Last reviewed · How we verify
Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physician's Choice of Chemotherapy Sequential Endocrine Therapy in HR+/HER2- Advanced Breast Cancer: a Phase II Randomised Controlled Clinical Trial
Evaluate the efficacy and safety of Ribociclib in combination with NSAI versus physician's choice of chemotherapy sequential endocrine therapy in HR+/HER2- advanced breast cancer.
Details
| Lead sponsor | The First Affiliated Hospital with Nanjing Medical University |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 144 |
| Start date | 2024-01-09 |
| Completion | 2025-12 |
Conditions
- Advanced Breast Cancer
Interventions
- physician's choice of chemotherapy sequential Ribociclib combined with NSAI±OFS
- Ribociclib combined with NSAI±OFS
Primary outcomes
- Progression Free Survival — From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Progression-free survival is defined as the time from the date of randomization to the date of the first documented progression as per local review and according to RECIST 1.1 or death due to any cause.
Countries
China