By retrospectively collecting and arranging real-world data of multi-center HR+/HER2- advanced breast cancer in China combined with CDK4/6 inhibitor and endocrine therapy, we analyzed different HER2 expression levels (HER2 0, 1+, 2+ and FISH-), especially Clinical outcomes of endocrine therapy for metastatic breast cancer with low HER2 expression (HER2 1+, 2+ and FISH-), exploring potential biomarkers of CDK4/6 inhibitors, and understanding the outcome characteristics of HER2 heterogeneity in MBC through multivariate analysis , and guide clinical application.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
500
CDK4/6 inhibitor + AI/fulvestrant therapy,According to clinical guidelines or drug instructions, the treating physician will adjust the drug dose in accordance with the clinical reality and the patient's personal situation.
Progression-free survival (PFS) From enrollment to progression or death (for any reason) Progression-free survival (PFS)
From enrollment to progression or death (for any reason)
Time frame: Estimated 24 months
Objective response rate (ORR)
Ratio of CR and PR in all subjects
Time frame: Estimated 24 months
Disease Control Rate (DCR)
Ratio of CR ,PR and SD in all subjects
Time frame: Estimated 24 months
Overall survival (OS)
From enrollment to death (for any reason)
Time frame: Estimated 36 months
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