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

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