Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer

Exclusion Criteria

• •1. Documented medical history or ongoing gastrointestinal disease or other malabsorption that may affect the absorption of oral study drug.
• •2. Participated in other clinical trials of investigational drugs or investigational devices within 28 days before the first medication; or received chemotherapy, targeted therapy, immunotherapy and clinical trial medication and other anti-tumor treatment within 4 days or 5 half-lives of the first medication (whichever is shorter), or received radiotherapy, endocrine drugs or Chinese patent medicines with anti-tumor indications 2 weeks before the first medication;
• •3. The toxicity of previous anti-tumor treatment has not recovered to grade 0 or 1 (alopecia, chemotherapy-induced peripheral neurotoxicity ≤ grade 2 can be included).
• •4. Major surgical surgery (except biopsy) or incomplete healing of the surgical incision 4 times before the first study drug treatment;
• •5. Known other malignant tumors within 2 years before enrollment (except treated basal cell carcinoma, scaly cell carcinoma and/or radical carcinoma in situ);
• •6. Leptomeningeal metastasis confirmed by MRI or known cytology of CSF, or cranial Increased internal pressure or brain metastases with unstable central nervous symptoms (within 2 weeks prior to initial medication Treatment with any craniotropic, glucocorticokinin, or anticonvulsant);
• •7. Previous history of interstitial lung disease, drug-induced interstitial lung disease, symptomatic interstitial lung disease or any evidence of active pneumonia on chest CT scan 4 before the first study drug treatment;
• •8. known to interfere with the test requirements of mental illness or drug abuse disease.
• •9. History of human immunodeficiency virus HIV infection, or active bacterial or fungal infection requiring systemic treatment .
• •10. presence of active syphilis infection.
• •11. Subjects with known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with abnormal liver function.
• •12. History of clinically significant cardiovascular disease.
• •13. History of serious allergic reactions to the study drugs or excipients used in the protocol.
• •14. Women who are pregnant or lactating.
• •15. Prior use of SERD oral medications.
• •16. Subjects who use drugs or herbal supplements known to be moderate/strong inhibitors of CYP3A 2 Weeks before the first dose.Or Subjects who use drugs or herbal supplements known to be moderate/strong inducers of CYP3A 4 weeks before the first dose.
• •17. Other conditions that the investigator considers unsuitable for this study.