Letrozole as a Treatment of Endometrial Cancer
Predicting Aromatase Inhibitor Responsiveness in Endometrial Carcinoma
2 other identifiers
interventional
43
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 15, 2009
CompletedFirst Posted
Study publicly available on registry
October 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
April 6, 2015
CompletedMay 30, 2017
May 1, 2017
3.9 years
October 15, 2009
January 26, 2015
May 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
Letrozole
EXPERIMENTALletrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy.
control
NO INTERVENTIONno treatemtn prior to hysterectomy
Interventions
2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks
Eligibility Criteria
You may qualify if:
- FIGO grade 1 or 2 endometrioid adenocarcinoma of the endometrium
- Post menopausal status must be demonstrated
- Signed informed consent
You may not qualify if:
- FIGO grade 3 endometrioid adenocarcinoma or non-endometrioid cancers of the endometrium
- Younger than 40 or postmenopausal status not established
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of California Davis
Sacramento, California, 95817, United States
University of California, Davis
Sacramento, California, 95817, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lloyd H. Smith MD, PhD
- Organization
- UC Davis
Study Officials
- PRINCIPAL INVESTIGATOR
Lloyd H. Smith, MD, PhD
University of California, Davis
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2009
First Posted
October 19, 2009
Study Start
October 1, 2009
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
May 30, 2017
Results First Posted
April 6, 2015
Record last verified: 2017-05