Skip to main content
Top
Published in: Breast Cancer Research 3/2011

01-06-2011 | Review

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

Authors: Meredith M Regan, Karen N Price, Anita Giobbie-Hurder, Beat Thürlimann, Richard D Gelber, for the International Breast Cancer Study Group and BIG 1-98 Collaborative Group

Published in: Breast Cancer Research | Issue 3/2011

Login to get access

Abstract

The Breast International Group (BIG) 1-98 study is a four-arm trial comparing 5 years of monotherapy with tamoxifen or with letrozole or with sequences of 2 years of one followed by 3 years of the other for postmenopausal women with endocrine-responsive early invasive breast cancer. From 1998 to 2003, BIG -98 enrolled 8,010 women. The enhanced design f the trial enabled two complementary analyses of efficacy and safety. Collection of tumor specimens further enabled treatment comparisons based on tumor biology. Reports of BIG 1-98 should be interpreted in relation to each individual patient as she weighs the costs and benefits of available treatments.
Clinicaltrials.gov ID: NCT00004205.
Appendix
Available only for authorised users
Literature
1.
go back to reference BIG 1-98 Collaborative Group: A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med. 2005, 353: 2747-2757.CrossRef BIG 1-98 Collaborative Group: A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med. 2005, 353: 2747-2757.CrossRef
2.
go back to reference 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, Jacobsen 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, 25: 486-492. 10.1200/JCO.2006.08.8617.CrossRefPubMed 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, Jacobsen 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, 25: 486-492. 10.1200/JCO.2006.08.8617.CrossRefPubMed
3.
go back to reference Forbes JF, Cuzick J, Buzdar A, Howell A, Tobias JS, Baum M: Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial. Lancet Oncol. 2008, 9: 45-53.CrossRefPubMed Forbes JF, Cuzick J, Buzdar A, Howell A, Tobias JS, Baum M: Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial. Lancet Oncol. 2008, 9: 45-53.CrossRefPubMed
4.
go back to reference Jakesz R, Jonat W, Gnant M, Mittlboeck M, Greil R, Tausch C, Hilfrich J, Kwasny W, Menzel C, Samonigg H, Seifert M, Gademann G, Kaufmann M, Wolfgang J, ABCSG and the GABG: Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial. Lancet. 2005, 366: 455-462. 10.1016/S0140-6736(05)67059-6.CrossRefPubMed Jakesz R, Jonat W, Gnant M, Mittlboeck M, Greil R, Tausch C, Hilfrich J, Kwasny W, Menzel C, Samonigg H, Seifert M, Gademann G, Kaufmann M, Wolfgang J, ABCSG and the GABG: Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial. Lancet. 2005, 366: 455-462. 10.1016/S0140-6736(05)67059-6.CrossRefPubMed
5.
go back to reference Kaufmann M, Jonat W, Hilfrich J, Eidtmann H, Gademann G, Zuna I, von Minckwitz G: Improved overall survival in postmenopausal women with early breast cancer after anastrozole initiated after treatment with tamoxifen compared with continued tamoxifen: the ARNO 95 study. J Clin Oncol. 2007, 25: 2664-2670. 10.1200/JCO.2006.08.8054.CrossRefPubMed Kaufmann M, Jonat W, Hilfrich J, Eidtmann H, Gademann G, Zuna I, von Minckwitz G: Improved overall survival in postmenopausal women with early breast cancer after anastrozole initiated after treatment with tamoxifen compared with continued tamoxifen: the ARNO 95 study. J Clin Oncol. 2007, 25: 2664-2670. 10.1200/JCO.2006.08.8054.CrossRefPubMed
6.
go back to reference Boccardo F: Switching to anastrozole after tamoxifen improves survival in postmenopausal women with breast cancer. Nat Clin Pract Oncol. 2008, 5: 76-77.CrossRefPubMed Boccardo F: Switching to anastrozole after tamoxifen improves survival in postmenopausal women with breast cancer. Nat Clin Pract Oncol. 2008, 5: 76-77.CrossRefPubMed
7.
go back to reference Coombes RC, Kilburn LS, Snowdon CF, Paridaens R, Coleman RE, Jones SE, Jassem J, Van de Velde CJ, Delozier T, Alvarez I, Del Mastro L, Ortmann O, Diedrich K, Coates AS, Bajetta E, Holmberg SB, Dodwell D, Mickiewicz E, Andersen J, Lønning PE, Cocconi G, Forbes J, Castiglione M, Stuart N, Stewart A, Fallowfield LJ, Bertelli G, Hall E, Bogle RG, Carpentieri M, Colajori E, Subar M, Ireland E, Bliss JM, Intergroup Exemestane Study: Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial. Lancet. 2007, 369: 559-70. 10.1016/S0140-6736(07)60200-1.CrossRefPubMed Coombes RC, Kilburn LS, Snowdon CF, Paridaens R, Coleman RE, Jones SE, Jassem J, Van de Velde CJ, Delozier T, Alvarez I, Del Mastro L, Ortmann O, Diedrich K, Coates AS, Bajetta E, Holmberg SB, Dodwell D, Mickiewicz E, Andersen J, Lønning PE, Cocconi G, Forbes J, Castiglione M, Stuart N, Stewart A, Fallowfield LJ, Bertelli G, Hall E, Bogle RG, Carpentieri M, Colajori E, Subar M, Ireland E, Bliss JM, Intergroup Exemestane Study: Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial. Lancet. 2007, 369: 559-70. 10.1016/S0140-6736(07)60200-1.CrossRefPubMed
8.
go back to reference Jonat W, Gnant M, Boccardo F, Kaufmann M, Rubagotti A, Zuna I, Greenwood M, Jakesz R: Effectiveness of switching from adjuvant tamoxifen to anastrozole in postmenopausal women with hormone-sensitive early stage breast cancer: a meta-analysis. Lancet Oncol. 2006, 7: 991-996. 10.1016/S1470-2045(06)70948-2.CrossRefPubMed Jonat W, Gnant M, Boccardo F, Kaufmann M, Rubagotti A, Zuna I, Greenwood M, Jakesz R: Effectiveness of switching from adjuvant tamoxifen to anastrozole in postmenopausal women with hormone-sensitive early stage breast cancer: a meta-analysis. Lancet Oncol. 2006, 7: 991-996. 10.1016/S1470-2045(06)70948-2.CrossRefPubMed
9.
go back to reference Dowsett M, Cuzick J, Ingle J, Coates A, Forbes J, Bliss J, Buyse M, Baum M, Buzdar A, Colleoni M, Coombes C, Snowdon C, Gnant M, Jakesz R, Kaufmann M, Boccardo F, Godwin J, Davies C, Peto R: Meta-analysis of breast cancer outcomes in adjuvant trials of aromatase inhibitors versus tamoxifen. J Clin Oncol. 2010, 28: 509-518. 10.1200/JCO.2009.23.1274.CrossRefPubMed Dowsett M, Cuzick J, Ingle J, Coates A, Forbes J, Bliss J, Buyse M, Baum M, Buzdar A, Colleoni M, Coombes C, Snowdon C, Gnant M, Jakesz R, Kaufmann M, Boccardo F, Godwin J, Davies C, Peto R: Meta-analysis of breast cancer outcomes in adjuvant trials of aromatase inhibitors versus tamoxifen. J Clin Oncol. 2010, 28: 509-518. 10.1200/JCO.2009.23.1274.CrossRefPubMed
10.
go back to reference Burstein HJ, Prestrud AA, Seidenfeld J, Anderson H, Buchholz TA, Davidson NE, Gelmon KE, Giordano SH, Hudis CA, Malin J, Mamounas EP, Rowden D, Solky AJ, Sowers MR, Stearns V, Winer EP, Somerfield MR, Griggs JJ, American Society of Clinical Oncology: American Society of Clinical Oncology clinical practice guideline: update on adjuvant endocrine therapy for women with hormone receptor-positive breast cancer. J Clin Oncol. 2010, 28: 3784-3796. 10.1200/JCO.2009.26.3756.CrossRefPubMed Burstein HJ, Prestrud AA, Seidenfeld J, Anderson H, Buchholz TA, Davidson NE, Gelmon KE, Giordano SH, Hudis CA, Malin J, Mamounas EP, Rowden D, Solky AJ, Sowers MR, Stearns V, Winer EP, Somerfield MR, Griggs JJ, American Society of Clinical Oncology: American Society of Clinical Oncology clinical practice guideline: update on adjuvant endocrine therapy for women with hormone receptor-positive breast cancer. J Clin Oncol. 2010, 28: 3784-3796. 10.1200/JCO.2009.26.3756.CrossRefPubMed
11.
go back to reference Goldhirsch A, Ingle JN, Gelber RD, Coates AS, Thürlimann B, Senn HJ, Panel members: Thresholds for therapies: highlights of the St. Gallen International Expert Consensus on the primary therapy of early breast cancer. Ann Oncol. 2009, 20: 1319-1329. 10.1093/annonc/mdp322.CrossRefPubMedPubMedCentral Goldhirsch A, Ingle JN, Gelber RD, Coates AS, Thürlimann B, Senn HJ, Panel members: Thresholds for therapies: highlights of the St. Gallen International Expert Consensus on the primary therapy of early breast cancer. Ann Oncol. 2009, 20: 1319-1329. 10.1093/annonc/mdp322.CrossRefPubMedPubMedCentral
12.
go back to reference BIG 1-98 Collaborative Group: Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer. N Engl J Med. 2009, 361: 766-776.CrossRef BIG 1-98 Collaborative Group: Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer. N Engl J Med. 2009, 361: 766-776.CrossRef
13.
go back to reference Colleoni M, Giobbie-Hurder A, Regan MM, Thürlimann B, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Láng I, Smith I, Chirgwin J, Pienkowski T, Wardley A, Price KN, Gelber RD, Coates AS, Goldhirsch A: Analyses adjusting for selective crossover show improved overall survival with adjuvant letrozole compared with tamoxifen in the BIG 1-98 study. J Clin Oncol. 2011, 29: 1117-1124. 10.1200/JCO.2010.31.6455.CrossRefPubMedPubMedCentral Colleoni M, Giobbie-Hurder A, Regan MM, Thürlimann B, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Láng I, Smith I, Chirgwin J, Pienkowski T, Wardley A, Price KN, Gelber RD, Coates AS, Goldhirsch A: Analyses adjusting for selective crossover show improved overall survival with adjuvant letrozole compared with tamoxifen in the BIG 1-98 study. J Clin Oncol. 2011, 29: 1117-1124. 10.1200/JCO.2010.31.6455.CrossRefPubMedPubMedCentral
14.
go back to reference Giobbie-Hurder A, Price KN, Gelber RD, for the International Breast Cancer Study Group and BIG 1-98 Collaborative Group: Design, conduct, and analyses of Breast International Group (BIG) 1-98: a randomized, doubleblind, phase-III study comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive, early breast cancer. Clinical Trials. 2009, 6: 272-286. 10.1177/1740774509105380.CrossRefPubMedPubMedCentral Giobbie-Hurder A, Price KN, Gelber RD, for the International Breast Cancer Study Group and BIG 1-98 Collaborative Group: Design, conduct, and analyses of Breast International Group (BIG) 1-98: a randomized, doubleblind, phase-III study comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive, early breast cancer. Clinical Trials. 2009, 6: 272-286. 10.1177/1740774509105380.CrossRefPubMedPubMedCentral
15.
go back to reference Koeberle D, Thuerlimann B: Letrozole as upfront endocrine therapy for postmenopausal women with hormone-sensitive breast cancer: BIG 1-98. Breast Cancer Res Treat. 2007, 105: 55-66.CrossRefPubMedPubMedCentral Koeberle D, Thuerlimann B: Letrozole as upfront endocrine therapy for postmenopausal women with hormone-sensitive breast cancer: BIG 1-98. Breast Cancer Res Treat. 2007, 105: 55-66.CrossRefPubMedPubMedCentral
16.
go back to reference Finkelstein DM, Schoenfeld DA: Correcting for discretionary treatment crossover in an analysis of survival in the Breast International Group BIG 1-98 Trial by using the inverse probability of censoring weighted method. J Clin Oncol. 2011, 29: 1093-1095. 10.1200/JCO.2010.33.9374.CrossRefPubMed Finkelstein DM, Schoenfeld DA: Correcting for discretionary treatment crossover in an analysis of survival in the Breast International Group BIG 1-98 Trial by using the inverse probability of censoring weighted method. J Clin Oncol. 2011, 29: 1093-1095. 10.1200/JCO.2010.33.9374.CrossRefPubMed
17.
go back to reference Robins JM, Finkelstein DM: Correcting for noncompliance and dependent censoring in an AIDS clinical trial with inverse probability of censoring weighted (IPCW) log rank tests. Biometrics. 2000, 56: 779-788. 10.1111/j.0006-341X.2000.00779.x.CrossRefPubMed Robins JM, Finkelstein DM: Correcting for noncompliance and dependent censoring in an AIDS clinical trial with inverse probability of censoring weighted (IPCW) log rank tests. Biometrics. 2000, 56: 779-788. 10.1111/j.0006-341X.2000.00779.x.CrossRefPubMed
18.
go back to reference Mauriac L, Keshaviah A, Debled M, Mouridsen H, Forbes JF, Thürlimann B, Paridaens R, Monnier A, Láng I, Wardley A, Nogaret J-M, Gelber RD, Castiglione-Gertsch M, Price KN, Coates AS, Smith I, Viale G, Rabaglio M, Zabaznyi N, Goldhirsh A, for the BIG 1-98 Collaborative and the International Breast Cancer Study Groups: Predictors of early relapse in postmenopausal women with hormone receptor positive breast cancer in the BIG 1-98 trial. Ann Oncol. 2007, 18: 859-867. 10.1093/annonc/mdm001.CrossRefPubMed Mauriac L, Keshaviah A, Debled M, Mouridsen H, Forbes JF, Thürlimann B, Paridaens R, Monnier A, Láng I, Wardley A, Nogaret J-M, Gelber RD, Castiglione-Gertsch M, Price KN, Coates AS, Smith I, Viale G, Rabaglio M, Zabaznyi N, Goldhirsh A, for the BIG 1-98 Collaborative and the International Breast Cancer Study Groups: Predictors of early relapse in postmenopausal women with hormone receptor positive breast cancer in the BIG 1-98 trial. Ann Oncol. 2007, 18: 859-867. 10.1093/annonc/mdm001.CrossRefPubMed
19.
go back to reference Viale G, Regan MM, Maiorano E, Mastropasqua MG, Dell'Orto P, Rasmussen BB, Raff oul J, Neven P, Orosz Z, Braye S, Oehlschlegel C, Thürlimann B, Gelber RD, Castiglione-Gertsch M, Price KN, Goldhirsch A, Gusterson BA, Coates AS: Prognostic and predictive value of centrally reviewed expression of estrogen and progesterone receptors in a randomized trial comparing letrozole and tamoxifen adjuvant therapy for postmenopausal women with early breast cancer: BIG 1-98. J Clin Oncol. 2007, 25: 3846-3852. 10.1200/JCO.2007.11.9453.CrossRefPubMed Viale G, Regan MM, Maiorano E, Mastropasqua MG, Dell'Orto P, Rasmussen BB, Raff oul J, Neven P, Orosz Z, Braye S, Oehlschlegel C, Thürlimann B, Gelber RD, Castiglione-Gertsch M, Price KN, Goldhirsch A, Gusterson BA, Coates AS: Prognostic and predictive value of centrally reviewed expression of estrogen and progesterone receptors in a randomized trial comparing letrozole and tamoxifen adjuvant therapy for postmenopausal women with early breast cancer: BIG 1-98. J Clin Oncol. 2007, 25: 3846-3852. 10.1200/JCO.2007.11.9453.CrossRefPubMed
20.
go back to reference Lazar AA, Cole BF, Bonetti M, Gelber RD: Evaluation of treatment-effect heterogeneity using biomarkers measured on a continuous scale: subpopulation treatment effect pattern plot. J Clin Oncol. 2010, 28: 4539-4544. 10.1200/JCO.2009.27.9182.CrossRefPubMedPubMedCentral Lazar AA, Cole BF, Bonetti M, Gelber RD: Evaluation of treatment-effect heterogeneity using biomarkers measured on a continuous scale: subpopulation treatment effect pattern plot. J Clin Oncol. 2010, 28: 4539-4544. 10.1200/JCO.2009.27.9182.CrossRefPubMedPubMedCentral
21.
go back to reference 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, for the BIG 1-98 Collaborative and the International Breast Cancer Study Groups: Adjuvant letrozole vs. 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. 2009, 9: 23-28.CrossRef 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, for the BIG 1-98 Collaborative and the International Breast Cancer Study Groups: Adjuvant letrozole vs. 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. 2009, 9: 23-28.CrossRef
22.
go back to reference Viale G, Giobbie-Hurder A, Regan MM, Coates AS, Mastropasqua MG, Dell'Orto P, Maiorano E, MacGrogan G, Braye SG, Öhlschlegel C, Neven P, Orosz Z, Olszewski WP, Knox F, Thürlimann B, Price KN, Castiglione-Gertsch M, Gelber RD, Gusterson BA, Goldhirsch A: 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, 26: 5569-5575. 10.1200/JCO.2008.17.0829.CrossRefPubMedPubMedCentral Viale G, Giobbie-Hurder A, Regan MM, Coates AS, Mastropasqua MG, Dell'Orto P, Maiorano E, MacGrogan G, Braye SG, Öhlschlegel C, Neven P, Orosz Z, Olszewski WP, Knox F, Thürlimann B, Price KN, Castiglione-Gertsch M, Gelber RD, Gusterson BA, Goldhirsch A: 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, 26: 5569-5575. 10.1200/JCO.2008.17.0829.CrossRefPubMedPubMedCentral
23.
go back to reference 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, for the BIG 1-98 Collaborative and International Breast Cancer Study Groups: Which patients benefi t most from adjuvant aromatase inhibitors? Results using a composite measure of prognostic risk in the BIG 1-98 randomised trial. Ann Oncol. 2011, [Epub ahead of print], 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, for the BIG 1-98 Collaborative and International Breast Cancer Study Groups: Which patients benefi t most from adjuvant aromatase inhibitors? Results using a composite measure of prognostic risk in the BIG 1-98 randomised trial. Ann Oncol. 2011, [Epub ahead of print],
24.
go back to reference Leyland-Jones B, Regan MM, Bouzyk M, Kammler R, Tang W, Pagani O, Maibach R, Dell'Orto P, Thürlimann B, Price KN, Viale G, for the BIG 1-98 Collaborative Group and IBCSG: Outcome according to CYP2D6 genotype among postmenopausal women with endocrine-responsive early invasive breast cancer randomized in the BIG 1-98 trial. Cancer Res. 2010, 70 (24 suppl): 78s-Abstract S1-8. Leyland-Jones B, Regan MM, Bouzyk M, Kammler R, Tang W, Pagani O, Maibach R, Dell'Orto P, Thürlimann B, Price KN, Viale G, for the BIG 1-98 Collaborative Group and IBCSG: Outcome according to CYP2D6 genotype among postmenopausal women with endocrine-responsive early invasive breast cancer randomized in the BIG 1-98 trial. Cancer Res. 2010, 70 (24 suppl): 78s-Abstract S1-8.
25.
26.
go back to reference Mouridsen H, Keshaviah A, Coates AS, Rabaglio M, Castiglione-Gertsch M, Sun Z, Thürlimann B, Mauriac L, Forbes JF, Paridaens R, Gelber RD, Colleoni M, Smith I, Price KN, Goldhirsch A: Cardiovascular adverse events during adjuvant endocrine therapy for early breast cancer using letrozole or tamoxifen: safety analysis of trial BIG 1-98. J Clin Oncol. 2007, 25: 5715-5722. 10.1200/JCO.2007.12.1665.CrossRefPubMed Mouridsen H, Keshaviah A, Coates AS, Rabaglio M, Castiglione-Gertsch M, Sun Z, Thürlimann B, Mauriac L, Forbes JF, Paridaens R, Gelber RD, Colleoni M, Smith I, Price KN, Goldhirsch A: Cardiovascular adverse events during adjuvant endocrine therapy for early breast cancer using letrozole or tamoxifen: safety analysis of trial BIG 1-98. J Clin Oncol. 2007, 25: 5715-5722. 10.1200/JCO.2007.12.1665.CrossRefPubMed
27.
go back to reference Rabaglio M, Sun Z, Price KN, Castiglione-Gertsch M, Hawle H, Thürlimann B, Mouridsen H, Campone M, Forbes JF, Paridaens RJ, Colleoni M, Pienkowski T, Nogaret JM, Láng I, Smith I, Gelber RD, Goldhirsch A, Coates AS, for the BIG 1-98 Collaborative and International Breast Cancer Study Groups: Bone fractures among postmenopausal patients with endocrine-responsive early breast cancer treated with 5 years of letrozole or tamoxifen in the BIG 1-98 trial. Ann Oncol. 2009, 20: 1489-1498. 10.1093/annonc/mdp033.CrossRefPubMedPubMedCentral Rabaglio M, Sun Z, Price KN, Castiglione-Gertsch M, Hawle H, Thürlimann B, Mouridsen H, Campone M, Forbes JF, Paridaens RJ, Colleoni M, Pienkowski T, Nogaret JM, Láng I, Smith I, Gelber RD, Goldhirsch A, Coates AS, for the BIG 1-98 Collaborative and International Breast Cancer Study Groups: Bone fractures among postmenopausal patients with endocrine-responsive early breast cancer treated with 5 years of letrozole or tamoxifen in the BIG 1-98 trial. Ann Oncol. 2009, 20: 1489-1498. 10.1093/annonc/mdp033.CrossRefPubMedPubMedCentral
28.
go back to reference 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 endocrineresponsive early breast cancer: the BIG 1-98 trial. J Clin Oncol. 2008, 26: 1972-1979. 10.1200/JCO.2007.14.0459.CrossRefPubMed 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 endocrineresponsive early breast cancer: the BIG 1-98 trial. J Clin Oncol. 2008, 26: 1972-1979. 10.1200/JCO.2007.14.0459.CrossRefPubMed
29.
go back to reference Ewer MS, Glück S: A women's heart: the impact of adjuvant endocrine therapy on cardiovascular health. Cancer. 2009, 115: 1813-1826. 10.1002/cncr.24219.CrossRefPubMed Ewer MS, Glück S: A women's heart: the impact of adjuvant endocrine therapy on cardiovascular health. Cancer. 2009, 115: 1813-1826. 10.1002/cncr.24219.CrossRefPubMed
30.
go back to reference Perez EA: The balance between risks and benefits: long-term use of aromatase inhibitors. Eur J Cancer. 2006, 4 (suppl): 16-25.CrossRef Perez EA: The balance between risks and benefits: long-term use of aromatase inhibitors. Eur J Cancer. 2006, 4 (suppl): 16-25.CrossRef
31.
go back to reference Phillips KA, Ribi K, Sun Z, Stephens A, Thompson A, Harvey V, Thürlimann B, Cardoso F, Pagani O, Coates AS, Goldhirsch A, Price KN, Gelber RD, Bernhard J: Cognitive function in postmenopausal women receiving adjuvant letrozole or tamoxifen for breast cancer in the BIG 1-98 randomized trial. Breast. 2010, 19: 388-395. 10.1016/j.breast.2010.03.025.CrossRefPubMedPubMedCentral Phillips KA, Ribi K, Sun Z, Stephens A, Thompson A, Harvey V, Thürlimann B, Cardoso F, Pagani O, Coates AS, Goldhirsch A, Price KN, Gelber RD, Bernhard J: Cognitive function in postmenopausal women receiving adjuvant letrozole or tamoxifen for breast cancer in the BIG 1-98 randomized trial. Breast. 2010, 19: 388-395. 10.1016/j.breast.2010.03.025.CrossRefPubMedPubMedCentral
32.
go back to reference Phillips KA, Aldridge J, Ribi K, Sun Z, Thompson A, Harvey V, Thürlimann B, Cardoso F, Pagani O, Coates AS, Goldhirsch A, Price KN, Gelber RD, Bernhard J: Cognitive function in postmenopausal breast cancer patients one year after completing adjuvant endocrine therapy. Breast Cancer Res Treat. 2011, 126: 221-226. 10.1007/s10549-010-1235-y.CrossRefPubMed Phillips KA, Aldridge J, Ribi K, Sun Z, Thompson A, Harvey V, Thürlimann B, Cardoso F, Pagani O, Coates AS, Goldhirsch A, Price KN, Gelber RD, Bernhard J: Cognitive function in postmenopausal breast cancer patients one year after completing adjuvant endocrine therapy. Breast Cancer Res Treat. 2011, 126: 221-226. 10.1007/s10549-010-1235-y.CrossRefPubMed
Metadata
Title
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
Authors
Meredith M Regan
Karen N Price
Anita Giobbie-Hurder
Beat Thürlimann
Richard D Gelber
for the International Breast Cancer Study Group and BIG 1-98 Collaborative Group
Publication date
01-06-2011
Publisher
BioMed Central
Published in
Breast Cancer Research / Issue 3/2011
Electronic ISSN: 1465-542X
DOI
https://doi.org/10.1186/bcr2837

Other articles of this Issue 3/2011

Breast Cancer Research 3/2011 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine