Status:
COMPLETED
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
Lead Sponsor:
Amgen
Conditions:
Breast Cancer
Low Bone Mineral Density
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2009
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT00089661
Start Date
October 1 2004
End Date
May 27 2009
Last Update
October 17 2018
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