[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630723":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":32,"responsibleParty":61,"collaborators":30,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":30,"enrollmentInfo":73,"targetDuration":30,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":84,"whyStopped":30,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Institut Curie","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Blood samples collection in breast cancer in patients receiving CDK4\u002F6 inhibitors","EXPERIMENTAL","Five blood samples will be collected at a single time point during treatment, in accordance with the routine TDM schedule (the treatment duration will remain as per the prescribed CDK4\u002F6 regimen).\n\nThe patients will also complete an acceptability Questionnaire following the samplings.",[13],"Other: Capillary samples using the VAMS Mitra device",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Capillary samples using the VAMS Mitra device","Five blood samples will be collected at a single time point during treatment, in accordance with the routine TDM schedule (the treatment duration will remain as per the prescribed CDK4\u002F6 regimen).\n\n* 4 capillary samples (using the VAMS Mitra device) including 2 samples collected by the study nurse then 2 samples collected by the patient.\n* 1 venous sample (5 mL heparinized tube).",[9],[20],"Venous sample",[22],{"name":23,"affiliation":5,"role":24},"Manon Launay, PH","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Marie-Emmanuelle Legrier","CONTACT","0033156245649",null,"drci.promotion@curie.fr",[33,49],{"facility":34,"status":30,"city":35,"state":30,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Institut Curie Paris","Paris","75005","France","FR",{"type":40,"coordinates":41},"Point",[42,43],2.3488,48.85341,{"lat":43,"lon":42},[46,48],{"name":47,"role":28,"phone":30,"phoneExt":30,"email":30},"Audrey BELLESOEUR",{"name":47,"role":24,"phone":30,"phoneExt":30,"email":30},{"facility":5,"status":30,"city":50,"state":30,"zip":51,"country":37,"countryCode":38,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Saint-Cloud","92210",{"type":40,"coordinates":53},[54,55],2.20289,48.84598,{"lat":55,"lon":54},[58,60],{"name":59,"role":28,"phone":30,"phoneExt":30,"email":30},"Bringuier MICHAEL",{"name":59,"role":24,"phone":30,"phoneExt":30,"email":30},{"type":62,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100630723","validation-of-capillary-microsampling-for-therapeutic-drug-monitoring-of-cdk46-inhibitors-in-breast-cancer-patients-tdhome-100630723",false,"NCT07491380","Validation of Capillary Microsampling for Therapeutic Drug Monitoring of CDK4\u002F6 Inhibitors in Breast Cancer Patients (TDHOME)","Validation of Capillary Microsampling for Therapeutic Drug Monitoring (TDM) of CDK4\u002F6 Inhibitors in Breast Cancer Patients","TDHOME","Inclusion Criteria:\n\n1. Adult patients (≥ 18 years) with breast cancer.\n2. Patients currently receiving ribociclib, abemaciclib, or palbociclib.\n3. Patients capable of performing capillary sampling (with or without assistance).\n4. Patient information and signing of informed consent.\n5. Patient ability to comply with protocol requirements.\n6. Patients covered by a health insurance system.\n\nExclusion Criteria:\n\n1. Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.\n2. Persons deprived of their liberty or under guardianship.","ALL","18 Years",{"count":74,"type":75},90,"ESTIMATED","INTERVENTIONAL",[78],"NA","This is a prospective validation study, multicenter, open-label, single-arm study, evaluating the concordance between capillary microsampling (using the VAMS Mitra device) and venous sampling in patients undergoing CDK4\u002F6 therapy.",[81],"Breast Cancer",[83],"Capillary microsampling, therapeutic drug monitoring, ribociclib, abemaciclib, palbociclib, breast cancer, pharmacokinetics, personalized treatment","NOT_YET_RECRUITING","2026-04-13",{"date":87,"type":88},"2026-04-16","ACTUAL",{"date":90,"type":75},"2026-05-15",{"date":92,"type":75},"2028-12-15",{"name":5,"class":6},2]