NCT02099461

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 24, 2015

Completed
Last Updated

September 24, 2015

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

February 25, 2014

Results QC Date

June 22, 2015

Last Update Submit

August 24, 2015

Conditions

Healthy Volunteer, Female, Breast

Outcome Measures

Primary Outcomes (1)

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

    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.

    Baseline and Day 28

Study Arms (3)

No treatment

OTHER

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

Procedure: Percutaneous core needle breast biopsy

Denosumab 60 mg

EXPERIMENTAL

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.

Drug: DenosumabProcedure: Percutaneous core needle breast biopsy

Denosumab 120 mg

EXPERIMENTAL

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.

Drug: DenosumabProcedure: Percutaneous core needle breast biopsy

Interventions

DenosumabDRUG

Single sucutaneous dose

Denosumab 120 mgDenosumab 60 mg
Percutaneous core needle breast biopsyPROCEDURE
Denosumab 120 mgDenosumab 60 mgNo treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Cypress, California, 90630, United States

Location

Research Site

Hollywood, Florida, 33024, United States

Location

Research Site

Miami, Florida, 33143, United States

Location

Related Links

MeSH Terms

Interventions

Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2014

First Posted

March 31, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

September 24, 2015

Results First Posted

September 24, 2015

Record last verified: 2015-08

Locations

US(3)