The Efficacy and Safety of Different Combination Regimens of Inetetamab in First-line Treatment of HER2 Positive Metastatic Breast Cancer

Exclusion Criteria

• •Have received other clinical study drugs within 4 weeks prior to the first study drug administration;
• •Have received any systematic anti-tumor treatment during the recurrence/metastasis stage (excluding endocrine therapy previously performed for recurrence/metastasis stage);
• •During the (new) adjuvant phase, other anti-HER2 treatments were received in addition to trastuzumab, pertuzumab, and pyrotinib;
• •Patients who experience disease progression during (new) adjuvant trastuzumab treatment, as well as patients who experience recurrence/metastasis within 12 months after completing (new) adjuvant system treatment;
• •Evidence of symptomatic central nervous system metastasis or leptomeningeal disease (patients with brain metastases who have received radiation therapy and have been stable for ≥ 4 weeks can be enrolled);
• •Patients with only bone or skin as the sole target lesion;
• •Serious heart disease or discomfort, including but not limited to the following situations:
• •1. History of heart failure or systolic dysfunction (LVEF\<50%);
• •2. High risk or treatable angina pectoris or arrhythmia (such as second degree type 2 atrioventricular block or third degree atrioventricular block, ventricular tachycardia);
• •3. Clinically significant heart valve disease;
• •4. Electrocardiogram indicates transmural myocardial infarction;
• •5. Uncontrolled hypertension (excluding stable cases where systolic blood pressure\>150 mmHg and/or diastolic blood pressure\>90 mmHg can be controlled after stable treatment);
• •Gastrointestinal dysfunction or gastrointestinal diseases (including active ulcers);
• •Presence of active hepatitis B (HBsAg positive and HBV DNA ≥ 500 IU/mL), hepatitis C (hepatitis C antibody positive and HCV RNA above the upper limit of normal range), and cirrhosis;
• •History of immunodeficiency, including HIV infection, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
• •There is a third fluid accumulation (such as pleural effusion or ascites) that cannot be controlled by drainage or other methods;
• •Suffering from serious accompanying diseases or other comorbidities that may interfere with the planned treatment, or any other circumstances that are not suitable for participation in this study, such as pulmonary infections that require treatment;
• •Other malignant tumors within the past five years, except for those cured of cervical, basal cell carcinoma, and squamous cell carcinoma;
• •The patient has undergone major surgical procedures or significant trauma within the first 4 weeks of randomization, or is expected to undergo major surgical treatment;
• •Peripheral neuropathy of grade ≥ 3 judged according to CTCAE 5.0 standards;
• •Those who are known to have a history of allergies to the components of this drug regimen;
• •Researchers determine that individuals are not suitable for receiving systemic chemotherapy;
• •Pregnant or lactating female patients who are unable to use effective contraception throughout the entire trial period and are of childbearing age;
• •The researchers believe that it is not appropriate to participate in this trial, as any other medical, social, or psychological factors may affect safety or compliance with research procedures.