"Incidence of Venous Thromboembolism and Cardiovascular Events in Patients with Breast Cancer Treated with Cyclin-Dependent Kinase Inhibitors 4/6, the BRAVE-Cyclin Study" is national, single-center, observational, prospective cohort study, conducted at Fondazione Policlinico Universitario A. Gemelli IRCCS. According to recent evidence, patients with advanced or metastatic breast cancer receiving cyclin-dependent kinase (CDK) 4/6 inhibitors - ribociclib, palbociclib, and abemaciclib - may have an increased risk of arterial or venous thrombosis. Currently, there are no validated tools to stratify breast cancer patients receiving CDK 4/6 inhibitors according to their thromboembolic or cardiovascular risk. The prospective BRAVE-Cyclin study aims to evaluate the incidence of venous thromboembolism, major cardiovascular events, and major adverse peripheral vascular events in breast cancer patients receiving CDK 4/6 inhibitors. The objective is to identify the main determinants of thromboembolic and cardiovascular risk, thus improving risk stratification and management strategies.
Study Type
OBSERVATIONAL
Enrollment
300
Planned new line of Cyclin-dependent Kinase 4/6 Inhibitor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, Italy
• Incidence rate of vascular events
Vascular events are defined as episodes of Venous Thromboembolism (VTE) in usual or unusual site, Major Adverse Cardiovascular Events (MACE), and/or Major Adverse Limbs Events (MALE)
Time frame: From enrollment to the end of 60 months follow-up
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