Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of TQB3616 Combined With Endocrine Therapy Versus Placebo Combined With Endocrine Therapy in Hormone Receptors (HR)-Positive and Human Epidermal GrowthFactor Receptor-2 (HER2) -Negative Breast Cancer Adjuvant Therapy
This is a Phase III, randomized, double-blind, parallel, multi-center trail to evaluate the efficacy and safety of TQB3616 capsule combined with endocrine compared to placebo compared with endocrine in HR-positive and HER2-negative breast cancer adjuvant therapy. Approximately 1946 female subjects will be randomized to either TQB3616 combined with endocrine group or TQB3616-matching placebo combined endocrine group. Randomization will follow a 2:1 ratio, 1297 subjects in experimental group and 649 in the the Placebo Comparator group.
• 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：
‣ Blood biochemical tests should meet the following criteria (no corrective therapy has been used within 7 days prior to screening)：
• Hemoglobin (HB) ≥90 g/L；
∙ Neutrophil absolute value (NEUT) ≥ 1.5×109/L；
∙ Platelet count (PLT) ≥ 100 ×109/L；
⁃ Blood biochemical tests should meet the following criteria (no corrective therapy has been used within 7 days prior to screening)：
• Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN)；
∙ Alanine transferase (ALT) and aspartate transferase (AST) ≤ 1.5×ULN；
∙ Serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance (Ccr) ≥ 60 ml/min；
⁃ Blood clotting tests must meet the following criteria (no anticoagulant therapy)：
• Prothrombin time (PT) ≤ 1.5×ULN;
∙ Activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
∙ International Normalized ratio (INR) ≤ 1.5×ULN.
⁃ Left ventricular ejection fraction (LVEF) ≥50%.