Healthy Volunteer, Female, Breast Clinical Trial
Official title:
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
| Verified date | August 2015 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 82 |
| Est. completion date | July 2014 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Cypress | California |
| United States | Research Site | Hollywood | Florida |
| United States | Research Site | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |