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 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