drugset / Trial / NCT05896566
A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
PREcoopERA is a randomized (2:2:1), multicenter, open-label, three-arm (A, B, C), Window-of-Opportunity (WOO) trial to evaluate the activity and safety of giredestrant (A) versus giredestrant plus triptorelin (B) versus anastrozole plus triptorelin (C).
Timeline
- Start
- 2024-01-23
- Primary completion
- 2025-09-18
- Completion
- 2025-09-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anastrozole | Other / unclassified | 1 mg | Oral |
| Subject | Giredestrant | Small molecule | 30 mg | Oral |
| Subject | Triptorelin | Other / unclassified | 3.75 mg | Intramuscular |