A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Time to Progression (TTP)
Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).
RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
No
Faslodex Medical Science Director, MD
Study Director
AstraZeneca
United States: Food and Drug Administration
D6997C00002
NCT00099437
February 2005
September 2013
Name | Location |
---|---|
Research Site | Mesa, Arizona |
Research Site | Anaheim, California |
Research Site | Danbury, Connecticut |
Research Site | Boca Raton, Florida |
Research Site | Arlington Heights, Illinois |
Research Site | Baltimore, Maryland |
Research Site | Battle Kreek, Michigan |
Research Site | Branson, Missouri |
Research Site | Belleville, New Jersey |
Research Site | Abilene, Texas |
Research Site | Appleton, Wisconsin |