Breast Carcinoma Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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