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SOFT

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IBCSG 24-02/BIG 2-02: SOFT

BCT Study Chair:

Prue Francis

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.

international

2826

INTERNATIONAL

Total number of trial

participants internationally

australia & new zealand

240

AUSTRALIA & NEW ZEALAND

Total number of trial participants

in Australia and New Zealand

institutions

51

INSTITUTIONS

Total number of participating institutions

in Australia and New Zealand

SOFT PUBLICATIONS

2026

Final outcomes of the SOFT and TEXT phase III trials in premenopausal hormone receptor-positive early breast cancer.

Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Rubovszky G, Tondini C, Ciruelos EM, Gomez HL, Bonnefoi HR, Burstein HJ, Chini C, Puglisi F, Spazzapan S, Bernardo A, Climent MA, Bellet M, Ruhstaller T, Bermejo B, Chia SKL, Martino S, Geyer CE, Goetz MP, Ingle JN, Stearns V, Davidson NE, Le Du F, Muller B, Coleman RE, Loible S, Winer EP, Ruepp B, Loi S, Lang I, Coates AS, Gelber RD, Goldhirsch A & Regan MM, for the IBSCG, and the SOFT and TEXT Investigators. Annals of Oncology. Published online 01 June 2026. 2026; 1-19, DOI: 10.1016/j.annonc.2026.05.704, Journal

Effects of ovarian ablation or suppression on breast cancer recurrence and survival: patient-level meta-analysis of 15000 women in 23 randomised trials.

Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). The Lancet 2026; 4071699-16711, E-pub

Identifying premenopausal patients with early-stage hormone receptor-positive breast cancer at minimal risk of distant recurrence by breast cancer index.

O’Regan RM, Ren Y, Zhang Y, Fleming GF, Francis PA, Pagani O, Walley BA, Kammler R, Dell’Orto P, Viale G, Loi S, Colleoni M, Treuner K, Regan MM. The Breast 2026; 86: 104714:doi: 10.1016/j.breast.2026.104714, pub ahead of print 29 January 2026, E-pub

2025

Assessment of adjuvant endocrine therapy with ovarian function suppression by Breast Cancer Index.

O’Regan RM, Ren Y, Zhang Y, Siuliukina N, Schnabel CA, Kammler R, Viale G, Dell’Orto P, Munzone E, Lang I, Tondini C, Gomez HL, Chini C, Nicoletti SVL, Puglisi F, Zaman K, Goetz MP, Stearns V, Martino S, Salim M, Loibl S, Geyer CE, Bennefoi HR, Ciruelos EV, Loi S, Colleoni M, Fleming GF, Francis PA, Walley BA, Pagani O, Treuner K, Regan MM. JAMA Network Open. 2025; 8(11):e2540931, doi:10.1001/jamanetworkopen.2025.40931, E-pub

Prognostic value of patient-reported depression in women with hormone-responsive early breast cancer in TEXT and SOFT.

Ribi K, Cole BF, Fleming GF, Walley BA, Francis PA, Abdi E, Burstein HJ, Cheng KL, Chia SKL, Dakhil SR, Davidson NE, Della-Fiorentina SA, Frith AE, Levine E, Lupichick S, Pritchard K, Salim M, Stearns V, Stewart J, Valero V, dan der Westhuizen A, Pagani O, Loi S, Colleoni M, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J. Cancer 2025; 131(19):e70094, doi: 10.1002/cncr.70094, E-pub

15-year outcomes for women with premenopausal hormone receptor-positive early breast cancer (BC) in the SOFT and TEXT trials assessing benefits from adjuvant exemestane (E) + ovarian function suppression (OFS) or tamoxifen (T)+OFS.

Francis PA, Fleming GF, Pagani O, Walley B, Loi S, Colleoni M, Regan MM, on behalf of SOFT and TEXT Investigators, IBCSG, BIG and North American BC Groups. Journal of Clinical Oncology. 2025; 43(16 suppl):ASCO Abs505. DOI: 10.1200/JCO.2025.43.16_suppl.505, Presentation

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