An international randomised trial, involving tens of thousands of women, of 10 versus 5 years of adjuvant tamoxifen in the treatment of oestrogen receptor positive breast cancer, to assess the effects on relapse free and overall survival

niversity of Oxford (UK)0 个研究点目标入组 15,262 人开始时间: 2012年10月18日最近更新: 2016年10月17日

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•Women were eligible for randomisation if:
•1. They had had early breast cancer (in which, by definition, all detected disease could be removed surgically)
•2. They had subsequently been on adjuvant tamoxifen for several years and were still on it (or had stopped only recently, and could therefore resume treatment without much interruption)
•3. They still appeared clinically free of disease (with any local recurrence removed and no distant recurrence ever detected)
•4. Long-term follow-up appeared practicable; and, fundamentally,
•5. Substantial uncertainty was shared by the woman and her doctor about whether to stop tamoxifen or to continue for several more years, so compliance with random allocation to stop or to continue both seemed likely. There were no restrictions on age, type of initial surgery or histology, hormone receptor status, nodal status or what other treatments had also been given.

•Any perceived contraindications to continuing tamoxifen precluded entry. These were specified not by the ATLAS protocol but by the judgment of the responsible clinician. However, the protocol suggested as possible contraindications to tamoxifen continuation (and hence to trial entry):
•1. Intended or actual pregnancy or breast feeding
•2. Retinopathy
•3. Need for coagulation therapy
•4. Significant endometrial hyperplasia
•5. Any other serious toxicity thought to be due to tamoxifen
•6. Negligibly low risk of breast cancer death
•7. Presence of another major life-threatening disease

发起方

niversity of Oxford (UK)