Endometrial CarcinomaNCT00997373
Letrozole as a Treatment of Endometrial Cancer
A study testing Letrozole in people with Endometrial Carcinoma, run by University of California, Davis at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Endometrial Carcinoma
- What is being tested?
- Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FIGO grade 1 or 2 endometrioid adenocarcinoma of the endometrium
- Post menopausal status must be demonstrated
- Signed informed consent
Who cannot join
- FIGO grade 3 endometrioid adenocarcinoma or non-endometrioid cancers of the endometrium
- Younger than 40 or postmenopausal status not established
- Pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California Davis
Sacramento, California, 95817
University of California, Davis
Sacramento, California, 95817
About this study
Official title: Predicting Aromatase Inhibitor Responsiveness in Endometrial Carcinoma
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.
- Conditions
- Endometrial Carcinoma
- Being tested
- Letrozole
- Keywords
- Endometrial Cancer, Endometrial Carcinoma, Aromatase Inhibitor, Letrozole, Femara
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Femara, 4-[(4-cyanophenyl)-(1,2,4-triazol-1-yl)methyl]benzonitrile,, CAS number 112809-51-5
2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Experimental | letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy. Receives: Drug: Letrozole |
| control | No intervention | no treatemtn prior to hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At time of consent and after hysterectomy (generally about 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometrial CarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lloyd H. Smith, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997373
- Sponsor's protocol ID
- 200917341
- Other IDs
- CFEM 345AUS63
- Status last verified
- May 2017
- First submitted
- 15 Oct 2009
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Aromatase Inhibitor Responsiveness in Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT00997373
- Acronym / sponsor ID
- 200917341
- Conditions
- Endometrial Carcinoma
- Keywords
- Endometrial Cancer, Endometrial Carcinoma, Aromatase Inhibitor, Letrozole, Femara
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 19 Oct 2009 (estimated)
- Results
- Posted 6 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Experimental | Drug: Letrozoleletrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy. |
| control | No intervention | –no treatemtn prior to hysterectomy |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- FIGO grade 1 or 2 endometrioid adenocarcinoma of the endometrium
- Post menopausal status must be demonstrated
- Signed informed consent
Key exclusion criteria (3 listed)
- FIGO grade 3 endometrioid adenocarcinoma or non-endometrioid cancers of the endometrium
- Younger than 40 or postmenopausal status not established
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetrozoleAlso: Femara, 4-[(4-cyanophenyl)-(1,2,4-triazol-1-yl)methyl]benzonitrile,, CAS number 112809-51-52.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks | Drug | Letrozole |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lloyd H. Smith, MD, PhD principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letrozole in people with Endometrial Carcinoma, run by University of California, Davis at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.