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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Amgen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Daiichi Sankyo Inc.
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00321464
First received: May 2, 2006
Last updated: July 1, 2010
Last verified: July 2010
History of Changes
  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
Bone Metastases in Subjects With Advanced Breast Cancer
 Biological: Denosumab
Drug: Zoledronic Acid
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Time to first on-study Skeletal Related Event (SRE) [ Time Frame: Study is event driven. May take longer than 33 months of study duration to observe 745 first on-study SREs in study population. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first and subsequent on-study SREs [ Time Frame: Study is event driven. May take longer than 33 months of study duration to observe 745 first on-study SREs in study population. ] [ Designated as safety issue: Yes ]

Enrollment: 2049
Study Start Date: April 2006
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 980 subjects with advanced breast cancer: zoledronic acid
Active Comparator IV over 15 minutes + placebo SC Q4W
 Drug: Zoledronic Acid
4mg IV Zoledronic Acid over 15 minutes
Other Name: Zometa
Experimental: 980 subjects with advanced breast cancer: denosumab
Experimental SC + placebo IV over 15 minutes Q4W
 Biological: Denosumab
120 mg SC Q4W

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321464

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United States, Arizona
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Tucson, Arizona, United States
United States, Arkansas
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Little Rock, Arkansas, United States
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Berkeley, California, United States
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Sponsors and Collaborators
Amgen
Daiichi Sankyo Inc.
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00321464     History of Changes
Other Study ID Numbers: 20050136
Study First Received: May 2, 2006
Last Updated: July 1, 2010
Health Authority: Argentina: Ministry of Health, Australia: Therapeutic Goods Administration
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: Central Ethics Committee
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)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Therapeutic Goods Administration
Austria: Secretariat of Health, Belgium: Pharmaceutical Inspectorate Brazil: Ministry of Health
Belgium: Federal Agency for Medicines and Health Products, FAMHP
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
France and Sweden: European Medicines Agency
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
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

Keywords provided by Amgen:
Fractures
Compressions
Bisphosphonates
Bone metastases
 Breast cancer
Skeletal
Radiation
Surgery to Bone

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
 Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013