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Study Complete
Sponsor ID
20130349

Effect of Denosumab on Cellular Biomarkers in the Human Breast

Sponsor ID
20130349
Clinicaltrials.gov ID
NCT02099461
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
82
Additional Study Details

Protocol Summary

Primary Outcome Measures

Ratio of post-baseline to baseline Ki-67 index

Timeframe: Approximately 1 month

Secondary Outcome Measures
Not Available

Locations

Location
Status
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Location
Research Site
Cypress, CA, United States, 90630
Status
Recruiting
Location
Research Site
Hollywood, FL, United States, 33024
Status
Recruiting
Location
Research Site
Miami, FL, United States, 33143
Status
Recruiting
Study Info
Age
18 - 45 Years
Condition
  • Healthy Subjects
    • Sex
    Assigned Female at Birth
    Trial Dates
    Apr 2014 - Jul 2014
    Inclusion and Exclusion 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