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Study of Oral Drug Bazedoxifene Plus Conjugated Estrogens for Treating Hot Flashes in Women at High Risk for Breast Cancer

https://www.facingourrisk.org/research-clinical-trials/study/218/bazedoxifene-plus-conjugated-estrogens-for-hot-flashes-in-women-at-high-risk-for-breast-cancer

Clinicaltrials.gov identifier:
NCT04821141 (https://clinicaltrials.gov/show/NCT04821141)

Quality of Life
Women at high risk for breast cancer due to ATM, CDH1, CHEK2, NBN, NF1, PALB2, PTEN, STK11, P53 or PTEN mutation who have hot flashes

Study Contact Information:

Amy L Kreutzjans, [email protected]
Bruce F Kimler, PhD: 913-205-6382: [email protected]   
Contact: Carol J Fabian, MD: 913-588-7791: [email protected]   


About the Study

Bazedoxifene is a type of drug known as a selective estrogen receptor modulator (SERM) that is similar to the drug tamoxifen. A combination of bazedoxifene and estrogen taken orally has been used to control hot flashes. This study will look at hot flashes, quality of life and breast changes in high-risk women taking the combination of drugs compared with women not taking the combination of drugs. The study will involve breast imaging, blood tests and small sampling of breast tissue at the beginning and end of the study. 

What the Study Involves

Participants will be selected at random and assigned to one of two groups. 

Participants will be asked to undergo the following tests at baseline and 6 months: 

Study Sites

California

Illinois

Kansas

Massachusetts


This Study is Open To:

Women, ages 45-60, who meet the following may be eligible:

Contact study team for full eligibility and ineligibility.

This Study is Not Open To:

People with the following may not participate: 

Medications

Willing to comply with study procedures.

Contact study team for full eligibility and ineligibility. 


About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.