SOFT
Disease site: Breast Cancer
Treatment Modality: Hormone Therapy
Status: In active follow-up
Patients are randomised to one of three treatment arms:
- Tamoxifen Alone
- Tamoxifen plus Ovarian Function Suppression (OFS)
- Exemestane plus OFS
The trial has two aims:
- To evaluate the worth of OFS plus tamoxifen, compared with tamoxifen alone, in premenopausal women with steroid hormone receptor positive early invasive breast cancer, either following surgery alone, or after completion of adjuvant/ neoadjuvant chemotherapy
- To evaluate the worth of exemestane in this setting, by comparing OFS plus exemestane with tamoxifen alone and by comparing OFS plus exemestane with OFS plus tamoxifen
The trial will recruit 3000 premenopausal women with steroid hormone receptor positive breast cancer. SOFT is one of three complementary trials (the STP Trials) coordinated by the IBCSG. These trials opened to recruitment internationally on the 4th August 2003.
UK Chief Investigator: Prof R. Coleman, University of Sheffield.
Sponsor: International Breast Cancer Study Group (IBCSG) Berne, Switzerland