[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620161":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":54,"collaborators":11,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":11,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":11,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Shandong Suncadia Medicine Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HRS-8080 combined with Dalpiciclib","EXPERIMENTAL",null,[13],"Drug: HRS-8080 Tablet ; Dalpiciclib Isethionate",{"label":15,"type":16,"description":11,"interventionNames":17},"Fulvestrant combined with Dalpiciclib","ACTIVE_COMPARATOR",[18],"Drug: Fulvestrant injection ;Dalpiciclib Isethionate",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","HRS-8080 Tablet ; Dalpiciclib Isethionate","* HRS-8080 Tablet\n* Dalpiciclib Isethionate",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Fulvestrant injection ;Dalpiciclib Isethionate","* Fulvestrant injection\n* Dalpiciclib Isethionate",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Zhan Zhang","CONTACT","+86 17721286165","Zhan.zhang@hengrui.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Chinese PLA General Hospital Fifth Medical Center","RECRUITING","Beijing","Beijing Municipality","100000","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},[51],{"name":52,"role":53,"phone":11,"phoneExt":11,"email":11},"Zefei Jiang","PRINCIPAL_INVESTIGATOR",{"type":55,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100620161","phase-3-a-study-to-evluate-efficacy-and-safety-of-hrs-8080-combined-with-dalpiciclib-in-patients-with-advanced-or-metastatic-breast-cancer-resistant-to-adjuvant-endocrine-therapy-100620161",false,"NCT07354022","A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.","A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HRS-8080 Combined With Dalpiciclib Versus Fulvestrant Combined With Dalpiciclib in Patients With Locally Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.","Inclusion Criteria:\n\n1. Women aged 18 - 75 years old;\n2. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1;\n3. Patients with histologically confirmed locally advanced or metastatic breast cancer;\n4. Patients with prior adjuvant endocrine resistance following curative-intent surgery;\n5. Menstrual status: postmenopausal, perimenopausal, or premenopausal;\n6. Presence of evaluable lesions;\n7. Organ function must meet required criteria.\n\nExclusion Criteria:\n\n1. Patients with rapidly progressing disease, as judged by the investigator to be unsuitable for endocrine therapy;\n2. Patients who have previously received fulvestrant or other novel SERMs (excluding tamoxifen and toremifene);\n3. Patients with uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression;\n4. Patients with a history of clinically significant cardiovascular disease;\n5. Participants who have not recovered from adverse effects caused by prior therapies;\n6. Participants with a history of another malignancy within the past 5 years or currently having another malignancy;\n7. Known hypersensitivity to HRS-8080, fulvestrant, dalpiciclib, or any of their components, etc.","FEMALE","18 Years","75 Years",{"count":67,"type":68},912,"ESTIMATED","INTERVENTIONAL",[71],"PHASE3","The study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced\u002Fmetastatic breast cancer who had developed drug resistance to prior adjuvant endocrine therapy.",[74],"Locally Advanced or Metastatic Breast Cancer","2026-06-01",{"date":77,"type":78},"2026-06-02","ACTUAL",{"date":80,"type":78},"2026-05-05",{"date":82,"type":68},"2031-12",{"name":5,"class":6},1]