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

University of Kansas

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Duavee

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02729701

STUDY00002440

Details and patient eligibility

About

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.

Full 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

Enrollment

28 patients

Sex

Female

Ages

Under 61 years old

Volunteers

No Healthy Volunteers

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