Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation
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ClinicalTrials.gov Identifier: NCT02729701 |
Recruitment Status :
Active, not recruiting
First Posted : April 6, 2016
Last Update Posted : February 6, 2019
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Drug: Duavee | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Duavee
Participants will be asked to take Duavee for 6 months while on the study.
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Drug: Duavee
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

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Ages Eligible for Study: | up to 61 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women with vasomotor symptoms with a uterus who are postmenopausal or in late menopause transition
- Body Mass Index (BMI) <36 kg/m2
- Class I-III mammogram within 6 months of Random Periareolar Fine Needle Aspiration (RPFNA); If Class 0 or 4, must be resolved with additional procedures
- If previously on oral contraceptives or hormone replacement, off for 8 weeks or more prior to baseline RPFNA; the exception is low dose vaginal hormones
- Confirmed moderate risk of developing breast cancer
- RPFNA results within study defined range
- Kidney and liver function within study defined range
- Willing and able to comply with study related procedures
Exclusion Criteria:
- Previous biopsy showing evidence of breast cancer
- Have a predisposition to or prior history of thromboembolism, deep venous thrombosis, pulmonary embolism, or stroke
- History of renal or liver disease
- Prior ovarian or endometrial cancer
- Stopped or started hormone replacement within 8 weeks
- Any other condition or intercurrent illness that in the opinion of the investigator makes the woman a poor candidate for RPFNA
- Currently taking or have taken specific medications in the past 6 months
- Participation on any chemoprevention trial within 6 months
- Current illness which would make potential participant unsuitable for enrollment

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
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 |
Responsible Party: | Carol Fabian, MD, Professor, Director Breast Cancer Prevention Center, University of Kansas Medical Center |
ClinicalTrials.gov Identifier: | NCT02729701 |
Other Study ID Numbers: |
STUDY00002440 |
First Posted: | April 6, 2016 Key Record Dates |
Last Update Posted: | February 6, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Results will be published in aggregate; no individual participant data will be made available. |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bazedoxifene Estrogens Estrogens, Conjugated (USP) |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Bone Density Conservation Agents |