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

Exclusion criteria

• ✕. Has had other malignant tumors within 3 years or currently has other malignant tumors;
• ✕. Have a variety of factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
• ✕. Unmitigated toxicity above CTCAE1 grade due to any prior treatment;
• ✕. Severe infections (≥CTCAE2 grade) that were active or uncontrolled before the study treatment started;
• ✕. Cirrhosis, active hepatitis；
• ✕. Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
• ✕. Clinical evidence or history of central nervous system metastases (CNS) and/or cancerous meningitis or pneumomeningeal disease;
• ✕. 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);