Clinical Trial

A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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+/HER2- locally advanced or metastatic breast cancer who have had previous treatment with CDK4/6 inhibitor.
Protocol Amendment History 2 changes
critical Enrollment closed, study ongoing 2026-08-12
notable Trial sites reduced: 60 -> 57 locations 2026-08-12
Trial Details
NCT Number NCT06680921
Lead Sponsor Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborators: Nanjing Zaiming Pharmaceutical Co., Ltd.
Conditions Locally Advanced or Metastatic Breast Cancer
Enrollment 482 participants
Start Date 2024-11-14
Primary Completion 2028-08-31 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-11