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Letrozole as a Treatment of Endometrial Cancer

Primary Purpose

Endometrial Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Letrozole
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Carcinoma focused on measuring Endometrial Cancer, Endometrial Carcinoma, Aromatase Inhibitor, Letrozole, Femara

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Davis
  • University of California, Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Letrozole

control

Arm Description

letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy.

no treatemtn prior to hysterectomy

Outcomes

Primary Outcome Measures

Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer
Changes in %Ki67 staining cells by immunoperoxidase of paraffin embedded, formalin fixed tissue

Secondary Outcome Measures

Full Information

First Posted
October 15, 2009
Last Updated
May 25, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT00997373
Brief Title
Letrozole as a Treatment of Endometrial Cancer
Official Title
Predicting Aromatase Inhibitor Responsiveness in Endometrial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Carcinoma
Keywords
Endometrial Cancer, Endometrial Carcinoma, Aromatase Inhibitor, Letrozole, Femara

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Letrozole
Arm Type
Experimental
Arm Description
letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy.
Arm Title
control
Arm Type
No Intervention
Arm Description
no treatemtn prior to hysterectomy
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Femara, 4-[(4-cyanophenyl)-(1,2,4-triazol-1-yl)methyl]benzonitrile,, CAS number 112809-51-5
Intervention Description
2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks
Primary Outcome Measure Information:
Title
Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer
Description
Changes in %Ki67 staining cells by immunoperoxidase of paraffin embedded, formalin fixed tissue
Time Frame
At time of consent and after hysterectomy (generally about 3 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lloyd H. Smith, MD, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Letrozole as a Treatment of Endometrial Cancer

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