[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593597":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":17,"responsibleParty":29,"collaborators":7,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":7,"enrollmentInfo":42,"targetDuration":7,"studyType":45,"phases":7,"briefSummary":46,"conditions":47,"keywords":49,"overallStatus":55,"whyStopped":7,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DRUG","Cyclin-dependent Kinase 4\u002F6 Inhibitor","Planned new line of Cyclin-dependent Kinase 4\u002F6 Inhibitor",[14,15,16],"Palbociclib","Abemaciclib","Ribociclib",[18],{"facility":5,"status":7,"city":19,"state":20,"zip":21,"country":20,"countryCode":22,"cosmosGeoPoint":23,"geoPoint":28,"contacts":7},"Rome","Italy","00168","IT",{"type":24,"coordinates":25},"Point",[26,27],12.51133,41.89193,{"lat":27,"lon":26},{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"PRINCIPAL_INVESTIGATOR","Pola Roberto","Prof.","100593597","incidence-of-venous-thromboembolism-and-cardiovascular-events-in-breast-cancer-patients-undergoing-cyclin-dependent-kinase-46-inhibitors-the-breast-cancer-associated-vascular-events-during-cyclin-dependent-kinase-46-inhibitors-therapy-brave-cyclin-study-100593597",false,"NCT07008508","Incidence of Venous Thromboembolism and Cardiovascular Events in Breast Cancer Patients Undergoing Cyclin-dependent Kinase 4\u002F6 Inhibitors: The Breast Cancer Associated Vascular Events During Cyclin-dependent Kinase 4\u002F6 Inhibitors Therapy (BRAVE-Cyclin) Study","BRAVE-Cyclin","Inclusion Criteria:\n\n* Female sex;\n* Diagnosis of advanced or metastatic breast cancer.\n* Indication for therapy with Cyclin-dependent Kinase 4\u002F6 Inhibitor, as clinical practice;\n* Age of 18 years or older;\n* Signing Informed Consent.\n\nExclusion Criteria:\n\n• Pregnant or breastfeeding women.","FEMALE","18 Years",{"count":43,"type":44},300,"ESTIMATED","OBSERVATIONAL","\"Incidence of Venous Thromboembolism and Cardiovascular Events in Patients with Breast Cancer Treated with Cyclin-Dependent Kinase Inhibitors 4\u002F6, the BRAVE-Cyclin Study\" is national, single-center, observational, prospective cohort study, conducted at Fondazione Policlinico Universitario A. Gemelli IRCCS.\n\nAccording to recent evidence, patients with advanced or metastatic breast cancer receiving cyclin-dependent kinase (CDK) 4\u002F6 inhibitors - ribociclib, palbociclib, and abemaciclib - may have an increased risk of arterial or venous thrombosis.\n\nCurrently, there are no validated tools to stratify breast cancer patients receiving CDK 4\u002F6 inhibitors according to their thromboembolic or cardiovascular risk.\n\nThe 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\u002F6 inhibitors.\n\nThe objective is to identify the main determinants of thromboembolic and cardiovascular risk, thus improving risk stratification and management strategies.",[48],"Breast Cancer",[50,51,52,53,54,14,16,15],"venous thromboembolism","breast cancer","Cyclin-dependent Kinase 4\u002F6 Inhibitors","CDK 4\u002F6 Inhibitors","cardiovascular disease","ACTIVE_NOT_RECRUITING","2025-05-29",{"date":58,"type":59},"2025-06-06","ACTUAL",{"date":61,"type":59},"2025-05-15",{"date":63,"type":44},"2032-05",{"name":5,"class":6},1]