drugset / Trial / NCT05963984
A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of samuraciclib in combination with fulvestrant versus fulvestrant alone in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.
Timeline
- Start
- 2023-11-16
- Primary completion
- 2025-03-20
- Completion
- 2025-08-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fulvestrant | Small molecule | — | — |
| Subject | Samuraciclib | Unknown | 240 mg | Oral |
| Subject | Samuraciclib | Unknown | 360 mg | Oral |