A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)
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|ClinicalTrials.gov Identifier: NCT00183963|
Recruitment Status : Terminated (Insufficient accrual)
First Posted : September 16, 2005
Results First Posted : December 6, 2012
Last Update Posted : May 22, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Carcinoma||Drug: Tamoxifen Drug: Fulvestrant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
|No Intervention: 1|
Active Comparator: 2
Tamoxifen 20 mg
Active Comparator: 3
Active Comparator: 4
Fulvestrant 500mg IM
500 mg IM
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183963
|United States, California|
|Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Dennis Holmes||University of Southern California|