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| Sponsored by: |
Amgen |
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00321464 |
Purpose
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.
| Condition | Intervention | Phase |
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Bone Metastases in Subjects With Advanced Breast Cancer |
Biological: Denosumab Drug: Zoledronic Acid |
Phase III |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer |
| Drug Information available for: | Zoledronic acid Denosumab |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 1960 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
980 subjects with advanced breast cancer: zoledronic acid: Active Comparator
Active Comparator IV over 15 minutes + placebo SC Q4W
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Drug: Zoledronic Acid
4mg IV Zoledronic Acid over 15 minutes
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980 subjects with advanced breast cancer: denosumab: Experimental
Experimental SC + placebo IV over 15 minutes Q4W
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Biological: Denosumab
120 mg SC Q4W
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Adults with histologically or cytologically confirmed breast adenocarcinoma; radiographic evidence of at least one bone mets; ECOG 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
Contacts and Locations More Information
AmgenTrials clinical trials website
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| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20050136 |
| First Received: | May 2, 2006 |
| Last Updated: | March 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00321464 |
| Health Authority: | France: CCPPRB Central Ethics Committee; France: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe; Hungary: National Institute of Pharmacy; India: Central Drugs Standard Control Organization; Israel: Ministry of Health; Italy: Ministry of Health; Japan: Ministry of Health, Labor and Welfare; Japan: Pharmaceuticals and Medical Devices Evaluation Center; Latvia: State Agency of Medicines, Mexico: Ministry of Health; Lithuania: Ministry of Health; Mexico: COFEPRIS; Mexico: SSA (Secretaria de Salud Publica); Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research; Netherlands: Medicines Evaluation Board; Panama: Ministry of Health; Peru: Ministry of Health; Poland: Drug Institut; Romaina: National Medicines Agency; Romania: Ministry of Health and the Family; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Romania: Romanian National Drug Agency; Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health); Russia: Ministry of Health; Slovakia: Ministry of Health; Slovakia: State Institiute for Drug Control; South Africa: Department of Health; South Africa: Department of Health, Spain: Spanish Drug Agency, Sweden: Medical Products Agency, Switzerland: Agency for Therapeutic Products; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Spain: Spanish Agency of Medicines; Spain: Spanish Drug Agency; Sweden: Medical Products Agency; Switzerland: Agency for Therapeutic Products; Switzerland: Local Ethics Committee; Switzerland: Swissmedic (Swiss Agency for Therapeutic Products); Turkey: Ministry of Health; Ukraine: Ministry of Health; Ukraine: Pharmacological Centre at the Ministry of Health of the Ukraine (Pharma Centre); Argentina: Ministry of Health, Australia: Therapeutic Goods Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; France and Sweden: European Medicines Agency; Australia: Therapeutic Goods Administration; Austria: Secretariat of Health, Belgium: Pharmaceutical Inspectorate Brazil: Ministry of Health; Belgium: Directorate general for the protection of Public health: Medicines; Belgium: Directorate-General for Medicinal Products; Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment; Belgium: FPS of Public Health, Food Chain Security and Environment; Belgium: Pharmaceutical Inspectorate; Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement; Belgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne alimentaire et Environnement; Brazil: ANVISA (Agência Nacional de Vigilância Sanitária); Brazil: Ministry of Health; Bulgaria: Bulgarian Drug Agency; Bulgaria: Ministry of Health; Canada: Health Canada; Canada: Health Products and Food Branch; Canada: Institutional Review Board; Chile: Health Ministry; Czech Republic: State Institute for Drug Control; Denmark: Ministry of Health; Estonia: State Agency of Medicines, France: Ministry of Health; EU: CHMP; European Union: European Medicines Agency; Finland: Lääkelaitos; United States: Food and Drug Administration; Sweden: Central Ethics Committee |
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