A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs. Randomisation to Faslodex ± Arimidex / Arimidex-Placebo or exemestane will be open (1:1:1). For Faslodex treated patients the randomisation to Arimidex or Arimidex-Placebo will be double-blind.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.
Tablet, oral, once daily until disease progression.
Tablet, oral, once daily until disease progression.
Research Site
Ilsan, South Korea
Research Site
Seoul, South Korea
Progression-free survival
Time frame: every 3 months during treatment and, at time of discontinuation from treatment
Objective complete response (CR) and partial response (PR) rate
Time frame: every 3 months during treatment and, at time of discontinuation from treatment
Duration of response
Time frame: every 3 months during treatment and, at time of discontinuation from treatment
Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate
Time frame: every 3 months during treatment and, at time of discontinuation from treatment
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