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

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas Medical Center
• Collaborator: Pfizer
• Treatments: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)

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