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IBCSG 25-02/BIG 3-02: TEXT

BCT Study Chair:

Prue Francis

A phase III trial evaluating the role of exemestane plus GnRH analogue as adjuvant therapy for premenopausal women with endocrine responsive breast cancer.

international

2423

INTERNATIONAL

Total number of trial

participants internationally

australia & new zealand

249

AUSTRALIA & NEW ZEALAND

Total number of trial participants

in Australia and New Zealand

institutions

24

INSTITUTIONS

Total number of participating institutions

in Australia and New Zealand

TEXT 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

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

Assessment of ovarian function suppression (OFS)-containing adjuvant endocrine therapy in premenopausal women by Breast Cancer Index.

O’Regan R, Ren Y, Zhang Y, Siuliukina N, Schnabel CA, Kammler R, Viale G, Dell’Orto P, Panagi O, Walley B, Fleming GF, Francis PA, Loi S, Colleoni M, Treuner K, Regan MM. Journal of Clinical Oncology. 2025; 43(16 suppl).:ASCO Abs557. DOI: 10.1200/JCO.2025.43.16_suppl.557, Abstract

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

2024

Reductions in recurrence in women with early breast cancer entering clinical trials between 1990 and 2009: a pooled analysis of 155,746 women in 151 trials.

Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Lancet 2024; 404(10461):1407-1418, epub 12 October 2024, Journal

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