ATAC trial did not report interim results

doi:10.1136/bmj.327.7422.1050

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Michael Baum, visiting professor of medical humanities,
Aman Buzdar, doctor,
Anthony Howell, professor of medical oncology

Clinical Trials Group, Department of Surgery, University College London, London W1W 7EJ
Department of Medical Oncology, Medical Breast Cancer Service, University of Texas, MD Anderson Cancer Center, Houston, TX 77030, USA
Department of Medical Oncology, Cancer Research UK, University of Manchester, Manchester M20 4BX

EDITOR—We agree with Goodare et al that it is inappropriate to publish interim analyses.1 However, the results of the ATAC (arimidex, tamoxifen, alone or in combination) trial published in the Lancet were the first major analysis as fully defined in the protocol, not an interim analysis.2

The statistical power of the trial, defined in the protocol, determined that this analysis would be triggered at 1056 events. Using first event as the primary end point in breast cancer trials is …