- Title
- Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer: design of the TEXT and SOFT trials
- Creator
- Regan, Meredith M.; Pagani, Olivia; Colleoni, Marco; Gelber, Richard D.; Francis, Prudence A.; International Breast Cancer Study Group (IBCSG),; SOFT Investigators,; TEXT Investigators,; Fleming, Gini F.; Walley, Barbara A.; Price, Karen N.; Rabaglio, Manuela; Maibach, Rudolf; Ruepp, Barbara; Coates, Alan S.; Goldhirsch, Aron
- Relation
- The Breast Vol. 22, Issue 6, p. 1094-1100
- Publisher Link
- http://dx.doi.org/10.1016/j.breast.2013.08.009
- Publisher
- Elsevier
- Resource Type
- journal article
- Date
- 2013
- Description
- Objectives: In 2003 the International Breast Cancer Study Group (IBCSG) initiated the TEXT and SOFT randomized phase III trials to answer two questions concerning adjuvant treatment for premenopausal women with endocrine-responsive early breast cancer: 1-What is the role of aromatase inhibitors (AI) for women treated with ovarian function suppression (OFS)? 2-What is the role of OFS for women who remain premenopausal and are treated with tamoxifen? Methods: TEXT randomized patients to receive exemestane or tamoxifen with OFS. SOFT randomized patients to receive exemestane with OFS, tamoxifen with OFS, or tamoxifen alone. Treatment was for 5 years from randomization. Results: TEXT and SOFT successfully met their enrollment goals in 2011. The 5738 enrolled women had lower-risk disease and lower observed disease-free survival (DFS) event rates than anticipated. Consequently, 7 and 13 additional years of follow-up for TEXT and SOFT, respectively, were required to reach the targeted DFS events (median follow-up about 10.5 and 15 years). To provide timely answers, protocol amendments in 2011 specified analyses based on chronological time and median follow-up. To assess the AI question, exemestane + OFS versus tamoxifen + OFS, a combined analysis of TEXT and SOFT became the primary analysis (n = 4717). The OFS question became the primary analysis from SOFT, assessing the unique comparison of tamoxifen + OFS versus tamoxifen alone (n = 2045). The first reports are anticipated in mid- and late-2014. Conclusions: We present the original designs of TEXT and SOFT and adaptations to ensure timely answers to two questions concerning optimal adjuvant endocrine treatment for premenopausal women with endocrine-responsive breast cancer.
- Subject
- premenopausal; endocrine-responsive; early breast cancer; adjuvant therapy; trial design
- Identifier
- http://hdl.handle.net/1959.13/1043213
- Identifier
- uon:14183
- Identifier
- ISSN:0960-9776
- Language
- eng
- Full Text
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