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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00089661
• Other study ID #: 20040135
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2004
• Est. completion date: May 27, 2009

Study information

• Verified date: September 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: May 27, 2009
• Est. primary completion date: May 11, 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Breast Cancer
• Breast Neoplasms
• Low Bone Mineral Density
• Osteopenia

Intervention

Drug:
• Placebo
60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months
• AMG 162 / Denosumab
60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.	6 months
Secondary	Total Hip Bone Mineral Density Percent Change From Baseline at Month 12	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.	12 months
Secondary	Total Hip Bone Mineral Density Percent Change From Baseline at Month 6	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.	6 months
Secondary	Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.	12 months
Secondary	Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.	6 months

External Links

•   AmgenTrials clinical trials website