BIG 1-98

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BIG 1-98/IBCSG 18-98: Adjuvant Letrozole

BCT Study Chair:

Jacquie Chirgwin

A phase III study to evaluate Letrozole as adjuvant endocrine therapy for postmenopausal women with receptor (ER and/or PgR) positive tumours.

5526

INTERNATIONAL

Total number of trial

participants internationally

667

AUSTRALIA & NEW ZEALAND

Total number of trial participants

in Australia and New Zealand

29

INSTITUTIONS

Total number of participating institutions

in Australia and New Zealand

BIG 1-98 PUBLICATIONS

2022

Historical early treatment effects of adjuvant endocrine therapy for breast cancer in high-risk subgroups: Reanalysis of BIG 1-98, SOFT and TEXT.

Regan MM, Niman SM, Fleming GF, Walley B, Viale G, Thurlimann BJK, Loi S, Colleoni M, Pagani O, Francis PA. Journal of Clinical Oncology. 2022; 40(16 suppl):ASCO Abstract #508, Abstract

2020

Clinical behavior of recurrent hormone receptor-positive breast cancer by adjuvant endocrine therapy within the Breast International Group 1-98 Clinical Trial.

Leone JP, Cole BF, Regan MM, Thurlimann B, Coates AS, Rabaglio M, Giobbie-Hurder A, Gelber RD, Ejlertsen B, Harvey VJ, Neven P, Lang I, Bonnefoi H, Wardley An, Goldhirsch A, Di Leo A, Colleoni M, Vaz-Luis I, Lin NU. Cancer. 2020; epub 08 December 2020 E-pub

Cumulative incidence of cardiovascular events under tamoxifen and letrozole alone and in sequence: a report from the BIG 1-98 trial.

Rabaglio M, Sun Z, Maibach R, Giobbie-Hurder A, Ejlertsen B, Harvey VJ, Neven P, Láng I, Bonnefoi H, Wardley A, Ruepp B, Castiglione M, Coates AS, Gelber RD, Goldhirsch A, Colleoni M, Thürlimann B, Regan MM. Breast Cancer Research and Treatment. 2020; 07 Nov 2020. epub ahead of print:doi: 10.1007/s10549-020-05981-z., E-pub

Identifying oncogenic drivers associated with increased risk of late distant recurrence in post-menopausal, estrogen receptor-positive, HER2-negative early breast cancer: results from the BIG 1-98 study.

Luen SJ, Asher R, Lee CK, Savas P, Kammler R, Dell’Orto P, Biasi M, Demanse D, Hackl W, Thurlimann B, Viale G, Di Leo A, Colleoni M, Regan* MM, Loi* S (*Co-last authors). Annals of Oncology. 2020; epub 8 July 2020https://doi.org/10.1016/j.annonc.2020.06.024, E-pub

2019

Clinical and analytical validation of Ki-67 in 9069 patients from IBCSG VIII + IX, BIG1-98 and GeparTrio trial: systematic modulation of interobserver variance in a comprehensive in silico ring trial.

Denkert C, Budczies J, Regan MM, Loibl S, Dell’Orto P, von Minckwitz G, Mastropasqua MG, Solbach C, Thürlimann B, Mehta K, Blohmer JU, Colleoni M, Müller V, Klauschen F, Ataseven B, Engels K, Kammler R, Pfitzner BM, Dietel M, Fasching PA, Viale G. Breast Cancer Research and Treatment. 2019; 176(3):557-568, doi: 10.1007/s10549-018-05112-9, Journal

Independent validation of EarlyR gene signature in BIG 1-98: A randomized, double-blind, phase III trial comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive, early breast cancer.

Buechler S, Gray KP, Gökmen-Polar Y, Willis S, Thürlimann B, Kammler R, Viale G, Leyland-Jones B, Badve* SS, Regan* MM. * Co-last authors. JNCI Cancer Spectrum. 2019; epub 16 August 2019, E-pub

BIG 1-98