Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease per RECIST criteria, were made eligible to participate in the study. Clarification of following: - That either bone scans or skeletal surveys were to be performed at baseline for all patients, then every 4 months until progression for patients with any metastatic bone lesions at baseline. - Exclusion of patients with known brain or CNS metastases (Exclusion # 12). - Tumor assessments in accordance with RECIST criteria. - Addition of safety info for fulvestrant & exemestane. - Concomitant treatments permitted and prohibited. - Exclusion of intercurrent systemic anti cancer therapy after prior non-steroidal AI therapy. - Tumor assessment schedule for patients who withdrew for reasons other than progression. - QoL completion & removal of the 1-month post progression QoL completion time point. - Health care resource completion and timing of health care resource collection. - Exclusion laboratory values for ALT or AST (Exclusion #6). - Timing of AE collection. - AE reporting including serious adverse events. - Change to details of hormone assessments. - Timing of PK assessments

To allow patients who were on study drug therapy at the time of final survival analysis to continue on their assigned study therapy and go into an open label extension phase. The extension phase allowed patients who are receiving benefit from study therapy to continue to receive study therapy after the time of final survival analysis. During the extension AstraZeneca only collected safety assessments (i.e. SAE’s and drug accountability data). Radiological assessments, haematology & clinical chemistry assessments were continued to be followed as normal standard level of care but data were not collected on the CRF.