Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg in Postmenopausal Women With ER +ve 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
Objective Response (OR)
Number of participants who were objective responders over the number of participants evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diameters of the measurable lesions + no new lesions + no progression of non-measurable lesions)
RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomisation to until data cut off on 13th June 2008
No
AstraZeneca Breast Cancer Established Brands Team Medical Science Director, MD
Study Director
AstraZeneca
Belgium: Federal Agency for Medicines and Health Products, FAMHP
D6997C00006
NCT00313170
May 2006
December 2012
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