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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- • Incidence rate of vascular events
研究概览
简要总结
"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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnant or breastfeeding women.
结局指标
主要结局
• Incidence rate of vascular events
时间窗: From enrollment to the end of 60 months follow-up
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)
次要结局
未报告次要终点
研究者
Pola Roberto
Prof.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS