Letrozole as a Treatment of Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00997373
Recruitment Status : Completed
First Posted : October 19, 2009
Results First Posted : April 6, 2015
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Endometrial Carcinoma Drug: Letrozole Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Predicting Aromatase Inhibitor Responsiveness in Endometrial Carcinoma
Study Start Date : October 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00997373

United States, California
University of California Davis
Sacramento, California, United States, 95817
University of California, Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Principal Investigator: Lloyd H. Smith, MD, PhD University of California, Davis

Responsible Party: University of California, Davis Identifier: NCT00997373     History of Changes
Other Study ID Numbers: 200917341
First Posted: October 19, 2009    Key Record Dates
Results First Posted: April 6, 2015
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by University of California, Davis:
Endometrial Cancer
Endometrial Carcinoma
Aromatase Inhibitor

Additional relevant MeSH terms:
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Aromatase Inhibitors
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs