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NCT00379197 · ClinicalTrials.gov registry record · Phase 2
Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer
A Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT00379197: Clinical Trial Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT00379197 is a Phase 2 study that was terminated before completion, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00379197, a Phase 2 study, was terminated before completion, sponsored by Masonic Cancer Center, University of Minnesota.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Naltrexone may fight breast cancer by blocking the use of estrogen by the tumor cells. Naltrexone may also stop the growth of breast cancer by impairing blood flow to the tumor. PURPOSE: This phase II trial is studying how well naltrexone works in treating women with metastatic breast cancer that is no longer responsive to previous hormone therapy.
Primary Outcome
A response is the number of participants whose tumor demonstrated a decrease in FDG uptake (SUV) by 50% or greater in at least one of the metastatic sites as measured by PET imaging at the end of 4 weeks of treatment compared to baseline.
Interventions
- PROCEDURE PET scan
- DRUG naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2006-07 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
Why NCT00379197 stopped before completion
NCT00379197 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which PET scan is the first listed.
NCT00379197 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00379197 about?
NCT00379197 is a clinical study titled "Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer". RATIONALE: Estrogen can cause the growth of breast cancer cells. Naltrexone may fight breast cancer by blocking the use of estrogen by the tumor cells. Naltrexone may also stop the growth of breast cancer by impairing blood flow to the tumor. PURPOSE: This phase II trial is studying how well naltre...
What is the current status of trial NCT00379197?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2006-07. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00379197?
The interventions under investigation include: PET scan (PROCEDURE), naltrexone (DRUG).
Who is sponsoring clinical trial NCT00379197?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00379197's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 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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