Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation

March 8, 2022 updated by: Carol Fabian, MD, University of Kansas Medical Center

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

The purpose of this study is to learn whether daily use of Duavee® is accepted and tolerated by peri- and post-menopausal women at moderate risk for development of breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Duavee® is tissue specific estrogen complex of bazedoxifene plus conjugated estrogen which is FDA approved for relief of menopausal symptoms and prevention of osteoporosis in women with a uterus who have not been diagnosed with estrogen dependent neoplasia. The overall purpose of this research is to demonstrate in a preliminary fashion that despite reduction in menopausal symptoms, (Duavee®) does not increase and may decrease proliferation in benign breast tissue in a cohort of peri- or post-menopausal women at moderately increased risk for breast cancer. If this pilot shows rapid accrual, good retention, and lack of significant increase in the risk biomarker Ki-67 in benign breast tissue, a larger prevention trial is envisioned

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University Of Kansas Medical Center
      • Westwood, Kansas, United States, 66208
        • University of Kansas Medical Center Breast Cancer Prevention Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 61 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Duavee
Participants will be asked to take Duavee for 6 months while on the study.
Drug: Duavee
Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))
Other Names:
  • conjugated estrogens/bazedoxifene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Ki-67
Time Frame: Change from Baseline to Month 6

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%
Change from Baseline to Month 6
Change in Fibroglandular Volume (FGV)
Time Frame: Change from Baseline to Month 6
Assessment of mammograms for percent of breast defined as FGV by Volpara automated assessment.
Change from Baseline to Month 6
Change in Body Composition (Total Mass)
Time Frame: Change from Baseline to Month 6
Assessment by Dual Energy X-ray Absorptivity (DEXA)
Change from Baseline to Month 6
Levels of Bazedoxifene in the Blood
Time Frame: Month 6
Assessment of concentration of bazedoxifene in plasma by High-performance liquid chromatography (HPLC)
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

Pfizer

Investigators

  • Principal Investigator: Carol Fabian, MD, University Of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimate)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002440

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Results will be published in aggregate; no individual participant data will be made available.

IPD Sharing Time Frame

2021-2022

IPD Sharing Access Criteria

upon request.

IPD Sharing Supporting Information Type

  • Study Protocol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Duavee

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe