Trial Outcomes & Findings for Letrozole as a Treatment of Endometrial Cancer (NCT NCT00997373)
NCT ID: NCT00997373
Last Updated: 2017-05-30
Results Overview
Changes in %Ki67 staining cells by immunoperoxidase of paraffin embedded, formalin fixed tissue
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
At time of consent and after hysterectomy (generally about 3 weeks)
Results posted on
2017-05-30
Participant Flow
Recruitment by providing gynecologic oncologist beginning 11/2/2009
Non-randomized selection of control subjects
Participant milestones
| Measure |
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).
|
Control
No treatment prior to hysterectomy
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
15
|
|
Overall Study
Received Letrozole
|
23
|
0
|
|
Overall Study
Completed Hysterectomy
|
17
|
15
|
|
Overall Study
COMPLETED
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
15
|
0
|
Reasons for withdrawal
| Measure |
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).
|
Control
No treatment prior to hysterectomy
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
|
Overall Study
wrong tumor type
|
4
|
0
|
|
Overall Study
could not have hysterectomy
|
6
|
0
|
Baseline Characteristics
Letrozole as a Treatment of Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Letrozole Arm
n=12 Participants
Grade 1 or 2 endometrial cancer treated 3 weeks before hysterectomy of repeat biopsy. Letrozole 2.5 mg PO daily.
|
Control
n=12 Participants
No letrozole before hysterectomy
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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).
Changes in %Ki67 staining cells by immunoperoxidase of paraffin embedded, formalin fixed tissue
Outcome measures
| Measure |
Letrozole
n=12 Participants
letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy.
Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks
|
Control
n=12 Participants
no treatemtn prior to hysterectomy
|
|---|---|---|
|
Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer
|
-3.75 percentage of Ki67 staining cells
Interval -18.0 to 24.0
|
1.583 percentage of Ki67 staining cells
Interval -30.0 to 21.0
|
Adverse Events
Letrozole
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Letrozole
n=23 participants at risk
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).
|
Control
No treatment prior to hysterectomy
|
|---|---|---|
|
Cardiac disorders
death
|
4.3%
1/23 • Number of events 1 • Weekly by telephone interview during treatment
Adverse events for control arm not collected.
|
—
0/0 • Weekly by telephone interview during treatment
Adverse events for control arm not collected.
|
Other adverse events
| Measure |
Letrozole
n=23 participants at risk
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).
|
Control
No treatment prior to hysterectomy
|
|---|---|---|
|
General disorders
fatigue
|
13.0%
3/23 • Weekly by telephone interview during treatment
Adverse events for control arm not collected.
|
—
0/0 • Weekly by telephone interview during treatment
Adverse events for control arm not collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place