Aminoglutethimide in advanced breast cancer: clinical results of a French multicenter randomized trial comparing 500 mg and 1 g/day.

We have conducted a multicenter randomized clinical trial comparing in advanced post-menopausal breast cancer patients 500 mg vs 1 g AG/day. The hydrocortisone dose was 40 mg/day in both groups. One hundred and seventy patients have been randomized; 161 were evaluable for tolerability, 149 for effectiveness. Response rates were similar in both groups, 19 and 24% respectively for the 500 mg and 1 g groups. No difference was observed according to tumor site. Duration of response was the same in both groups (14 months), as was mean time to response (about 3 months). Survival (studies in 125 patients) was similar in both groups (responders and non-responders). No response could be obtained with 1 g after relapse or failure with 500 mg (n = 17). Tolerability was good in 91% of the 500 mg group patients and 78% of the 1 g group patients (P less than 0.03). It was poor in 4 and 15% respectively (P less than 0.03). Side-effects were the same in both groups but less frequent and less severe in the 500 mg group; however, these patients more frequently had 'moon face'.

RCT Entities:   Population Interventions Outcomes