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Letrozole as a Treatment of Endometrial Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00997373
First Posted: October 19, 2009
Last Update Posted: May 30, 2017
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.
Information provided by (Responsible Party):
University of California, Davis
  Purpose
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 Intervention
Endometrial Carcinoma Drug: Letrozole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Predicting Aromatase Inhibitor Responsiveness in Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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


Enrollment: 43
Study Start Date: October 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00997373


Locations
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
Investigators
Principal Investigator: Lloyd H. Smith, MD, PhD University of California, Davis
  More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00997373     History of Changes
Other Study ID Numbers: 200917341
CFEM 345AUS63
First Submitted: October 15, 2009
First Posted: October 19, 2009
Results First Submitted: January 26, 2015
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
Letrozole
Femara

Additional relevant MeSH terms:
Carcinoma
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Letrozole
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