Letrozole as a Treatment of Endometrial Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Endometrial Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Letrozole

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

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

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

control

no treatemtn prior to hysterectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Letrozole

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

Intervention Type DRUG

Other Intervention Names

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Femara 4-[(4-cyanophenyl)-(1,2,4-triazol-1-yl)methyl]benzonitrile, CAS number 112809-51-5

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No