Letrozole in Uterine Leiomyosarcoma

March 26, 2026 updated by: GOG Foundation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Cancer Center - Anschutz Cancer Pavilion
        • Principal Investigator:
          • Bradley Corr, MD
      • Highlands Ranch, Colorado, United States, 80129
        • Recruiting
        • Highlands Ranch Hospital
        • Principal Investigator:
          • Bradley Corr, MD
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Recruiting
        • Broward Health Medical Center
        • Principal Investigator:
          • Scott Jordan, MD
        • Contact:
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Comprehensive Cancer Center
        • Principal Investigator:
          • Brian Slomovitz, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute, Emory Hospital
        • Principal Investigator:
          • Susan Modesitt, MD
        • Contact:
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Endeavor Health - Kellogg Cancer Center
        • Contact:
        • Principal Investigator:
          • Endeavor Health - Kellogg Cancer Center Jenkins-Vodel, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
        • Contact:
        • Sub-Investigator:
          • Lisa Landrum, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • LSU Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Tara Castellano, MD
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • WK Physician Network-Gynecologic Oncology Associates
        • Principal Investigator:
          • Destin Black, MD
        • Contact:
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Recruiting
        • University of Massachusetts Memorial Medical Center
        • Principal Investigator:
          • Susan Zweizig, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Jordan Mattson, MD
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Women's Cancer Center of Nevada
        • Contact:
        • Principal Investigator:
          • Nicola Spirtos, MD
      • Las Vegas, Nevada, United States, 89511
        • Recruiting
        • Women's Cancer Center of Nevada
        • Contact:
        • Principal Investigator:
          • Peter Lim, MD
    • New Jersey
      • Morristown, New Jersey, United States, 07960
      • Summit, New Jersey, United States, 07901
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Recruiting
        • University of New Mexico Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Carolyn Muller
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University Health Medical Center
        • Contact:
        • Principal Investigator:
          • Grainger Lanneau, MD
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • OhioHealth Research Institute
        • Principal Investigator:
          • Aine Clements, MD
        • Contact:
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • OhioHealth Riverside Methodist Hospital
        • Principal Investigator:
          • Aine Clements, MD
        • Contact:
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • OhioHealth Arthur G.H. Bing, MD Cancer Center
        • Principal Investigator:
          • Aine Clements, MD
        • Contact:
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • OhioHealth Grant Medical Center
        • Principal Investigator:
          • Aine Clements, MD
        • Contact:
      • Marion, Ohio, United States, 43302
        • Recruiting
        • OhioHealth Marion General Hospital
        • Principal Investigator:
          • Aine Clements, MD
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Stephenson Cancer Center
        • Principal Investigator:
          • Laura Holman, MD
        • Contact:
    • Pennsylvania
      • Willow Grove, Pennsylvania, United States, 19090
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Woman and Infants Hospital of Rhode Island
        • Principal Investigator:
          • Matthew Oliver, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Exclusion Criteria:

Exclusion Criteria 1. Patients who do not have pure uterine sarcomas (i.e., no mixed malignant mullerian tumors are permitted).

2. Patients with any other severe concurrent disease, which would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases.

3. Patients with concomitant invasive malignancy or a history of prior malignancy except non-melanoma skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol.

4. Patients who have a history of taking any aromatase inhibitor within the past 5 years.

5. Patients with active or uncontrolled systemic infection. 6. Patients with history of uncontrolled cardiac disease, i.e., uncontrolled hypertension (defined as systolic greater than 150 mm Hg or diastolic greater than 90 mm HR despite antihypertensive medications), unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure (NYHA Class II or greater), clinically significant cardiac arrhythmias, and cardiomyopathy with an ejection fraction under 40%.

7. Patients currently receiving chemotherapy or radiation therapy. 8. Patients with severe hepatic impairment and/or cirrhosis. 9. Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication.

10. Patients deemed otherwise clinically unfit for clinical trial per investigators discretion.

11. Patients with known hypersensitivity to any of the excipients of letrozole. 12. Patients who are pregnant or breast-feeding. 13. Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 30 days of prior to enrollment.

14. Patients currently using systemic estrogens, including herbals and supplements with estrogenic properties. The use of vaginal estrogen is permitted if symptoms are refractory to moisturizers and lubricants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Observation
Experimental: Letrozole
Letrozole 2.5 mg orally
Drug: Letrozole
Letrozole 2.5 mg PO daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: Measured from time of enrollment until date of progression or death up 3 years from randomization
Measured from time of enrollment until date of progression or death up 3 years from randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Measured for time of enrollment to time of death assessed up to 5 years from randomization
Measured for time of enrollment to time of death assessed up to 5 years from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GOG Foundation

Investigators

  • Study Chair: Bradley Corr, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2024

Primary Completion (Estimated)

July 30, 2028

Study Completion (Estimated)

July 30, 2029

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

December 6, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-3088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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