drugset / Trial / NCT05601700
Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)
Phase 3
Recruiting
132 enrolled
Ente Ospedaliero Ospedali Galliera
Humanitas Hospital, Italy · collabIstituto Di Ricerche Farmacologiche Mario Negri · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an Italian, multicenter, randomized, open-label phase III trial which will evaluate if Letrozole is superior to standard adjuvant chemotherapy in patients with hormone receptor positive low-grade serous epithelial carcinoma of the ovary (LGSCO). The hypothesis is that letrozole will significantly prolong median progression free survival (PFS) compared with the standard chemotherapy treatment, namely carboplatin AUC 5 and paclitaxel 175 mg/m2.
Timeline
- Start
- 2022-09-22
- Primary completion
- 2029-09-22
- Completion
- 2029-09-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Subject | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Comparator | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |