Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physician's Choice of Chemotherapy Sequential Endocrine Therapy in HR+/HER2- Advanced Breast Cancer

Inclusion Criteria

• •1. Patient is an adult female ≥ 18 years old at the time of informed consent.
• •2. ECGO rating 0-2.
• •3. Histologically confirmed recurrent or metastatic breast cancer, including patients initially diagnosed as stage IV or locally advanced inoperable patients.
• •4. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory. ER should be more than 10% ER positive by local laboratory testing.
• •5. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1 + or 2 + If IHC is 2 +, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample.
• •6. Determination by the physician that the patient is in a rapid disease progression situation:
• •* Symptomatic visceral metastases
• •* Rapid progression of disease or impending visceral compromise.
• •* Markedly symptomatic non visceral disease if the treating physician opt to give chemotherapy for rapid palliation of patients symptoms.
• •7. Patient hasn't received systemic anti-cancer therapy at the stage of recurrence/metastasis.
• •8. Patient must have at least one measurable lesion (according to RECIST 1.1 criteria)
• •9. Postmenopausal or pre/perimenopausal female patients are eligible for enrolment; pre or perimenopausal female patients must be willing to receive LHRHa during the study period.
• •10. All patients were required to meet the following laboratory biochemical values prior to enrolment:
• •* Haematology: Hb ≥90 g/L, WBC ≥3.5×109/L, ANC ≥1.5×109/L, PLT ≥100×109/L;
• •* Renal function: serum creatinine ≤ upper limit of normal value;
• •* Liver function: for those without liver metastases, AST, ALT, ALP ≤2.5 times the upper limit of normal values, and ≤1.25 x the upper limit of normal values for total bilirubin; for those with liver metastases, AST, ALT, ALP ≤ 5 times the upper limit of normal value, and total bilirubin ≤ 1.5 x upper limit of normal value.