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Aromatase Inhibitor

Letrozole for Leiomyosarcoma

Phase 2

Recruiting

Research Sponsored by GOG Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have adequate organ and marrow function as defined below: Absolute neutrophil count (ANC) greater than or equal to 1500/mcl, Platelets greater than or equal to 100,000 cells/mcl, Hemoglobin greater than or equal to 8 g/dL, Creatinine less than or equal to 1.5 x ULN, Bilirubin less than or equal to 1.5 x ULN, ALT and AST less than or equal to 3 x ULN, Alkaline phosphatase less than or equal to 2.5 x ULN, Albumin greater than or equal to 2.8 g/dL, Patients must have signed an approved informed consent and authorization permitting release of personal health information, Patients must be at least 18 years of age

Patient must be able to swallow oral medications

Must not have

Patients who do not have pure uterine sarcomas (i.e., no mixed malignant mullerian tumors)

Patients who have a history of taking any aromatase inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a drug called letrozole in patients with a type of cancer called uterine leiomyosarcoma. The goal is to see if letrozole can help patients live

Who is the study for?

This trial is for patients with a specific cancer of the uterus called leiomyosarcoma, limited to early stages (1 or 2). Participants must have had surgery to remove their uterus and ovaries recently, show estrogen receptor positivity in tumor cells, be able to take pills orally, and have good overall health and organ function. They should not have any measurable disease left.

What is being tested?

The trial is testing if letrozole at doses of 2/5 mg daily can extend the time patients live without their cancer getting worse. Letrozole is a hormone therapy that lowers estrogen levels which may help slow the growth of certain cancers.

What are the potential side effects?

Letrozole can cause side effects like hot flashes, joint pain, fatigue, increased sweating, nausea and bone thinning over time. Some people might also experience changes in mood or cholesterol levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow pills.

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My tumor is ER positive, with at least 10% cells showing ER positivity.

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I had surgery to remove my uterus and both ovaries within the last 12 weeks.

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I am able to get out of my bed or chair and move around.

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My cancer is a type of uterine cancer called leiomyosarcoma, and it's only in my uterus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is not a mixed type but a pure uterine sarcoma.

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I have taken aromatase inhibitors before.

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I do not have any ongoing or uncontrolled infections.

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I have a condition that affects how my body absorbs pills.

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I am currently undergoing chemotherapy or radiation therapy.

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I have a history of heart disease that is not well-controlled.

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I have not had any other cancer besides this one in the last two years.

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I do not have severe liver, kidney, or stomach diseases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 4 trial • 79 Patients • NCT02137538

10%

Fracture

Acne

Scoliosis

Hair loss

Sacroiliitis

Neuro event

100%

80%

60%

40%

20%

Study treatment Arm

Anastrozole

Letrozole

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LetrozoleExperimental Treatment1 Intervention

Letrozole 2.5 mg orally

Group II: ObservationActive Control1 Intervention

Observation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Letrozole

2002

Completed Phase 4

~3590

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

GOG FoundationLead Sponsor

46 Previous Clinical Trials

17,914 Total Patients Enrolled

Bradley Corr, MDStudy ChairUniversity of Colorado, Denver

2 Previous Clinical Trials

132 Total Patients Enrolled

~27 spots leftby Jul 2028

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