Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02729701|
Recruitment Status : Recruiting
First Posted : April 6, 2016
Last Update Posted : January 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Duavee||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 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 :||March 2019|
|Estimated Study Completion Date :||May 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729701
|Contact: Bruce Kimler, PhD||(913) firstname.lastname@example.org|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|University of Kansas Medical Center Breast Cancer Prevention Center||Recruiting|
|Westwood, Kansas, United States, 66208|
|Principal Investigator:||Carol Fabian, MD||University of Kansas Medical Center|