Clinical trial 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: venous thromboembolism
breast cancer
Cyclin-dependent Kinase 4/6 Inhibitors
CDK 4/6 Inhibitors
cardiovascular disease
Palbociclib
Ribociclib
Abemaciclib
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: • Incidence rate of vascular events
timeFrame: From enrollment to the end of 60 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References: