NCT07008508

Incidence of Venous Thromboembolism and Cardiovascular Events in Breast Cancer Patients Undergoing Cyclin-dependent Kinase 4/6 Inhibitors: The Breast Cancer Associated Vascular Events During Cyclin-dependent Kinase 4/6 Inhibitors Therapy (BRAVE-Cyclin) Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

"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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Cyclin-dependent Kinase 4/6 Inhibitor	Planned new line of Cyclin-dependent Kinase 4/6 Inhibitor

Timeline

• Start date: 2025-05-15
• Primary completion: 2032-05-01
• Completion: 2032-05-01
• First posted: 2025-06-06
• Last updated: 2025-06-06

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study