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

NCT05601700 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-01-27

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Letrozole tablets

ATC: L02BG04

DRUG

carboplatin AUC 5 and paclitaxel 175 mg/m2

ATC: L01XA02 and ATC: L01CD01 respectively

Sponsors & Collaborators

  • Istituto Di Ricerche Farmacologiche Mario Negri

    collaborator OTHER

  • Humanitas Hospital, Italy

    collaborator OTHER

  • Ente Ospedaliero Ospedali Galliera

    lead OTHER

Principal Investigators

  • Andrea DeCensi, MD · E.O.Ospedali Galliera

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-22
Primary Completion
2029-09-22
Completion
2029-09-22

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05601700 on ClinicalTrials.gov