[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539253":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":22,"armGroups":23,"interventions":29,"overallOfficials":33,"centralContacts":38,"locations":43,"responsibleParty":58,"collaborators":18,"id":60,"slug":18,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":18,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":18,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":18,"briefSummary":72,"conditions":73,"keywords":18,"overallStatus":45,"whyStopped":18,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"RenJi Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival","The time from the date of starting dalpiciclib to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first.","From the date of starting dalpiciclib to the date of first documentation of progression or death (up to approximately 1 years)",[14],{"measure":15,"description":16,"timeFrame":17},"Adverse events","Adverse events during dalpiciclib treatment will be assessed according to the NCI CTCAE v5.0.","From the date of starting dalpiciclib to the end of the treatment (up to approximately 1 year)",null,{"allocation":18,"interventionModel":18,"interventionModelDescription":18,"primaryPurpose":18,"observationalModel":20,"timePerspective":21,"maskingInfo":18},"COHORT","PROSPECTIVE","Hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer",[24],{"label":25,"type":18,"description":26,"interventionNames":27},"dalpiciclib","dalpiciclib oral day 1-21, every 28 days",[28],"Drug: dalpiciclib",[30],{"type":31,"name":25,"description":26,"armGroupLabels":32,"otherNames":18},"DRUG",[25],[34],{"name":35,"affiliation":36,"role":37},"Wenjin Yin","Renji Hospital, School of Medicine, Shanghai Jiaotong University","PRINCIPAL_INVESTIGATOR",[39],{"name":35,"role":40,"phone":41,"phoneExt":18,"email":42},"CONTACT","86(21)68385569","yinwenjin@renji.com",[44],{"facility":36,"status":45,"city":46,"state":18,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Shanghai","200127","China","CN",{"type":51,"coordinates":52},"Point",[53,54],121.45806,31.22222,{"lat":54,"lon":53},[57],{"name":35,"role":40,"phone":41,"phoneExt":18,"email":42},{"type":37,"investigatorFullName":35,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Deputy Chief of Breast Surgery Department","100539253",false,"NCT06301438","Dalpiciclib in HR+\u002FHER2- ABC","Efficacy and Safety of Dalpiciclib in HR+\u002FHER2- Advanced Breast Cancer: a Real-world Study","Inclusion Criteria:\n\n* Histologically confirmed advanced breast cancer\n* Hormone receptor-positive and human epidermal growth factor receptor 2-negative\n* ECOG 0-1\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* History of immunodeficiency","ALL","18 Years",{"count":69,"type":70},103,"ESTIMATED","OBSERVATIONAL","To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive\u002FHER2-positive advanced breast cancer.",[74],"Advanced Breast Cancer","2026-02-01",{"date":77,"type":78},"2026-02-03","ACTUAL",{"date":80,"type":78},"2024-05-03",{"date":82,"type":70},"2028-12",{"name":5,"class":6},1]