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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 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. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04067726
The ClinicalTrials.gov registry entry for NCT04067726 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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