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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729701
• Other study ID #: STUDY00002440
• Status: Completed
• Phase: Phase 2
• Start date: May 2016
• Est. completion date: June 2019

Study information

• Verified date: March 2021
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 61 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Kansas Medical Center Breast Cancer Prevention Center	Westwood	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fabian CJ, Nye L, Powers KR, Nydegger JL, Kreutzjans AL, Phillips TA, Metheny T, Winblad O, Zalles CM, Hagan CR, Goodman ML, Gajewski BJ, Koestler DC, Chalise P, Kimler BF. Effect of Bazedoxifene and Conjugated Estrogen (Duavee) on Breast Cancer Risk Biom — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility for a Larger Trial	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	Change in Ki-67	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
Secondary	Change in Fibroglandular Volume (FGV)	Assessment of mammograms for percent of breast defined as FGV by Volpara automated assessment.	Change from Baseline to Month 6
Secondary	Change in Body Composition (Total Mass)	Assessment by Dual Energy X-ray Absorptivity (DEXA)	Change from Baseline to Month 6
Secondary	Levels of Bazedoxifene in the Blood	Assessment of concentration of bazedoxifene in plasma by High-performance liquid chromatography (HPLC)	Month 6