The design of advanced breast cancer trials. New approaches

The treatment of advanced breast cancer is always palliative. Only a modest prolongation of life is achieved even in the best series, and the traditional criteria of assessment of response take no account of factors other than tumour bulk. Restrictive entry criteria have resulted from the inability to quantify any other measurement of response, and so the power of such chemotherapy trials has been unnecessarily curtailed. We report on the progress being made in this department to develop a self-assessment diary to record quality of life in these patients and to mount a pragmatic trial of two different regimens in advanced breast cancer using this measure.