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 | Active Not Recruiting DMC FDA Drug

• 1 other identifier: ID7674
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• • 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)

  From enrollment to the end of 60 months follow-up

Interventions

Cyclin-dependent Kinase 4/6 Inhibitor DRUG

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

Also known as: Palbociclib, Abemaciclib, Ribociclib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will consist of subsequent patients prospectively enrolled in case of indication of systemic antineoplastic treatment with CDK 4/6 Inhibitor for advanced breast cancer. Patients will be recruited in the setting of the Gynecologic Oncology Day Hospital and evaluated by the U.O.S.D Percorso Trombosi of the Agostino Gemelli University Polyclinic Foundation I.R.C.C.S. in Rome.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy, 00168, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Venous Thromboembolism; Cardiovascular Diseases

Interventions

palbociclib; abemaciclib; ribociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Thromboembolism; Embolism and Thrombosis; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 1, 2032
• Study Completion (Estimated): May 1, 2032
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)