SOFT & TEXT trials - providing new treatment options for young women

Intro text: 

The SOFT trial, along with its sister trial, TEXT, was cited in several articles* as the “year’s best” trial in a year of significant developments in breast cancer research. The trial’s practice changing results indicated that for young women with early, hormone-sensitive breast cancer who remained pre-menopausal after chemotherapy, selective ovarian suppression reduces the risk of breast cancer recurrence.

In 2014, researchers presented the results of the SOFT clinical trial, conducted by the International Breast Cancer Study Group (IBSCG) under the BIG umbrella, at two major global oncology conferences: the American Society of Clinical Oncology (ASCO) Annual Meeting and the San Antonio Breast Cancer Symposium (SABCS). Results were also published online in the New England Journal of Medicine (

The new treatment combination reduced risk of disease recurrence by 35%

The drug tamoxifen has been the standard treatment after surgery for pre-menopausal women with hormone-sensitive breast cancer. However, the benefit of adding ovarian suppression to the tamoxifen treatment had been uncertain. SOFT showed that this group of women do benefit from adding ovarian suppression to tamoxifen, reducing the risk of recurrence by 22%, compared to tamoxifen alone. Even better results were achieved by treating this group of women with a combination of ovarian suppression and exemestane, an aromatase inhibitor. In this arm of the randomized trial, the risk of disease recurrence was reduced by 35%, compared to tamoxifen alone, resulting in 7 or 8 fewer women out of 100 having a breast cancer recurrence within 5 years.

The benefit of adding ovarian suppression to tamoxifen was most pronounced in women younger than 35, an age group at particularly high risk of recurrence. This benefit was even greater with exemestane plus ovarian suppression: after 5 years, 1-in-6 women under age 35 receiving exemestane plus ovarian suppression experienced further breast cancer, compared to 1-in-3 under age 35 receiving tamoxifen alone.

SOFT is the “Year’s Best” trial of 2014 (according to several articles in scientific publications)

These results will change clinical practice,” said study co-chair Prudence Francis, M.D., Head of Breast Medical Oncology, Peter MacCallum Cancer Centre, Australia. “For the youngest women with hormone-sensitive breast cancer, ovarian suppression will increasingly be recommended. For women who have not reached menopause and have hormone-sensitive breast cancer that carries sufficient risk of recurrence to warrant chemotherapy, doctors are likely to discuss the option of treatment with ovarian suppression plus an aromatase inhibitor as an alternative to tamoxifen.

* Sources: 1) Schapira, Lydia. Breast Cancer 2014: SOFT Proves Year’s Best. Medscape Oncology. 24 December 2014. 2) Sullivan, Michelle. What Was The Most Interesting Thing You Learned At The Meeting? Oncology Practice. 14 December 2014.