drugset / Trial / NCT07207070
A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a randomised, open-label, multicentre phase III clinical study evaluating the efficacy and safety of JS105 combined with Dalpiciclib and Fulvestrant compared with Dalpiciclib and Fulvestrant in patients with PIK3CA-mutated, HR-positive, HER2-negative recurrent or metastatic breast cancer.
Timeline
- Start
- 2025-11-12
- Primary completion
- 2029-05-31
- Completion
- 2030-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JS105 | Unknown | — | Oral |
| Background | Dalpiciclib | Small molecule | — | Oral |
| Background | Fulvestrant | Small molecule | 50 mg/ml | Intramuscular |