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

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ClinicalTrials.gov Identifier: NCT02729701
Recruitment Status : Recruiting
First Posted : April 6, 2016
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center

March 21, 2016
April 6, 2016
January 17, 2018
April 2016
March 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02729701 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation
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.
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
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Breast Cancer
Drug: Duavee
Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))
Other Name: conjugated estrogens/bazedoxifene
Experimental: Duavee
Participants will be asked to take Duavee for 6 months while on the study.
Intervention: Drug: Duavee
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Same as current
May 2019
March 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
up to 61 Years   (Child, Adult)
No
Contact: Bruce Kimler, PhD (913) 588-4523 bkimler@kumc.edu
United States
 
 
NCT02729701
STUDY00002440
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: Results will be published in aggregate; no individual participant data will be made available.
Carol Fabian, MD, University of Kansas Medical Center
University of Kansas Medical Center
Pfizer
Principal Investigator: Carol Fabian, MD University of Kansas Medical Center
University of Kansas Medical Center
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP