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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

NCT07008508 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-06-06

No results posted yet for this study

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

Interventions

DRUG

Cyclin-dependent Kinase 4/6 Inhibitor

Planned new line of Cyclin-dependent Kinase 4/6 Inhibitor

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2032-05-31
Completion
2032-05-31
FDA Drug
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07008508 on ClinicalTrials.gov