NCT03629717

RANKL Inhibition and Breast Tissue Biomarkers

RANKL Inhibition and Breast Tissue Biomarkers in Premenopausal Women With Dense Breasts

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Prevention
• Mammographic Density

Interventions

Type	Name	Description
PROCEDURE	Ultrasound-guided core needle biopsy	Tissue collection for this research proposal will be used for research purposes only and will not inform participant care
DRUG	Denosumab	Denosumab is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL
PROCEDURE	Blood draw	20 mL of fasting whole blood will be collected before denosumab (Day 1) and one month after denosumab administration (day 60 +/- 10 days)
DRUG	Calcium	1200mg daily
DRUG	Vitamin D	800 IU daily

Timeline

• Start date: 2018-06-01
• Primary completion: 2018-12-03
• Completion: 2018-12-03
• First posted: 2018-08-14
• Last updated: 2024-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study