[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542363":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":28,"locations":34,"responsibleParty":50,"collaborators":27,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":27,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":27,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":27,"overallStatus":37,"whyStopped":27,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Dalpiciclib and endocrine therapy",[13,14],"Drug: Dalpiciclib","Drug: Endocrine therapy",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Dalpiciclib","CDK4\u002F6 inhibitor dalpiciclib, 100mg orally qd",[9],[22],"CDK4\u002F6 inhibitor",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Endocrine therapy","Fulvestrant\u002FAI",[9],null,[29],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},"Xiaoan Liu, Professor","CONTACT","025-68308162","liuxiaoan@126.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":27,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"The First Affiliated Hospital of Nanjing Medical University","RECRUITING","Nanjing","Jiangsu","China","CN",{"type":43,"coordinates":44},"Point",[45,46],118.77778,32.06167,{"lat":46,"lon":45},[49],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Liu Xiaoan","Professor","100542363","phase-2-efficacy-and-safety-of-dalpiciclib-with-endocrine-therapy-as-adjuvant-treatment-in-hr-her2--early-breast-cancer-100542363",false,"NCT06341894","Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+\u002F HER2- Early Breast Cancer","Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer","Inclusion Criteria:\n\n* Patient is ≥ 18 years-old\n* Patient is female with known menopausal status (postmenopausal or premenopausal\u002Fperimenopause)\n* Patient with histologically confirmed HR+\u002FHER2- early breast cancer (immunohistochemical ER and\u002For PR≥10%)\n* Histologically confirmed invasive breast cancer with anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0\n* Patients with or without neoadjuvant or adjuvant chemotherapy\u002F radiotherapy were eligible for inclusion\n* From operation to enrollment should not exceed 12 months\n* Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n\nExclusion Criteria:\n\n* metastatic disease (Stage IV) or inflammatory breast cancer\n* Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.\n* Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180\u002F110);\n* A history of allergy to the drugs in this study；\n* Unable or unwilling to swallow tablets\n* History of gastrointestinal disease with diarrhea as the major symptom.","FEMALE","18 Years","75 Years",{"count":65,"type":66},1163,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium \u002Fhigh risk hormone receptor-positive, HER2-negative Early Breast Cancer.",[72],"Early Breast Cancer","2024-03-25",{"date":75,"type":76},"2024-04-02","ACTUAL",{"date":78,"type":76},"2023-11-17",{"date":80,"type":66},"2029-06",{"name":5,"class":6},1]