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Letrozole or Tamoxifen in Treating Postmenopausal Women With Breast Cancer (BIG 1-98)
This study is ongoing, but not recruiting participants.
Study NCT00004205   Information provided by International Breast Cancer Study Group
First Received: January 21, 2000   Last Updated: July 26, 2012   History of Changes

No Study Results Posted on ClinicalTrials.gov for this Study
About Study Results Reporting on ClinicalTrials.gov
  Study Status: This study is ongoing, but not recruiting participants.
  Estimated Study Completion Date: No date given
  Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Publications:
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 Feb 14; [Epub ahead of print]
Ejlertsen B, Aldridge J, Nielsen KV, Regan MM, Henriksen KL, Lykkesfeldt AE, Müller S, Gelber RD, Price KN, Rasmussen BB, Viale G, Mouridsen H; for the Danish Breast Cancer Cooperative Group, the BIG 1-98 Collaborative Group and the International Breast Cancer Study Group. Prognostic and predictive role of ESR1 status for postmenopausal patients with endocrine-responsive early breast cancer in the Danish cohort of the BIG 1-98 trial. Ann Oncol. 2011 Oct 10; [Epub ahead of print]
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 with letrozole and/or tamoxifen in the BIG 1-98 trial. Breast Cancer Res Treat. 2011 Feb;126(1):221-6. Epub 2010 Nov 3.
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; for the members of the BIG 1-98 Collaborative Group and the 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):1101-1108. Epub 2011 Oct 20.
Regan MM, Price KN, Giobbie-Hurder A, Thürlimann B, Gelber RD; for the 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 [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 benefit most from adjuvant aromatase inhibitors? Results using a composite measure of prognostic risk in the BIG 1-98 randomized trial. Ann Oncol. 2011 Feb 18; [Epub ahead of print]
Zaman K, Thürlimann B, Huober J, Schönenberger A, Pagani O, Lüthi J, Simcock M, Giobbie-Hurder A, Berthod G, Genton C, Brauchli P, Aebi S; on behalf of the Swiss Group for Clinical Cancer Research (SAKK). Bone mineral density in breast cancer patients treated with adjuvant letrozole, tamoxifen, or sequences of letrozole and tamoxifen in the BIG 1-98 study (SAKK 21/07). Ann Oncol. 2011 Oct 14; [Epub ahead of print]
Antonov J, Popovici V, Delorenzi M, Wirapati P, Baltzer A, Oberli A, Thürlimann B, Giobbie-Hurder A, Viale G, Altermatt HJ, Aebi S, Jaggi R. Molecular risk assessment of BIG 1-98 participants by expression profiling using RNA from archival tissue. BMC Cancer. 2010 Feb 9;10:37.
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 Oct;19(5):388-95. Epub 2010 Apr 10.
Ribi K, Aldridge J, Phillips K, et al.: Changes in cognitive function in postmenopausal women 1 year after completing adjuvant letrozole or tamoxifen in the Breast International Group (BIG) 1-98 trial. [Abstract] J Clin Oncol 28 (Suppl 15): A-527, 2010.
BIG 1-98 Collaborative Group; Mouridsen H, Giobbie-Hurder A, Goldhirsch A, Thürlimann B, Paridaens R, Smith I, Mauriac L, Forbes JF, 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.
Giobbie-Hurder A, Price KN, Gelber RD. 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. Clin Trials. 2009 Jun;6(3):272-87.
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 May 27; [Epub ahead of print]
Regan MM, Colleoni M M, Giobbie-Hurder A, et al.: Adjusting for selective crossover in analyses of letrozole (Let) versus tamoxifen (Tam) in the BIG 1-98 trial. [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-16, 2009.
Ribi KE, Phillips KA, Sun Z, et al.: Cognitive function in postmenopausal women receiving adjuvant letrozole or tamoxifen in the Breast International Group (BIG) 1-98 trial. [Abstract] J Clin Oncol 27 (Suppl 15): A-510, 2009.
Sun Z, Goldhirsch A, Price KN, Colleoni M, Ravaioli A, Simoncini E, Campbell I, Gelber RD, Towler M. Bone Quality Test (BQT) scores of fingernails in postmenopausal patients treated with adjuvant letrozole or tamoxifen for early breast cancer. Breast. 2009 Apr;18(2):84-8. Epub 2009 Feb 24.
Viale G, Regan MM, Dell'Orto P, et al.: Central review of ER, PgR and HER2 in BIG 1-98 evaluating letrozole vs. letrozole followed by tamoxifen vs. tamoxifen followed by letrozole as adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive breast cancer. [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-76, 2009.
Zaman K, Thürlimann B, Huober J, et al.: Modelling bone mineral density in Swiss breast cancer patients treated with letrozole, tamoxifen and sequences of letrozole and tamoxifen in the BIG 1-98 study (SAKK 21/07). [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-5037, 2009.
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 Mar 10; [Epub ahead of print]
Doughty JC. A review of the BIG results: the Breast International Group 1-98 trial analyses. Breast. 2008 Jan;17 Suppl 1:S9-S14.
Mouridsen HT, Giobbie-Hurder A, Mauriac L, et al.: BIG 1-98: a randomized double-blind phase III study evaluating letrozole and tamoxifen given in sequence as adjuvant endocrine therapy for postmenopausal women with receptor-positive breast cancer. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-13, 2008.
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.
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. 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 Nov 3; [Epub ahead of print]
Wardley AM. Understanding the BIG results: Insights from the BIG 1-98 trial analyses. Adv Ther. 2008 Dec;25(12):1257-75.
Coates AS, Keshaviah A, Thurlimann B, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Castiglione-Gertsch M, Gelber RD, Colleoni M, Lang 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 Jan 2; [Epub ahead of print]
Coates AS, Mouridsen H, Sun Z, et al.: Cardiovascular adverse events during adjuvant endocrine therapy for early breast cancer using letrozole or tamoxifen: updated safety analysis of trial BIG 1-98. [Abstract] J Clin Oncol 25 (Suppl 18): A-521, 2007.
Crivellari D, Sun Z, Coates AS, et al.: Aromatase inhibitors (AI) for elderly patients: efficacy, compliance and safety according to patient age in the BIG 1-98 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-9033, 501s, 2007.
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 Suppl 1:55-66. Epub 2007 Oct 3.
Mauriac L, Keshaviah A, Debled M, Mouridsen H, Forbes J, Thurlimann B, Paridaens R, Monnier A, Lang I, Wardley A, Nogaret JM, Gelber R, Castiglione-Gertsch M, Price K, Coates A, Smith I, Viale G, Rabaglio M, Zabaznyi N, Goldhirsch A. Predictors of early relapse in postmenopausal women with hormone receptor-positive breast cancer in the BIG 1-98 trial. Ann Oncol. 2007 Feb 14; [Epub ahead of print]
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.
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 BIG 1-98 Trial. J Clin Oncol. 2007 Nov 12; [Epub ahead of print]
Rasmussen BB, Regan MM, Lykkesfeldt AE, et al.: Central assessment of ER, PgR and HER2 in BIG 1-98 evaluating letrozole (L) compared to tamoxifen (T) as initial adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive breast cancer. [Abstract] J Clin Oncol 25 (18 Suppl 20): A-538, 2007.
Viale G, Regan MM, Maiorano E, Mastropasqua MG, Dell'orto P, Bruun Rasmussen B, Raffoul J, Neven P, Orosz Z, Braye S, Ohlschlegel C, Thurlimann 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: Results From the BIG 1-98 Collaborative Groups. J Clin Oncol. 2007 Aug 6; [Epub ahead of print]
Forbes JF. The use of early adjuvant aromatase inhibitor therapy: contributions from the BIG 1-98 letrozole trial. Semin Oncol. 2006 Apr;33(2 Suppl 7):S2-7.
Thurlimann B, Keshaviah A, Coates AS, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Castiglione-Gertsch M, Gelber RD, Rabaglio M, Smith I, Wardly A, Price KN, Goldhirsch A; Breast International Group (BIG) 1-98 Collaborative Group. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med. 2005 Dec 29;353(26):2747-57.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):