Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer
NCT ID: NCT00091832
Last Updated: 2014-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
255 participants
INTERVENTIONAL
2004-09-30
2006-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Denosumab 60 mg every 12 weeks
Denosumab 60 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.
Denosumab
Denosumab administered by subcutaneous injection
Denosumab 120 mg every 4 weeks
Denosumab 120 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
Denosumab
Denosumab administered by subcutaneous injection
Denosumab 180 mg every 4 weeks
Denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
Denosumab
Denosumab administered by subcutaneous injection
IV bisphosphonates every 4 weeks
Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion for 25 weeks.
IV Bisphosphonates
Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid
Denosumab 180 mg every 12 weeks
Denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.
Denosumab
Denosumab administered by subcutaneous injection
Denosumab 30 mg every 4 weeks
Denosumab 30 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
Denosumab
Denosumab administered by subcutaneous injection
Interventions
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Denosumab
Denosumab administered by subcutaneous injection
IV Bisphosphonates
Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
FEMALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
References
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Campbell-Baird C, Lipton A, Sarkenshik M, Ma H, Jun S.Incidence of Acute Phase Events Following Denosumab or Intravenous Bisphosphonates: Results From a Randomized, Controlled Phase 2 Study in Patients With Breast Cancer and Bone Metastases.Journal-001752;2010;7:85-89.
Lipton A, Steger GG, Figueroa J, Alvarado C, Solal-Celigny P, Body JJ, de Boer R, Berardi R, Gascon P, Tonkin KS, Coleman RE, Paterson AH, Gao GM, Kinsey AC, Peterson MC, Jun S. Extended efficacy and safety of denosumab in breast cancer patients with bone metastases not receiving prior bisphosphonate therapy. Clin Cancer Res. 2008 Oct 15;14(20):6690-6. doi: 10.1158/1078-0432.CCR-07-5234.
Lipton A, Steger GG, Figueroa J, Alvarado C, Solal-Celigny P, Body JJ, de Boer R, Berardi R, Gascon P, Tonkin KS, Coleman R, Paterson AH, Peterson MC, Fan M, Kinsey A, Jun S. Randomized active-controlled phase II study of denosumab efficacy and safety in patients with breast cancer-related bone metastases. J Clin Oncol. 2007 Oct 1;25(28):4431-7. doi: 10.1200/JCO.2007.11.8604. Epub 2007 Sep 4.
Peterson M, Rodriquez R., Gurrola E., Sohn W, Jun S (others??).Population pharmacokinetics and pharmacodynamics of denosumab in breast cancer patients with bone metastases.Journal-000709;
Related Links
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AmgenTrials clinical trials website
Notice regarding posted summaries of trial results
Other Identifiers
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20040113
Identifier Type: -
Identifier Source: org_study_id
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