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A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ.
The main purpose of this study is to determine if taking the study drug, conjugated
estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the
breast tissue of the study subjects. The study drug is approved by the US Food and Drug
Administration in healthy postmenopausal women to treat certain symptoms of menopause such
as hot flashes. Since it is not approved in women with DCIS, its use in this study is
experimental. This study will also look at whether taking the study drug causes any
significant or undesirable side effects in women with DCIS. The researchers hope that this
study will help them determine if taking the study drug is safe in women taking DCIS and if
it can possibly reduce the risk of developing breast cancer in women with DCIS.
Some of the eligibility criteria include: - Participants must be postmenopausal women with newly diagnosed DCIS scheduled to undergo surgical therapy. - Patients must be able to swallow the oral medication. - Patients must be able to understand and the willing to sign a written informed consent document and comply to all procedures. Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
NCT02694809 STU00202100 |