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RANKL Inhibition and Breast Tissue Biomarkers

NCT03629717 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-10-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Adetunji T Toriola, M.D., Ph.D., MPH · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2018-12-03
Completion
2018-12-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03629717 on ClinicalTrials.gov