NCT05649956

Letrozole in Uterine Leiomyosarcoma

A Randomized Phase II Study of Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: GOG Foundation · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical trial to test letrozole in patients with uterine leiomyosarcoma. The main question is will treatment with letrozole extend progression-free survival in patients. Patients will receive 2/5 mg of letrozole daily.

Detailed description

This is a randomized phase II study of letrozole (Femara) administered 2.5 mg orally daily to patients with newly diagnosed clinical stage I and II LMS. Using an adaptive randomization, patients will be assigned to either the treatment arm (letrozole group) or observation. The primary outcome for this trial is the time to progression.

Conditions

• Uterine Leiomyosarcoma

Interventions

Type	Name	Description
DRUG	Letrozole	Letrozole 2.5 mg PO daily

Timeline

• Start date: 2024-07-17
• Primary completion: 2028-07-30
• Completion: 2029-07-30
• First posted: 2022-12-14
• Last updated: 2026-03-31

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study