Effect of Denosumab on Cellular Biomarkers in the Human Breast

Phase 1

Completed

• Conditions: Healthy Volunteer, Female, Breast
• Interventions: Drug: Denosumab; Procedure: Percutaneous core needle breast biopsy

• Registration Number: NCT02099461
• Lead Sponsor: Amgen

Brief Summary

To evaluate whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-31
• Study Start: 2014-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2015-06-22
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-24
• Last Update Submitted: 2015-08-24
• Results First Posted: 2015-09-24
• Last Update Posted: 2015-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Denosumab 60 mg	Percutaneous core needle breast biopsy	Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 (prior to study treatment) and Day 28.
No treatment	Percutaneous core needle breast biopsy	Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
Denosumab 120 mg	Percutaneous core needle breast biopsy	Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 (prior to study treatment) and Day 28.
Denosumab 120 mg	Denosumab	Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 (prior to study treatment) and Day 28.
Denosumab 60 mg	Denosumab	Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 (prior to study treatment) and Day 28.

Primary Outcome Measures

Name	Time	Method
Log Ratio of Post-baseline to Baseline Ki-67 Index in Mammary Epithelial Cells	Baseline and Day 28	Ki-67 is a marker for cell proliferation. Participants underwent percutaneous core needle breast biopsies on Day 1 (Baseline, prior to treatment) and Day 28. Levels of Ki67 were measured using immunohistochemical staining and digital imaging. The proliferation index was calculated as the percentage of Ki-67 positive terminal ductal lobular unit (TDLU) and duct epithelial cells. The higher the percentage, the higher the rate of epithelial cell proliferation.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Miami, Florida, United States