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Letrozole as a Treatment of Endometrial Cancer

University of California (UC) Davis logo

University of California (UC) Davis

Status

Completed

Conditions

Endometrial Carcinoma

Treatments

Drug: Letrozole

Study type

Interventional

Funder types

Other

Identifiers

NCT00997373
CFEM 345AUS63
200917341

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

Female

Ages

40+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

43 participants in 2 patient groups

Letrozole
Experimental group
Description:
letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy.
Treatment:
Drug: Letrozole
control
No Intervention group
Description:
no treatemtn prior to hysterectomy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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