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.
Phase:
Phase 2
Details
Lead Sponsor:
Washington University School of Medicine
Collaborator:
National Institutes of Health (NIH)
Treatments:
Calcium Calcium, Dietary Cholecalciferol Denosumab Ergocalciferols Vitamin D Vitamins