Clinical trial NCT00321464: A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bone Metastases
Keywords: Fractures
Compressions
Bisphosphonates
Bone metastases
Breast cancer
Skeletal
Radiation
Surgery to Bone
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo
First posted: 2006-05-03
Enrollment: 2049
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The 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.


Eligibility criteria: Inclusion Criteria:

* Adults with histologically or cytologically confirmed breast adenocarcinoma
* radiographic evidence of at least one bone mets
* Easter Cooperative Oncology Group status of 0, 1 or 2;
* adequate organ function

Exclusion Criteria:

* Current or prior IV bisphosphonate administration
* current or prior oral bisphosphonates for bone mets
* life expectancy of less than 6 months

Primary outcomes:
measure: Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)
timeFrame: Up to 34 months
Secondary outcomes:
measure: Time to First On-Study Skeletal-Related Event (Superiority)
timeFrame: Up to 34 months
measure: Time to First and Subsequent On-Study Skeletal-Related Event
timeFrame: Up to 34 months
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
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