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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 is a Phase 2 study that has completed, run by Carol Fabian, MD. The registered enrollment target is 55 participants.
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.
Interventions
- DRUG Placebo
- DRUG Letrozole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2006-10 |
| Est. Completion | 2018-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00579826
The ClinicalTrials.gov registry entry for NCT00579826 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carol Fabian, MD, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00579826 reports 0 study locations.
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.
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