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Abstract
Hormone replacement therapy (HRT) is currently con-traindicated in women with a previous history of breast cancer on the grounds that it may promote the growth or dissemination of occult malignant cells, although this supposition is not supported by any prospective or observational clinical trials. To investigate the practicality of undertaking a national prospective trial of HRT in symptomatic patients with a history of breast cancer, a feasibility study has been undertaken to investigate whether patients would accept randomization to a treatment that might increase their chance of a recurrence. The aim of this study is to recruit 100 symptomatic women with early-stage breast cancer, stratify them according to tamoxifen use and then randomize them to receive HRT or no HRT for 6 months. Predominantly, women refusing to enter the study appear to be concerned about the side-effects of HRT and not just the potential risk of recurrence with HRT use. The accrual rate into the trial is encouraging as a third of eligible patients approached have consented to participate and compliance in both arms of the study is greater than 80%. These factors suggest that a multicenter randomized trial may indeed be practicable. We believe that practitioners must acknowledge that the role of HRT, both in the etiology of breast cancer and stimulation of disease recurrence, is uncertain and that this must be explained to patients if they are to be fully informed about its use.