Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer With SNF4 Subtype

Exclusion Criteria

• •1. Uncontrolled central nervous system metastasis (referring to symptoms or the need for corticosteroids or mannitol to control symptoms);
• •2. Left ventricular ejection fraction (LVEF) \<50% (as determined by echocardiography);
• •3. History of any of the following cardiac diseases: (1) angina pectoris; (2) clinically significant arrhythmia requiring medication; (3) myocardial infarction; (4) heart failure; (5) any other cardiac disease deemed unsuitable for participation in this trial by the investigator;
• •4. previously suffered from clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, pneumonia, pulmonary fibrosis, and radiation pneumonia (excluding radiation changes that do not require corrective treatment), or have been found to have suspected such diseases during screening period examinations;
• •5. Individuals who have received radiotherapy, chemotherapy, surgical treatment (excluding minor outpatient surgeries such as placement of vascular access) or other targeted and immunotherapy treatments for advanced HR+/HER2- breast cancer within 3 weeks prior to the first administration of study drugs;
• •6. Individuals who have ongoing ≥ Grade 1 adverse reactions due to previous treatments. Exceptions to this include hair loss or conditions that the investigator deems should not be excluded. Such cases should be clearly documented in the investigator's notes;
• •7. Pregnant or lactating patients;
• •8. Individuals who have had malignant tumors within the past three years (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• •9. Significant comorbidities, including mental illnesses that the investigator believes may adversely affect the patient's participation in the study;
• •11. Patients who have experienced abdominal fistula, gastrointestinal perforation, or abdominal abscess within 28 days before participating in this study;
• •12. Patients with imaging findings indicating tumor invasion around important blood vessels or, in the judgment of the investigator, a high likelihood of tumor invasion during treatment causing fatal massive hemorrhage;
• •13. Patients who have experienced arterial/venous thromboembolic events within one year before screening, such as cerebrovascular accidents (including transient ischemic attacks), deep venous thrombosis (excluding cases where venous thrombosis caused by venous catheterization during previous chemotherapy has been judged by the investigator to have healed), and pulmonary embolism;
• •14. Patients with urine routine test showing urine protein ≥++ or confirmed 24-hour urine protein quantitation \>1.0g;
• •15. Patients with hypertension who cannot be brought to normal range by antihypertensive medication (systolic blood pressure \>140mmHg, diastolic blood pressure \>90mmHg);
• •16. Patients with swallowing difficulties, chronic diarrhea, and intestinal obstruction, which affect drug administration and absorption in various ways;
• •17. Patients with third-space effusion that cannot be controlled by drainage or other methods (such as large amounts of pleural effusion and ascites);
• •18. Patients with allergic constitution, or known history of allergy to components of the study drugs; or patients allergic to other monoclonal antibodies;
• •19. Patients with known active HBV or HCV infection or HBV DNA ≥500, or chronic phase with abnormal liver function;
• •20. Any other situations where the investigator deems the patient unsuitable for participation in this study.