To evaluate the efficacy and safety of adjuvant CDK4/6 inhibitors in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.
Study Type
OBSERVATIONAL
Enrollment
229
abemaciclib OR ribociclib
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China
RECRUITINGInvasive Disease-free Survival (iDFS)
Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.
Time frame: From the date of surgery until time of event up to 2 years.
Disease-free Survival (DFS)
Disease-free survival time is defined as the time from date of surgery until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ (DCIS),or distant recurrence and death from any cause.
Time frame: From the date of surgery until time of event up to 2 years
Overall Survival (OS)
Overall survival is defined as the time from surgery to death from any cause.
Time frame: From the date of surgery until time of event up to 2 years
Adverse events
Adverse events will be assessed according to the NCI CTCAE v5.0.
Time frame: From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 3 years)
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