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Completed

NCT Number: NCT02729701

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

Up to 61 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duavee

Drug

Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))

Other names: conjugated estrogens/bazedoxifene

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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%

  2. 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.

  3. Change in Body Composition (Total Mass)

    Time frame: Change from Baseline to Month 6

    Assessment by Dual Energy X-ray Absorptivity (DEXA)

  4. Levels of Bazedoxifene in the Blood

    Time frame: Month 6

    Assessment of concentration of bazedoxifene in plasma by High-performance liquid chromatography (HPLC)

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Pfizer

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 6, 2016
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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