CompletedPhase 3

A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.

2,049 participantsStarted 2006-04-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)

Timeframe: Up to 34 months

Trial details

NCT IDNCT00321464

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-07-20

Results submitted2010-12-10

View on ClinicalTrials.gov More Bone Metastases trials