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

Amgen

Status and phase: Completed; Phase 3

Conditions: Osteopenia; Breast Cancer; Low Bone Mineral Density

Treatments: Drug: AMG 162 / Denosumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00089661

20040135

Details and patient eligibility

About

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.

Enrollment: 252 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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252 participants in 2 patient groups, including a placebo group

AMG 162 / Denosumab

Experimental group

Treatment:

Drug: AMG 162 / Denosumab

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo