The Efficacy and Safety of Different Combination Regimens of Inetetamab in First-line Treatment of HER2 Positive Metastatic Breast Cancer
This study is to explore the efficacy and safety of the first-line treatment of HER2 positive recurrent/metastatic breast cancer with Inetetamab combined with Pertuzumab or Pyrotinib combined with chemotherapy, hoping to have better clinical benefits and provide a new treatment mode for targeted treatment.
• Female patients aged ≥ 18 years and ≤ 70 years old;
• Pathological diagnosis of HER-2 was positive (definition: immunohistochemical results were + + + or in situ hybridization results were positive);
• Invasive breast cancer confirmed by pathological examination, with evidence of local recurrence or imaging metastasis, and those with local recurrence must be confirmed by the researcher as unable to undergo radical surgery;
• Have not received first-line anti-HER2 treatment or (new) adjuvant anti-HER2 drug treatment that is effective and has been discontinued for more than 12 months;
• ECOG PS score 0-2, expected survival period ≥ 6 months, and able to follow up;
• According to the Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, there must be at least one clearly measurable and/or assessable lesion present, and the lesion diameter evaluated by CT or MRI must be ≥ 1cm;
• 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) ≥ 1.5×10\^9/L; platelets (PLT) ≥ 90×10\^9/L; hemoglobin (Hb) ≥ 90g/L. Blood biochemistry: total bilirubin (TBIL) ≤1.5×ULN,known as Gilbert syndrome patients, TBIL ≤ 2 × ULN; ALT and AST ≤2.5×ULN; and liver metastasis patients require ALT and AST ≤5×ULN; Alkaline phosphatase ≤ 2.5 × ULN; BUN and Cr ≤1.5×ULN;
• Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal, unless drugs known to alter INR and APTT are used;
• Left ventricular ejection fraction (LVEF) ≥50%;
• 12 lead electrocardiogram: Fridericia corrected QT interval (QTcF)\<470msec;
• No history of major organs such as the heart, lungs, liver, kidneys, or endocrine system;
• Female patients of childbearing age who have negative pregnancy tests and voluntarily adopt effective and reliable contraceptive measures;
• Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.