Letrozole as a Treatment of Endometrial Cancer

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.

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Key information

Conditions

Endometrial Carcinoma Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis, Sacramento, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

letrozole

Drug

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Predicting Aromatase Inhibitor Responsiveness in Endometrial Carcinoma

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Oct 19, 2009
Registry last updated: May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed