Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation
|ClinicalTrials.gov Identifier: NCT02729701|
Recruitment Status : Active, not recruiting
First Posted : April 6, 2016
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Duavee||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation in Peri or Post-menopausal Women at Moderate Risk for Development of Breast Cancer|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Participants will be asked to take Duavee for 6 months while on the study.
Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))
Other Name: conjugated estrogens/bazedoxifene
- Feasibility for a larger trial [ Time Frame: 6 Months ]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.
- Change in Ki-67 [ Time Frame: Change from Baseline to Month 6 ]Assessment by immunocytochemistry of the percent of breast epithelial cells staining positive.
- Change in benign breast tissue estrogen responsive genes [ Time Frame: Change from Baseline to Month 6 ]Assessment by RT-qPCR of breast epithelial cells of relative rate of gene expression.
- Change in hormone levels [ Time Frame: Change from Baseline to Month 6 ]Assessment of concentrations of hormones in serum by radioimmunoassay
- Change in levels of Duavee in the blood [ Time Frame: Change from Baseline to Month 6 ]Assessment of concentration of Duavee and metabolites in plasma
- Change in body composition [ Time Frame: Change from Baseline to Month 6 ]Assessment by Dual Energy X-ray Absorptivity (DEXA)
- Change in breast density [ Time Frame: Change from Baseline to Month 6 ]Assessment of mammograms for percent of breast considered to be at increased density
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729701
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|University of Kansas Medical Center Breast Cancer Prevention Center|
|Westwood, Kansas, United States, 66208|
|Principal Investigator:||Carol Fabian, MD||University of Kansas Medical Center|