Trial Outcomes & Findings for Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation (NCT NCT02729701)
NCT ID: NCT02729701
Last Updated: 2022-03-09
Results Overview
Outcome will be based on three separate factors used collectively to determine feasibility of the study and consideration of a subsequent larger trial. These are accrual rate (ability to accrue target number of subjects in a timely manner), dropout rate (frequency of subjects who are compliant and complete the intervention) and change in Ki-67 (increase vs decrease in percent of cells stained positive in the majority of subjects). Should accrual be inadequate or too slow; or if retention is too low; then a decision would be made not to proceed to a larger trial. Also, if there is evidence of an increase in proliferation (Ki-67) then no further studies would be planned.
COMPLETED
PHASE2
28 participants
6 Months
2022-03-09
Participant Flow
Women were recruited from the Breast Cancer Prevention Center. Accrual May 2016 - August 2018. 42 women were considered medically eligible and were screened by Random Periareolar Fine Needle Aspiration (RPFNA). 14 did not enter the trial for a variety of reasons.
Participant milestones
| Measure |
Duavee
Participants asked to take Duavee for 6 months while on the study.
Duavee: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation
Baseline characteristics by cohort
| Measure |
Duavee
n=28 Participants
Participants will be asked to take Duavee for 6 months while on the study.
Duavee: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))
|
|---|---|
|
Age, Continuous
|
53 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
|
Proliferation Index (percent of breast epithelial cells that are Ki-67 immunocytochemistry positive)
|
1 percent
n=99 Participants
|
|
Fibroglandular Volume (FGV)
|
133 cm-squared
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: potential subjects screened for eligibility.
Outcome will be based on three separate factors used collectively to determine feasibility of the study and consideration of a subsequent larger trial. These are accrual rate (ability to accrue target number of subjects in a timely manner), dropout rate (frequency of subjects who are compliant and complete the intervention) and change in Ki-67 (increase vs decrease in percent of cells stained positive in the majority of subjects). Should accrual be inadequate or too slow; or if retention is too low; then a decision would be made not to proceed to a larger trial. Also, if there is evidence of an increase in proliferation (Ki-67) then no further studies would be planned.
Outcome measures
| Measure |
Duavee
n=42 Participants
Participants asked to take Duavee for 6 months while on the study.
Duavee: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))
|
|---|---|
|
Feasibility for a Larger Trial
Screened
|
42 Participants
|
|
Feasibility for a Larger Trial
Eligible
|
28 Participants
|
|
Feasibility for a Larger Trial
Complete
|
28 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 6Population: All subjects with baseline Ki-67 \>1%
Assessment by immunocytochemistry of the percent of breast epithelial cells staining positive. Per protocol, restricted to those subjects with baseline Ki-67 positivity \>1.0% but \< 4%
Outcome measures
| Measure |
Duavee
n=15 Participants
Participants asked to take Duavee for 6 months while on the study.
Duavee: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))
|
|---|---|
|
Change in Ki-67
|
-1.2 change in percent positivity
Interval -3.2 to 3.2
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 6Population: Subjects with baseline and post-intervention mammograms assessed by Volpara
Assessment of mammograms for percent of breast defined as FGV by Volpara automated assessment.
Outcome measures
| Measure |
Duavee
n=26 Participants
Participants asked to take Duavee for 6 months while on the study.
Duavee: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))
|
|---|---|
|
Change in Fibroglandular Volume (FGV)
|
-12 cm-squared
Interval -204.0 to 62.0
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 6Population: All subjects enrolled and completed
Assessment by Dual Energy X-ray Absorptivity (DEXA)
Outcome measures
| Measure |
Duavee
n=28 Participants
Participants asked to take Duavee for 6 months while on the study.
Duavee: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))
|
|---|---|
|
Change in Body Composition (Total Mass)
|
0.9 kg
Interval -11.8 to 10.4
|
SECONDARY outcome
Timeframe: Month 6Population: With residual plasma available for analysis
Assessment of concentration of bazedoxifene in plasma by High-performance liquid chromatography (HPLC)
Outcome measures
| Measure |
Duavee
n=25 Participants
Participants asked to take Duavee for 6 months while on the study.
Duavee: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))
|
|---|---|
|
Levels of Bazedoxifene in the Blood
|
1.83 ng/ml
Interval 0.004 to 7.86
|
Adverse Events
Duavee
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bruce F. Kimler, Ph.D.
University of Kansas Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place