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Letrozole for Estrogen/Progesterone Receptor positive low-grade serous Epithelial ovarian cancer. A randomized phase III trial. LEPRE Trial

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516874-31-00
Acronym
10UCS2018
Enrollment
132
Registered
2024-12-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FIGO III-IV stage and with ER+ and/or PgR+ after primary surgery are eligible., Patients with a low-grade serous epithelial carcinoma of the ovary (LGSCO) including cancer of fallopian tube and peritoneum

Brief summary

The primary endpoint is PFS, defined for each patient as the time from the date of randomization to the date of local or regional relapse, distant metastasis, or death from any cause, whichever comes first.

Detailed description

Objective Response Rate (ORR), defined as the percentage of patients with an objective response determined by a complete response (CR) or a partial response (PR) as determined by RECIST 1.1.

Interventions

DRUGLetrix 2
DRUG5 mg compresse rivestite con film.
DRUGCARBOPLATIN
DRUGPACLITAXEL

Sponsors

Ente Ospedaliero Ospedali Galliera Di Genova
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is PFS, defined for each patient as the time from the date of randomization to the date of local or regional relapse, distant metastasis, or death from any cause, whichever comes first.

Secondary

MeasureTime frame
Objective Response Rate (ORR), defined as the percentage of patients with an objective response determined by a complete response (CR) or a partial response (PR) as determined by RECIST 1.1.

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026