Women at risk for development of breast cancer and experiencing vasomotor menopausal symptoms (hot flashes) will be randomized to bazedoxifene (BZA) plus conjugated estrogens (CE) for 6 months versus a wait list control. Two risk factors for development of breast cancer will be studied pre-study and after 6 months: fibroglandular volume (FGV) on mammogram as assessed by Volpara software and proliferation by Ki-67 immunocytochemistry in benign breast tissue acquired by random periareolar fine needle aspiration (RPFNA). Change in biomarkers will be compared between groups.
Women at risk for development of breast cancer and experiencing vasomotor menopausal symptoms (hot flashes) will be randomized to bazedoxifene (BZA) plus conjugated estrogens (CE) for 6 months versus a wait list control. Two risk factors for development of breast cancer will be studied pre-study and after 6 months: fibroglandular volume (FGV) on mammogram as assessed by Volpara software and proliferation by Ki-67 immunocytochemistry in benign breast tissue acquired by random periareolar fine needle aspiration (RPFNA). Change in biomarkers will be compared between groups.
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
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City of Hope Medical Center, Duarte, California, United States, 91010
University of California San Francisco, San Francisco, California, United States, 94115
Northwestern Medical Center, Chicago, Illinois, United States, 60601
University of Kansas Medical Center, Kansas City, Kansas, United States, 66160
Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
45 Years to 64 Years
FEMALE
Yes
University of Kansas Medical Center,
Carol J Fabian, MD, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center
2027-07-31