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Content archived on 2024-05-07

ATLAS: An international trial of tamoxifen duration

Objective



In 1995, about 850.000 new cases of breast cancer were diagnosed worldwide. In Europe alone about 200.000 women developed the disease and about half will die from breast cancer. As breast cancer is so common, establishing reliably whether a new approach to treatment could improve survival just moderately could save thousands of lives worldwide if the treatment is widely available and if it is of benefit to a large proportion of women who develop the disease. The worldwide overview by the Early Breast Cancer Trialists' Collaborative Group of randomised trials of tamoxifen in women with early breast cancer demonstrated a moderate but highly significant improvement in 10-year survival with tamoxifen. Indirect comparisons of trials assessing different tamoxifen durations suggest that more prolonged treatment confers a greater survival benefit and preliminary results from direct comparisons of different tamoxifen durations support the evidence in favour of longer treatment.

However, there is insufficient randomised evidence of the risks and benefits of different durations of treatment. Further randomised trials involving several tens of thousands of women with long-term follow-up are required before any additional benefit from longer treatment can be detected or refuted reliably. Such large numbers requires collaboration throughout Europe and beyond.

ATLAS (Adjuvant Tamoxifen: Longer Against Shorter) is an international megatrial which aims to recruit some 20 000 women worldwide and thereby to provide definitive evidence on the optimal duration of tamoxifen treatment. The trial uses a pragmatic design for randomisation and any woman who has been on tamoxifen for some years, usually at least 2 years, for whom there is uncertainty about whether to stop or continue tamoxifen, is eligible for randomisation between either stopping tamoxifen or continuing for 5 more years. Almost no documentation is requested as the chief analysis will be of all-cause mortality to establish whether the more prolonged treatment improves 10-year survival. If ATLAS demonstrates that an extra 5 years of tamoxifen produces a moderate but definite improvement in survival, then the implementation of this result throughout Europe and the rest of the world would avoid several thousands of deaths and would resolve the major uncertainty, which currently exists regarding the optimal duration of treatment.

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CON - Coordination of research actions

Coordinator

THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
EU contribution
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Address
Radcliffe Infirmary
OX2 6HE OXFORD
United Kingdom

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Participants (2)

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