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ACTIVE NOT RECRUITING
NCT04067726
PHASE2

RANKL Inhibition and Mammographic Breast Density

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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.

Official title: Randomized Clinical Trial of RANKL Inhibition With Denosumab on Mammographic Density in Premenopausal Women With Dense Breasts (TRIDENT)

Key Details

Gender

FEMALE

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2019-08-27

Completion Date

2026-08-31

Last Updated

2026-03-31

Healthy Volunteers

No

Conditions

Interventions

DRUG

Denosumab

Denosumab is commercially available and will be provided at no cost to participants.

DRUG

Placebo

Placebo will be made available as 1 mL sterile, non-pyrogenic water solution in a single-use prefilled syringe.

DRUG

Calcium

-Participants will be instructed to take calcium (at least 500 mg) daily for 12 months between baseline examination and 12- month mammographic breast density examination.

DRUG

Vitamin D3

Participants will be instructed to take vitamin D3 (at least 400 IU) supplements daily for 12 months between baseline examination and 12- month mammographic breast density examination.

PROCEDURE

Core needle biopsy

Baseline and 12 months

PROCEDURE

Blood draw

Baseline and 12 months

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States