Intended for healthcare professionals

Education And Debate

Contribution of randomised controlled trials to understanding and management of early breast cancer

BMJ 1999; 319 doi: (Published 28 August 1999) Cite this as: BMJ 1999;319:568
  1. Michael Baum, professor of surgery (,
  2. Joan Houghton, director (CRC unit)
  1. CRC and UCL Cancer Trials Centre, Royal Free and University College Medical School, Macdonald Buchanan Building, John Astor House, London W1P 8AN
  1. Correspondence to: M Baum

    The randomised controlled trial has become the gold standard for evidence based medicine; through the unbiased comparison of competing treatments it is possible to accurately quantify the cost-benefits and harm of individual treatments. This allows clinicians to offer patients an informed choice and provides the data on which purchasing authorities can make financial decisions. We, of course, subscribe to this view but also recognise this as a gross oversimplification of the power of the randomised controlled trial. The randomised controlled trial is the expression of deductive science in clinical medicine. Not only is it the most powerful tool we have for subjecting therapeutic hypotheses to the hazard of refutation1 but also the biological fallout from such trials should allow clinical scientists to refine biological hypotheses. Trials of treatments for breast cancer have, at least twice, contributed substantially to a paradigm shift in our understanding of the disease.2

    Summary points

    Clinical trials allow clinicians to accurately inform patients with breast cancer of the benefits and harm of different treatments

    Breast conserving techniques produce equivalent survival outcomes as more radical operations, but without the anticipated improvement in psychosocial morbidity

    The introduction of adjuvant systemic treatments has been associated with a significant fall in mortality from breast cancer in all age groups antedating the start of the national breast screening programme

    Counterintuitive results from clinical trials are being incorporated into an emerging conceptual model of the disease

    Trials of local therapy

    Postoperative radiotherapy

    The first randomised trial in the management of early breast cancer can be credited to the Christie Hospital in Manchester. Patients undergoing radical mastectomy were randomised to receive postoperative radiotherapy or not.3 The study found no difference in survival, although the morbidity of the combined procedure was substantial, with 30% of patients who received radiotherapy suffering lymphoedema. It took nearly two decades for the biological …

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