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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

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. The Lancet. 2024; 4041407-18, epub 12 October 2024, E-pub

Breast cancer index in premenopausal women with early-stage hormone receptor-positive breast cancer.

O’Regan RM, Zhang Y, Fleming GF, Francis PA, Kammler R, Viale G, Dell’Orto P, Lang I, Bellet M, Bonnefoi HR, Tondini C, Villa F, Bernardo A, Ciruelos EM, Neven P, Karlsson P, Muller B, Jochm W, Zaman K, Marino S, Geyer CE, Jerzak KJ, Davidson NE, Coleman RI, Ingle JN, van Mackelenbergh MR, Loi S, Colleoni M, Schnabel CA. JAMA Oncology. 2024; epub 15 August 2024; doi:10.1001/jamaoncol.2024.3044, E-pub

2023

Evaluation of PAM50 intrinsic subtypes and risk of recurrence (ROR) scores in pre-menopausal women with early-stage HR+ breast cancer: A secondary analysis of the SOFT trial.

Brown LC, Luen SJ, Molania R, Caramia F, Savas P, VanGeelen C, Chic N, Fleming GF, Kammler R, Colleoni M, Viale G, Speed TP, Regan MM, Francis PA, Loi S. Journal of Clinical Oncology 2023; 41(suppl 16):Oral Abstract 504, Abstract

Genomic characterisation of hormone receptor-positive breast cancer arising in young women.

Luen SJ, Viale G, Nik-Zainal S, Savas P, Kammler R, Dell’Orto P, Biasi O, Degasperi A, Brown LC, Lang I, MacGrogan G, Tondini C, Bellet M, Villa F, Bernardo A, Ciruelos E, Karlsson P, Neven P, Climent M, Muller B, Joshum W, Bonnefoi H, Martino S, Davidson NE, Geyer CE Jr, Walley BA, Ingle JN, Coleman R, Solbach C, Thurlimann B, Colleoni M, Coates AS, Goldhirsch A, Fleming GF, Francis PA, Speed TP, Regan MM, Loi S. Annals of Oncology. 2023; epub 25 January 2023, doi: 10.1016/j.annonc.2023.01.009;, E-pub

2022

Adjuvant exemestane with ovarian suppression in premenopausal breast cancer: long-term follow-up of the combined TEXT and SOFT trials.

Pagani* O, Walley* BA, Francis GF, Colleoni M, Láng I, Gomez Hl, Tondini C, Burstein HJ, Goetz MP, Ciruelos EM, Stearns V, Bonnefoi HR, Martino S, Geyer CE Jr, Chini C, Puglisi F, Spazzapan S, Ruhstaller T, Winder EP, Ruepp B, Loi S, Coates AS, Gelber RD, Goldhirsch A, Regan** MM, Francis** PA, for the SOFT and TEXT Investigators and the International Breast Cancer Study Group. *Co-lead authors. **Co-last authors. Journal of Clinical Oncology. 2022; Epub 15 December 2022. doi: 10.1200/JCO.22.01064, E-pub

Adjuvant endocrine therapy in premenopausal breast cancer: 12-year results from SOFT.

Francis* PA, Fleming* GF, Láng I, Ciruelos EM, Bonnefoi HR, Bellet M, Bernardo A, Climent MA, Martino S, Bermejo B, Burstein HJ, Davidson NE, Geyer CE Jr, Walley BA, Ingle, JN, Coleman RE, Müller B, Le Du F, Loibl S, Winer EP, Ruepp B, Loi S, Colleoni M, Coates AS, Gelber RD, Goldhirsch A, Regan MM, for the SOFT Investigators and the International Breast Cancer Study Group. *Co-lead authors. Journal of Clinical Oncology. 2022; Epub 9 December 2022. doi: 10.1200/JCO.22.01065., E-pub

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