Group Administrators Office
|Canadian Cancer Trials Group MAC.4 / IBCSG 24-02 - A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer (SOFT - Suppression of Ovarian Function Trial)
The International Breast Cancer Study Group (IBSCG) presented results of the randomized, phase III SOFT clinical trial at the 2014 San Antonio Breast Cancer Symposium (SABCS) and published the results online in the New England Journal of Medicine.
They found that the addition of ovarian suppression to adjuvant treatment (post-surgery) with tamoxifen reduced breast cancer recurrence in young women with hormone-sensitive early breast cancer who received chemotherapy and had not reached menopause. The addition of ovarian suppression to tamoxifen did not benefit all young women.
"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."
The Canadian Cancer Trials Group enrolled 133 patients from 20 centres onto the trial. The Canadian study chair is Dr. Barbara Walley from the Tom Baker Cancer Centre in Calgary, Alberta.
You can find more information about these results on IBCSG's website at http://www.ibcsg.org/News/Pages/sabcs2014.aspx.
Here also is the link to the NEJM publication ... http://www.nejm.org/doi/full/10.1056/NEJMoa1412379.
The results of the combined analysis of SOFT and MAC.5 (IBCSG 25-02) Tamoxifen and Exemestane Trial (TEXT) were also published earlier this year in the New England Journal of Medicine (http://www.nejm.org/doi/full/10.1056/NEJMoa1404037#t=articleBackground).
Canadian Cancer Trials Group MA.27 - A Randomized Phase III Trial of Exemestane versus Anastrozole in Postmenopausal Women with Receptor Positive Primary Breast Cancer
Stearns V, Chapman JA, Ma CX, Ellis MJ, Ingle JN, Pritchard KI, Budd GT, Rabaglio M, Sledge GW, Le Maitre A, Kundapur J, Liedke PER, Shepherd LE, Goss PE. Treatment-Associated Musculoskeletal and Vasomotor Symptoms and Relapse-Free Survival in the Canadian Cancer Trials Group MA.27 Adjuvant Breast Cancer Aromatase Inhibitor Trial (ONLINE). J Clin Oncol 2014.