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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

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07008508
Acronym
BRAVE-Cyclin
Enrollment
300
Registered
2025-06-06
Start date
2025-05-15
Completion date
2032-05-31
Last updated
2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

venous thromboembolism, breast cancer, Cyclin-dependent Kinase 4/6 Inhibitors, CDK 4/6 Inhibitors, cardiovascular disease, Palbociclib, Ribociclib, Abemaciclib

Brief 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.

Interventions

DRUGCyclin-dependent Kinase 4/6 Inhibitor

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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Female sex; * Diagnosis of advanced or metastatic breast cancer. * Indication for therapy with Cyclin-dependent Kinase 4/6 Inhibitor, as clinical practice; * Age of 18 years or older; * Signing Informed Consent.

Exclusion criteria

• Pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frameDescription
• Incidence rate of vascular eventsFrom enrollment to the end of 60 months follow-upVascular 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)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026