Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CFEM 345AUS63 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole | Experimental | letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy. |
|
| control | No Intervention | no treatemtn prior to hysterectomy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug | 2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lloyd H. Smith, MD, PhD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis | Sacramento | California | 95817 | United States | ||
| University of California, Davis |
Non-randomized selection of control subjects
Recruitment by providing gynecologic oncologist beginning 11/2/2009
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Letrozole | Letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy or re-biopsy. Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery (generally about 3 weeks) or to the day of repeat endometrial biopsy 9medical treatment arm). |
| FG001 | Control | No treatment prior to hysterectomy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects and controls selected to give groups similar in age and tumor grade. Four subjects excluded - wrong tumor type. One treatment arm completed but was excluded from analysis because of late completion.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Letrozole Arm | Grade 1 or 2 endometrial cancer treated 3 weeks before hysterectomy of repeat biopsy. Letrozole 2.5 mg PO daily. |
| BG001 | Control | No letrozole before hysterectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Subjects completing treatment who had confirmed histopathology compared to a non-randomized group of untreated control subjects. "Aromatase inhibitor responsiveness" was defined as a proportionate decline in %Ki67 staining of at least 70% between pre-treatment biopsy and hysterectomy 9or repeat biopsy). | Posted | Mean | Full Range | percentage of Ki67 staining cells | At time of consent and after hysterectomy (generally about 3 weeks) |
|
Weekly by telephone interview during treatment
Adverse events for control arm not collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Letrozole | Letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy or re-biopsy. Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery (generally about 3 weeks) or to the day of repeat endometrial biopsy 9medical treatment arm). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Cardiac disorders | Non-systematic Assessment | Subject with severe pre-existing pulmonary hypertension expired at home suddenly of apparent acute cardiac event 2 weeks after starting letrozole. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | General disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lloyd H. Smith MD, PhD | UC Davis | 916-734-6945 | lhsmith@ucdavis.edu |
Not provided
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sacramento |
| California |
| 95817 |
| United States |
| could not have hysterectomy |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | no treatemtn prior to hysterectomy |
|
|
|
| 1 |
| 23 |
| 3 |
| 23 |
| EG001 | Control | No treatment prior to hysterectomy | 0 | 0 | 0 | 0 |
|
Not provided
Not provided
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |