• 22% risk reduction of developing invasive breast cancer with tamoxifen plus ovarian suppression, versus tamoxifen alone;
• Ovarian suppression was obtained entirely by monthly injections of triptorelin over 5 years for 81% of patients.
Paris (France), 12 December 2014 Ipsen today announced that the International Breast Cancer Study Group (IBCSG) presented results of the randomized phase III SOFT clinical trial at the 2014 San Antonio Breast Cancer Symposium.
Suppression of Ovarian Function Trial (SOFT) assessed the value of ovarian suppression in reducing breast cancer recurrence in young women receiving tamoxifen, and evaluated the role of the aromatase inhibitor exemestane plus ovarian suppression in this population. Ovarian suppression was obtained entirely by monthly injections of triptorelin (active ingredient of Ipsen’s Decapeptyl®) over 5 years for 81% of patients.
Treatment combining tamoxifen plus ovarian suppression reduced the relative risk of developing invasive breast cancer recurrence by 22% in women who did not transition into menopause after receiving chemotherapy, when compared to treatment with tamoxifen alone. On average, these women were 40 years old when starting hormonal therapy after chemotherapy. A secondary analysis revealed that further benefit could be gained by treating these women with exemestane plus ovarian suppression, which reduced their relative risk of breast cancer recurrence by 35%, compared to tamoxifen alone, resulting in 7 or 8 fewer women out of 100 having a breast cancer recurrence within 5 years.
Prudence Francis, M.D., Head of Breast Medical Oncology, Peter MacCallum Cancer Centre, Australia stated: “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.
Gini Fleming, M.D., Clinical Medical Oncology Breast Program Director, University of Chicago, USA added: “While ovarian suppression is not recommended for everyone, adding it to tamoxifen can reduce breast cancer recurrence in higher-risk patients who remain premenopausal after chemotherapy, particularly in women under the age of 35.”
Claude Bertrand, Executive Vice-President, Research & Development and Chief Scientific Officer of Ipsen stated: “Ipsen is very pleased to have participated in this landmark study, which could change clinical practice in breast cancer treatment. In addition to solid efficacy results, the SOFT study provides the largest clinical trial safety database for the long term use of triptorelin in women.”
More information can be found in SABCS Abstract S3-08 (SOFT Efficacy) and SABCS Abstract S3-09 (SOFT Quality of Life).
About the study
SOFT (Suppression of Ovarian Function Trial) enrolled more than 3,000 premenopausal women with hormone receptor-positive early-stage breast cancer and estradiol levels in the premenopausal range between December 2003 and April 2011. Trial treatment lasted 5 years and women continue to be followed for life to assess long-term prognosis and side effects. The trial is led by the International Breast Cancer Study Group (IBCSG), in partnership with the Breast International Group (BIG) and the North American Breast Cancer Group (NABCG), and supported by IBSCG, Pfizer, Ipsen and the U.S. National Cancer Institute (NCI).
SOFT was designed to assess the value of ovarian suppression in reducing breast cancer recurrence in young women receiving tamoxifen, and to assess the role of the aromatase inhibitor exemestane plus ovarian suppression in treating young women. Premenopausal women with estrogen and/or progesterone receptor-positive, breast cancer were randomly assigned to treatment with tamoxifen alone for 5 years, tamoxifen plus ovarian suppression for 5 years, or exemestane plus ovarian suppression for 5 years.
About triptorelin (active substance of Decapeptyl®)
Decapeptyl® is a peptide formulation for injection to be used mainly in the treatment of locally advanced or metastatic prostate cancer. Additional indications developed subsequently include the treatment of uterine fibroids (a benign tumour of muscle tissues in the uterus), endometriosis (proliferation of endometrial tissue, the mucous membrane that lines the uterine wall outside the reproductive tract) after surgery or when surgery is not deemed appropriate, as well as early onset puberty and female infertility (in vitro fertilisation). The active substance in Decapeptyl® is triptorelin pamoate or acetate, a decapeptide analogue of GnRH (Gonadotrophin Releasing Hormone), a hormone secreted by the hypothalamus, which initially stimulates the release of pituitary gonadotrophins (hormones produced by the pituitary gland), which in turn control hormonal secretions by the testicules and ovaries. Administration of triptorelin results in the suppression of the GnRH activity leading to menopause in women and hormonal castration in men. The formulations of Decapeptyl® marketed by the Ipsen Group include a daily formulation, onemonth, three-month and six-month formulations.
Ipsen (ipsen.com) is a global specialty-driven pharmaceutical company with total sales exceeding €1.2 billion in 2013. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by 3 franchises: neurology, endocrinology and uro-oncology. Moreover, the Group has an active policy of partnerships. Ipsen's R&D is focused on its innovative and differentiated technological platforms, peptides and toxins. In 2013, R&D expenditure totaled close to €260 million, representing more than 21% of Group sales. Moreover, Ipsen also has a significant presence in primary care. The Group has close to 4,600 employees worldwide. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY.
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