Clinical Trial: A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)

Brief Summary:

The subjects in this trial have been diagnosed as having a pre-cancerous disease of the breast called ductal carcinoma in situ (DCIS). This condition is associated with the development of breast cancer in up to 50% of cases.

The subjects are being asked to participate in this research study. They are being offered voluntary admission to this study to test the effects of a new investigational drug called Fulvestrant (Faslodex). This drug is approved by the United States Food and Drug Administration (FDA) for the treatment of advanced breast cancer but has not been approved for the treatment of DCIS. However, the FDA has given permission for the drug to be tested in this study. The purpose of this study is to find out if Fulvestrant has any effect on the subject's precancerous changes by comparing samples taken before and after receiving Fulvestrant.


Detailed Summary:
Sponsor: University of Southern California

Current Primary Outcome: Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment [ Time Frame: 6 months after treatment of last patient enrolled ]

Molecular measures of effect will be measured in tissue obtained at baseline biopsy (paraffin specimen) and on surgical specimen obtained at end of 3 weeks of treatment.


Original Primary Outcome:

Current Secondary Outcome: Number of Participants With Changes in Mammographic Density [ Time Frame: 6 months after treatment of last patient enrolled ]

The mammograms will be scanned and a validated computer based threshold method will be used to determine the mammographic densities.


Original Secondary Outcome:

Information By: University of Southern California

Dates:
Date Received: September 12, 2005
Date Started: August 2006
Date Completion:
Last Updated: May 20, 2014
Last Verified: May 2014