drugset / Trial / NCT06680921
A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)
Phase 3
Recruiting
460 enrolled
Jiangsu Simcere Pharmaceutical Co., Ltd.
Nanjing Zaiming Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-11-14
- Primary completion
- 2028-08-31
- Completion
- 2028-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | — | Oral |
| Comparator | Exemestane | Small molecule | — | Oral |
| Comparator | Fulvestrant | Small molecule | — | Other |
| Subject | SIM0270 | Unknown | — | Oral |