort 3：tcbhp (docetaxel, carboplatin, trastuzumab and pertuzumab) for 6 cycles. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.


Eligibility criteria:
inclusion criteria: * age: 18-70 years old, ecog 0-1 point. * clinical t2-t4, with any ln, m0. * her2+, invasive breast cancer confirmed by histopathology;(her2 positive expression means that there is at least one case of tumor cell immunohistochemical staining intensity of 3+or positive confirmed by fluorescence in situ hybridization \[fish\] in the pathological test/review of the primary focus conducted by the pathology department of the research center hospital). * having clinically measurable lesions: measurable lesions displayed on ultrasound, mammography, or mr (optional) within the first month of randomization. * organ and bone marrow function tests within one month before chemotherapy indicate no contraindications to chemotherapy：absolute value of neutrophil count ≥ 1.5 × 10\^9/l; hemoglobin ≥ 90g/l; platelet count ≥ 100 × 10\^9/l; total bilirubin≤1.5 uln (upper limit of normal value); creatinine≤1.5 × uln; ast/alt ≤ 2.5 × uln. * cardiac ultrasound: left ventricular ejection fraction (lvef ≥ 50%). * women of childbearing age tested negative for serum pregnancy test 7 days before randomization. * sign an informed consent form. exclusion criteria: * stage iv (metastatic) breast cancer. * has received chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. for this disease. * the patient has a second primary malignant tumor, except for fully treated skin cancer. * the patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical procedures. * the presence of uncontrolled cardiovascular and cerebrovascular disease, including (but not limited to) any of the following within the 6 months prior to the first dose: congestive heart failure (nyha iii or iv), myocardial infarction or cerebral infarction, pulmonary embolism, unstable angina, or arrhythmia requiring treatment at the time of screening; primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restricted cardiomyopathy, undefined cardiomyopathy); a clinically significant history of prolonged qtc, grade ii type ii atrioventricular block or grade iii atrioventricular block or qtc interphase (f method) \> 470 msec (female); atrial fibrillation (ehra grade ≥2b); unmanageable hypertension, which the investigators judged unsuitable for study participation. * due to serious and uncontrollable other medical diseases, researchers believe that there are contraindications to chemotherapy. * individuals with a known history of allergies to the drug components of this protocol; * having a history of immunodeficiency, including hiv testing positive, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.

Keywords: breast cancer her2-positive breast cancer pathologic complete response shr-a1811 pertuzumab albumin-paclitaxel