Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00183963
Status:
TERMINATED
Last Update Posted:
2014-05-22
First Post:
2005-09-12
Brief Title:
A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ DCIS
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ DCIS
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subjects precancerous changes by comparing samples taken before and after receiving Fulvestrant
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 subjects precancerous changes by comparing samples taken before and after receiving Fulvestrant
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None