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.
A Phase II Randomized-double Blinded Placebo Controlled Window of Opportunity Trial Comparing Conjugated Estrogens/Bazedoxifene to Placebo in Women Undergoing Surgical Therapy for Ductal Carcinoma in Situ (DCIS)
PRIMARY OBJECTIVES; I. To assess whether CE/BZA (conjugated estrogens/bazedoxifene) for 28 days +/- 7 days reduces proliferation as measured by marker of proliferation Ki-67 (Ki-67) protein expression.
I. To assess whether CE/BZA alters markers associated with progression to invasive cancer (abrogated response to cellular stress [ARCS] signature) in postmenopausal women with ductal carcinoma in situ [DCIS] compared to placebo).
II. To assess changes in quality of life (QOL) using the Menopause-specific Quality of Life (MENQOL) questionnaire at baseline and at the conclusion of the intervention in women with DCIS treated with CE/BZA compared to placebo.
I. To assess changes in the stromal marker cluster of differentiation (CD)36, in women with DCIS with CE/BZA compared to placebo.
II. To assess changes in hormone receptor (estrogen receptor alpha [ERa] and progesterone receptor [PR]) expression in women with DCIS treated with CE/BZA compared to placebo.
III. To assess changes in global gene expression profiling (ribonucleic acid [RNA] sequencing) in women with DCIS treated with CE/BZA compared to placebo.
IV. To identify possible polymorphisms that may affect the metabolism of CE/BZA.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive conjugated estrogens/bazedoxifene orally (PO) once daily (QD) on days 1-28 in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
ARM II: Patients receive placebo PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
After completion of study treatment, patients are followed up for 30 days.
Ductal Breast Carcinoma In Situ Postmenopausal Estrogens Estrogens, Conjugated (USP) Bazedoxifene
Open to females ages 18 years to 75 years
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02694809.
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