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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

2025

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

Genomic Characterization and Prognostic Significance of Human Epidermal Growth Factor Receptor 2–Low, Hormone Receptor–Positive, Early Breast Cancers from the BIG 1-98 and SOFT Clinical Trials.

Luen SJ, Brown LC, van Geelen CT, Savas P, Kammler R, Dell’Orto P, Biasi O, Coates AS, Gelber RD, Thuerlimann B, Colleoni M, Fleming GF, Francis PA, Regan MM, Viale G, Loi S. JCO Precision Oncology. 2025; 9, e2400599(2025).:1-12, E-pub

2024

Effect of obesity in premenopausal ER+ early breast cancer: EBCTCG data on 80,000 patients in 70 trials.

Pan H, Gray R, on behalf of the EBCTCG. Journal of Clinical Oncology. 2024; 32:5s(SABCS 2024), [Abstract Number SESS-1911; GS2-09], Abstract

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

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Institutions