TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail

Exclusion Criteria

• •1 Complicated diseases and medical history:
• •1. Has had other malignant tumors within 3 years or currently has other malignant tumors;
• •2. Have a variety of factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
• •3. Unmitigated toxicity above CTCAE1 grade due to any prior treatment;
• •4. Severe infections (≥CTCAE2 grade) that were active or uncontrolled before the study treatment started;
• •5. Cirrhosis, active hepatitis；
• •6. Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
• •2 Tumor-related symptoms and treatment:
• •1. Clinical evidence or history of central nervous system metastases (CNS) and/or cancerous meningitis or pneumomeningeal disease;
• •2. Had received chemotherapy within 3 weeks prior to the start of study treatment, and had received radiotherapy (except palliative radiotherapy for non-target lesions), hormone therapy, or other anti-tumor therapy within 2 weeks prior to the start of study treatment (washout period was calculated from the end of last treatment);
• •3. Uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (as determined by the investigator).
• •3 Known to be allergic to fluvestone, TQB3616 or any excipient.
• •4 Participated in clinical trials of other antitumor drugs within 4 weeks prior to the initiation of study therapy.
• •5 Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.