A multicentre trial to compare a loading dose regimen of tamoxifen ('Nolvadex') with conventional dosing in the treatment of advanced breast cancer. The British Tamoxifen Study Group.

In this open randomized trial 193 eligible patients with advanced breast cancer were randomized to either a conventional schedule of tamoxifen (40 mg/day) or a loading dose schedule (160 mg for two days followed by 40 mg/day). Response was assessed every three weeks for the first three months and at three-monthly intervals thereafter. The loading dose regimen did not confer any benefit to the patients in terms of time taken to obtain a clinical response, rate and duration of response and subsequent survival even though steady-state plasma levels are achieved at least two weeks earlier with a loading dose regimen.