Letrozole as a Treatment of Endometrial Cancer

May 25, 2017 updated by: University of California, Davis

Predicting Aromatase Inhibitor Responsiveness in Endometrial Carcinoma

Some cases of endometrial cancer are dependent on estrogen for their growth. Letrozole blocks estrogen production in the body. The purpose of this study is to determine if the investigators can predict which patients might benefit from Letrozole treatment by studying the many different forms of the estrogen receptor molecule that exist within the cancer tissues. To participate in this study, the patients must be 40 years of age or older and have biopsy-proven endometrial carcinoma, either well differentiated or moderately differentiated forms. Also, to be eligible to participate in this study, the patients need to be healthy enough to have a hysterectomy. If the patients are less than age 60, they will need a blood test (FSH) to confirm that they have gone into menopause.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis
      • Sacramento, California, United States, 95817
        • University of California, Davis

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • FIGO grade 1 or 2 endometrioid adenocarcinoma of the endometrium
  • Post menopausal status must be demonstrated
  • Signed informed consent

Exclusion Criteria:

  • FIGO grade 3 endometrioid adenocarcinoma or non-endometrioid cancers of the endometrium
  • Younger than 40 or postmenopausal status not established
  • Pregnant or breastfeeding

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Letrozole
letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy.
Drug: Letrozole
2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks
Other Names:
  • Femara
  • 4-[(4-cyanophenyl)-(1,2,4-triazol-1-yl)methyl]benzonitrile,
  • CAS number 112809-51-5
No Intervention: control
no treatemtn prior to hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer
Time Frame: At time of consent and after hysterectomy (generally about 3 weeks)
Changes in %Ki67 staining cells by immunoperoxidase of paraffin embedded, formalin fixed tissue
At time of consent and after hysterectomy (generally about 3 weeks)

Collaborators and Investigators

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

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Lloyd H. Smith, MD, PhD, University of California, Davis

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

October 1, 2009

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

October 16, 2009

First Posted (Estimate)

October 19, 2009

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200917341
  • CFEM 345AUS63

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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