Completed

NCT Number: NCT02099461

Effect of Denosumab on Cellular Biomarkers in the Human Breast

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.

Completed

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Key information

Conditions

Healthy Volunteer, Female, Breast

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Cypress, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Willing to use, in combination with her partner, 2 non-hormonal methods of effective contraception or practice sexual abstinence. Subjects who are surgically sterile (eg, history of hysterectomy) or whose sexual partner is sterile (eg, history of vasectomy) are not required to use contraceptive measures
Laboratory tests are within clinically acceptable range
Clinically acceptable physical exam and no history or evidence of any clinically significant medical disorder that would pose a risk to subject safety or interfere with study evaluations or procedures.

Exclusion criteria

Female subject with a prior history of breast cancer; breast implant in the breast to be biopsied; Known history of fibrocystic breast disease
Subject is unable or unwilling to provide breast biopsy tissue from the upper outer quadrant of her breast
Pregnant or plans to become pregnant while exposed to investigational product
Lactating/breastfeeding or plans to breastfeed while exposed to investigational product
Recent use of any non-approved medications or devices
Uncontrolled thyroid disorder
Significant dental/oral disease
Planned invasive dental procedures
Positive urine screen for alcohol and/or drugs

Treatment and study plan

Denosumab

Drug

Single sucutaneous dose

Percutaneous core needle breast biopsy

Procedure

Primary outcomes

Log Ratio of Post-baseline to Baseline Ki-67 Index in Mammary Epithelial Cells

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Randomized, Stratified, Open-label, No-treatment-controlled, Parallel Group, Multicenter Phase 1 Trial to Evaluate the Effect of Denosumab on Cellular Proliferation in the Human Breast

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Mar 31, 2014
Registry last updated: Sep 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.