ATAC - Bone Density Sub-Protocol

A Randomised, Double-Blind Trial to Assess the Effects on Bone Mineral Density and Metabolism of Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, (in Comparison to a Control Group) When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women

To assess and quantify the changes in bone mineral density between the ARIMIDEX and ARIMIDEX plus NOLVADEX groups when compared to the NOLVADEX alone treatment group whilst receiving trial therapy.

Inclusion Criteria:

• Eligible for entry into the main ATAC trial 1033IL/0029
• Women defined as post-menopausal
• Patients with histologically proven operable invasive breast cancer
• Who following primary surgery have a good prognosis and would be ethically suitable to remain untreated

Exclusion Criteria:

• Excluded from entry into the main ATAC trial (1033IL/0029)
• Patients who have received hormone replacement therapy within the previous 12 months prior to randomisation
• Patients who have received bisphosphonate therapy within the previous 12 months prior to randomisation
• Patients who have had a bone fracture within the previous 6 months prior to randomisation