drugset / Trial / NCT05982093
Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
PREMIERE parallel, non-comparative, two-arm, randomized 1:1, open-label, multicenter, exploratory window of opportunity study in premenopausal women with primary operable HR+/HER2-negative breast cancer with aiming at evaluating the biological effects of elacestrant with or without triptorelin.
Timeline
- Start
- 2023-02-03
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elacestrant | Other / unclassified | 400 mg | Oral |
| Comparator | Tamoxifen | Small molecule | 20 mg | Oral |
| Comparator | Triptorelin | Other / unclassified | 3.75 mg | Other |