drugset / Trial / NCT05963997
A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant 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
- 2023-10-09
- Primary completion
- 2026-03-06
- Completion
- 2026-03-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elacestrant | Other / unclassified | 300 mg | Oral |
| Subject | Elacestrant | Other / unclassified | 400 mg | Oral |
| Subject | Samuraciclib | Unknown | 240 mg | Oral |
| Subject | Samuraciclib | Unknown | 360 mg | Oral |