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

NCT00089661 | Completed Phase 3 Results

• 1 other identifier: 20040135
• Study Type: interventional
• Target: 252
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6

  6 months

• Total Hip Bone Mineral Density Percent Change From Baseline at Month 12

  12 months

• Total Hip Bone Mineral Density Percent Change From Baseline at Month 6

  6 months

• Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12

  12 months

• Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6

  6 months

Study Arms (2)

AMG 162 / Denosumab

EXPERIMENTAL

Drug: AMG 162 / Denosumab

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months

Placebo

AMG 162 / Denosumab DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Amgen: lead

Related Publications (3)

• 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.

  PMID: 19308727 BACKGROUND

• 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.

  PMID: 18725648 BACKGROUND

• Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.

  PMID: 38979716 DERIVED

Related Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results

MeSH Terms

Conditions

Breast Neoplasms; Bone Diseases, Metabolic

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2004
• First Posted: August 11, 2004
• Study Start: October 1, 2004
• Primary Completion: May 11, 2007
• Study Completion: May 27, 2009
• Last Updated: October 17, 2018
• Results First Posted: January 26, 2010

Record last verified: 2018-09