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Clinical Trial
. 2013 Dec;22(6):1094-100.
doi: 10.1016/j.breast.2013.08.009. Epub 2013 Oct 2.

Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer: design of the TEXT and SOFT trials

Meredith M Regan  1 , Olivia Pagani, Gini F Fleming, Barbara A Walley, Karen N Price, Manuela Rabaglio, Rudolf Maibach, Barbara Ruepp, Alan S Coates, Aron Goldhirsch, Marco Colleoni, Richard D Gelber, Prudence A Francis; International Breast Cancer Study; GroupSOFT and TEXT Investigators
Affiliations
Clinical Trial

Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer: design of the TEXT and SOFT trials

Meredith M Regan et al. Breast. 2013 Dec.

Abstract

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. Trial Registration TEXT: Clinicaltrials.govNCT00066703 SOFT: Clinicaltrials.govNCT00066690.

Keywords: Adjuvant therapy; Early breast cancer; Endocrine-responsive; Premenopausal; Trial design.

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Conflict of interest statement

CONFLICTS OF INTEREST

None of the authors have any conflicts to declare.

Figures

Fig. 1
Fig. 1
Designs for the TEXT (IBCSG 25-02/BIG 3-02) and SOFT (IBCSG 24-02/BIG 2- 02) international, randomized phase III clinical trials Abbreviations: TEXT=Tamoxifen and Exemestane Trial; SOFT=Suppression of Ovarian Function Trial; Chemo=chemotherapy; OFS=ovarian function suppression; i.m.=intramuscular; p.o.=by mouth
Fig. 2
Fig. 2
Enrollment in the TEXT and SOFT trials. (A) TEXT: Between November 2003 and April 2011, TEXT enrolled 2672 patients; enrollment was suspended 1 December 2007 and re-opened by protocol amendment released in July 2008, with enrollment restarted in December 2008. (B) SOFT: Between December 2003 and January 2011, SOFT enrolled 3066 patients; as of January 2010 enrollment was limited to sites participating in substudies. Abbreviations: TEXT=Tamoxifen and Exemestane Trial; SOFT=Suppression of Ovarian Function Trial.
Fig. 3
Fig. 3
The two planned primary efficacy analyses to answer questions concerning adjuvant treatment for premenopausal women with endocrine-responsive early breast cancer: (A) What is the role of aromatase inhibitors? Comparison of exemestane+OFS versus tamoxifen+OFS by combining the common treatment arms of the TEXT and SOFT trials (N=4717 randomized). (B) What is the role of OFS for women who remain premenopausal? Comparison of tamoxifen+OFS versus tamoxifen alone in SOFT (N=2045 randomized) Abbreviations: TEXT=Tamoxifen and Exemestane Trial; SOFT=Suppression of Ovarian Function Trial; Chemo=chemotherapy; OFS=ovarian function suppression
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References

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