[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514493":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":41,"studyPopulation":41,"armGroups":45,"interventions":52,"overallOfficials":41,"centralContacts":57,"locations":67,"responsibleParty":84,"collaborators":41,"id":88,"slug":41,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":41,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":41,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":41,"overallStatus":106,"whyStopped":41,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"West China Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Progression Free Survival (PFS)","The time from the enrollment of the subject until the first recording of tumor progression (evaluated according to RECIST 1.1 criteria) or death from any cause.","Estimated up to 23 months",[14],{"measure":15,"description":16,"timeFrame":17},"Progression Free Survival 2(PFS2)","The time from the first chemotherapy for the metastatic stage by the subject to the first recording of tumor progression (evaluated according to RECIST 1.1 standards) or death from any cause.","Estimated up to 27-31 months",[19,23,26,29,32,35],{"measure":20,"description":21,"timeFrame":22},"Overall Survival(OS)","OS was defined as the time from the first study treatment to the date of death from any cause","Estimated up to 5 years",{"measure":24,"description":25,"timeFrame":12},"Objective Response Rate（ORR）","Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)",{"measure":27,"description":28,"timeFrame":12},"Clinical Benefit Rate (CBR)","The percentage of participants who received study treatment and evaluated the best overall efficacy according to RECIST 1.1 criteria as complete remission (CR), partial remission (PR), and disease stability (SD) ≥ 24 weeks.",{"measure":30,"description":31,"timeFrame":12},"Disease Control Rate (DCR)","Disease Control Rate (DCR) was defined as the percentage of patients with a complete response (CR), partial response (PR) and stable disease (SD).",{"measure":33,"description":34,"timeFrame":22},"Patient Reported Outcome (PRO)","Using the European Five Dimensional Health Scale (EQ-5D) to allow patients to self-evaluate their quality of life",{"measure":36,"description":37,"timeFrame":22},"Adverse events (AEs)","The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0.",{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":41,"timePerspective":41,"maskingInfo":43},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":44,"maskingDescription":41,"whoMasked":41},"NONE",[46],{"label":47,"type":48,"description":49,"interventionNames":50},"Dalpiciclib combined with Letrozole","EXPERIMENTAL","Dalpiciclib combined with Letrozole,28 days as one cycle.\n\n1. Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle.\n2. Letrozole: 2.5mg, p.o., once a day, continuous administration.",[51],"Drug: Dalpiciclib combined with Letrozole",[53],{"type":54,"name":47,"description":55,"armGroupLabels":56,"otherNames":41},"DRUG","A multicenter, single arm, prospective Phase II clinical study",[47],[58,63],{"name":59,"role":60,"phone":61,"phoneExt":41,"email":62},"Ting Luo, post-doctor","CONTACT","18602866299","tina621@163.com",{"name":64,"role":60,"phone":65,"phoneExt":41,"email":66},"Xiaorong Zhong, post-doctor","18980605984","zhongxiaorong@126.com",[68],{"facility":69,"status":41,"city":70,"state":71,"zip":41,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"West China Hospital, Sichuan University","Chengdu","Sichuan","China","CN",{"type":75,"coordinates":76},"Point",[77,78],104.06667,30.66667,{"lat":78,"lon":77},[81],{"name":82,"role":60,"phone":61,"phoneExt":83,"email":62},"Ting Luo, MD","+86",{"type":85,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","Shuangyue Liu","Clinical Professor","100514493",false,"NCT05979220","Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy","A Multicenter, Single Arm, Prospective Phase II Clinical Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy","Inclusion Criteria:\n\n1. Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.\n2. Age: 18 - 75 years old\n3. Eastern Cooperative Oncology Group performance status (ECOG PS)=0\\~1\n4. Functions of liver and kidney is normal\n5. Agreed to take contraceptive measures during treatment\n\nExclusion Criteria:\n\n1. Confirmed diagnosis of HER2 positive disease.\n2. Central nervous system metastasis\n3. Patients who received prior treatment with any CDK4\u002F6 inhibitor.\n4. Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \\> 2), or ventricular arrhythmia which need medical intervention；\n5. Researchers believe that is not suitable for the study","FEMALE","18 Years","75 Years",{"count":98,"type":99},178,"ESTIMATED","INTERVENTIONAL",[102],"PHASE2","This study aimed to evaluate the efficacy and safety of Dalpiciclib combined with Letrozole in the maintenance treatment of HR positive and HER2 negative metastatic breast cancer after first-line chemotherapy.",[105],"Breast Cancer","NOT_YET_RECRUITING","2023-08-03",{"date":109,"type":110},"2023-08-07","ACTUAL",{"date":112,"type":99},"2023-12-01",{"date":114,"type":99},"2028-06-30",{"name":86,"class":6},1]