RANKL Inhibition and Mammographic Breast Density

Study acronym: TRIDENT
StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Results posted: Oct 9, 2026
    • Study completion pushed from Aug 31, 2026 to Sep 30, 2027
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 9 to 2
    • Collaborator revised
  2. Primary completion date: Sep 25, 2025 to Sep 17, 2025v16
  3. Primary completion date changed from estimate of Aug 31, 2025 to Sep 25, 2025v15
  4. Re-verified, no change to tracked fieldsv14
  5. Secondary endpoints: 10 to 9v13
Show 11 earlier versionsHide 11 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v12
  2. Secondary endpoints: 2 to 10v11
  3. Re-verified, no change to tracked fieldsv10
  4. Site contact updatedv9
  5. Eligibility criteria expanded, about 23 words
    • Site contact updated
    v8
  6. Site contact updatedv7
  7. Eligibility criteria shortened, about 21 wordsv6
  8. Site contact updated
    • Eligibility criteria shortened, about 1 word
    v5
  9. Eligibility criteria shortened, about 49 wordsv4
  10. Eligibility criteria expanded, about 13 wordsv3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 31, 2019 to Aug 27, 2019
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04067726
Lead Sponsor Washington University School of Medicine
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Dense Breasts
Related terms Breast Neoplasms
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov