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Can a common breast cancer drug slow uterine sarcoma?

NCT ID NCT05649956

Disease control Sponsor: GOG Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether the drug letrozole can extend the time before uterine leiomyosarcoma returns after initial treatment. About 40 women with early-stage disease will be randomly assigned to take letrozole daily or to be observed without treatment. The main goal is to see if letrozole improves progression-free survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
letrozole
What this could lead to
If it works, this could offer a way to delay cancer recurrence after initial treatment for uterine leiomyosarcoma.
What could go wrong
This is a small early-phase trial with only 40 participants, so results may not apply broadly. Letrozole may not improve outcomes and could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

leiomyosarcoma of the corpus uteri

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Uterine leiomyosarcoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    34 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asplundh Cancer Pavilion

    RECRUITING

    Willow Grove, Pennsylvania, 19090, United States

  • Atlantic Health System

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Bay Park Hospital

    RECRUITING

    Oregon, Ohio, 43616, United States

  • Broward Health Medical Center

    RECRUITING

    Fort Lauderdale, Florida, 33316, United States

  • East Carolina University Health Medical Center

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Endeavor Health - Kellogg Cancer Center

    RECRUITING

    Evanston, Illinois, 60201, United States

  • Highlands Ranch Hospital

    RECRUITING

    Highlands Ranch, Colorado, 80129, United States

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • LSU Health Sciences Center

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Mount Sinai Comprehensive Cancer Center

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • OhioHealth Arthur G.H. Bing, MD Cancer Center

    RECRUITING

    Columbus, Ohio, 43214, United States

  • OhioHealth Grant Medical Center

    RECRUITING

    Columbus, Ohio, 43215, United States

  • OhioHealth Marion General Hospital

    RECRUITING

    Marion, Ohio, 43302, United States

  • OhioHealth Research Institute

    RECRUITING

    Columbus, Ohio, 43214, United States

  • OhioHealth Riverside Methodist Hospital

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Overlook Medical Center

    RECRUITING

    Summit, New Jersey, 07901, United States

  • ProMedica Charles and Virginia Hickman Hospital,

    RECRUITING

    Adrian, Michigan, 49221, United States

  • ProMedica Defiance Regional Hospital

    RECRUITING

    Defiance, Ohio, 43512, United States

  • ProMedica Flower Hospital

    RECRUITING

    Sylvania, Ohio, 43560, United States

  • ProMedica Fostoria Community Hospital

    RECRUITING

    Fostoria, Ohio, 44830, United States

  • ProMedica Laboratories Perrysburg

    RECRUITING

    Perrysburg, Ohio, 43551, United States

  • ProMedica Memorial Hospital

    RECRUITING

    Fremont, Ohio, 43420, United States

  • ProMedica Monroe Regional Hospital

    RECRUITING

    Monroe, Michigan, 48162, United States

  • ProMedica Toledo Hospital

    RECRUITING

    Toledo, Ohio, 43606, United States

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Massachusetts Memorial Medical Center

    RECRUITING

    Worcester, Massachusetts, 01605, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of New Mexico Comprehensive Cancer Center

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • University of Oklahoma Health Stephenson Cancer Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • WK Physician Network-Gynecologic Oncology Associates

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Winship Cancer Institute, Emory Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Woman and Infants Hospital of Rhode Island

    RECRUITING

    Providence, Rhode Island, 02905, United States

  • Women's Cancer Center of Nevada

    RECRUITING

    Las Vegas, Nevada, 89106, United States

  • Women's Cancer Center of Nevada

    RECRUITING

    Las Vegas, Nevada, 89511, United States

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