Clinical trial NCT02729701: Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2016-04-06
Enrollment: 28
Sex: FEMALE
Maximum age (years): 61
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility for a Larger Trial
timeFrame: 6 Months
Secondary outcomes:
measure: Change in Ki-67
timeFrame: Change from Baseline to Month 6
measure: Change in Fibroglandular Volume (FGV)
timeFrame: Change from Baseline to Month 6
measure: Change in Body Composition (Total Mass)
timeFrame: Change from Baseline to Month 6
measure: Levels of Bazedoxifene in the Blood
timeFrame: Month 6
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Westwood
country: United States
facility: University of Kansas Medical Center Breast Cancer Prevention Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Carol Fabian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.