Endometrial Carcinoma
Conditions
Keywords
Endometrial Cancer, Endometrial Carcinoma, Aromatase Inhibitor, Letrozole, Femara
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.
Interventions
DRUGLetrozole
2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks
Sponsors
University of California, Davis
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer | At time of consent and after hysterectomy (generally about 3 weeks) | Changes in %Ki67 staining cells by immunoperoxidase of paraffin embedded, formalin fixed tissue |
Countries
United States
Participant flow
Recruitment details
Recruitment by providing gynecologic oncologist beginning 11/2/2009
Pre-assignment details
Non-randomized selection of control subjects
Participants by arm
| Arm | Count |
|---|---|
| Letrozole Arm Grade 1 or 2 endometrial cancer treated 3 weeks before hysterectomy of repeat biopsy. Letrozole 2.5 mg PO daily. | 12 |
| Control No letrozole before hysterectomy | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | could not have hysterectomy | 6 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
| Overall Study | wrong tumor type | 4 | 0 |
Baseline characteristics
| Characteristic | Letrozole Arm | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 5 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 7 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 11 Participants | 23 Participants |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 23 | 0 / 0 |
| serious Total, serious adverse events | 1 / 23 | 0 / 0 |
Outcome results
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
Time frame: At time of consent and after hysterectomy (generally about 3 weeks)
Population: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Letrozole | Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer | -3.75 percentage of Ki67 staining cells |
| Control | Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer | 1.583 percentage of Ki67 staining cells |
p-value: 0.0373Fisher Exact