drugset / Trial / NCT03629717

RANKL Inhibition and Breast Tissue Biomarkers

NCT03629717

Phase 0 Completed 10 enrolled Washington University School of Medicine
NaSingle-groupOpen-labelPrevention

Summary

A robust knowledge of how to reduce breast density could play a key role in breast cancer prevention in premenopausal women, but viable preventative targets to reduce breast density-associated breast cancer risk are yet to be developed. The investigators propose to investigate the effect of RANKL inhibition with denosumab on breast tissue markers in high-risk premenopausal women with dense breasts. Study findings could provide robust evidence to move forward with a clinical trial targeting RANKL inhibition in premenopausal breast cancer prevention.

Timeline

Start
2018-06-01
Primary completion
2018-12-03
Completion
2018-12-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 60 mg Subcutaneous
Background Calcium carbonate Other / unclassified 1200 mg
Background Vitamin D Other / unclassified 800 iu