N/A
N=43
Letrozole as a Treatment of Endometrial Cancer
Endometrial Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00997373 ↗Enrolled (actual)
43
Serious AEs
4.4%
Results posted
Apr 2015
Primary outcome: Primary: Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer — -3.75; 1.583 percentage of Ki67 staining cells — p=0.0373
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Letrozole (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- University of California, Davis
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer |
-3.75; 1.583 | 0.0373 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT00997373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.