NCT05601700

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

Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer: a Randomized Phase III Trial (LEPRE Trial)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Ente Ospedaliero Ospedali Galliera · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary objective: To determine if letrozole is superior to standard chemotherapy in terms of progression-free survival (PFS) in the first line treatment of patients with advanced low-grade serous epithelial ovarian carcinoma positive for estrogen and/or progesterone receptors. Secondary objectives: * to evaluate the response of tumor to letrozole compared with standard chemotherapy in terms of objective response rate (ORR); * to test the predictive effect of ER and PgR on response to letrozole in terms of PFS and ORR; * to evaluate the possible negative association between the effect of letrozole, in terms of PFS and ORR, and the proliferative index Ki67; * to evaluate the impact of letrozole compared with the impact of standard chemotherapy on patients' health related quality of life evaluated by Menopausal Quality of Life Questionnaire (MENQOL); * to evaluate the impact of letrozole compared with standard chemotherapy on patients' musculoskeletal pain evaluated by Brief Pain Inventory - Short Form (BPISF); * to evaluate the effect on overall survival (OS). As most patients will recur and will be switched to chemotherapy and vice versa, OS is not expected to be significantly different; * to evaluate the safety of letrozole compared with standard chemotherapy according to CTCAE v 5.0. Translational objectives: * to characterize the mutational profile and gene expression of the disease by NGS (next-generation sequencing) methodology on tissue samples; * to evaluate the circulating tumor DNA (ctDNA) on liquid biopsies as a tool to monitor the disease response.

Conditions

• Carcinoma, Ovarian Epithelial
• Low Grade Serous Adenocarcinoma of Ovary

Interventions

Type	Name	Description
DRUG	Letrozole tablets	ATC: L02BG04
DRUG	carboplatin AUC 5 and paclitaxel 175 mg/m2	ATC: L01XA02 and ATC: L01CD01 respectively

Timeline

• Start date: 2022-09-22
• Primary completion: 2029-09-22
• Completion: 2029-09-22
• First posted: 2022-11-01
• Last updated: 2025-01-27

Locations

19 sites across 1 country: Italy