Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Menopause

All Drugs and Chemicals

Bone Density Conservation Agents

Estrogens, Conjugated (USP)

Estrogens

Bazedoxifene

Hormones

Hormone Antagonists

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Participants will be asked to take Duavee for 6 months while on the study.

Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))

Duavee

Carol Fabian, MD

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

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

Results will be published in aggregate; no individual participant data will be made available.

Outcome will be based on three separate factors used collectively to determine feasibility of the study and consideration of a subsequent larger trial. These are accrual rate (ability to accrue target number of subjects in a timely manner), dropout rate (frequency of subjects who are compliant and complete the intervention) and change in Ki-67 (increase vs decrease in percent of cells stained positive in the majority of subjects). Should accrual be inadequate or too slow; or if retention is too low; then a decision would be made not to proceed to a larger trial. Also, if there is evidence of an increase in proliferation (Ki-67) then no further studies would be planned.

Assessment by immunocytochemistry of the percent of breast epithelial cells staining positive.

Per protocol, restricted to those subjects with baseline Ki-67 positivity \>1.0% but \< 4%

Assessment of mammograms for percent of breast defined as FGV by Volpara automated assessment.

Assessment by Dual Energy X-ray Absorptivity (DEXA)

Assessment of concentration of bazedoxifene in plasma by High-performance liquid chromatography (HPLC)

Pfizer

University of Kansas Medical Center

Professor, Director Breast Cancer Prevention Center

Participants asked to take Duavee for 6 months while on the study.

Duavee: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))

Participants will be asked to take Duavee for 6 months while on the study.

Duavee: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Proliferation Index (percent of breast epithelial cells that are Ki-67 immunocytochemistry positive)

total fibroglandular volume for both breasts derived from assessment of mammograms using the Volpara(R) software program.

Fibroglandular Volume (FGV)

Pfizer, Inc. provided the study agent Duavee but was otherwise not involved in the design, conduct, or analysis of the trial.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation	NCT02729701	Breast Cancer	Duavee	- 61 Years	University of Kansas Medical Center
Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation	NCT02729701	Breast Cancer	Duavee	- 61 Years	University of Kansas Medical Center

Spots Global Cancer Trial Database for duavee

Every month we try and update this database with for duavee cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for duavee

Every month we try and update this database with for duavee cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for duavee cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.