# SOFT & TEXT

Source: https://onco.cc/trials/soft-text/  
OnCo record `soft-text` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT00066690
- Phase: 3
- Setting: Premenopausal HR+ early breast cancer: ovarian function suppression + exemestane vs + tamoxifen vs tamoxifen alone
- Sponsor: IBCSG
- Enrolled: 5738
- Result: Exemestane + OFS: DFS and DRFI improved; no OS difference at 12 years.
- Outcomes: 12-year disease-free survival (TEXT+SOFT): Exemestane + OFS 80.5% vs Tamoxifen + OFS 75.9%, HR 0.79
- Replication: Consistent with the ABCSG-12 and EBCTCG meta-analyses on OFS.

## Sources

- ClinicalTrials.gov NCT00066690: https://clinicaltrials.gov/study/NCT00066690

## Connected records

- cancers: [High-risk early HR-positive breast cancer](https://onco.cc/cancers/hr-positive-early-high-risk/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- technologies: [Endocrine therapy (SERMs, AIs, SERDs)](https://onco.cc/technologies/endocrine-therapy/)
- drugs: [Exemestane](https://onco.cc/drugs/exemestane/), [Goserelin / leuprolide (ovarian function suppression)](https://onco.cc/drugs/goserelin/), [Letrozole (and other aromatase inhibitors)](https://onco.cc/drugs/letrozole/), [Tamoxifen](https://onco.cc/drugs/tamoxifen/)
- companies: [Breast Cancer Trials](https://onco.cc/companies/breast-cancer-trials/), [ETOP IBCSG Partners Foundation](https://onco.cc/companies/etop-ibcsg/)
- terms: [Ovarian function suppression (OFS)](https://onco.cc/terms/ovarian-function-suppression/)
- people: [Prudence A. Francis](https://onco.cc/people/prudence-francis/)
- key papers: [Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT](https://onco.cc/key-papers/paper-soft-text-j-clin-oncol-2023-update/), [Adjuvant ovarian suppression in premenopausal breast cancer](https://onco.cc/key-papers/paper-soft-text-n-engl-j-med-2015/)
- ideas: [Use residual disease tests to decide who needs ten years of hormone therapy](https://onco.cc/ideas/idea-bio2-mrd-guided-endocrine-duration/)
- roadmaps: [Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test](https://onco.cc/roadmaps/hormonal-therapy-roadmap/)

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