Clinical Trial

Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)

Study acronym: LEPRE
Recruiting Phase 3
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-10-26; most recent amendment 2025-01-23.
Trial Details
NCT Number NCT05601700
Lead Sponsor Ente Ospedaliero Ospedali Galliera
Collaborators: Istituto Di Ricerche Farmacologiche Mario Negri, Humanitas Hospital, Italy
Conditions Carcinoma, Ovarian Epithelial, Low Grade Serous Adenocarcinoma of Ovary
Enrollment 132 participants
Start Date 2022-09-22
Primary Completion 2029-09-22 (estimated)
Study Completion 2029-09-22 (estimated)
Updated on ClinicalTrials.gov 2025-01-27