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

NCT02729701 | Completed Phase 2 Results DMC

• 1 other identifier: STUDY00002440
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Ki-67

  Change from Baseline to Month 6

• Change in Fibroglandular Volume (FGV)

  Change from Baseline to Month 6

• Change in Body Composition (Total Mass)

  Change from Baseline to Month 6

• Levels of Bazedoxifene in the Blood

  Month 6

Study Arms (1)

Duavee

EXPERIMENTAL

Participants will be asked to take Duavee for 6 months while on the study.

Drug: Duavee

Interventions

Duavee DRUG

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

Also known as: conjugated estrogens/bazedoxifene

Duavee

Eligibility Criteria

• Age: Up to 61 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Pfizer: collaborator

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas Medical Center Breast Cancer Prevention Center

Westwood, Kansas, 66208, United States

Location

Related 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 Biomarkers in High-Risk Women: A Pilot Study. Cancer Prev Res (Phila). 2019 Oct;12(10):711-720. doi: 10.1158/1940-6207.CAPR-19-0315. Epub 2019 Aug 16.

  PMID: 31420361 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Estrogens, Conjugated (USP); bazedoxifene

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Pfizer, Inc. provided the study agent Duavee but was otherwise not involved in the design, conduct, or analysis of the trial.

Results Point of Contact

• Title: Bruce F. Kimler, Ph.D.
• Organization: University of Kansas Medical Center

bkimler@kumc.edu

913-205-6382

Study Officials

• Carol Fabian, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director Breast Cancer Prevention Center

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 6, 2016
• Study Start: May 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: March 9, 2022
• Results First Posted: March 9, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2021-2022
• Access Criteria: upon request.

Locations

US (2)