A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients

Exclusion Criteria

• •1. With symptomatic visceral metastases deemed unfit for endocrine therapy by the investigator;
• •2. With active brain metastases, carcinomatous meningitis, spinal cord compression, or a history of primary tumors of the central nervous system;
• •3. History of clinically significant cardiovascular disease;
• •4. Abnormal ECG findings, which are judged by the investigator to be clinically significantand and need to intervene ;
• •5. With factors that affect oral medication, active gastrointestinal diseases, or other diseases that may obviously affect drug absorption, distribution, metabolism, or excretion;
• •6. With clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding;
• •7. Active infection or unexplained fever \> 38.5 °C during the screening period or on the day of first dose;
• •8. With uncontrollable chronic systemic complications as judged by the investigator.
• •9. With active autoimmune diseases, history of immunodeficiency and history of autoimmune diseases, history of diseases or syndromes that require systemic corticosteroids or immunosuppressive drugs, other acquired (HIV infection) or congenital immunodeficiency, or history of organ transplantation (including allogeneic bone marrow transplantation);
• •10. With acute infection or active tuberculosis requiring medication.
• •11. With a known history of clinically significant liver disease, untreated active hepatitis;
• •12. Had other concurrent malignant tumors in the past 5 years;
• •13. Use of moderate and strong CYP3A4 inhibitors within 1 week or moderate and strong CYP3A4 inducers within 2 weeks prior to the first dose;
• •14. Use of any drugs with the risk of prolonging QT/QTc interval or causing torsade de pointes (TdP) within 4 weeks prior to the first dose, and with previous congenital QT interval prolongation syndrome or a family history of QT interval prolongation;
• •15. Pregnant or lactating women, or females planning to become pregnant during the study period;
• •16. With clear history of neural or mental disorders or with history of psychotropic abuse or drug abuse;
• •19\) Subjects who are expected to receive other anti-tumor therapies or drugs during this study.