A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer

Exclusion Criteria

• •1. Patient with visceral crisis, inflammatory breast cancer, or brain metastases, except for patient with stable brain metastases;
• •2. Patient had clinically significant pleural effusions, ascites effusions, or pericardial effusions in the 4 weeks before enrollment;
• •3. Patient who received prior treatment with mTOR inhibitors, CDK4/6 inhibitors or fulvestrant;
• •4. Participation in a prior treatment of major surgery, chemotherapy, radiotherapy, and any anti-tumor treatment within 14 days before enrollment；
• •5. Patient who participated in other clinical trials within 14 days before enrollment or within 5 half-lives of the trial drug, whichever is longer;
• •6. Patient used CYP3A4 potent inhibitors or potent inducers within 14 days before enrollment or within 5 half-lives of the drug, whichever is longer;
• •7. Patient who used bisphosphonates or RANKL inhibitors within 7 days before enrollment, patient who have started treatment during the study should not change the method of use;
• •8. Any other malignant tumor has been diagnosed within 3 years before randomization;
• •9. Patient is in the active stage of HBV, HCV or co-infected with HBV, HCV, or Patient with positive HIV antibody;
• •10. Patient with severe infection within 4 weeks before enrollment, or unexplained fever\> 38.5℃ during screening/before enrollment;
• •11. Patient with heart function impaired or clinically significant heart disease within 6 months before enrollment;
• •12. Cerebrovascular accident occurred within 6 months before enrollment, including history of transient ischemic attack or stroke; symptomatic pulmonary embolism;
• •13. Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug;
• •14. Patient with a known hypersensitivity to any of the excipients in this study;
• •15. A prior history of autologous or allogeneic hematopoietic stem cell transplantation;
• •16. A prior history of psychotropic drug abuse or drug use;
• •17. Pregnant or breastfeeding;
• •18. The researchers considered that there were some cases that were not suitable for inclusion.