A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.
A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the
Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg with Anastrozole (ARIMIDEX) 1 mg
as Hormonal Treatment for Postmenopausal Women with Hormone Receptor-Positive Locally
Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal
Therapy.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Compare the progression free survival (PFS) in patients treated with Fulvestrant with those treated with Anastrozole.
Baseline RECIST 1.1 assessments and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease.
No
Yuri E Rukazenkov, MD
Study Director
AstraZeneca
Argentina: Human Research Bioethics Committee
D699BC00001
NCT01602380
October 2012
September 2017
Name | Location |
---|---|
Research Site | Anaheim, California |
Research Site | Boulder, Colorado |
Research Site | Boca Raton, Florida |
Research Site | Arlington Heights, Illinois |
Research Site | Bangor, Maine |
Research Site | Baltimore, Maryland |
Research Site | Beverly, Massachusetts |
Research Site | Battle Kreek, Michigan |
Research Site | Branson, Missouri |
Research Site | Grand Island, Nebraska |
Research Site | Belleville, New Jersey |
Research Site | Albany, New York |
Research Site | Asheville, North Carolina |
Research Site | Akron, Ohio |
Research Site | Abilene, Texas |
Research Site | Abington, Virginia |
Research Site | Clarksburg, West Virginia |