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NCT02099461 · ClinicalTrials.gov registry record · Phase 1
Effect of Denosumab on Cellular Biomarkers in the Human Breast
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
NCT02099461: Completed Phase 1 study, sponsored by Amgen.
NCT02099461 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 82 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02099461, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 82 participants
- Enrollment target
Study Summary
To evaluate whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index.
Primary Outcome
Ki-67 is a marker for cell proliferation. Participants underwent percutaneous core needle breast biopsies on Day 1 (Baseline, prior to treatment) and Day 28. Levels of Ki67 were measured using immunohistochemical staining and digital imaging. The proliferation index was calculated as the percentage of Ki-67 positive terminal ductal lobular unit (TDLU) and duct epithelial cells. The higher the percentage, the higher the rate of epithelial cell proliferation.
Interventions
- DRUG Denosumab
- PROCEDURE Percutaneous core needle breast biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2014-04 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
What the finished NCT02099461 record still lists
NCT02099461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 2 interventions - of which Denosumab is the first listed.
NCT02099461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02099461 about?
NCT02099461 is a clinical study titled "Effect of Denosumab on Cellular Biomarkers in the Human Breast". To evaluate whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index.
What is the current status of trial NCT02099461?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2014-04. Estimated completion is 2014-07.
What interventions are being tested in trial NCT02099461?
The interventions under investigation include: Denosumab (DRUG), Percutaneous core needle breast biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT02099461?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02099461's enrollment target sits among peer trials
82 669th of 2000 higher than 1,330 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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