An International, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression free survival (PFS), as measured by Response Evaluation Criteria in Solid Tumors criteria (modified RECIST) per local review
Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient
No
MD
Study Director
Amgen
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
20060362
NCT00626106
March 2008
August 2011
Name | Location |
---|---|
Research Site | Mesa, Arizona |
Research Site | Anaheim, California |
Research Site | Danbury, Connecticut |
Research Site | Boca Raton, Florida |
Research Site | Albany, Georgia |
Research Site | Arlington Heights, Illinois |
Research Site | Hooksett, New Hampshire |
Research Site | Belleville, New Jersey |
Research Site | Asheville, North Carolina |
Research Site | Allentown, Pennsylvania |
Research Site | Chattanooga, Tennessee |
Research Site | Ivins, Utah |
Research Site | Auburn, Washington |