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
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Low Bone Mineral Density, Osteopenia
Female
Breast Cancer, Low Bone Mineral Density, Osteopenia
Trial Information
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
Inclusion 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Outcome Description:
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Food and Drug Administration
Study ID:
20040135
NCT ID:
NCT00089661
Start Date:
October 2004
Completion Date:
May 2009
Related Keywords:
- Breast Cancer
- Low Bone Mineral Density
- Osteopenia
- Breast Cancer
- Bone loss associated with Aromatase Inhibitor therapy (AIT) for non-metastatic BC
- osteopenia
- Low bone density
- Breast Neoplasms
- Bone Diseases, Metabolic
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