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Aromatase Inhibitor

Letrozole for Uterine 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured for time of enrollment to time of death assessed up to 5 years from randomization

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured for time of enrollment to time of death assessed up to 5 years from randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured for time of enrollment to time of death assessed up to 5 years from randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured for time of enrollment to time of death assessed up to 5 years from randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival

Secondary outcome measures

Overall Survival

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

~3240

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

GOG FoundationLead Sponsor

42 Previous Clinical Trials

16,701 Total Patients Enrolled

Bradley Corr, MDStudy ChairUniversity of Colorado, Denver

2 Previous Clinical Trials

191 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment phase for this investigation currently ongoing?

"Affirmative. The information available on clinicaltrials.gov indicates that this trial is actively seeking participants. Initial posting of the trial took place on March 1, 2024 and its latest update occurred on February 21, 2024. A total of 40 patients are sought from a single research site."

Answered by AI

What is the collective count of participants involved in this clinical investigation?

"Indeed, details on clinicaltrials.gov specify that this particular research study is actively seeking potential participants. The trial was initially made public on March 1st, 2024 and underwent its most recent update on February 21st, 2024. Recruitment aims to enlist a total of forty individuals from one designated site."

Answered by AI

Has Letrozole received approval from the FDA?

"Based on our assessment at Power, Letrozole's safety is rated as 2. This evaluation considers the existing safety data in this Phase 2 study; however, evidence supporting efficacy is currently lacking."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Letrozole in Uterine Leiomyosarcoma

2024. "Letrozole in Uterine Leiomyosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05649956.

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