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NCT00579826 · ClinicalTrials.gov registry record · Phase 2
Study of Breast Cancer Prevention by Letrozole in High Risk Women
A Phase 2 study, sponsored by Carol Fabian, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT00579826: Completed Phase 2 study, sponsored by Carol Fabian, MD.
NCT00579826 is a Phase 2 study that has completed, run by Carol Fabian, MD. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00579826, a Phase 2 study, has completed, sponsored by Carol Fabian, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
This is a multi-institution double-blind placebo-controlled trial whose main objective is to determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by Ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have random periareolar fine needle aspiration (RPFNA) evidence of hyperplasia with atypia or borderline atypia, and a minimum Ki-67 of \>1.5%. The primary hypothesis is that proliferation and expression of other estrogen response genes will be favorably modulated by six months of letrozole relative to placebo without substantially increasing hot flashes or worsening overall quality of life.
Primary Outcome
Change in proliferation rate (percent positively stained cells for Ki-67 antigen by immunocytochemistry) in benign breast epithelial cells acquired by random periareolar fine needle aspiration (RPFNA) from women at high risk for the development of breast cancer.
Interventions
- DRUG Placebo
- DRUG Letrozole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2006-10 |
| Est. Completion | 2018-08 |
| Phase | Phase 2 |
What the finished NCT00579826 record still lists
NCT00579826 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00579826 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00579826 about?
NCT00579826 is a clinical study titled "Study of Breast Cancer Prevention by Letrozole in High Risk Women". This is a multi-institution double-blind placebo-controlled trial whose main objective is to determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by Ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have random periareolar fine need...
What is the current status of trial NCT00579826?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2006-10. Estimated completion is 2018-08.
What interventions are being tested in trial NCT00579826?
The interventions under investigation include: Placebo (DRUG), Letrozole (DRUG).
Who is sponsoring clinical trial NCT00579826?
This trial is sponsored by Carol Fabian, MD, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00579826's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 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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