[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613958":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":22,"responsibleParty":83,"collaborators":87,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":105,"sex":111,"minAge":112,"maxAge":10,"enrollmentInfo":113,"targetDuration":10,"studyType":116,"phases":10,"briefSummary":117,"conditions":118,"keywords":122,"overallStatus":25,"whyStopped":10,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Region Jönköping County","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Frail and fit older (≥70 years) breast cancer patients",null,"Older (≥70 years) patients, with early stage breast cancer, initiating adjuvant CDK4\u002F6 inhibitors that are defined as frail or fit according to G8 and VES-13",[13],{"name":14,"affiliation":15,"role":16},"Christine Lundgren, MD","Department of Oncology, Jönköping, Region Jönköping County, Jönköping; Sweden,","STUDY_CHAIR",[18],{"name":14,"role":19,"phone":20,"phoneExt":10,"email":21},"CONTACT","+46102422907","christine.lundgren@rjl.se",[23,39,49,60,71],{"facility":24,"status":25,"city":26,"state":10,"zip":10,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Department of Oncology","RECRUITING","Gävle","Sweden","SE",{"type":30,"coordinates":31},"Point",[32,33],17.14174,60.67452,{"lat":33,"lon":32},[36],{"name":37,"role":19,"phone":10,"phoneExt":10,"email":38},"Ilke Cikman, MD","ilke.cikman@regiongavleborg.se",{"facility":24,"status":25,"city":40,"state":10,"zip":41,"country":27,"countryCode":28,"cosmosGeoPoint":42,"geoPoint":46,"contacts":47},"Jönköping","55312",{"type":30,"coordinates":43},[44,45],14.15618,57.78145,{"lat":45,"lon":44},[48],{"name":14,"role":19,"phone":20,"phoneExt":10,"email":21},{"facility":24,"status":25,"city":50,"state":10,"zip":10,"country":27,"countryCode":28,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Kalmar",{"type":30,"coordinates":52},[53,54],16.36163,56.66157,{"lat":54,"lon":53},[57],{"name":58,"role":19,"phone":10,"phoneExt":10,"email":59},"Petra Hinnen, MD","petra.hinnen@regionkalmar.se",{"facility":24,"status":25,"city":61,"state":10,"zip":10,"country":27,"countryCode":28,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Linköping",{"type":30,"coordinates":63},[64,65],15.62157,58.41086,{"lat":65,"lon":64},[68],{"name":69,"role":19,"phone":10,"phoneExt":10,"email":70},"Jimmy Ekstrand, MD","jimmy.ekstrand@regionostergotland.se",{"facility":24,"status":72,"city":73,"state":10,"zip":10,"country":27,"countryCode":28,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"NOT_YET_RECRUITING","Örebro",{"type":30,"coordinates":75},[76,77],15.2066,59.27412,{"lat":77,"lon":76},[80],{"name":81,"role":19,"phone":10,"phoneExt":10,"email":82},"Antonios Valachis, MD","antonios.valachis@oru.se",{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Christine Lundgren","Principal Investigator",[88,91,93,95,97,99,101],{"name":89,"class":90},"Region Örebro County","OTHER",{"name":92,"class":90},"Region Östergötland",{"name":94,"class":90},"Region Gävleborg",{"name":96,"class":90},"Västra Götalandsregionen",{"name":98,"class":6},"Linkoeping University",{"name":100,"class":90},"Örebro University, Sweden",{"name":102,"class":90},"Kalmar County Hospital","100613958","aspects-of-adjuvant-cdk46-inhibitors-in-older-breast-cancer-patients---focusing-on-geriatric-screening-100613958",false,"NCT07273357","Aspects of Adjuvant CDK4\u002F6 Inhibitors in Older Breast Cancer Patients - Focusing on Geriatric Screening","Follow-Up After adjuvanT CDK4\u002F6i Use in oldeR brEast Cancer Patients - Aspects on Geriatric Screening, Toxicities, and Quality of Life (FUTURE)","FUTURE","Inclusion Criteria:\n\n* ≥70 years old\n* Female\u002Fmale\n* Completed surgery (primary or after neoadjuvant therapy)\n* Starting adjuvant CDK4\u002F6i and endocrine therapy\n* Cognitive performance to be able answer questionaries\n* No language difficulties\n\nExclusion Criteria:\n\n* Impaired cognitive function not able to understand the study intention or perform questionaries\n* Declining adjuvant CDK4\u002F6i","ALL","70 Years",{"count":114,"type":115},200,"ESTIMATED","OBSERVATIONAL","Older breast cancer patients should not be categorically excluded from adjuvant therapies, including the recommended CDK4\u002F6 inhibitors (CDK4\u002F6i) administered in combination with endocrine therapy. Nevertheless, this population frequently presents with comorbidities that may increase susceptibility to treatment-related toxicities, including impacts on quality of life, which must be carefully considered when selecting therapeutic regimens. Given the limited representation of older patients in the clinical trials behind the recommendations for adjuvant CDK4\u002F6i therapy, coupled with the uncertain magnitude of clinical benefit and the reported rates of toxicity and treatment discontinuation, it is essential to critically evaluate both efficacy and safety in this specific patient subgroup. National and international guidelines recommend the integration of geriatric assessments into routine clinical practice to facilitate individualized treatment decisions; however, such assessments are not yet widely implemented in many oncology departments and are not routinely in use to guide adjuvant CDK4\u002F6i therapy.\n\nThis study aims to investigate the implementation of geriatric assessments in older breast cancer patients (≥70 years) and to examine multiple dimensions of CDK4\u002F6i treatment in this cohort, including short- and medium-term effects on quality of life, dose intensity, and clinical outcomes. By doing so, the investigators seek to more accurately delineate the benefits and risks of adjuvant CDK4\u002F6i therapy in this specific patient population.",[119,120,121],"Geriatric Assessment","Adjuvant Drug Therapy","Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[123,124,125,126],"Older patients","Geriatric screening","Adjuvant CDK4\u002F6 inhibitors","Breast cancer","2026-06-09",{"date":129,"type":130},"2026-06-10","ACTUAL",{"date":132,"type":130},"2026-04-01",{"date":134,"type":115},"2039-08-01",{"name":5,"class":6},5]