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Clinical Trial NU 15B06

Title
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.
Principal Investigator
Swati Kulkarni
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic
  • Protocol No:.NU 15B06
Purpose
The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (DuaveeĀ®) causes any changes in the proliferation markers within the breast tissue of the study subjects
Overview
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.
Eligibility
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.
Description of Treatment
After the screening visit, signing of informed consent form and baseline tests, the participants will be randomized to either receive the study drug or the placebo control to be taken orally.
Contact
Clinical Trials Recruitment Nurse
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 19-Oct-17 07:34 AM

 

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