Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Who Have Failed Standard Therapy

Exclusion Criteria

• •1\. Previous pathological diagnosis of HER2-positive breast cancer.
• •2\. Patients judged by the investigator to be unsuitable for endocrine therapy.
• •3\. Patients who have previously received PI3K/AKT/mTOR inhibitors.
• •4\. Received chemotherapy, radiotherapy, biological therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before randomization.
• •5\. Received other unapproved investigational drugs within 4 weeks before randomization.
• •6\. Underwent major surgery within 4 weeks before randomization or has not fully recovered from any previous invasive procedures.
• •7\. Received systemic glucocorticoids (prednisone \>10 mg/day or equivalent) or other immunosuppressive treatments within 2 weeks before randomization.
• •8\. Had an infection within 2 weeks before randomization requiring systemic (oral or IV) anti-infective treatment (uncomplicated urinary tract infections or upper respiratory tract infections excluded).
• •9\. Received inactivated or live attenuated vaccines or COVID-19 vaccines within 4 weeks before randomization.
• •10\. Used strong inhibitors or inducers of CYP3A4 hepatic metabolic enzymes within 2 weeks before randomization or still need to continue using such drugs.
• •11\. Diagnosed with other malignancies within 5 years before randomization.
• •12\. Suffering from severe cardiovascular or cerebrovascular diseases.
• •13\. Adverse reactions from previous anti-tumor treatments have not recovered to CTCAE 5.0 grade ≤1.
• •14\. Active leptomeningeal disease or poorly controlled central nervous system metastases.
• •15\. Presence of pleural/abdominal effusion or pericardial effusion with clinical symptoms or requiring symptomatic treatment.
• •16\. Known bleeding tendency (constitution) or coagulation disorders.
• •17\. History of severe lung diseases such as interstitial lung disease and/or pneumonia, pulmonary hypertension, or radiation pneumonitis requiring glucocorticoid treatment.
• •18\. Known hypersensitivity or intolerance to any component of the study drug or its excipients, or LHRH agonists (if applicable).
• •19\. History of autoimmune diseases (except tuberous sclerosis), immunodeficiency diseases, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or organ transplant history.
• •20\. Active HBV, HCV, syphilis, or tuberculosis infection.
• •21\. Other conditions judged by the investigator to be unsuitable for participation in this study.