A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)|
- 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 ] [ Designated as safety issue: No ]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.
- Number of Participants With Changes in Mammographic Density [ Time Frame: 6 months after treatment of last patient enrolled ] [ Designated as safety issue: No ]The mammograms will be scanned and a validated computer based threshold method will be used to determine the mammographic densities.
|Study Start Date:||August 2006|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
|No Intervention: 1|
Active Comparator: 2
Tamoxifen 20 mg
Active Comparator: 3
Active Comparator: 4
Fulvestrant 500mg IM
500 mg IM
|United States, California|
|Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Dennis Holmes||University of Southern California|