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NCT00183963 · ClinicalTrials.gov registry record · Phase 2
A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)
A Phase 2 study, sponsored by University of Southern California.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT00183963: Clinical Trial Phase 2 study, sponsored by University of Southern California.
NCT00183963 is a Phase 2 study that was terminated before completion, run by University of Southern California. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00183963, a Phase 2 study, was terminated before completion, sponsored by University of Southern California.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Tamoxifen
- DRUG Fulvestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2006-08 |
| Est. Completion | 2008-06 |
| Phase | Phase 2 |
Why NCT00183963 stopped before completion
NCT00183963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Tamoxifen is the first listed.
NCT00183963 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00183963 about?
NCT00183963 is a clinical study titled "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 a...
What is the current status of trial NCT00183963?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2006-08. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00183963?
The interventions under investigation include: Tamoxifen (DRUG), Fulvestrant (DRUG).
Who is sponsoring clinical trial NCT00183963?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00183963's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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