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18018850676",{"facility":675,"status":49,"city":649,"state":650,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":676,"geoPoint":678,"contacts":679},"Shanghai General Hospital",{"type":55,"coordinates":677},[654,655],{"lat":655,"lon":654},[680],{"name":681,"role":43,"phone":682,"phoneExt":28,"email":28},"Qi Li","+86 13818207333",{"facility":684,"status":49,"city":685,"state":686,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":687,"geoPoint":691,"contacts":692},"Sichuan Cancer Hospital","Chengdu","Sichuan",{"type":55,"coordinates":688},[689,690],104.06667,30.66667,{"lat":690,"lon":689},[693],{"name":694,"role":43,"phone":695,"phoneExt":28,"email":28},"Hui Li","+86 18908178707",{"facility":697,"status":49,"city":698,"state":699,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":700,"geoPoint":704,"contacts":705},"Tianjin Medical University Cancer Institute & Hospital","Tianjin","Tianjin Municipality",{"type":55,"coordinates":701},[702,703],117.17667,39.14222,{"lat":703,"lon":702},[706],{"name":707,"role":43,"phone":708,"phoneExt":28,"email":28},"Yehui Shi","+86 13602088477",{"facility":710,"status":49,"city":711,"state":712,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":713,"geoPoint":717,"contacts":718},"Zhejiang Cancer Hospital","Hangzhou","Zhejiang",{"type":55,"coordinates":714},[715,716],120.16142,30.29365,{"lat":716,"lon":715},[719],{"name":720,"role":43,"phone":721,"phoneExt":28,"email":28},"Yabing Zheng","+86 13858065353",{"facility":723,"status":49,"city":711,"state":712,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":724,"geoPoint":726,"contacts":727},"Zhejiang Provincial People's Hospital",{"type":55,"coordinates":725},[715,716],{"lat":716,"lon":715},[728],{"name":729,"role":43,"phone":730,"phoneExt":28,"email":28},"Xuli Meng","+86 13757128803",{"facility":732,"status":49,"city":733,"state":712,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":734,"geoPoint":738,"contacts":739},"Ningbo Medical Center Lihuili Hospital","Ningbo",{"type":55,"coordinates":735},[736,737],121.54945,29.87819,{"lat":737,"lon":736},[740],{"name":741,"role":43,"phone":742,"phoneExt":28,"email":28},"Weizhu Wu","+86 13957402451",{"type":744,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[746],{"name":747,"class":6},"Nanjing Zaiming Pharmaceutical Co., Ltd.","100568415","phase-3-a-study-of-sim0270-combined-with-everolimus-vs-treatment-of-physicians-choice-in-patients-with-erher2--advanced-breast-cancer-simrise-100568415",false,"NCT06680921","A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+\u002FHER2- Advanced Breast Cancer (SIMRISE)","A Randomized, Open-label, Phase III Study of SIM0270 Combined With Everolimus Versus Treatment of Physician's Choice in Patients With CDK4\u002F6 Inhibitors Previously Treated , ER+\u002FHER2- Locally Advanced or Metastatic Breast Cancer","Inclusion criteria:\n\n1. Subjects with histologically or cytologically confirmed ER+\u002FHER2- locally advanced or metastatic breast cancer\n2. Subjects must have at least one RECIST 1.1 measurable disease and \u002For at least 1 lytic or mixed (lytic + sclerotic) bone lesion\n3. For women who are post menopausal must meet criteria as defined in the protocol.For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for screening period and the duration of study treatment\n4. Have disease that has demonstrated progression on or after prior treatment:\n\n   1. subjects had received 1 to 2 endocrine therapies in the locally advanced or metastatic setting with disease recurrence\u002Fdisease progression while being treated with adjuvant endocrine therapy for ≥ 24 months and\u002For endocrine therapy in the locally advanced or metastatic setting, and derived a clinical benefit from therapy\n   2. subjects had received ≤ 1 chemotherapy in the locally advanced or metastatic setting.\n5. Eastern Cooperative Oncology Group Performance Status 0-1\n6. Adequate organ function\n\nexclusion criteria:\n\n1. Prior treatment with a oral selective estrogen receptor degrader (SERD) or other investigational-ER-directed therapy, or any PI3K-AKI-mTOR inhibitors\n2. Treatment with any investigational therapy within 28 days prior to study treatment.Treatment with moderate\u002Fstrong CYP3A inhibitors or P-gP inhibitor within 14 days prior to first dose or moderate\u002Fstrong CYP3A inducer within 28 days prior to first dose\n3. Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term\n4. Active or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease\n5. Active cardiac disease or history of cardiac dysfunction, as defined in the protocol\n6. Pregnant or breastfeeding","ALL","18 Years",{"count":758,"type":759},460,"ESTIMATED","INTERVENTIONAL",[762],"PHASE3","This Phase III, randomized, open label, multicenter study will evaluate the efficacy and safety of SIM0270 combined with everolimus compared to physician's choice of treatment in subjects with ER+\u002FHER2- locally advanced or metastatic breast cancer who have had previous treatment with CDK4\u002F6 inhibitor.",[765],"Locally Advanced or Metastatic Breast Cancer","2025-09-18",{"date":768,"type":769},"2025-09-22","ACTUAL",{"date":771,"type":769},"2024-11-14",{"date":773,"type":759},"2028-08-31",{"name":5,"class":6},60]