[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542363":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":28,"locations":34,"responsibleParty":49,"collaborators":27,"id":53,"slug":27,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":27,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":27,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":27,"overallStatus":37,"whyStopped":27,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"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,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"The First Affiliated Hospital of Nanjing Medical University","RECRUITING","Nanjing","Jiangsu","China",{"type":42,"coordinates":43},"Point",[44,45],118.77778,32.06167,{"lat":45,"lon":44},[48],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Liu Xiaoan","Professor","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":63,"type":64},1163,"ESTIMATED","INTERVENTIONAL",[67],"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.",[70],"Early Breast Cancer","2024-03-25",{"date":73,"type":74},"2024-04-02","ACTUAL",{"date":76,"type":74},"2023-11-17",{"date":78,"type":64},"2029-06",{"name":5,"class":6},1]