The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,163
CDK4/6 inhibitor dalpiciclib, 100mg orally qd
Fulvestrant/AI
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGinvasive Disease-free Survival (iDFS)
Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause
Time frame: From enrollment until time of events up to 3 years
Disease-free Survival (DFS)
Disease-free survival time is defined as the time from date of enrollment until the first disease recurrence（including carcinoma in situ）or death from any cause.
Time frame: From enrollment until time of events up to 3 years
AEs and SAEs
Adverse events and Adverse events and serious adverse events according to CACTE 5.0
Time frame: From the first administration to one months after the last drug administration，up to one month
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