A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer

Exclusion Criteria

• •1\. Concomitant disease and medical history:
• •1. Has other malignant tumors within 3 years;
• •2. Has multiple factors affecting oral medication;
• •3. Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy;
• •4. Has active or uncontrolled severe infections before the first dose;
• •5. Cirrhosis, active hepatitis#
• •6. Have a history of immunodeficiency; 2. Tumor-related symptoms and treatment:
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• •1. Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;
• •2. Had received chemotherapy within 3 weeks prior to the first dose, and had received radiotherapy , hormone therapy, or other anti-tumor therapy within 2 weeks prior to the first dose;
• •3. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
• •3\. Has known to be allergic to Fulvestrant injection , TQB3616 or any excipient.
• •4\. Has Participated in other clinical trials within 4 weeks before first dose. 5. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.