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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Bone Metastases in Subjects With Advanced Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to first on-study Skeletal Related Event (SRE)

Outcome 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.

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Argentina: Ministry of Health, Australia: Therapeutic Goods Administration

Study ID:

20050136

NCT ID:

NCT00321464

Start Date:

April 2006

Completion Date:

July 2011

Related Keywords:

  • Bone Metastases in Subjects With Advanced Breast Cancer
  • Fractures
  • Compressions
  • Bisphosphonates
  • Bone metastases
  • Breast cancer
  • Skeletal
  • Radiation
  • Surgery to Bone
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

Research SiteMesa, Arizona  
Research SiteBentonville, Arkansas  
Research SiteAnaheim, California  
Research SiteDanbury, Connecticut  
Research SiteWashington, District of Columbia  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteHonolulu, Hawaii  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteAmes, Iowa  
Research SiteAshland, Kentucky  
Research SiteBaton Rouge, Louisiana  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteAlexandria, Minnesota  
Research SiteBillings, Montana  
Research SiteLas Vegas, Nevada  
Research SiteBelleville, New Jersey  
Research SiteAlbuquerque, New Mexico  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteBismarck, North Dakota  
Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteIvins, Utah  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington  
Research SiteClarksburg, West Virginia  
Research SiteAppleton, Wisconsin