{"entity":{"id":"soft-text","kind":"trial","name":"SOFT & TEXT","aka":[],"tldr":"For younger women, shutting down the ovaries and adding an aromatase inhibitor prevents more recurrences than tamoxifen alone, with the largest gains in the highest-risk women.","summary":"Combined 12-13-year analysis: exemestane + OFS improved DFS and distant recurrence-free interval over tamoxifen + OFS (absolute 4-5%) without an OS difference; SOFT 12-year: adding OFS to tamoxifen improved OS in the chemotherapy cohort (HR ~0.79). Basis for OFS in premenopausal women at higher risk.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00066690","url":"https://clinicaltrials.gov/study/NCT00066690"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["exemestane","tamoxifen","goserelin"],"companies":["breast-cancer-trials","etop-ibcsg"],"institutions":[],"pathways":[],"terms":["ovarian-function-suppression"],"trials":[],"people":["prudence-francis"],"bottlenecks":[],"keyPapers":["paper-soft-text-n-engl-j-med-2015","paper-soft-text-j-clin-oncol-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00066690","phase":"3","setting":"Premenopausal HR+ early breast cancer: ovarian function suppression + exemestane vs + tamoxifen vs tamoxifen alone","sponsor":"IBCSG","result":"Exemestane + OFS: DFS and DRFI improved; no OS difference at 12 years.","started":"2003-12-17","startedType":"actual","yearReported":2014,"enrolled":5738,"enrolledBasis":"registry","outcomes":[{"endpoint":"12-year disease-free survival (TEXT+SOFT)","primary":true,"unit":"%","arms":[{"name":"Exemestane + OFS","value":80.5},{"name":"Tamoxifen + OFS","value":75.9}],"hr":0.79,"ci":[0.7,0.9],"source":"https://ascopubs.org/doi/10.1200/JCO.22.01064"}],"replication":"Consistent with the ABCSG-12 and EBCTCG meta-analyses on OFS."},"route":"/trials/soft-text/","neighbours":{"cancer":[{"id":"hr-positive-early-high-risk","kind":"cancer","name":"High-risk early HR-positive breast cancer","route":"/cancers/hr-positive-early-high-risk/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"technology":[{"id":"endocrine-therapy","kind":"technology","name":"Endocrine therapy (SERMs, AIs, SERDs)","route":"/technologies/endocrine-therapy/"}],"drug":[{"id":"exemestane","kind":"drug","name":"Exemestane","route":"/drugs/exemestane/"},{"id":"goserelin","kind":"drug","name":"Goserelin / leuprolide (ovarian function suppression)","route":"/drugs/goserelin/"},{"id":"letrozole","kind":"drug","name":"Letrozole (and other aromatase inhibitors)","route":"/drugs/letrozole/"},{"id":"tamoxifen","kind":"drug","name":"Tamoxifen","route":"/drugs/tamoxifen/"}],"company":[{"id":"breast-cancer-trials","kind":"company","name":"Breast Cancer Trials","route":"/companies/breast-cancer-trials/"},{"id":"etop-ibcsg","kind":"company","name":"ETOP IBCSG Partners Foundation","route":"/companies/etop-ibcsg/"}],"term":[{"id":"ovarian-function-suppression","kind":"term","name":"Ovarian function suppression (OFS)","route":"/terms/ovarian-function-suppression/"}],"person":[{"id":"prudence-francis","kind":"person","name":"Prudence A. Francis","route":"/people/prudence-francis/"}],"paper":[{"id":"paper-soft-text-j-clin-oncol-2023-update","kind":"paper","name":"Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT","route":"/key-papers/paper-soft-text-j-clin-oncol-2023-update/"},{"id":"paper-soft-text-n-engl-j-med-2015","kind":"paper","name":"Adjuvant ovarian suppression in premenopausal breast cancer","route":"/key-papers/paper-soft-text-n-engl-j-med-2015/"}],"idea":[{"id":"idea-bio2-mrd-guided-endocrine-duration","kind":"idea","name":"Use residual disease tests to decide who needs ten years of hormone therapy","route":"/ideas/idea-bio2-mrd-guided-endocrine-duration/"}],"roadmap":[{"id":"hormonal-therapy-roadmap","kind":"roadmap","name":"Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test","route":"/roadmaps/hormonal-therapy-roadmap/"}]}}