A Randomised, Double-blind Trial Comparing ARIMIDEX™ Alone with NOLVADEX™ Alone with ARIMIDEX and NOLVADEX in Combination, as Adjuvant Treatment in Postmenopausal Women with Breast Cancer

For 1033IL/0029 - Several sets of results are provided as follows:

• Approval date 12 February 2002: this is the protocol-defined major efficacy and safety analysis and the data cut-off date was 29th June 2001. The median duration of follow-up for efficacy endpoints was 33.3 months and the median duration of treatment for safety endpoints was 30.9 months.
  
• Approval date 2 July 2002: this is a safety update requested by various national regulatory authorities during the review process for Arimidex in early breast cancer. The data cut-off date was 25th January 2002 and the median duration of treatment for safety endpoints was 37.3 months.
  
• Approval date 20 February 2003: this is an efficacy update requested by the ATAC Steering Committee and the data cut-off date was 28th June 2002. The median duration of follow-up for efficacy endpoints was 47.2 months.
  
• Approval date 20 October 2004: this is a safety and efficacy update requested by various national regulatory authorities, and includes the protocol-defined analysis of overall survival. The data cut-off date was 31st March 2004. The median duration of follow-up for efficacy endpoints was 68 months and the median duration of treatment for safety endpoints was 60 months.
  
• Approval date 4 December 2007: This update analysis was provided following a regulatory request and provides both efficacy and safety data beyond the 5 year treatment period defined in the ATAC protocol. The data cut-off for the analysis was 31st March 2007. The median follow-up for overall survival was 100 months.

Please note that the names for some of the variables reported in the results for Approval Date 20 October 2004 were different to those used in the previous analyses. The table below clarifies the terminology at different analyses.

Note that some minor differences exist between the analyses included in these synopses compared to the analyses presented in the corresponding publications. These differences arise because the information included here is based on analyses defined strictly according to the protocol (as required by international regulatory authorities), whereas the information presented in the corresponding publications are based on the scientific requirements of the ATAC Steering Committee (membership of the Steering Committee is described within the publications referenced). In all cases the differences between the analyses are of a small magnitude and the conclusions from them are the same.