Bibliographical Reference

1. Breast International Group (BIG) 1-98 Collaborative Group., Thürlimann B, Keshaviah A, Coates AS, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Castiglione-Gertsch M, Gelber RD, Rabaglio M, Smith I, Wardley A, Price KN, Goldhirsch A.
A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer.
N Engl J Med. 2005 Dec 29;353(26):2747-57.
Erratum in: N Engl J Med. 2006 May 18;354(20):2200. Wardly, Andrew [corrected to Wardley, Andrew ]. PubMed [citation] PMID: 16382061


2. Coates AS, Keshaviah A, Thürlimann B, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Castiglione-Gertsch M, Gelber RD, Colleoni M, Láng I, Del Mastro L, Smith I, Chirgwin J, Nogaret JM, Pienkowski T, Wardley A, Jakobsen EH, Price KN, Goldhirsch A.
Five years of letrozole compared with tamoxifen as initial adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer:
update of study BIG 1-98. J Clin Oncol. 2007 Feb 10;25(5):486-92. Epub 2007 Jan 2. PubMed [citation] PMID: 17200148


3. Monnier AM. The Breast International Group 1-98 trial: big results for women with hormone-sensitive early breast cancer.
Expert Rev Anticancer Ther. 2007 May;7(5):627-34. Review. PubMed [citation] PMID: 17492927


4. Rasmussen BB, Regan MM, Lykkesfeldt AE, Dell'Orto P, Del Curto B, Henriksen KL, Mastropasqua MG, Price KN, Méry E, Lacroix-Triki M, Braye S, Altermatt HJ, Gelber RD, Castiglione-Gertsch M, Goldhirsch A, Gusterson BA, Thürlimann B, Coates AS, Viale G; BIG 1-98 Collaborative and International Breast Cancer Study Groups..
Adjuvant letrozole versus tamoxifen according to centrally-assessed ERBB2 status for postmenopausal women with endocrine-responsive early breast cancer:
supplementary results from the BIG 1-98 randomised trial. Lancet Oncol. 2008 Jan;9(1):23-8. Epub 2007 Dec 20. PubMed [citation] PMID: 18083065


5. Crivellari D, Sun Z, Coates AS, Price KN, Thürlimann B, Mouridsen H, Mauriac L, Forbes JF, Paridaens RJ, Castiglione-Gertsch M, Gelber RD, Colleoni M, Láng I, Del Mastro L, Gladieff L, Rabaglio M, Smith IE, Chirgwin JH, Goldhirsch A.
Letrozole compared with tamoxifen for elderly patients with endocrine-responsive early breast cancer: the BIG 1-98 trial. J Clin Oncol. 2008 Apr 20;26(12):1972-9.
doi: 10.1200/JCO.2007.14.0459. Epub 2008 Mar 10. PubMed [citation] PMID: 18332471


6. Viale G, Giobbie-Hurder A, Regan MM, Coates AS, Mastropasqua MG, Dell'Orto P, Maiorano E, MacGrogan G, Braye SG, Ohlschlegel C, Neven P, Orosz Z, Olszewski WP, Knox F, Thürlimann B, Price KN, Castiglione-Gertsch M, Gelber RD, Gusterson BA, Goldhirsch A; Breast International Group Trial 1-98..
Prognostic and predictive value of centrally reviewed Ki-67 labeling index in postmenopausal women with endocrine-responsive breast cancer: results from Breast International Group Trial
1-98 comparing adjuvant tamoxifen with letrozole. J Clin Oncol. 2008 Dec 1;26(34):5569-75. doi: 10.1200/JCO.2008.17.0829. Epub 2008 Nov 3. PubMed [citation] PMID: 18981464, PMCID: PMC2651094


7. Wardley AM. Understanding the BIG results: Insights from the BIG 1-98 trial analyses. Adv Ther.
2008 Dec;25(12):1257-75. doi: 10.1007/s12325-008-0128-5.
Review. PubMed [citation] PMID: 19096768


8. Design, conduct, and analyses of Breast International Group (BIG) 1-98: A randomized, double-blind, phase-III study comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive, early breast cancer.
Giobbie-Hurder A, Price KN, Gelber RD.
Clinical trials (London, England). 2009 Jun; 6(3): 272-287 PMC [article] PMCID: PMC2893024, PMID: 19528136, DOI: 10.1177/1740774509105380


9. Viale G, Giobbie-Hurder A, Gusterson BA, Maiorano E, Mastropasqua MG, Sonzogni A, Mallon E, Colleoni M, Castiglione-Gertsch M, Regan MM, Price KN, Brown RW, Golouh R, Crivellari D, Karlsson P, Ohlschlegel C, Gelber RD, Goldhirsch A, Coates AS.
Adverse prognostic value of peritumoral vascular invasion: is it abrogated by adequate endocrine adjuvant therapy? Results from two International Breast Cancer Study Group randomized trials of chemoendocrine adjuvant therapy for early breast cancer. Ann Oncol. 2010 Feb;21(2):245-54. doi: 10.1093/annonc/mdp317. Epub 2009 Jul 24. PubMed [citation] PMID: 19633051, PMCID: PMC2813305


10. BIG 1-98 Collaborative Group., Mouridsen H, Giobbie-Hurder A, Goldhirsch A, Thürlimann B, Paridaens R, Smith I, Mauriac L, Forbes J, Price KN, Regan MM, Gelber RD, Coates AS. Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer. N Engl J Med. 2009 Aug 20;361(8):766-76. doi:
10.1056/NEJMoa0810818. PubMed [citation] PMID: 19692688, PMCID: PMC2921823


11. Viale G, Regan MM, Dell'Orto P, Mastropasqua MG, Maiorano E, Rasmussen BB, MacGrogan G, Forbes JF, Paridaens RJ, Colleoni M, Láng I, Thürlimann B, Mouridsen H, Mauriac L, Gelber RD, Price KN, Goldhirsch A, Gusterson BA, Coates AS; BIG 1-98 Collaborative and International Breast Cancer Study Groups.
Which patients benefit most from adjuvant aromatase inhibitors? Results using a composite measure of prognostic risk in the BIG 1-98 randomized trial.
Ann Oncol. 2011 Oct;22(10):2201-7. doi: 10.1093/annonc/mdq738. Epub 2011 Feb 18. PMID: 21335417; PMCID: PMC3179413.


12. Regan MM, Price KN, Giobbie-Hurder A, Thürlimann B, Gelber RD; International Breast Cancer Study Group and BIG 1-98 Collaborative Group..
Interpreting Breast International Group (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. Breast Cancer Res. 2011 May 26;13(3):209. doi: 10.1186/bcr2837. Review. PubMed [citation] PMID: 21635709, PMCID: PMC3218925


13. Chirgwin J, Sun Z, Smith I, Price KN, Thürlimann B, Ejlertsen B, Bonnefoi H, Regan MM, Goldhirsch A, Coates AS; BIG 1-98 Collaborative and International Breast Cancer Study Groups..
The advantage of letrozole over tamoxifen in the BIG 1-98 trial is consistent in younger postmenopausal women and in those with chemotherapy-induced menopause. Breast Cancer Res Treat. 2012 Jan;131(1):295-306.
doi: 10.1007/s10549-011-1741-6. Epub 2011 Sep 4. PubMed [citation] PMID: 21892704, PMCID: PMC4802157


14. Regan MM, Neven P, Giobbie-Hurder A, Goldhirsch A, Ejlertsen B, Mauriac L, Forbes JF, Smith I, Láng I, Wardley A, Rabaglio M, Price KN, Gelber RD, Coates AS, Thürlimann B; BIG 1-98 Collaborative Group.; International Breast Cancer Study Group (IBCSG).. Assessment of letrozole and tamoxifen alone and in sequence for postmenopausal women with steroid hormone receptor-positive breast cancer:
the BIG 1-98 randomised clinical trial at 8·1 years median follow-up. Lancet Oncol.
2011 Nov;12(12):1101-8. doi: 10.1016/S1470-2045(11)70270-4. Epub 2011 Oct 20.
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10.1007/s10549-013-2792-7. Epub 2013 Dec 5. PubMed [citation] PMID: 24305979,
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16. Metzger Filho O, Giobbie-Hurder A, Mallon E, Gusterson B, Viale G, Winer EP, Thürlimann B, Gelber RD, Colleoni M, Ejlertsen B, Debled M, Price KN, Regan MM, Coates AS, Goldhirsch A.
Relative Effectiveness of Letrozole Compared With Tamoxifen for Patients With Lobular Carcinoma in the BIG 1-98 Trial. J Clin Oncol. 2015 Sep 1;33(25):2772-9. doi: 10.1200/JCO.2015.60.8133. Epub 2015 Jul 27.
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17. Regan MM. Predicting benefit of endocrine therapy for early breast cancer.
Breast. 2015 Nov;24 Suppl 2:S129-31. doi: 10.1016/j.breast.2015.07.029. Epub 2015 Aug 5. PubMed [citation] PMID: 26255197, PMCID: PMC4641802


18. Ruhstaller T, Giobbie-Hurder A, Colleoni M, Jensen MB, Ejlertsen B, de Azambuja E, Neven P, Láng I, Jakobsen EH, Gladieff L, Bonnefoi H, Harvey VJ, Spazzapan S, Tondini C, Del Mastro L, Veyret C, Simoncini E, Gianni L, Rochlitz C, Kralidis E, Zaman K, Jassem J, et al. Adjuvant Letrozole and Tamoxifen Alone or Sequentially for Postmenopausal Women With Hormone Receptor-Positive Breast Cancer:
Long-Term Follow-Up of the BIG 1-98 Trial. J Clin Oncol. 2019 Jan 10;37(2):105-114. doi:
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1: Pagani O, Francis PA, Fleming GF, Walley BA, Viale G, Colleoni M, Láng I, Gómez HL, Tondini C, Pinotti G, Di Leo A, Coates AS, Goldhirsch A, Gelber RD, Regan MM;
SOFT and TEXT Investigators and International Breast Cancer Study Group. Absolute Improvements in Freedom From Distant Recurrence to Tailor Adjuvant Endocrine Therapies for Premenopausal Women:
Results From TEXT and SOFT. J Clin Oncol. 2020 Apr 20;38(12):1293-1303. doi: 10.1200/JCO.18.01967. Epub 2019 Oct 16. PMID: 31618131; PMCID: PMC7164485.


2: Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Láng I, Gómez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer CE Jr, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio-Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A, Regan MM;
SOFT and TEXT Investigators and the International Breast Cancer Study Group. Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. N Engl J Med. 2018 Jul 12;379(2):122-137. doi: 10.1056/NEJMoa1803164. Epub 2018 Jun 4. PMID: 29863451; PMCID: PMC6193457.


3: Regan MM, Francis PA, Pagani O, Fleming GF, Walley BA, Viale G, Colleoni M, Láng I, Gómez HL, Tondini C, Pinotti G, Price KN, Coates AS, Goldhirsch A, Gelber RD.
Absolute Benefit of Adjuvant Endocrine Therapies for Premenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer:
TEXT and SOFT Trials. J Clin Oncol. 2016 Jul 1;34(19):2221-31. doi: 10.1200/JCO.2015.64.3171. Epub 2016 Apr 4. PMID: 27044936; PMCID: PMC4962708.


4: Regan MM, Pagani O, Fleming GF, Walley BA, Price KN, Rabaglio M, Maibach R, Ruepp B, Coates AS, Goldhirsch A, Colleoni M, Gelber RD, Francis PA;
International Breast Cancer Study; GroupSOFT and TEXT Investigators. Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer:
design of the TEXT and SOFT trials. Breast. 2013 Dec;22(6):1094-100. doi: 10.1016/j.breast.2013.08.009. Epub 2013 Oct 2. PMID: 24095609; PMCID: PMC3855346.