Precision Treatment of HR+ HER2- Advanced Breast Cancer Based on SNF Molecular Subtyping

Exclusion Criteria

• •Patients with any of the following could not be enrolled in this study:
• •1. Use of radiotherapy within 3 weeks prior to treatment.
• •2. Patients with known CNS metastases or a history of CNS metastases prior to screening. For patients with clinically suspected CNS metastases, enhanced CT or enhanced magnetic resonance imaging (MRI) must be performed within 28 days prior to the first dose to rule out CNS metastases.
• •3. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
• •4. The patient has active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment.
• •5. The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \<30ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
• •6. ≥ grade 1 adverse reactions due to previous treatment that are still ongoing. Exceptions are alopecia or the cases that, in the opinion of the investigator, should not be excluded. Such cases should be clearly documented in the investigator's notes.
• •7. The patient has had major surgery within 14 days prior to randomization.
• •8. Females who are pregnant or lactating.
• •9. Malignant tumor within the past five years (except cured basal-cell carcinoma and cervical carcinoma in situ)
• •10. Inability to swallow, chronic diarrhoea and intestinal obstruction, and the presence of multiple factors that affect the administration and absorption of medication.
• •11. Presence of third spacing that cannot be controlled by drainage or other methods (e.g., large amounts of pleural effusion and ascites).
• •12. Non-healing wounds for a long time or fractures that are not fully healed.
• •13. Allergic individuals, or those with a known history of allergy to the components of the drug involved in this protocol.
• •14. Long-term use of oral steroid hormones. For occasional use in the past, a 4-week discontinuation period is required before enrollment.
• •15. Previous use of PAM pathway inhibitors such as Everolimus and PARP inhibitors such as Fluzoparib.
• •16. Use of any chemotherapy drugs during metastatic relapse.
• •17. Have received specific regimen of Abemaciclib combined with Fulvestrant during metastatic relapse (i.e., the control group in this study).
• •18. Have received CDK 4/6 inhibitors for \> 1 treatment period.
• •19. The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.