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SOLE

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IBCSG 35-07/BIG 1-07: SOLE

BCT Study Chair:

Jacquie Chirgwin

A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy, for postmenopausal women with hormone receptor-positive, node-positive early stage breast cancer.

international

4512

INTERNATIONAL

Total number of trial

participants internationally

australia & new zealand

372

AUSTRALIA & NEW ZEALAND

Total number of trial participants

in Australia and New Zealand

institutions

27

INSTITUTIONS

Total number of participating institutions

in Australia and New Zealand

SOLE PUBLICATIONS

2021

Continuous versus intermittent extended adjuvant letrozole for breast cancer: final results of randomized phase III SOLE (Study of Letrozole extension) and SOLE Estrogen Substudy.

Jerusalem G, Farah S, Courtois A, Chrigwin J, Aebi S, Karlsson P, Neven P, Hitre E, Graas MP, Simoncini E, Abdi E, Kamby C, Thompson A, Loible S, Gavila J, Kuroi K, Marth C, Muller B, O’Reilly S, Gombos A, Ruhstaller T, Burstein HJ, Rabaglio M, Ruepp B, Ribi K, Viale G, Gelber RD, Coates AS, Loi S, Goldhirsch A, Regan MM, Colleoni M, on behalf of the SOLE Investigators. Annals of Oncology. 2021; 32(10):1256-1266, https://doi.org/10.1016/j.annonc.2021.07.017, Journal

2020

Genomic aberrations and late recurrence in postmenopausal women with hormone receptor-positive early breast cancer: Results from the SOLE trial.

Guerini-Rocco E, Gray KP, Fumagalli C, Reforgiato MR, Leone I, Raviele PR, Munzone E, Kammler R, Neven P, Hitre E, Jerusalem G, Simoncini E, Gombos A, Deleu I, Karlsson P, Aebi S, Chirgwin J, Di Lauro V, Thompson A, Graas M-P, Barber M, Fontaine C, Loibl S, Gavila J, Kuroi K, Muller B, O’Reilly S, Di Leo A, Goldhirsch A, Viale G, Barberis M, Regan MM, Colleoni M. Clinical Cancer Research 2020; 20 Oct 2020epub ahead of print: doi: 10.1158/1078-0432.CCR-20-0126., E-pub

2019

SOLE (study of letrozole extension), a phase 3 randomized clinical trial of continuous vs intermittent letrozole in postmenopausal women who have received 4-6 years of adjuvant endocrine therapy for lymph node-positive, early breast cancer (BC): Final analysis and sole estrogen substudy (SOLE-EST).

Jerusalem G, Farah S, Chirgwin J, Aebi S, Karlsson P, Neven P, Hitre E, Graas M-P, Simoncini E, Kamby C, Thompson A, Loibl S, Gavila J, Kuroi K, Marth C, Muller B, O’Reilly S, Gombos A, Ruhstaller T, Burstein H, Rabaglio M, Ruepp B, Viale G, Gelber RD, Coates AS, Di Leo A, Goldhirsch A, Regan M, Colleoni M. SOLE Investigators and IBCSG. SABCS 2019; P5-12-01, Poster

Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial.

Ribi K, Luo W, Colleoni M, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Di Lauro V, Gomez HL, Ruhstaller T, Abdi E, Biganzoli L, Muller B, Barbeaux A, Graas M-P, Rabaglio M, Francis PA, Foukakis T, Pagani O, Graiff C, Vorobiof D, Maibach R, Di Leo A, Gelber RD, Goldhirsh A, Coates AS, Regan MM, Bernhard J on behalf of SOLE investigators. British Journal of Cancer. 2019; 120(10):259-267, (epub 10 Apr 19), E-pub

2018

Molecular alterations and late recurrence in postmeopausal women with hormone receptor-positive node-positive breast cancer (BC): Results from the "SOLE" trial.

Rocco EG, Gray KP, Munzone E, Fumagalli C, Reforgiato MR, Leone I, Kammler R, Viale G, Neven P, Hitre E, Jerusalem GHM, Somoncini E, Gombos A, Deleu I, Di Leo A, Goldhirxh A, Barberis M, Regan MM, Colleoni M. Journal of Clinical Oncology. 2018; 36(15_suppl):517, Poster

Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial.

Colleoni M, Luo W, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Hitre E, Graas MP, Simoncini E, Kamby C, Thompson A, Loibl S, Gavilá J, Kuroi K, Marth C, Müller B, O’Reilly S, Di Lauro V, Gombos A, Ruhstaller T, Burstein H, Ribi K, Bernhard J, Viale G, Maibach R, Rabaglio-Poretti M, Gelber RD, Coates AS, Di Leo A, Regan MM, Goldhirsch A; SOLE Investigators. Lancet Oncology. 2018; 19(1):127-138 (epub 17 November 2017), DOI:https://doi.org/10.1016/S1470-2045(17)30715-5, Journal