Letrozole as a Treatment of Endometrial Cancer

Not Applicable

Completed

• Conditions: Endometrial Carcinoma
• Interventions: Drug: Letrozole

• Registration Number: NCT00997373
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-16
• Study First Posted: 2009-10-19
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Results First Submitted: 2015-01-26
• Results First Submitted QC: 2015-04-03
• Results First Posted: 2015-04-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Letrozole	Letrozole	letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy.

Primary Outcome Measures

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

Trial Locations

Locations (2)

University of California Davis; 🇺🇸 Sacramento, California, United States

University of California, Davis; 🇺🇸 Sacramento, California, United States