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

• Status: Completed
• Trial end date: 2009-05-27
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Aromatase Inhibitors; Denosumab

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.