A partially blind Phase III randomised Trial of Fulvestrant (Faslodex TM) with or without concomitant Anastrozole (Arimidex TM) compared with exemestane in post-menopausal women with ER or PR +ve locally advanced/metastatic breast cancer following progression on non-steroidal aromatase inhibitors

Study schema

Objectives

Primary: 

• To compare the progression-free survival of patients treated with Faslodex plus concomitant Arimidex (F+A) versus Faslodex (F) alone.
  
  
• To compare the progression-free survival of patients treated with Faslodex (F) alone versus those treated with the current standard exemestane (E)

Secondary:

• To assess the objective tumour response rate (CR + PR), duration of response, clinical benefit rate (CR/PR + SD >6 months), duration of clinical benefit, time to treatment failure, and overall survival of patients treated with Faslodex plus concomitant Arimidex (F+A) compared with Faslodex (F) alone.
  
  
• To assess the objective response rate, duration of response, clinical benefit rate, duration of clinical benefit, time to treatment failure, progression-free and overall survival of patients treated with Faslodex (without concomitant Arimidex) compared with exemestane.
  
  
• In the case that concomitant use of Arimidex with Faslodex provides equivalent outcome to Faslodex alone, to compare the progression-free survival of all Faslodex treated patients with those treated with exemestane.
  To determine the tolerability of Faslodex with or without concomitant Arimidex and compared with exemestane.

Target Accrual: 750

For more information contact Susan Russell