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Breast

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

Unique Data Set IDBreast_AmgenI_2006_122
DownloadableYes
SponsorAmgenData ProviderAmgenTotal Study Enrolled Patients2049Comparator (Control) Arm Enrolled Patients756RandomizationYesClinicalTrial.gov IDNCT00321464 ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00321464?term=denosumab+breast+cancer&rank=8
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeBiologicsData Set TypeADS

Clinical Trial Title

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

Trial Summary and Conditions

Bone complications associated with cancer arise from increased bone resorption and include bone pain, pathologic bone fractures, nerve compression, and hypercalcemia. Accumulating evidence suggests that most pathologic bone resorption relies on the RANK/RANKL pathway, which regulates the differentiation, survival, and activation of osteoclasts. Another key component of RANK/RANKL pathway is OPG, an endogenous decoy receptor that binds and neutralizes RANKL. The antiresorptive property of OPG has been demonstrated in murine models of hypercalcemia of malignancy and metastatic bone destruction. According to recent findings, it appears that maximum anti-resorptive effects due to RANKL-RANK pathway inhibition are more pronounced than those due to bisphosphonates.

Data Summary

These datasets are analysis datasets that bear some resemblance to CDISC ADaM standards. These datasets has been subsetted to include data from only the comparator arm of this clinical trial.

Study Objectives

PRIMARY 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

Outcome Measures

Outcomes documented in the protocol

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: Amgen 20050136 Protocol.pdf

CRF: Amgen 20050136 CRF.pdf

DATA DICTIONARY: Amgen 20050136 DDT.pdf

DATA (COMPARATOR ARM): Amgen 20050136 SAS datasets.zip