NCT00183963

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
DRUG	Tamoxifen	20mg
DRUG	Fulvestrant	250mg
DRUG	Fulvestrant	500 mg IM

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2005-09-16
• Last updated: 2014-05-22
• Results posted: 2012-12-06

Locations

1 site across 1 country: United States