Phase 1 N=82 Randomized Basic Science

Effect of Denosumab on Cellular Biomarkers in the Human Breast

Healthy Volunteer, Female, Breast

Bottom Line

View on ClinicalTrials.gov: NCT02099461 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2015

Primary outcome: Primary: Log Ratio of Post-baseline to Baseline Ki-67 Index in Mammary Epithelial Cells — 0.084; -0.100; -0.081 log ratio — p=0.2966

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Denosumab (Drug); Percutaneous core needle breast biopsy (Procedure)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Amgen
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Log Ratio of Post-baseline to Baseline Ki-67 Index in Mammary Epithelial Cells	0.084; -0.100; -0.081	0.2966

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02099461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.