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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
July 2009
NCT00321464Uploaded 03-24-2015
Available for Download
PDS UID: Breast_AmgenI_2006_122
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Subjects With Advanced Breast Cancer
Provider Information
Provider Data DescriptionPRIMARY OBJECTIVE To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal related event (SRE). SRE is defined as pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression in subjects with advanced breast cancer and bone metastases. SECONDARY OBJECTIVES - To determine if denosumab is superior to zoledronic acid with respect to first on-study SRE - To determine if denosumab is superior to zoledronic acid with respect to first-and-subsequent on-study SRE (multiple event analysis) - To assess the safety and tolerability of denosumab compared with zoledronic acid
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset2049
# of Patients Control756
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/9pwj-jx29
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.
ConditionsBone Metastases
Intervention TypeBiological: Denosumab
Drug: Zoledronic Acid
Drug(s)Drug: Zoledronic Acid
Total Enrolled2049
RandomizationRandomized
Blinding MethodTriple
Arms Interventionzoledronic acid - Active Comparator
denosumab - Experimental
Secondary IDN/A
PubMed (PMID)22951813
22893628
21060033
26335402
26093811
25976743
23975226
22975218
Collaborator(s)Daiichi Sankyo
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLAmgen 20050136 Protocol.pdf
CRFAmgen 20050136 CRF.pdf
DATA DICTIONARYAmgen 20050136 DDT.pdf
DATA SUMMARYProc Contents Data Dictionary PDS122.pdf
DATA (COMPARATOR ARM)Amgen 20050136 SAS datasets.zip
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