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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 Site Mesa, Arizona  
Research Site Bentonville, Arkansas  
Research Site Anaheim, California  
Research Site Danbury, Connecticut  
Research Site Washington, District of Columbia  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Honolulu, Hawaii  
Research Site Arlington Heights, Illinois  
Research Site Bloomington, Indiana  
Research Site Ames, Iowa  
Research Site Ashland, Kentucky  
Research Site Baton Rouge, Louisiana  
Research Site Baltimore, Maryland  
Research Site Beverly, Massachusetts  
Research Site Battle Kreek, Michigan  
Research Site Alexandria, Minnesota  
Research Site Billings, Montana  
Research Site Las Vegas, Nevada  
Research Site Belleville, New Jersey  
Research Site Albuquerque, New Mexico  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Bismarck, North Dakota  
Research Site Allentown, Pennsylvania  
Research Site Charleston, South Carolina  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Ivins, Utah  
Research Site Abington, Virginia  
Research Site Auburn, Washington  
Research Site Clarksburg, West Virginia  
Research Site Appleton, Wisconsin