The international randomised SOFT&TEXT clinical trials – together involving 5,738 patients from 510 hospitals and cancer centres linked to 13 BIG groups in 27 countries – were developed in parallel to test the optimal adjuvant endocrine treatment in premenopausal women with hormone-sensitive early breast cancer. SOFT and TEXT are led by the International Breast Cancer Study Group (IBCSG), under the BIG umbrella.
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These trials demonstrated that, when combined with ovarian function suppression (OFS), exemestane, compared to tamoxifen significantly improved patient disease outcome, reducing the risk of cancer recurrence by 34%. Patients with a high risk of relapse who had received adjuvant chemotherapy especially benefitted from this treatment.
The primary results of SOFT and TEXT, which were published in the New England Journal of Medicine in 2014, were supported by a 5-year analysis presented at the 2017 San Antonio Breast Cancer Symposium (SABCS). The most recent results presented at the 2021 SABCS, with patients having been followed-up for an average of 12.5 years since starting treatment, show a persistent long-term reduction of risk of distant recurrence when OFS is added to tamoxifen or exemestane, with the greatest reduction found in combination with exemestane. The updated results also demonstrate a reduction in death with both combinations, although the reduction was higher with exemestane.