{"entity":{"id":"simrise","kind":"trial","name":"A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)","aka":["SIMRISE"],"tldr":"A phase 3 trial testing SIM0270 in HR-positive / HER2-negative breast cancer, active and no longer recruiting.","summary":"A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE) is a phase 3 interventional study registered as NCT06680921, led by Jiangsu Simcere Pharmaceutical with Nanjing Zaiming Pharmaceutical, and active but no longer recruiting on the registry. Official title: A Randomised, Open-label, Phase III Study of SIM0270 Combined With Everolimus Versus Treatment of Physician's Choice in Patients With CDK4/6 Inhibitors Previously Treated, ER+/HER2- Locally Advanced or Metastatic Breast Cancer. Planned enrolment is 482 participants (actual). The study started in 2024-11-14 and primary completion is expected in 2028-08-31. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06680921","url":"https://clinicaltrials.gov/study/NCT06680921"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":[],"targets":[],"drugs":["sim0270"],"companies":["simcere"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06680921","phase":"3","setting":"A Randomized, Open-label, Phase III Study of SIM0270 Combined With Everolimus Versus Treatment of Physician's Choice in Patients With CDK4/6 Inhibitors Previously Treated, ER+/HER2- Locally Advanced or Metastatic Breast Cancer","sponsor":"Jiangsu Simcere Pharmaceutical","started":"2024-11-14","startedType":"actual","enrolled":482,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/simrise/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"hr-positive-metastatic-post-cdk46","kind":"cancer","name":"HR-positive metastatic breast cancer after CDK4/6 inhibitors","route":"/cancers/hr-positive-metastatic-post-cdk46/"}],"drug":[{"id":"sim0270","kind":"drug","name":"SIM0270","route":"/drugs/sim0270/"}],"company":[{"id":"simcere","kind":"company","name":"Simcere Pharmaceutical","route":"/companies/simcere/"}]}}