SOFEA

This is an NCRI Phase III randomised trial in postmenopausal women with oestrogen receptor (ER) and/or progesterone receptor (PgR) positive locally advanced/metastatic breast cancer following progression on non-steroidal aromatase inhibitors (NSAIs). The primary aims of the trial are progression-free survival of patients treated with faslodex (fulvestrant) plus concomitant arimidex (anastrozole) versus faslodex alone, and to compare the progression-free survival of patients treated with faslodex alone versus those treated with the current standard treatment exemestane. The trial aims to recruit 750 patients who will be randomly allocated to receive faslodex (given by monthly injection) together with arimidex or arimidex-placebo tablets taken daily or to daily exemestane tablets. The trial has the support of oncologists from more than 100 centres throughout the UK. Trial recruitment commenced in March 2004.

This trial is supported by the NCRI Breast Clinical Studies Group and is run in collaboration with ISD Cancer Clinical Trials Team, Scotland.

Chief Investigator: Professor S. Johnston, Royal Marsden Hospital, Sutton.

Sponsor: Institute of Cancer Research and Royal Marsden NHS Foundation Trust

Source of funding: Cancer Research UK and AstraZeneca as an unrestricted educational grant

ISRCTN: 44195747.