drugset / Trial / NCT05601700

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

NCT05601700

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

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 5 unknown Intravenous
Subject Letrozole Other / unclassified 2.5 mg Oral
Comparator Paclitaxel Small molecule 175 mg/m2 Intravenous