AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer

Study Overview
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Brief Summary
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The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer

Conditions
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Breast Cancer, Low Bone Mineral Density, Osteopenia

Intervention / Treatment
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* Drug: Placebo
* Drug: AMG 162 / Denosumab


Participation Criteria
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Eligibility Criteria
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Histologically or cytologically confirmed adenocarcinoma of the breast Subjects with early stage disease who are estrogen receptor positive and who have completed their treatment pathway (surgery, chemo-therapy, radiation, and/or hormone therapy) and are currently on or will initiate aromatase inhibitor therapy, and are expected to stay on aromatase inhibitor therapy for the duration of the 24-month study All treatment pathway must be completed ≥ 4 weeks prior to study entry, and all acute toxic effect of any above therapy must be resolved to ≤ Grade 1 by National Cancer Institution (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Female > 18 years of age ECOG Performance status 0 and 1 Lumbar spine, total hip or femoral neck BMD equivalent to a t-score classification of -1.0 to -2.5 Subject is willing and able to provide signed consent before any study-specific procedure Other criteria also apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 162 / Denosumab<br> | Drug: AMG 162 / Denosumab<br>* 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 6 months | 
| Total Hip Bone Mineral Density Percent Change From Baseline at Month 12 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 12 months | 
| Total Hip Bone Mineral Density Percent Change From Baseline at Month 6 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 6 months | 
| Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 12 months | 
| Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Bone loss associated with Aromatase Inhibitor therapy (AIT) for non-metastatic BC, osteopenia, Low bone density