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Letrozole in Uterine Leiomyosarcoma

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05649956
Enrollment
40
Registered
2022-12-14
Start date
2024-07-17
Completion date
2029-07-30
Last updated
2026-07-30

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

Conditions

Uterine Leiomyosarcoma

Brief 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.

Interventions

DRUGLetrozole

Letrozole 2.5 mg PO daily

Sponsors

GOG Foundation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patient or a legally authorized representative must have signed an approved informed consent and authorization permitting the release of personal health information. 2. Patient must have histologically confirmed newly diagnosed uterine leiomyosarcoma with disease limited to the uterus (FIGO 2009 Stage I). Submission of pathology report documenting uterine leiomyosarcoma histology is required in the IRT Source Document Portal following randomization. 3. Patient tumors must express ER positivity by immunohistochemistry (ER expression greater than 10% by immunohistochemistry). ER status test results must be provided at enrollment. Sites are required to report results of ER status testing in the IRT Source Document Portal. 4. Patient must have completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks from enrollment. 5. All patients must have NO measurable disease as defined by RECIST 1.1 within 6 weeks of enrollment. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be greater than or equal to 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or greater than or equal to 20 mm when measured by chest x-ray. Lymph nodes must be greater than or equal to 15 mm in short axis when measured by CT or MRI. 6. Patients must have an ECOG performance status of 0, 1, or 2. 7. Patients must have adequate organ and marrow function as defined below: NOTE: Institutional/laboratory upper limit of normal = ULN Institutional/laboratory lower limit of normal = LLN Bone marrow function: * Absolute neutrophil count (ANC) greater than or equal to 1500 cells/mcl * Platelet count greater than or equal to 100,000 cells/mcl * Hemoglobin greater than or equal to 9.0 g/dL (Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the Investigator. Initial treatment must not begin earlier than the day after erythrocyte transfusion). Renal function: • Serum creatinine less than or equal to 1.5 x ULN Hepatic function: * AST (aspartate aminotransferase) and ALT (alanine aminotransferase) less than or equal to 3.0 x ULN * Serum albumin greater than or equal to 2.5 g/dL 8. Patient must be at least 18 years of age. 9. Patient must be able to swallow oral medication.

Design outcomes

Primary

MeasureTime frame
Progression Free SurvivalMeasured from time of enrollment until date of progression or death up 3 years from randomization

Countries

United States

Contacts

CONTACTSarin Chhab
schhab@gog.org2158540770
CONTACTShanon Matkin
smatkin@gog.org
STUDY_CHAIRBradley Corr, MD

University of Colorado, Denver

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026