Letrozole as a Treatment of Endometrial Cancer

Endometrial Carcinoma Clinical Trial

Official title:

Predicting Aromatase Inhibitor Responsiveness in Endometrial Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997373
• Other study ID #: 200917341
• Secondary ID: CFEM 345AUS63
• Status: Completed
• Phase: N/A
• First received: October 15, 2009
• Last updated: May 25, 2017
• Start date: October 2009
• Est. completion date: September 2013

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Carcinoma
• Endometrial Neoplasms

Intervention

Drug:
• Letrozole
2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks

Locations

Country	Name	City	State
United States	University of California Davis	Sacramento	California
United States	University of California, Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At time of consent and after hysterectomy (generally about 3 weeks)