Back to resultsAMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
Primary Purpose
Breast Cancer, Low Bone Mineral Density, Osteopenia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
AMG 162 / Denosumab
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Bone loss associated with Aromatase Inhibitor therapy (AIT) for non-metastatic BC, osteopenia, Low bone density
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AMG 162 / Denosumab
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Secondary Outcome Measures
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 6
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00089661
Brief Title
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2004 (Actual)
Primary Completion Date
May 11, 2007 (Actual)
Study Completion Date
May 27, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Low Bone Mineral Density, Osteopenia
Keywords
Breast Cancer, Bone loss associated with Aromatase Inhibitor therapy (AIT) for non-metastatic BC, osteopenia, Low bone density
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
252 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMG 162 / Denosumab
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months
Intervention Type
Drug
Intervention Name(s)
AMG 162 / Denosumab
Intervention Description
60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months
Primary Outcome Measure Information:
Title
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Description
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6
Description
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time Frame
6 months
Title
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
Description
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time Frame
12 months
Title
Total Hip Bone Mineral Density Percent Change From Baseline at Month 6
Description
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time Frame
6 months
Title
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12
Description
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time Frame
12 months
Title
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6
Description
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19308727
Citation
Ellis GK, Bone HG, Chlebowski R, Paul D, Spadafora S, Fan M, Kim D. Effect of denosumab on bone mineral density in women receiving adjuvant aromatase inhibitors for non-metastatic breast cancer: subgroup analyses of a phase 3 study. Breast Cancer Res Treat. 2009 Nov;118(1):81-7. doi: 10.1007/s10549-009-0352-y. Epub 2009 Mar 24.
Results Reference
background
PubMed Identifier
18725648
Citation
Ellis GK, Bone HG, Chlebowski R, Paul D, Spadafora S, Smith J, Fan M, Jun S. Randomized trial of denosumab in patients receiving adjuvant aromatase inhibitors for nonmetastatic breast cancer. J Clin Oncol. 2008 Oct 20;26(30):4875-82. doi: 10.1200/JCO.2008.16.3832. Epub 2008 Aug 25.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
URL
http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
Description
Notice regarding posted summaries of trial results
Learn more about this trial
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
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