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

Fecha de inicio: 1 de octubre de 2004

* 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.