clinical trial · NCT06680921
A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)
Jiangsu Simcere Pharmaceutical Co., Ltd.·phase3·recruiting·n = 460
Locally Advanced or Metastatic Breast CancerSIM0270Everolimus (Afinitor®)Exemestane tabletsFulvestrant injection
brief 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.
started
Nov 14, 2024
primary completion
Aug 31, 2028
completion
Aug 31, 2028
last updated
Sep 22, 2025
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol