Effect of Denosumab on Cellular Biomarkers in the Human Breast

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

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.

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