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



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 61
Updated:2/8/2019
Start Date:April 2016
End Date:June 2019

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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

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
We found this trial at
2
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Westwood, KS
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Kansas City, KS
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