Clinical Trial: Conjugated Estrogens/Bazedoxifene in Treating Patients With Ductal Carcinoma in Situ Undergoing Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief Summary: 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.

Detailed Summary:

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.

SECONDARY OBJECTIVES:

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.

TERTIARY OBJECTIVES:

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 unaccepta
Sponsor: Northwestern University

Current Primary Outcome: Change in Ki-67 protein expression [ Time Frame: Baseline to 4 weeks ]

Evaluating if CE/BZA reduces proliferation as measured by Ki-67 protein expression. Change in Ki-67 between baseline and end of the intervention (4 weeks) will be measured.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in ARCS signature [ Time Frame: Baseline to 4 weeks ]
    To assess whether CE/BZA alters markers associated with progression to invasive cancer (ARCS signature) in postmenopausal women with DCIS compared to placebo.
  • Change in QOL using MENQOL questionnaire [ Time Frame: Baseline to 4 weeks ]
    The difference in the MENQOL answers between baseline and end of the intervention will be evaluated.


Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: February 24, 2016
Date Started: January 2017
Date Completion:
Last Updated: January 3, 2017
Last Verified: January 2017