SOFT

NCT00066690 📎

Regimen

Experimental
Exemestane 25 mg daily plus OFS (triptorelin/oophorectomy/RT) for 5 years; or tamoxifen 20 mg daily plus OFS for 5 years.
Control
Tamoxifen 20 mg daily alone for 5 years.

Population

Premenopausal women with HR+ early breast cancer who remained premenopausal after surgery (and, if given, adjuvant chemotherapy). Stratified by prior chemotherapy use.

Key finding

SOFT established that adding OFS to tamoxifen, or using exemestane plus OFS, improves outcomes over tamoxifen alone in premenopausal HR+ early breast cancer, especially in women at sufficient risk to warrant adjuvant chemotherapy. With TEXT it underpins NCCN BINV-K recommendations for OFS in higher-risk premenopausal disease.

Source: PMID 25495490

Timeline

  • Publication: 2015 Jan 29

Guideline citations

  • NCCN BREAST