SOFT

Trial details

SOFT is a phase III, randomised, multicentre study evaluating the role of ovarian function suppression and the role of exemestane as adjuvant therapies for pre-menopausal women with endocrine responsive breast cancer.

Patients were 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 recruited 3,000 premenopausal women with steroid hormone receptor positive breast cancer. SOFT is one of three complementary trials (the STP Trials) coordinated by the International Breast Cancer Study Group (IBCSG). These trials opened to recruitment internationally on the 4th August 2003. SOFT closed to recruitment in January 2011.

UK Chief Investigator: Professor R. Coleman, University of Sheffield

UK trial management contact: Agnieszka Yongue, [email protected]

Sponsor: International Breast Cancer Study Group (IBCSG) Berne, Switzerland

Funding: Pfizer

Further information

Further information on the SOFT trial may be found on the IBCSG SOFT trial webpage.

A summary of SOFT trial results for patients is available on the CRUK website 
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-blocking-oestrogen-from-the-ovaries-in-premenopausal-women-with-hormone-receptor-positive-early-breast-cancer