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NCT00001378 · ClinicalTrials.gov registry record · Phase 1
A Pilot Trial of Tamoxifen and 4-HPR (4-N-Hydroxyphenyl Retinamide) in Persons at High Risk for Developing Breast Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT00001378: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00001378 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001378, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is a pilot, chemoprevention study. Patients receive fenretinide daily for 25 of every 28 days for 4 months and tamoxifen daily for 23 months, beginning the second month of fenretinide. Patients are removed from study for unacceptable toxicity, the development of invasive breast cancer, or for dysfunctional uterine bleeding.
Interventions
- DRUG fenretinide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 1994-01 |
| Est. Completion | 2000-11 |
| Phase | Phase 1 |
What the finished NCT00001378 record still lists
NCT00001378 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 1 intervention - of which fenretinide is the first listed.
NCT00001378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001378 about?
NCT00001378 is a clinical study titled "A Pilot Trial of Tamoxifen and 4-HPR (4-N-Hydroxyphenyl Retinamide) in Persons at High Risk for Developing Breast Cancer". This is a pilot, chemoprevention study. Patients receive fenretinide daily for 25 of every 28 days for 4 months and tamoxifen daily for 23 months, beginning the second month of fenretinide. Patients are removed from study for unacceptable toxicity, the development of invasive breast cancer, or for ...
What is the current status of trial NCT00001378?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 1994-01. Estimated completion is 2000-11.
What interventions are being tested in trial NCT00001378?
The interventions under investigation include: fenretinide (DRUG).
Who is sponsoring clinical trial NCT00001378?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001378's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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