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NCT04067726 · ClinicalTrials.gov registry record · Phase 2
RANKL Inhibition and Mammographic Breast Density
A Phase 2 study of Dense Breasts, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 2
- Development phase
- 210
- Enrollment target
- 1
- Study location
NCT04067726: Active Phase 2 study of Dense Breasts, sponsored by Washington University School of Medicine.
NCT04067726 is a Phase 2 study of Dense Breasts that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 210 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04067726, a Phase 2 study of Dense Breasts, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 210 participants
- Enrollment target
- 1
- Study location
Study Summary
Data supporting a role for RANKL signaling in mammographic density and breast cancer development has begun to emerge, but clinical trial data providing definitive evidence that would allow the adoption of RANKL inhibition in primary breast cancer prevention are not yet available. The hypothesis is that RANKL inhibition with denosumab will decrease mammographic density in high-risk premenopausal women with dense breasts. To address this, the investigators have developed this clinical trial to quantify the impact of RANKL inhibition on mammographic density in high-risk premenopausal women with dense breasts and to determine the effect of RANKL inhibition on markers of proliferation and biomarkers of breast cancer risk. Successful demonstration that RANKL inhibition reduces mammographic density could open up additional approaches to primary breast cancer prevention in high-risk premenopausal women, who do not have dominant genetic predisposition.
Primary Outcome
-The investigators will use volumetric percent density (VPD) as the primary mammographic breast density measure.
Conditions Studied
Interventions
- DRUG Placebo
- PROCEDURE Core needle biopsy
- DRUG Denosumab
- DRUG Vitamin D3
- DRUG Calcium
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2019-08-27 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 2 |
What the registry record for NCT04067726 still lists
NCT04067726 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% higher).
The record links to 1 condition, with Dense Breasts appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT04067726 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04067726 about?
NCT04067726 is a clinical study titled "RANKL Inhibition and Mammographic Breast Density". Data supporting a role for RANKL signaling in mammographic density and breast cancer development has begun to emerge, but clinical trial data providing definitive evidence that would allow the adoption of RANKL inhibition in primary breast cancer prevention are not yet available. The hypothesis is t...
What is the current status of trial NCT04067726?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 210 participants. The study started on 2019-08-27. Estimated completion is 2026-08-31.
What conditions does trial NCT04067726 study?
This clinical trial studies the following conditions: Dense Breasts.
What interventions are being tested in trial NCT04067726?
The interventions under investigation include: Placebo (DRUG), Core needle biopsy (PROCEDURE), Denosumab (DRUG), Vitamin D3 (DRUG), Calcium (DRUG).
Who is sponsoring clinical trial NCT04067726?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04067726 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04067726's enrollment target sits among peer trials
210 290th of 2000 higher than 1,707 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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