Effect of Denosumab on Cellular Biomarkers in the Human Breast

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteer, Female, Breast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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No treatment

Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.

Group Type OTHER

Percutaneous core needle breast biopsy

Intervention Type PROCEDURE

Denosumab 60 mg

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.

Group Type EXPERIMENTAL

Denosumab

Intervention Type DRUG

Single sucutaneous dose

Percutaneous core needle breast biopsy

Intervention Type PROCEDURE

Denosumab 120 mg

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.

Group Type EXPERIMENTAL

Denosumab

Intervention Type DRUG

Single sucutaneous dose

Percutaneous core needle breast biopsy

Intervention Type PROCEDURE

Interventions

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Denosumab

Single sucutaneous dose

Intervention Type DRUG

Percutaneous core needle breast biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes