This is an ambispective, single-center study to evaluate the survival outcomes, adverse events and predictive biomarkers for CDK4/6 inhibitors in patients with hormone receptor-positive advanced breast cancer.
Study Type
OBSERVATIONAL
Enrollment
172
CDK4/6 inhibitors
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
RECRUITINGProgression-Free Survival (PFS)
PFS is defined as the time from the date of starting CDK4/6 inhibitor to the date of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death from any cause in the absence of documented PD, whichever occurs first.
Time frame: From the date of starting CDK4/6 inhibitor to the date of first documentation of progression or death (up to approximately 2.5 years)
Overall survival
Overall survival is defined as the time from starting CDK4/6 inhibitor to death from any cause.
Time frame: From the date of starting CDK4/6 inhibitor until death from any cause up to 3 years
Adverse events
Adverse events during CDK4/6 regimen 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 2.5 years)
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