Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced or Metastatic Hormone Receptor(HR)-Positive and Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Exclusion Criteria

• •It is known to suffer from spinal cord compression, cancerous meningitis, symptoms with brain metastasis or symptoms control for less than 4 weeks.
• •Combined diseases and medical history:
• •1. Have appeared within 3 years or have also suffered from other malignant tumors;
• •2. Adverse reactions from previous treatments have not been restored to CTCAE 5.0 grade≤1;
• •3. It affects oral and drug absorption
• •4. Those who have received major surgical treatment within 4 weeks before the first medication, obvious traumatic injury or expected to undergo major surgery during the study treatment, or have long-term uncured wounds or fractures;
• •5. Congenital bleeding , coagulation dysfunction disease;
• •6. Arterial/deep thrombosis events occurred;
• •7. Blood pressure control was not ideal;
• •8. Major cardiovascular disease;
• •9. Uncontrolled ≥CTCAE level 2 within 14 days before the start of study treatment
• •10. A history of active tuberculosis, pulmonary fibrosis or pneumonia;
• •11. a past or currently associated with interstitial lung disease/pneumonia;
• •12. active viral hepatitis and poor control;
• •13. treatment is required
• •14. uncontrollable kidney disease;
• •15. a history of immunodeficiency;
• •16. a person who is prepared to undergo or has undergone genealogical bone marrow transplants or solid organ transplants;
• •17. uncontrollable diabetes;
• •18. a person who suffers from People with epilepsy and need treatment;
• •19. People with a history of psychotropic substance abuse and cannot be abstained or have mental disorders.
• •Tumor-related symptoms and treatment:
• •1. If it is not controlled, the third gap effusion still needs to be repeatedly drained;
• •2. There is lung cancer pharyngitis;
• •3. During the study period, the tumor is very likely to invade important blood vessels and cause it Fatal severe bleeding;
• •4. Use strong CYP3A4 inhibitor or strong inducer, and the drug half-life is less than 3 before the start of the study treatment;
• •5. Have received anti-tumor treatment within 3 weeks before the start of the study treatment, and the washing is calculated from the end of the last treatment
• •6. Within 2 weeks before the start of the study treatment, Chinese patent medicine treatment with anti-tumor indications was received in the National Medical Products Administration (NMPA) approved drug instructions.
• •Research and treatment related:
• •1. Used phosphatidylinositol 3 kinase (PI3K)/AKT/mammalian target of rapamycin (mTOR) inhibitors;
• •2. Used fulvestrant or other selective estrogen receptor degrading agents (SERD);
• •3. Used in any study drug or drug Allergic to any ingredient or excipient;
• •4. a history of live attenuated vaccination within 28 days before the first medication or planned to undergo live attenuated vaccination during the study period;
• •5. is receiving systemic glucocorticoid therapy or any other form of immunosuppression therapy, and Continued use within 2 weeks before the start of the study treatment
• •According to the judgment of the researcher, there are situations that seriously endanger the safety of the subject or affect the subject's completion of the research.