Effect of Denosumab on Cellular Biomarkers in the Human Breast

Amgen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer, Female, Breast

Treatments: Procedure: Percutaneous core needle breast biopsy; Drug: Denosumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02099461

20130349

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 3 patient groups

No treatment

Other group

Description:

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

Treatment:

Procedure: Percutaneous core needle breast biopsy

Denosumab 60 mg

Experimental group

Description:

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.

Treatment:

Procedure: Percutaneous core needle breast biopsy

Drug: Denosumab

Denosumab 120 mg

Experimental group

Description:

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.

Treatment:

Procedure: Percutaneous core needle breast biopsy

Drug: Denosumab