Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer

Inclusion Criteria

• •The subjects voluntarily joined the study and signed the informed consent, with good compliance.
• •Age: 18-75 years old (upon signing the informed consent); Eastern Cooperative Oncology Group Performance Status (PS) score: 0\~1;
• •Surgical treatment of radical mastectomy;
• •Pathological examination confirmed HR positive and HER2 negative invasive breast cancer;
• •The major organs are functioning well, meeting the following criteria：
• •1. Blood biochemical tests should meet the following criteria (no corrective therapy has been used within 7 days prior to screening)：
• •1. Hemoglobin (HB) ≥90 g/L；
• •2. Neutrophil absolute value (NEUT) ≥ 1.5×109/L；
• •3. Platelet count (PLT) ≥ 100 ×109/L；
• •2. Blood biochemical tests should meet the following criteria (no corrective therapy has been used within 7 days prior to screening)：
• •1. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN)；
• •2. Alanine transferase (ALT) and aspartate transferase (AST) ≤ 1.5×ULN；
• •3. Serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance (Ccr) ≥ 60 ml/min；
• •3. Blood clotting tests must meet the following criteria (no anticoagulant therapy)：
• •1. Prothrombin time (PT) ≤ 1.5×ULN;
• •2. Activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
• •3. International Normalized ratio (INR) ≤ 1.5×ULN.
• •4. Left ventricular ejection fraction (LVEF) ≥50%.