title: A Phase III Study to Evaluate Letrozole as Adjuvant Endocrine Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors

summary:
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. If is not yet known which treatment regimen is most effective for breast cancer.

PURPOSE: Randomized double-blind phase III trial to compare the effectiveness of letrozole with that of tamoxifen in treating postmenopausal women who have breast cancer that has been surgically removed.

ReferenceCitation: Lipsitz M, Delea TE, Guo A. Cost effectiveness of letrozole versus anastrozole in postmenopausal women with HR+ early-stage breast cancer. Curr Med Res Opin. 2010 Oct;26(10):2315-28. doi: 10.1185/03007995.2010.510784.

ReferenceCitation: Skedgel C, Rayson D, Younis T, et al.: Direct and indirect economic evaluation of upfront and sequential adjuvant treatment in postmenopausal women with breast cancer based on the BIG 1-98 trial. [Abstract] J Clin Oncol 27 (Suppl 15): A-6594, 2009.

ReferenceCitation: Delea TE, El-Ouagari K, Karnon J, Sofrygin O. Cost-effectiveness of letrozole versus tamoxifen as initial adjuvant therapy in postmenopausal women with hormone-receptor positive early breast cancer from a Canadian perspective. Breast Cancer Res Treat. 2008 Apr;108(3):375-87. Epub 2007 Jul 26.

ReferenceCitation: Delea TE, Karnon J, Sofrygin O, Thomas SK, Papo NL, Barghout V. Cost-effectiveness of letrozole versus tamoxifen as initial adjuvant therapy in hormone receptor-positive postmenopausal women with early-stage breast cancer. Clin Breast Cancer. 2007 Jun;7(8):608-18.

ReferenceCitation: Buzdar A, Chlebowski R, Cuzick J, Duffy S, Forbes J, Jonat W, Ravdin P. Defining the role of aromatase inhibitors in the adjuvant endocrine treatment of early breast cancer. Curr Med Res Opin. 2006 Aug;22(8):1575-85. Review.

ReferenceCitation: Scott LJ, Keam SJ. Letrozole : in postmenopausal hormone-responsive early-stage breast cancer. Drugs. 2006;66(3):353-62. Review.

ReferenceCitation: Wardley AM. Emerging data on optimal adjuvant endocrine therapy: Breast International Group trial 1-98/MA.17. Clin Breast Cancer. 2006 Feb;6 Suppl 2:S45-50. Review.

ReferenceCitation: Bouzyk M, Gray KP, Regan MM, et al.: ESR1 and ESR2 polymorphisms in BIG 1-98 comparing adjuvant letrozole (L) versus tamoxifen (T) or their sequence for early breast cancer. [Abstract] J Clin Oncol 29 (Suppl 15): A-1002, 2011.

ReferenceCitation: 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 Mar 20;29(9):1117-24. doi: 10.1200/JCO.2010.31.6455. Epub 2011 Feb 14.

name: From the European Institute of Oncology, Milan, Italy; International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute; Harvard School of Public Health; Frontier Science and Technology Research Foundation; Harvard Medical School, Boston, MA; Breast Center, Kantonsspital, St Gallen; International Breast Cancer Study Group, Swiss Group for Clinical Cancer Research, Bern; Oncology Institute of Southern Switzerland, Bellinzona, Switzerland; Danish Breast Cancer Cooperative Group,...

family: Colleoni

full_name: Marco Colleoni

given: Marco

family: Giobbie-Hurder

full_name: Anita Giobbie-Hurder

given: Anita

family: Regan

full_name: Meredith M. Regan

given: Meredith M.

family: Thürlimann

full_name: Beat Thürlimann

given: Beat

family: Mouridsen

full_name: Henning Mouridsen

given: Henning

family: Mauriac

full_name: Louis Mauriac

given: Louis

family: Forbes

full_name: John F. Forbes

given: John F.

family: Paridaens

full_name: Robert Paridaens

given: Robert

family: Láng

full_name: István Láng

given: István

family: Smith

full_name: Ian Smith

given: Ian

family: Chirgwin

full_name: Jacquie Chirgwin

given: Jacquie

family: Pienkowski

full_name: Tadeusz Pienkowski

given: Tadeusz

family: Wardley

full_name: Andrew Wardley

given: Andrew

family: Price

full_name: Karen N. Price

given: Karen N.

family: Gelber

full_name: Richard D. Gelber

given: Richard D.

family: Coates

full_name: Alan S. Coates

given: Alan S.

family: Goldhirsch

full_name: Aron Goldhirsch

given: Aron

journal_name: Journal of Clinical Oncology

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Analyses Adjusting for Selective Crossover Show Improved Overall Survival With Adjuvant Letrozole Compared With Tamoxifen in the BIG 1-98 Study

ReferenceCitation: De Censi A, Sun Z, Thurlimann BJK, et al.: Bone mineral density (BMD) in participants (pts) of trial BIG 1-98 comparing adjuvant letrozole (L) versus tamoxifen (T) or their sequence. [Abstract] J Clin Oncol 29 (Suppl 15): A-516, 2011.

ReferenceCitation: Ejlertsen B, Aldridge J, Nielsen KV, Regan MM, Henriksen KL, Lykkesfeldt AE, Müller S, Gelber RD, Price KN, Rasmussen BB, Viale G, Mouridsen H; 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. 2012 May;23(5):1138-1144. doi: 10.1093/annonc/mdr438. Epub 2011 Oct 10.

title: 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

ReferenceCitation: Huober JB, Cole BF, Wu J, et al.: Symptoms of endocrine treatment and outcome: A retrospective analysis of the monotherapy arms of the BIG 1-98 trial. [Abstract] J Clin Oncol 29 (Suppl 15): A-522, 2011.

ReferenceCitation: 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. doi: 10.1007/s10549-010-1235-y. Epub 2010 Nov 3.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repositories_institution: University Library Bern - BORIS - Bern Open Repository and Information System

title: 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

ReferenceCitation: 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.

title: 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

ReferenceCitation: 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.

name: for the International Breast Cancer Study Group and BIG 1-98 Collaborative Group

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repositories_institution: University of Zurich - Zurich Open Repository and Archive

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

ReferenceCitation: 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.

title: Which patients benefit most from adjuvant aromatase inhibitors? Results using a composite measure of prognostic risk in the BIG 1-98 randomized trial

ReferenceCitation: 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; 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. 2012 Jun;23(6):1474-81. doi: 10.1093/annonc/mdr448. Epub 2011 Oct 14.

repositories_institution:
Université de Lausanne - SERVAL
reroDoc Digital Library

title: 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)

ReferenceCitation: 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. doi: 10.1186/1471-2407-10-37.

title: Molecular risk assessment of BIG 1-98 participants by expression profiling using RNA from archival tissue

ReferenceCitation: 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. doi: 10.1016/j.breast.2010.03.025. Epub 2010 Apr 10.

title: Cognitive function in postmenopausal women receiving adjuvant letrozole or tamoxifen for breast cancer in the BIG 1-98 randomized trial

ReferenceCitation: 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.

ReferenceCitation: 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.

repository_institution: University of Newcastle, Australia - NOVA

repositories_institution: University of Newcastle, Australia - NOVA

title: Letrozole Therapy Alone or in Sequence with Tamoxifen in Women with Breast Cancer

ReferenceCitation: Giobbie-Hurder A, Price KN, Gelber RD; International Breast Cancer Study Group; BIG 1-98 Collaborative Group. 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. doi: 10.1177/1740774509105380.

name: International Breast Cancer Study Group Statistical Center (IBCSG), Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA,

name: International Breast Cancer Study Group Statistical Center (IBCSG), Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA, Frontier Science and Technology Research Foundation, Boston, MA, USA, Harvard School of Public Health and Harvard Medical School, Boston, MA, USA

title: 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

ReferenceCitation: 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; 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 Sep;20(9):1489-1498. doi: 10.1093/annonc/mdp033. Epub 2009 May 27.

repository_institution: University of Bern - Bern Open Repository and Information System

repositories_institution: University of Bern - Bern Open Repository and Information System

title: 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

ReferenceCitation: 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.

ReferenceCitation: 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.

ReferenceCitation: 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. doi: 10.1016/j.breast.2009.01.003. Epub 2009 Feb 24.

title: Bone Quality Test (BQT) scores of fingernails in postmenopausal patients treated with adjuvant letrozole or tamoxifen for early breast cancer

ReferenceCitation: 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.

ReferenceCitation: 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.

ReferenceCitation: 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.

name: From the Centro di Riferimento Oncologico, Aviano; Department of Medicine. European Institute of Oncology, Milan; National Cancer Research Institute, Genoa, Italy; International Breast Cancer Study Group (IBCSG) Statistical Center, Dana-Farber Cancer Institute; Harvard School of Public Health and Frontier Science and Technology Research Foundation, Boston, MA; IBCSG and University of Sydney, Sydney; Australian New Zealand Breast Cancer Trials Group, University of Newcastle, Calvary Mater Newcastle,...

title: Letrozole Compared With Tamoxifen for Elderly Patients With Endocrine-Responsive Early Breast Cancer: The BIG 1-98 Trial

ReferenceCitation: Doughty JC. A review of the BIG results: the Breast International Group 1-98 trial analyses. Breast. 2008 Jan;17 Suppl 1:S9-S14. doi: 10.1016/S0960-9776(08)70003-1. Review.

title: A review of the BIG results: the Breast International Group 1–98 trial analyses

ReferenceCitation: 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.

ReferenceCitation: 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.

ReferenceCitation: 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.

name: From the Division of Pathology and Laboratory Medicine, European Institute of Oncology, University of Milan, Milan; Department of Pathological Anatomy, University of Bari, Bari, Italy; International Breast Cancer Study Group (IBCSG) Statistical Center, Dana-Farber Cancer Institute, Harvard School of Public Health; Frontier Science and Technology Research Foundation, Boston, MA; IBCSG Coordinating Center; Swiss Group for Clinical Cancer Research (SAKK), Bern; Senology Center of Eastern Switzerland,...

title: 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

ReferenceCitation: 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.

title: Understanding the BIG results: Insights from the BIG 1–98 trial analyses

ReferenceCitation: 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.

ReferenceCitation: 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 Dec 20;25(36):5715-22. Epub 2007 Nov 12.

ReferenceCitation: 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.

ReferenceCitation: 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. Erratum in: Breast Cancer Res Treat. 2008 Nov;112(2):387.

ReferenceCitation: Mauriac L, Keshaviah A, Debled M, Mouridsen H, Forbes JF, Thürlimann B, Paridaens R, Monnier A, Láng I, Wardley A, Nogaret JM, Gelber RD, Castiglione-Gertsch M, Price KN, Coates AS, Smith I, Viale G, Rabaglio M, Zabaznyi N, Goldhirsch A; BIG 1-98 Collaborative Group; International Breast Cancer Study Group. Predictors of early relapse in postmenopausal women with hormone receptor-positive breast cancer in the BIG 1-98 trial. Ann Oncol. 2007 May;18(5):859-67. Epub 2007 Feb 14.

ReferenceCitation: 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.

ReferenceCitation: 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.

ReferenceCitation: Viale G, Regan MM, Maiorano E, Mastropasqua MG, Dell'Orto P, Rasmussen BB, Raffoul J, Neven P, Orosz Z, Braye S, Ohlschlegel 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 early breast cancer: BIG 1-98. J Clin Oncol. 2007 Sep 1;25(25):3846-52. Epub 2007 Aug 6.

ReferenceCitation: 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.

ReferenceCitation: 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 ].

ReferenceCitation: Gregg JR, Zhang X, Chapin BF, Ward JF, Kim J, Davis JW, Daniel CR. Adherence to the Mediterranean diet and grade group progression in localized prostate cancer: An active surveillance cohort. Cancer. 2021 Mar 1;127(5):720-728. doi: 10.1002/cncr.33182. Epub 2021 Jan 7.

name: Department of Urology The University of Texas MD Anderson Cancer Center Houston Texas

name: Department of Epidemiology The University of Texas MD Anderson Cancer Center Houston Texas

title: Adherence to the Mediterranean diet and grade group progression in localized prostate cancer: An active surveillance cohort

ReferenceCitation: Leone JP, Cole BF, Regan MM, Thürlimann B, Coates AS, Rabaglio M, Giobbie-Hurder A, Gelber RD, Ejlertsen B, Harvey VJ, Neven P, Láng I, Bonnefoi H, Wardley A, Goldhirsch A, Di Leo A, Colleoni M, Vaz-Luis I, Lin NU. Clinical behavior of recurrent hormone receptor-positive breast cancer by adjuvant endocrine therapy within the Breast International Group 1-98 clinical trial. Cancer. 2021 Mar 1;127(5):700-708. doi: 10.1002/cncr.33318. Epub 2020 Dec 8.

name: Department of Medical Oncology Dana‐Farber Cancer Institute Boston Massachusetts

name: Department of Mathematics and Statistics University of Vermont Burlington Vermont

name: International Breast Cancer Study Group Statistical Center Division of Biostatistics Dana‐Farber Cancer Institute, Harvard Medical School Boston Massachusetts

name: Kantonsspital St. Gallen St. Gallen Switzerland

name: International Breast Cancer Study Group and Swiss Group for Clinical Cancer Research Bern Switzerland

name: International Breast Cancer Study Group and University of Sydney Sydney New South Wales Australia

name: International Breast Cancer Study Group Coordinating Center Bern Switzerland

name: Department of Medical Oncology, Inselspital Bern University HospitalUniversity of Bern Bern Switzerland

name: Swiss Group for Clinical Cancer Research Bern Switzerland

name: Division of Biostatistics Dana‐Farber Cancer Institute, Harvard Medical School Boston Massachusetts

name: Department of Oncology Centre for Cancer and Organ Diseases University of Copenhagen Copenhagen Denmark

name: Regional Cancer and Blood Service Auckland City Hospital Auckland New Zealand

name: Department of Oncology Universitair Ziekenhuis Leuven Leuven Belgium

name: Oncology Clinic Istenhegyi Géndiagnosztika Private Health Center Budapest Hungary

name: Department of Medical Oncology Bergonié Institute Bordeaux France

name: National Institute for Health Research Manchester Clinical Research Facility at the Christie National Health Service Foundation Trust, Manchester Academic Health Science Centre and Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester Manchester United Kingdom

name: European Institute of OncologyIRCCS Milan Italy

name: Hospital of Prato–AUSL Toscana Centro Prato Italy

name: National Institute of Health and Medical Research Unit 981Gustave Roussy Institute Villejuif France

title: Clinical behavior of recurrent hormone receptor–positive breast cancer by adjuvant endocrine therapy within the Breast International Group 1‐98 clinical trial

ReferenceCitation: Luen SJ, Asher R, Lee CK, Savas P, Kammler R, Dell'Orto P, Biasi OM, Demanse D, Hackl W, Thuerlimann B, Viale G, Di Leo A, Colleoni M, Regan MM, Loi S. Identifying oncogenic drivers associated with increased risk of late distant recurrence in postmenopausal, estrogen receptor-positive, HER2-negative early breast cancer: results from the BIG 1-98 study. Ann Oncol. 2020 Oct;31(10):1359-1365. doi: 10.1016/j.annonc.2020.06.024. Epub 2020 Jul 8.

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_institution: University of Melbourne - Minerva Access

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

ReferenceCitation: Kensler KH, Regan MM, Heng YJ, Baker GM, Pyle ME, Schnitt SJ, Hazra A, Kammler R, Thürlimann B, Colleoni M, Viale G, Brown M, Tamimi RM. Prognostic and predictive value of androgen receptor expression in postmenopausal women with estrogen receptor-positive breast cancer: results from the Breast International Group Trial 1-98. Breast Cancer Res. 2019 Feb 22;21(1):30. doi: 10.1186/s13058-019-1118-z.

title: Prognostic and predictive value of androgen receptor expression in postmenopausal women with estrogen receptor-positive breast cancer: results from the Breast International Group Trial 1–98

ReferenceCitation: 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, Piccart-Gebhart M, Di Leo A, Gelber RD, Coates AS, Goldhirsch A, Thürlimann B, Regan MM; members of the BIG 1-98 Collaborative Group and the International Breast Cancer Study Group. 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: 10.1200/JCO.18.00440. Epub 2018 Nov 26.

name: Kantonsspital St Gallen, St Gallen, Switzerland

name: Dana-Farber Cancer Institute, Boston, MA

name: European Institute of Oncology Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy

name: Institut Jules Bordet and L’Université Libre de Bruxelles, Brussels, Belgium

name: National Institute of Oncology, Budapest, Hungary

name: Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse, France

name: Université de Bordeaux, Bordeaux, France

name: Auckland City Hospital, Auckland, New Zealand

name: CRO National Cancer Institute, Aviano, Italy

name: Ospedale Papa Giovanni XXIII, Bergamo, Italy

name: Ospedale Policlinico San Martino, Genoa, Italy

name: Centre de Cancérolgie Henri Becquerel, Rouen, France

name: ASST Spedali Civili di Brescia, Brescia, Italy

name: Ospedale Infermi di Rimini, AUSL della Romagna, Ravenna, Italy

name: University Hospital Vaud University Hospital Center, Lausanne, Switzerland

name: Medical University of Gdansk, Gdansk, Poland

name: Hospital of Prato-AUSL Toscana Centro, Prato, Italy

name: Harvard TH Chan School of Public Health and Frontier Science and Technology Research Foundation, Boston, MA

name: University of Sydney, Sydney, NSW, Australia

name: International Breast Cancer Study Group, Bern, Switzerland

name: for the members of the BIG 1-98 Collaborative Group and the International Breast Cancer Study Group

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repositories_institution: University of Copenhagen - Research at the University of Copenhagen

repositories_institution: University of Southern Denmark - University of Southern Denmark Research Portal

title: 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

ReferenceCitation: Luen SJ, Asher R, Lee CK, Savas P, Kammler R, Dell'Orto P, Biasi OM, Demanse D, JeBailey L, Dolan S, Hackl W, Thuerlimann B, Viale G, Colleoni M, Regan MM, Loi S. Association of Somatic Driver Alterations With Prognosis in Postmenopausal, Hormone Receptor-Positive, HER2-Negative Early Breast Cancer: A Secondary Analysis of the BIG 1-98 Randomized Clinical Trial. JAMA Oncol. 2018 Oct 1;4(10):1335-1343. doi: 10.1001/jamaoncol.2018.1778.

name: Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia

name: National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia

name: International Breast Cancer Study Group, Coordinating Center, Central Pathology Office, Bern, Switzerland

name: International Breast Cancer Study Group, Central Pathology Office, Department of Pathology, European Institute of Oncology, Milan, Italy

name: Division of Pathology and Laboratory Medicine, European Institute of Oncology, Milan, Italy

name: Novartis Institutes for Biomedical Research, Basel, Switzerland

name: Breast Center, Cantonal Hospital, St Gallen, Switzerland

name: International Breast Cancer Study Group Central Pathology Office, European Institute of Oncology, University of Milan, Milan, Italy

name: Division of Medical Senology, European Institute of Oncology, Milan, Italy

name: Department of Biostatistics and Computational Biology, International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts

title: Association of Somatic Driver Alterations With Prognosis in Postmenopausal, Hormone Receptor–Positive, HER2-Negative Early Breast Cancer

ReferenceCitation: Dowsett M, Sestak I, Regan MM, Dodson A, Viale G, Thürlimann B, Colleoni M, Cuzick J. Integration of Clinical Variables for the Prediction of Late Distant Recurrence in Patients With Estrogen Receptor-Positive Breast Cancer Treated With 5 Years of Endocrine Therapy: CTS5. J Clin Oncol. 2018 Jul 1;36(19):1941-1948. doi: 10.1200/JCO.2017.76.4258. Epub 2018 Apr 20. Erratum in: J Clin Oncol. 2020 Feb 20;38(6):656.

name: Mitch Dowsett and Andrew Dodson, Royal Marsden Hospital; Mitch Dowsett, Institute of Cancer Research; Ivana Sestak and Jack Cuzick, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom; Meredith M. Regan, Dana Farber Cancer Institute and Harvard Medical School, Boston, MA; Giuseppe Viale, University of Milan; Guiseppe Viale and Marco Colleoni, European Institute of Oncology, Milan, Italy; Beat Thürlimann, Kantonsspital St Gallen, St Gallen, and International...

repository_institution: Queen Mary University of London - Queen Mary Research Online

repositories_institution: Queen Mary University of London - Queen Mary Research Online

title: Integration of Clinical Variables for the Prediction of Late Distant Recurrence in Patients With Estrogen Receptor–Positive Breast Cancer Treated With 5 Years of Endocrine Therapy: CTS5

ReferenceCitation: Chirgwin JH, Giobbie-Hurder A, Coates AS, Price KN, Ejlertsen B, Debled M, Gelber RD, Goldhirsch A, Smith I, Rabaglio M, Forbes JF, Neven P, Láng I, Colleoni M, Thürlimann B. Treatment Adherence and Its Impact on Disease-Free Survival in the Breast International Group 1-98 Trial of Tamoxifen and Letrozole, Alone and in Sequence. J Clin Oncol. 2016 Jul 20;34(21):2452-9. doi: 10.1200/JCO.2015.63.8619. Epub 2016 May 23.

name: Jacquie H. Chirgwin and John F. Forbes, University of Newcastle; John F. Forbes, Calvary Mater Newcastle, Newcastle; Alan S. Coates, University of Sydney School of Public Health, Sydney, New South Wales; Jacquie H. Chirgwin, Box Hill Hospital; Jacquie H. Chirgwin, Maroondah Hospital; Jacquie H. Chirgwin, Monash University, Melbourne, Victoria, Australia; Anita Giobbie-Hurder, Karen N. Price, and Richard D. Gelber, International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute;...

title: Treatment Adherence and Its Impact on Disease-Free Survival in the Breast International Group 1-98 Trial of Tamoxifen and Letrozole, Alone and in Sequence

ReferenceCitation: Ignatiadis M, Azim HA Jr, Desmedt C, Veys I, Larsimont D, Salgado R, Lyng MB, Viale G, Leyland-Jones B, Giobbie-Hurder A, Kammler R, Dell'Orto P, Rothé F, Laïos I, Ditzel HJ, Regan MM, Piccart M, Michiels S, Sotiriou C. The Genomic Grade Assay Compared With Ki67 to Determine Risk of Distant Breast Cancer Recurrence. JAMA Oncol. 2016 Feb;2(2):217-24. doi: 10.1001/jamaoncol.2015.4377.

name: Breast Cancer Translational Research Laboratory, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium2Medical Oncology Clinic, Department of Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium

name: Breast Cancer Translational Research Laboratory, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium

name: Department of Breast and Gynecological Surgery, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium

name: Department of Pathology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium

name: Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark6Danish Breast Cancer Cooperative Group, Copenhagen, Denmark

name: Department of Pathology, European Institute of Oncology, University of Milan, Milan, Italy

name: Avera Cancer Institute, Sioux Falls, South Dakota

name: International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, Massachusetts

name: International Breast Cancer Study Group Coordinating Center and Central Pathology Office, Bern, Switzerland

name: Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark6Danish Breast Cancer Cooperative Group, Copenhagen, Denmark11Department of Oncology, Odense University Hospital, Odense, Denmark12AgeCare, Odense University Hospital, Odense, Denmark

name: Medical Oncology Clinic, Department of Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium

name: Service de Biostatistique et d’Epidémiologie, Gustave Roussy, Villejuif, France14INSERM U1018, CESP, Université Paris-Sud, Villejuif France

title: The Genomic Grade Assay Compared With Ki67 to Determine Risk of Distant Breast Cancer Recurrence

ReferenceCitation: Leyland-Jones B, Gray KP, Abramovitz M, Bouzyk M, Young B, Long B, Kammler R, Dell'Orto P, Biasi MO, Thürlimann B, Harvey V, Neven P, Arnould L, Maibach R, Price KN, Coates AS, Goldhirsch A, Gelber RD, Pagani O, Viale G, Rae JM, Regan MM; BIG 1-98 Collaborative Group. ESR1 and ESR2 polymorphisms in the BIG 1-98 trial comparing adjuvant letrozole versus tamoxifen or their sequence for early breast cancer. Breast Cancer Res Treat. 2015 Dec;154(3):543-55. doi: 10.1007/s10549-015-3634-6. Epub 2015 Nov 21.

title: ESR1 and ESR2 polymorphisms in the BIG 1-98 trial comparing adjuvant letrozole versus tamoxifen or their sequence for early breast cancer

ReferenceCitation: Munzone E, Giobbie-Hurder A, Gusterson BA, Mallon E, Viale G, Thürlimann B, Ejlertsen B, MacGrogan G, Bibeau F, Lelkaitis G, Price KN, Gelber RD, Coates AS, Goldhirsch A, Colleoni M; International Breast Cancer Study Group and the BIG 1-98 Collaborative Group. Outcomes of special histotypes of breast cancer after adjuvant endocrine therapy with letrozole or tamoxifen in the monotherapy cohort of the BIG 1-98 trial. Ann Oncol. 2015 Dec;26(12):2442-9. doi: 10.1093/annonc/mdv391. Epub 2015 Sep 19.

title: Outcomes of special histotypes of breast cancer after adjuvant endocrine therapy with letrozole or tamoxifen in the monotherapy cohort of the BIG 1-98 trial

ReferenceCitation: 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.

name: Otto Metzger Filho, Anita Giobbie-Hurder, and Eric P. Winer, Dana-Farber Cancer Institute; Richard D. Gelber and Meredith M. Regan, Harvard Medical School; Karen N. Price, Frontier Science and Technology Research, Boston, MA; Elizabeth Mallon, Southern General Hospital; Barry Gusterson, Institute of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom; Giuseppe Viale, European Institute of Oncology and University of Milan; Marco Colleoni and Aron Goldhirsch, European Institute of Oncology,...

title: Relative Effectiveness of Letrozole Compared With Tamoxifen for Patients With Lobular Carcinoma in the BIG 1-98 Trial

ReferenceCitation: Leyland-Jones B, Gray KP, Abramovitz M, Bouzyk M, Young B, Long B, Kammler R, Dell'Orto P, Biasi MO, Thürlimann B, Lyng MB, Ditzel HJ, Harvey VJ, Neven P, Treilleux I, Rasmussen BB, Maibach R, Price KN, Coates AS, Goldhirsch A, Pagani O, Viale G, Rae JM, Regan MM. CYP19A1 polymorphisms and clinical outcomes in postmenopausal women with hormone receptor-positive breast cancer in the BIG 1-98 trial. Breast Cancer Res Treat. 2015 Jun;151(2):373-84. doi: 10.1007/s10549-015-3378-3. Epub 2015 May 3.

title: CYP19A1 polymorphisms and clinical outcomes in postmenopausal women with hormone receptor-positive breast cancer in the BIG 1–98 trial

ReferenceCitation: Huober J, Cole BF, Rabaglio M, Giobbie-Hurder A, Wu J, Ejlertsen B, Bonnefoi H, Forbes JF, Neven P, Láng I, Smith I, Wardley A, Price KN, Goldhirsch A, Coates AS, Colleoni M, Gelber RD, Thürlimann B; BIG 1-98 Collaborative and International Breast Cancer Study Groups. Symptoms of endocrine treatment and outcome in the BIG 1-98 study. Breast Cancer Res Treat. 2014 Jan;143(1):159-69. doi: 10.1007/s10549-013-2792-7. Epub 2013 Dec 5.

name: for the BIG 1-98 Collaborative and International Breast Cancer Study Groups

repositories_institution:
PubMed Central - Europe PMC
reroDoc Digital Library

title: Symptoms of endocrine treatment and outcome in the BIG 1-98 study

ReferenceCitation: Regan MM, Leyland-Jones B, Bouzyk M, Pagani O, Tang W, Kammler R, Dell'orto P, Biasi MO, Thürlimann B, Lyng MB, Ditzel HJ, Neven P, Debled M, Maibach R, Price KN, Gelber RD, Coates AS, Goldhirsch A, Rae JM, Viale G; Breast International Group (BIG) 1-98 Collaborative Group. CYP2D6 genotype and tamoxifen response in postmenopausal women with endocrine-responsive breast cancer: the breast international group 1-98 trial. J Natl Cancer Inst. 2012 Mar 21;104(6):441-51. doi: 10.1093/jnci/djs125. Epub 2012 Mar 6.

journal_name: JNCI: Journal of the National Cancer Institute

title: CYP2D6 Genotype and Tamoxifen Response in Postmenopausal Women with Endocrine-Responsive Breast Cancer: The Breast International Group 1-98 Trial

ReferenceCitation: 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.

title: 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

publications_result: Bouzyk M, Gray KP, Regan MM, et al.: ESR1 and ESR2 polymorphisms in BIG 1-98 comparing adjuvant letrozole (L) versus tamoxifen (T) or their sequence for early breast cancer. [Abstract] J Clin Oncol 29 (Suppl 15): A-1002, 2011.

location_facility:
Rigshospitalet
Kantonsspital - St. Gallen
Institut Bergonie


title: Randomized Double-Blind Trial in Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen for 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen

summary:
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane or tamoxifen may fight breast cancer by blocking the uptake of estrogen. It is not yet known whether exemestane is more effective than tamoxifen in treating breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women with primary breast cancer who have already received 2-3 years of tamoxifen following surgery.

status: Unknown status

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Coleman RE, Banks LM, Girgis SI, Kilburn LS, Vrdoljak E, Fox J, Cawthorn SJ, Patel A, Snowdon CF, Hall E, Bliss JM, Coombes RC; Intergroup Exemestane Study group. Skeletal effects of exemestane on bone-mineral density, bone biomarkers, and fracture incidence in postmenopausal women with early breast cancer participating in the Intergroup Exemestane Study (IES): a randomised controlled study. Lancet Oncol. 2007 Feb;8(2):119-27.

ReferenceCitation: 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 Feb 17;369(9561):559-70. Erratum in: Lancet. 2007 Mar 17;369(9565):906.

ReferenceCitation: Coombes RC, Paridaens R, Jassem J, et al.: First mature analysis of the Intergroup Exemestane Study. [Abstract] J Clin Oncol 24 (Suppl 18): A-LBA527, 2006.

ReferenceCitation: Coombes RC, Hall E, Gibson LJ, Paridaens R, Jassem J, Delozier T, Jones SE, Alvarez I, Bertelli G, Ortmann O, Coates AS, Bajetta E, Dodwell D, Coleman RE, Fallowfield LJ, Mickiewicz E, Andersen J, Lønning PE, Cocconi G, Stewart A, Stuart N, Snowdon CF, Carpentieri M, Massimini G, Bliss JM, van de Velde C; Intergroup Exemestane Study. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N Engl J Med. 2004 Mar 11;350(11):1081-92. Erratum in: N Engl J Med. 2004 Dec 2;351(23):2461. N Engl J Med. 2006 Oct 19;355(16):1746. van de Velde, Cornelius [added].

lead_sponsor: International Collaborative Cancer Group

location_country:
United Kingdom
Belgium
France

location_facility:
Centre Antoine Lacassagne
U.Z. Gasthuisberg
Charing Cross Hospital

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


type: EudraCT Number

title: A Phase 1, First-in-human, Multicenter, Open-label, Dose-escalation Study to Characterize the Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors

summary: This study is investigating a new experimental therapy, MP0317, a DARPin® drug candidate targeting fibroblast activation protein (FAP) and CD40. Preclinical studies suggest that MP0317 may provide benefit for the treatment of tumors known to express high levels of FAP and for which approved therapies have been exhausted. This is the first study of MP0317 in humans and its main purpose is to test its safety and tolerability in patients with advanced solid tumors. This study will also examine the blood levels of MP0317 at several increasing dose levels and a recommended dose for further development will be determined. The recommended dose will be tested in a second part of the study to confirm safety and to further assess the preliminary biologic and anti-tumor activity.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

lead_sponsor: Molecular Partners AG

location_country: France Netherlands

location_facility:
IUCT-O Institut Claudius Régaud
UMCU
Centre Léon Bérard
NKI-AvL

status_simplified: Ongoing


title: Can Subthalamic Stimulation Using Directional Electrodes Improve Postoperative Management in Parkinson's Disease: A Post-market Study - Steeropt

acronym: Steeropt

summary: The primary objective of the study is to determine if subthalamic nucleus (STN) deep brain stimulation (DBS) using the Vercise directional leads improves neuropsychiatric state and neuropsychiatric fluctuations 12 months after surgery in a large consecutive series of STN-DBS Parkinson's disease (PD) patients.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital Inselspital, Berne

location_country: Germany France Switzerland

location_facility: Hospices Civils de Lyon (Centre Hospitalier Universitaire de Lyon)

location_facility: Insel Gruppe AG University Hospital Bern

intervention_type: Other

lead_sponsor_type: academique


title: Phase I Dose Escalation and Dose Expansion, International, Multicenter Study of W0180 as Single Agent and in Combination With Pembrolizumab (Anti-PD-1) in Adult Participants With Locally Advanced or Metastatic Solid Tumors

summary: The purpose of this study will be to determine the Maximum Tolerated Dose (MTD) and describe dose-limiting toxicities (DLTs) of W0180 given as monotherapy and in combination with pembrolizumab (anti-PD-1).

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Pierre Fabre Medicament

location_country: France Spain

location_facility:
IUCT, Toulouse
IGR, Villejuif
CUN, Madrid
CUN, Pamplona


ReferenceType: background

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status: Not yet recruiting

study_start_date_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Pointe-a-Pitre

primary_purpose: Prevention

location_country: Réunion France Guadeloupe

acronym: METNODTHYR

location_facility: University Hospital Center of Guadeloupe

source: euctr

title: Efficacy of Metformin Versus Sitagliptin on Benign Thyroid Nodules Size in Type 2 Diabetes: a 2-years Prospective Multicentric Study

summary: A 2-years prospective, randomized and multicentric study will be performed to assess the efficacy of metformin compared to sitagliptin on benign thyroid nodules size ≥ 2 cm, in newly diagnosed patients with type 2 diabetes.


title: Immune Mediators and Metabolites to Stratify Systemic Lupus Erythematosus Patients at High Risk of Cardio Vascular Diseases

acronym: ISLE

summary:
Accelerated atherosclerosis is an established complication of systemic autoimmune diseases, particularly SLE. Young female patients with SLE are more likely to develop myocardial infarction than matched healthy controls, and CVD is nowadays one of the most common causes of death (27%) in lupus patients. While traditional CV risk factors cannot explain such increased CV morbidity associated with SLE, common disease factors shared between SLE, atherosclerosis and treatment exposure may be of outmost importance in this process. Our group made 3 findings of particular interest that could link SLE pathogenesis and atherosclerosis-associated immune dysregulation: 1/ the investigators identified specific immunometabolites (circulating nucleotide-derived metabolites adenine and N4-acetylcytidine), which are increased in the circulation of SLE patients. These immunometabolites trigger a constitutive inflammasome activation resulting in aberrant IL1-β production. Given that IL1-β inhibition was reported to significantly reduce CV events without altering lipid levels, the investigators propose that these immunometabolites may represent novel candidate biomarkers of CV risk stratification in SLE. 2/ the investigators identified OX40L as an important costimulatory molecule implicated in follicular helper T cell (Tfh) activation in SLE. Interestingly, OX40L polymorphism has been associated to both SLE and atherosclerosis, and Tfh have been recently shown to accelerate atherosclerosis progression. 3/ Immune complexes-activated platelets sustain aberrant immune response in SLE and block immunosuppressive functions of regulatory T cells (Tregs) in a P-selectin/PSGL1 dependent manner. Selectins and Tregs cell dysfunction are well accepted players in atherosclerosis pathogenesis.

Thus there are multiple pathways that are shared between SLE and atherosclerosis and that may results in an increased risk of CV-associated morbidity in SLE patients. Exploring these interconnected pathways in SLE patients together with traditional and other well-established disease-related factors, might lead to a better stratification of CV risk in SLE.

The aim of this study is to investigate the accuracy, predictive value and utility of immunological disease-related biomarkers in stratifying CV risk in patients with SLE.

primary_purpose: Other

lead_sponsor: University Hospital, Bordeaux

location_country: Germany France Spain

location_facility: Biocruces Bizkaia Health Research Institute

location_facility: CHU de Bordeaux - service de médecine interne

location_facility: CHU de Strasbourd - service d'Immunologie Clinique


title: A Prospective, Interventional, Baseline Study In Young Male Subjects Aged From 5 to 9 Years

summary: Baseline Study on Duchenne Muscular Dystrophy (DMD) in view to collect data on the natural disease course in a cohort in young male subjects aged from 5 to 9 Years over a period of 6 to 36 months using disease appropriate evaluations.

lead_sponsor: Genethon

location_country:
United Kingdom
France

location_facility: Great Ormond Street Hospital & University College London Hospital


title: CLEVER: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms

acronym: CLEVER

summary: The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.

status: Active, not recruiting

enrollment_type: Actual

lead_sponsor: Microvention-Terumo, Inc.

location_country: Germany Hungary France

location_facility: National Institute of Clinical Neurosciences

intervention_type: Device


title: A Bioanalytical Method Cross-validation Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients

acronym: MITRA

summary: The purpose of this study is to assess relationship between tacrolimus concentrations determined via whole blood MITRA assay method with those determined using the established and validated whole blood venepuncture method using samples taken from liver and kidney transplant participants.

status: Completed

study_completion_date_type: Actual

ipd_sharing: Undecided

lead_sponsor: Astellas Pharma Europe Ltd.

location_facility:
Site FR33001
Site UK44001
Site FR33002
Site UK44002

status_simplified: Completed


type: Other Identifier

title: A Novel Phase I/IIa Open Label Study of IMM 101 in Combination With Selected Standard of Care (SOC) Regimens in Patients With Metastatic Cancer or Unresectable Cancer at Study Entry

acronym: MODULATE

summary:
During this open label study patients will receive IMM-101 in conjunction with a recognised standard of care for metastatic or unresectable cancer for the patient's specific tumour type.

The primary objective of the study is to provide safety data for IMM-101 in combination with a number of selected standard of care regimens.

status: Terminated

lead_sponsor: Immodulon Therapeutics Ltd

location_facility: Centre Léon Bérard, Dpt Medecine & INSERM

location_facility: St George's University of London, Institute of Infection and Immunity


title: MD1003 in Adrenomyeloneuropathy : a Randomized Double Blind Placebo Controlled Study

summary: The primary objective of the trial is to demonstrate the superiority of biotin at 300 mg/day over placebo in the clinical improvement (walking tests) of patients with adrenomyeloneuropathy

lead_sponsor: MedDay Pharmaceuticals SA


title: Complex Fractionated Atrial Electrocardiograms (CFAEs) Spatiotemporal Dispersion Guided Ablation Versus Pulmonary Vein Isolation (PVI) Guided Ablation in Persistent Atrial Fibrillation, a Multicenter Randomized Trial

acronym: CIPA

summary:
Objective: The purpose of this study is to compare the efficacy and safety of ablation of Atrial Fibrillation (AF) drivers marked by spatiotemporal dispersions and Complex Fractionated Atrial Electrocardiograms (CFAEs) to Pulmonary Vein Isolation (PVI) based ablation in patients with persistent AF.

Hypothesis: CFAE/spatiotemporal dispersion guided ablation will increase AF free survival compared to a PVI guided ablation.

Patient population: Patients with persistent AF will be randomized based on a 2:1 ratio into one of two study arms:

CFAE/spatiotemporal dispersion guided ablation: CFAE mapping and ablation during AF aimed at restoring sinus rhythm during ablation.
PVI guided ablation: wide antral pulmonary vein isolation during mapping catheter control of pulmonary vein signals

ReferenceCitation: Seitz J, Bars C, Théodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.

family: Seitz

full_name: Julien Seitz

given: Julien

sequence: first

family: Bars

full_name: Clément Bars

given: Clément

sequence: additional

family: Théodore

full_name: Guillaume Théodore

given: Guillaume

family: Beurtheret

full_name: Sylvain Beurtheret

given: Sylvain

family: Lellouche

full_name: Nicolas Lellouche

given: Nicolas

family: Bremondy

full_name: Michel Bremondy

given: Michel

family: Ferracci

full_name: Ange Ferracci

given: Ange

family: Faure

full_name: Jacques Faure

given: Jacques

family: Penaranda

full_name: Guillaume Penaranda

family: Yamazaki

full_name: Masatoshi Yamazaki

given: Masatoshi

family: Avula

full_name: Uma Mahesh R. Avula

given: Uma Mahesh R.

family: Curel

full_name: Laurence Curel

given: Laurence

family: Siame

full_name: Sabrina Siame

given: Sabrina

family: Berenfeld

full_name: Omer Berenfeld

given: Omer

family: Pisapia

full_name: André Pisapia

given: André

family: Kalifa

full_name: Jérôme Kalifa

given: Jérôme

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of the American College of Cardiology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_facility:
Kagoshima University
CHU de Nice
Isala
Hopital Saint Joseph


title: An Open Label Phase I of Oral Nintedanib Plus Weekly Docetaxel Therapy in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma After Failure of Platinum -Based First Line Chemotherapy

summary: Phase I study. To determine the MTD (Maximum Tolerated Dose) of nintedanib + weekly Docetaxel in patients with locally advanced or metastatic lung adenocarcinoma after failure of platinum-based first line chemotherapy.

lead_sponsor: Boehringer Ingelheim

location_country: Germany France

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: Krankenhaus Martha-Maria Halle-Dölau gGmbH


title: Phase I Multicenter Clinical Trial Evaluating the Combination of Trastuzumab Emtansine (T-DM1) and Non-pegylated Liposomal Doxorubicin in HER2-positive Metastatic Breast Cancer

summary:
The primary goal is to determine the maximum tolerated dose (MTD) of the combination of T-DM1 and non-pegylated liposomal doxorubicin in metastatic breast cancer (mBC) patients previously treated with taxanes and trastuzumab-based therapy.

In addition, pharmacokinetic data on the combination of T-DM1 and lyposomal doxorubicin will be obtained.

lead_sponsor: MedSIR


title: TARGIT-C(Consolidation) Prospective Phase IV Study of Intraoperative Radiotherapy (IORT) in Patients With Small Breast Cancer

acronym: TARGIT-C

summary:
This prospective, multicentric single arm phase IV study is based on the protocol of the international TARGIT-A and TARGIT-E study.

Patients ≥ 50 years with small, low-risk breast cancer who are operated but not irradiated show local relapse rates around 6% after 5 years. With adjuvant whole breast radiotherapy (WBRT) the local relapse rate drops to under 1% after 5 years under Tamoxifen (4).

It has been demonstrated (6, 9, 10) that the efficacy of radiation of the tumor bed only in a selected group can be non-inferior to WBRT.

The TARGIT C study should confirm the efficacy of a single dose of intraoperative radiotherapy (IORT) in a well selected group of patients with small breast cancer and absence of risk factors. In presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic treatment according to international guidelines.

Endpoints are the local relapse rate (within 2 cm of the tumor bed), ipsilateral relapse, cancer-specific and overall survival and contralateral breast cancer as well as documentation of quality of life and cosmetic outcome.

The expected local relapse rates are 0.825/1.375% after 3/5 years, respectively. Discontinuation of the trial is scheduled if rates of local relapse rates rise to 1.55/2.4/4% after 1/3/5 years. Power calculations result in 387 patients with a calculated dropout and loss to follow-up rate of 10%, an alpha of 0.05 and a beta of 0.10. There will be only a pre-pathology stratum.

It is a pragmatic trial in which each participating centre has the option to modify entry criteria and criteria for WBRT according to this core protocol after consultation with the steering committee and local ethics committee (e.g. size, free margins). Only centers with access to the Intrabeam® system (Carl Zeiss) can recruit patients into the trial.

ReferenceCitation: Fisher B, Anderson S, Redmond CK, Wolmark N, Wickerham DL, Cronin WM. Reanalysis and results after 12 years of follow-up in a randomized clinical trial comparing total mastectomy with lumpectomy with or without irradiation in the treatment of breast cancer. N Engl J Med. 1995 Nov 30;333(22):1456-61.

ReferenceCitation: Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32.

ReferenceCitation: Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717.

ReferenceCitation: Fyles AW, McCready DR, Manchul LA, Trudeau ME, Merante P, Pintilie M, Weir LM, Olivotto IA. Tamoxifen with or without breast irradiation in women 50 years of age or older with early breast cancer. N Engl J Med. 2004 Sep 2;351(10):963-70.

ReferenceCitation: Hughes KS, Schnaper LA, Berry D, Cirrincione C, McCormick B, Shank B, Wheeler J, Champion LA, Smith TJ, Smith BL, Shapiro C, Muss HB, Winer E, Hudis C, Wood W, Sugarbaker D, Henderson IC, Norton L; Cancer and Leukemia Group B; Radiation Therapy Oncology Group; Eastern Cooperative Oncology Group. Lumpectomy plus tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer. N Engl J Med. 2004 Sep 2;351(10):971-7.

ReferenceCitation: Polgár C, Fodor J, Major T, Németh G, Lövey K, Orosz Z, Sulyok Z, Takácsi-Nagy Z, Kásler M. Breast-conserving treatment with partial or whole breast irradiation for low-risk invasive breast carcinoma--5-year results of a randomized trial. Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):694-702. Epub 2007 May 25.

ReferenceCitation: Kraus-Tiefenbacher U, Bauer L, Kehrer T, Hermann B, Melchert F, Wenz F. Intraoperative radiotherapy (IORT) as a boost in patients with early-stage breast cancer -- acute toxicity. Onkologie. 2006 Mar;29(3):77-82. Epub 2006 Mar 3.

ReferenceCitation: Kraus-Tiefenbacher U, Bauer L, Scheda A, Fleckenstein K, Keller A, Herskind C, Steil V, Melchert F, Wenz F. Long-term toxicity of an intraoperative radiotherapy boost using low energy X-rays during breast-conserving surgery. Int J Radiat Oncol Biol Phys. 2006 Oct 1;66(2):377-81. Epub 2006 Aug 2.

ReferenceCitation: Vaidya JS, Joseph DJ, Tobias JS, Bulsara M, Wenz F, Saunders C, Alvarado M, Flyger HL, Massarut S, Eiermann W, Keshtgar M, Dewar J, Kraus-Tiefenbacher U, Sütterlin M, Esserman L, Holtveg HM, Roncadin M, Pigorsch S, Metaxas M, Falzon M, Matthews A, Corica T, Williams NR, Baum M. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial. Lancet. 2010 Jul 10;376(9735):91-102. doi: 10.1016/S0140-6736(10)60837-9. Erratum in: Lancet. 2010 Jul 10;376(9735):90.

ReferenceCitation: Vaidya JS, Wenz F, Bulsara M, Tobias JS, Joseph DJ, Keshtgar M, Flyger HL, Massarut S, Alvarado M, Saunders C, Eiermann W, Metaxas M, Sperk E, Sütterlin M, Brown D, Esserman L, Roncadin M, Thompson A, Dewar JA, Holtveg HM, Pigorsch S, Falzon M, Harris E, Matthews A, Brew-Graves C, Potyka I, Corica T, Williams NR, Baum M; TARGIT trialists' group. Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer: 5-year results for local control and overall survival from the TARGIT-A randomised trial. Lancet. 2014 Feb 15;383(9917):603-13. doi: 10.1016/S0140-6736(13)61950-9. Epub 2013 Nov 11. Erratum in: Lancet. 2014 Feb 15;383(9917):602.

ReferenceCitation: Vaidya JS, Bulsara M, Baum M, Wenz F, Massarut S, Pigorsch S, Alvarado M, Douek M, Saunders C, Flyger HL, Eiermann W, Brew-Graves C, Williams NR, Potyka I, Roberts N, Bernstein M, Brown D, Sperk E, Laws S, Sütterlin M, Corica T, Lundgren S, Holmes D, Vinante L, Bozza F, Pazos M, Le Blanc-Onfroy M, Gruber G, Polkowski W, Dedes KJ, Niewald M, Blohmer J, McCready D, Hoefer R, Kelemen P, Petralia G, Falzon M, Joseph DJ, Tobias JS. Long term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial. BMJ. 2020 Aug 19;370:m2836. doi: 10.1136/bmj.m2836.

lead_sponsor: Universitätsmedizin Mannheim

location_facility: Department of Radiotherapy University Hospital Mannheim

location_facility: Institut régional du Cancer de Montpellier

intervention_type: Radiation


title: Postoperative Patient-controlled Perineural Analgesia After Orthopedic Surgery: A Medico-economic Comparative Evaluation of Patient Management by Remote Control Versus Bedside Care

acronym: MICREL

summary: Perineural injection of local anesthesic is currently the reference method for the treatment of post operative pain in a patient undergoing major orthopedic surgery. Postoperative pain is a dynamic phenomena in every patient. It is classified as intense during the first postoperative hours after surgery, and decreases in a non-linear manner over the days following the procedure. PCA (patient control analgesia) infusion of local anesthesic allows an adaptation of the local analgesia doses to the evaluated pain scores, as well as permit a decrease in adverse events related to the continuous infusion technique (motor or sensory blockade, paresthesia, etc.). The physician can also modify the pump settings according to the postoperative rehabilitation plan.The use of new communication techniques such as "telemedecine" may be of interest in reducing treatment onset time and optimizing pain management. The remote control consists to change the settings of the pump after if the anesthesiologist was informed in real time (via a smartphone or a tablet) on patient pain level, sensory and motor blockades. The physician goes to a dedicated website (Micrel CareTM). and makes the necessary changes by remote control via a GPRS (General Packet Radio Service) connexion. The aim of this prospective, comparative, multicentric trial is to compare the effectiveness of patient management through two communication modalities: remote control versus bedside care.

ReferenceType: derived

ReferenceCitation: Capdevila X, Macaire P, Bernard N, Biboulet P, Cuvillon P, Choquet O, Bringuier S. Remote transmission monitoring for postoperative perineural analgesia after major orthopedic surgery: A multicenter, randomized, parallel-group, controlled trial. J Clin Anesth. 2021 Dec 1;77:110618. doi: 10.1016/j.jclinane.2021.110618. [Epub ahead of print]

lead_sponsor: University Hospital, Montpellier

location_country:
United Arab Emirates
France
Netherlands

location_facility: Department of Anesthesiology and critical care, Lapeyronie University Hospital

location_facility: Anesthesia Réanimation Department, Hôpital Saint Roch


title: A One Year Longitudinal Therapeutically Non-Interventional Study of MSRV-Env Burden in Multiple Sclerosis Patients (RRMS - SPMS - PPMS - CIS) as Assessed by PCR and ELISA in Blood

acronym: LOMBARD

summary: This study intends to explore evolution of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum of MS patients. The study will be conducted over one year in four cohorts of patients with different forms of MS (remitting-relapsing MS i.e. RRMS, primary-progressive MS i.e. PPMS and secondary-progressive MS i.e. SPMS) and in clinically isolated syndrome (CIS) patients who have suffered a single clinical event but do not comply with diagnosis criteria for definite MS. The MSRV RNA and MSRV-Env protein levels will be correlated with the clinical evolution of patients and with the reverse transcriptase activity, inflammatory markers assessed by cytokines levels. A control group of healthy subjects will be included (the study, GN-E-003, is performed in parallel and is part of another dedicated protocol).

lead_sponsor: GeNeuro Innovation SAS

location_country: France Switzerland Spain

location_facility: Centre Hospitalier Universitaire Vaudois - Dpt of Clinical Neurosciences - Neurology /Batiment 10-131 - Rue du Bugnon 46 -

location_facility: Hospital Universitari and Research Institute Vall d'Hebron - Servicio de Neuroimunologia de Nuestro Centro - Pg. Vall d'Hebron 119-129

location_facility: Hospices civils de Lyon - Service de Neurologie A - 59 Boulevard Pinel

location_facility: CHU Timone - Service de Neurologie et CRMBM CNRS 7339 - 264, rue Saint Pierre


title: A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-002200 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects With Chronic Hepatitis C Genotype 1 Infection

summary:
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered ALS-002200 in healthy volunteers (HV) and subjects with chronic hepatitis C (CHC) genotype 1 infection.

Part 1 will assess single ascending dosing pharmacokinetics and safety in HV. Part 2 will assess food effects on pharmacokinetics in HV. Part 3 will assess multiple ascending dosing pharmacokinetics and safety in subjects with CHC genotype 1 infection.

lead_sponsor: Alios Biopharma Inc.

location_country:
Moldova, Republic of
Romania
France

location_facility: Arensia Biotrial


title: An Open-label, Multicenter, Phase 1/2 Study of JNJ-40346527, an FMS Inhibitor, in Subjects With Relapsed or Refractory Hodgkin Lymphoma

summary: The purpose of this study is to determine the safety, pharmacokinetics, and preliminary efficacy information of JNJ-40346527 in patients with relapsed or refractory Hodgkin lymphoma.

lead_sponsor: Janssen Research & Development, LLC


location_country:
Germany
United Kingdom
France

location_facility:
Eurofins Optimed
Eurofins Optimed Lyon

title: Analgesic Profile of 3 New Ibuprofen Lozenges (V0498TA01A 15 mg, 25 mg, 35 mg) After Single Administration in Acute Sore Throat Pain

summary:
"Sore throat is one of the most common complaints encountered in clinical practice. And in 65% of cases, the infection is thought to be viral in nature.

The aim of this study is to evaluate the analgesic profile of 3 Ibuprofen lozenges after single administration in acute sore throat pain."


title: An Open-Label, Dose-escalation, Phase I/IIa Study to Determine the Maximum Tolerated Dose, Recommended Dose, Efficacy, Pharmacokinetics and Pharmacodynamics of the Dual VEGFR-FGFR Tyrosine Kinase Inhibitor, E-3810, Given Orally as Single Agent to Patients With Advanced Solid Tumours

summary:
Co-selective inhibition of VEGFRs and FGFR has the potential benefit of blocking the two most relevant players in tumor angiogenesis and simultaneously targeting proliferation in FGF-driven tumors. Lucitanib is a novel dual-targeted small molecule inhibitor of VEGFR1, 2, 3 and FGFR1 showing strong anti-angiogenic and anti-tumor activity in preclinical models at well-tolerated oral doses, with a favorable pharmacokinetic profile. These properties make it an attractive candidate for development in humans.

This is an open-label, uncontrolled, non-randomized, PhaseI/IIa study and its primary objective is to determine the Maximum Tolerated Dose (MTD) of Lucitanib administered orally, once daily, on a continuous schedule over the initial 28-day cycle.

Secondary objectives are to determine the safety profile, pharmacokinetics, pharmacodynamics and antitumour activity of Lucitanib, given as a single agent to adult patients with advanced solid tumours.

The study consists of two phases, a dose escalation phase followed by a dose-expansion phase at the identified Recommended Dose (RD). Eligible patients have histologically or cytologically confirmed locally advanced or metastatic solid tumours, relapsed or refractory to standard therapy. For the dose expansion, patients should have tumours bearing FGFR1 or 11q 12-14 amplification, assessed by FISH or CGH array, or "sensitive" to antiangiogenic treatment. These latter are defined as patients who have relapsed after having experienced stable disease (lasting at least six months) or partial response with prior treatment with an approved antiangiogenic regimen or patients with tumour types known to be potentially responsive to antiangiogenic agents but without such pretreatment if no antiangiogenic agents were approved and/or available for that specific condition (e.g thyroid cancer, thymic carcinoma).

Serial safety assessments, including evaluation of symptoms, physical examination and blood and urine laboratory analyses are performed throughout the study. Cardiac functions and blood pressure are monitored in consultation with a cardiologist. PK parameters are determined on plasma samples collected during the first 4-week cycle and analyzed using a validated LC-MS/MS method. Correlative studies include: (i) quantitative assessment of the effects of E-3810 on tumor vasculature by DCE-MRI and DCE-US imaging; (ii) assay of angiogenesis biomarkers i.e. soluble VEGFR2, VEGFR1, VEGF, bFGF, Collagen IV, FGF23 and PIGF(by ELISA) and circulating endothelial and progenitors cells (CEC and CEP). Tumor response is based on imaging according to RECIST; circulating tumor cells (CTC) are measured by the immunomagnetic CellSearch method.

In patients with tumours bearing FGFR1 amplifications the efficacy of Lucitanib will be formally tested according to a phase IIa design (one-stage Flaming design, H0=0.05, H1=0,30, power 0,80.

ipd_sharing: Yes

ipd_sharing_description:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

lead_sponsor: Institut de Recherches Internationales Servier

location_country: Italy France Spain

location_facility:
Institute Gustave Roussy
Hopital Louis Pradel
Vall d' Hebron University Hospital
European Institute of Oncology


title: Open Label Treatment of Patients With Chronic Hand Dermatitis Who Have Participated in a Previous Clinical Trial Involving Oral Alitretinoin

summary: The purpose of the study is to investigate the safety and efficacy of alitretinoin in chronic hand eczema that is refractory to topical corticosteroids.

lead_sponsor: Basilea Pharmaceutica


summary: Part 1: The primary purpose is to determine the recommended dose of E7070 in combination with capecitabine by dose adjustment. Part 2: The primary purpose is to determine the safety and efficacy of the combination in patients with metastatic CRC resistant to 5-fluorouracil and irinotecan.

lead_sponsor: Eisai Limited

location_country: Germany France Netherlands

location_facility:
Netherlands Cancer Institute
Centre Léon Bérard
Institut Curie
Universitätsklinikum der GHS-Essen


title: A Randomized, Eight-week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (300/5 mg and 300/10 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy

summary: This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone

ReferenceCitation: Glorioso N, Thomas M, Troffa C, Argiolas G, Patel S, Baek I, Zhang J. Antihypertensive efficacy and tolerability of aliskiren/amlodipine single- pill combinations in patients with an inadequate response to aliskiren monotherapy. Curr Vasc Pharmacol. 2012 Nov;10(6):748-55.

lead_sponsor: Novartis

location_country:
Italy
India
France
Lithuania
Venezuela
Spain
Estonia
Korea, Republic of
Iceland

location_facility:
Investigative Site
Investigative site


title: A Phase 1 Study of TAS2940 in Patients With Locally Advanced or Metastatic Solid Tumors With EGFR and / or HER2 Aberrations

summary: This is a first-in-human, open label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and the preliminary antitumor activity of TAS2940 in patients with advanced or metastatic solid tumors who are not candidates for approved or available therapies.

lead_sponsor: Taiho Oncology, Inc.

location_country:
United States
France

location_facility: University of Texas MD Anderson Cancer Center


title: Comparing Impact of Operation and Fertility Treatment on Fertility for Women With Deep Infiltrating Endometriosis: A Multicenter Randomized Controlled Trial

acronym: EFFORT

summary: The EFFORT study compares the impact on fertility of operation or fertility treatment (IVF, in vitro fertilization) in a multicenter randomized controlled trial. The study population consists of women with colorectal deep infiltrating endometriosis and a pregnancy intention. These women will be randomized to either of the two treatment groups: Group A = Operation or Group B = fertility treatment (IVF). Group A will be further divided postoperatively into spontaneous conception or IVF depending on the Endometriosis Fertility Index score.

lead_sponsor: Horsens Hospital

location_country: Denmark France

location_facility: The Endometriosis Center, Clinique Tivoli-Ducos

intervention_type: Procedure


title: Artificial Intelligence for Real-time Detection and Monitoring of Colorectal Polyps

summary: The investigators hypothesize that the clinical implementation of an AI system is an optimal tool to monitor, audit and improve the detection and classification of polyps during colonoscopy. The objectives of this study are to generate preliminary data to evaluate the effectiveness of AI-assisted colonoscopy on: a) the rate of detection of adenomas; b) the histological classification of polyps (which would reduce the need for pathological evaluation of polyps); c) the automatic evaluation of the quality of colonoscopy.

primary_purpose: Diagnostic

lead_sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

location_country: Canada France

location_facility: Centre Hospitalier Universitaire de Montréal

intervention_type: Diagnostic Test


title: A Phase 1 Study of TAS0612 in Patients With Locally Advanced or Metastatic Solid Tumors

summary: The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.

location_facility: Centre de Lutte Contre le Cancer Gustave Roussy


title: Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial

acronym: OligoRARE

summary:
This is a randomized open-label multicentre Phase III superiority study of the effect of adding SBRT to the standard of care treatment on overall survival in patients with rare oligometastatic cancers.

Patients will be randomized in a 1:1 ratio between current standard of care treatment vs. standard of care treatment + SBRT to all sites of known metastatic disease.

The primary objective of this trial is to assess if the addition of stereotactic body radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared to standard of care treatment alone in patients with rare oligometastatic cancers.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Belgium France

location_facility: Gasthuiszusters Antwerpen - Sint-Augustinus


title: Multicenter International Observational Study to Identify Trajectories of Cardiac Allograft Vasculopathy After Heart Transplantation and Their Specific Determinants

acronym: TRAJ-CAV

summary: This project aims: i) to identify Cardiac Allograft Vasculopathy (CAV) trajectories after heat transplantation using latent class mixed modeling, ii) to characterize the global and specific determinants of different trajectories and iii) to provide an easily accessible tool to project individual probability of CAV trajectory belonging.

ReferenceCitation: Loupy A, Coutance G, Bonnet G, Van Keer J, Raynaud M, Aubert O, Bories MC, Racapé M, Yoo D, Duong Van Huyen JP, Bruneval P, Taupin JL, Lefaucheur C, Varnous S, Leprince P, Guillemain R, Empana JP, Levine R, Naesens M, Patel JK, Jouven X, Kobashigawa J. Identification and Characterization of Trajectories of Cardiac Allograft Vasculopathy After Heart Transplantation: A Population-Based Study. Circulation. 2020 Jun 16;141(24):1954-1967. doi: 10.1161/CIRCULATIONAHA.119.044924. Epub 2020 May 4.

name: Université de Paris, INSERM, Paris Translational Research Centre for Organ Transplantation, France (A.L., G.C., G.B., M. Raynaud, O.A., M. Racapé, D.Y., C.L., J.-P.E., X.J.).

name: Kidney Transplant Department (A.L., O.A.), Necker Hospital, Assistance Publique-Hôpitaux de Paris, France.

family: Loupy

full_name: Alexandre Loupy

given: Alexandre

name: Department of Cardiac and Thoracic Surgery, Cardiology Institute, Pitié-Salpêtrière Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP), Sorbonne University Medical School, France (G.C., S.V., P.L.).

family: Coutance

full_name: Guillaume Coutance

name: Cardiology and Heart Transplant Department (G.B., M.-C.B., R.G., J.-P.E., X.J.), Georges Pompidou Hospital, Assistance Publique-Hôpitaux de Paris, France.

family: Bonnet

full_name: Guillaume Bonnet

name: Departments of Cardiology (J.V.K.), University Hospitals Leuven, Katholieke Universiteit Leuven, Belgium.

family: Van Keer

full_name: Jan Van Keer

given: Jan

family: Raynaud

full_name: Marc Raynaud

given: Marc

family: Aubert

full_name: Olivier Aubert

given: Olivier

family: Bories

full_name: Marie-Cécile Bories

given: Marie-Cécile

family: Racapé

full_name: Maud Racapé

given: Maud

family: Yoo

full_name: Daniel Yoo

given: Daniel

name: Pathology Department (J.P.D.V.H.), Necker Hospital, Assistance Publique-Hôpitaux de Paris, France.

family: Duong Van Huyen

full_name: Jean-Paul Duong Van Huyen

given: Jean-Paul

name: Pathology Department (P.B.), Georges Pompidou Hospital, Assistance Publique-Hôpitaux de Paris, France.

family: Bruneval

full_name: Patrick Bruneval

given: Patrick

name: Laboratory of Immunology and Histocompatibility, AP-HP, Saint Louis Hospital, Paris, France (J.-L.T.).

family: Taupin

full_name: Jean-Luc Taupin

given: Jean-Luc

family: Lefaucheur

full_name: Carmen Lefaucheur

given: Carmen

name: INSERM, UMRS 1166-ICAN, Institute of Cardiometabolism and Nutrition, Paris, France (S.V., P.L.).

family: Varnous

full_name: Shaida Varnous

given: Shaida

family: Leprince

full_name: Pascal Leprince

given: Pascal

family: Guillemain

full_name: Romain Guillemain

given: Romain

family: Empana

full_name: Jean-Philippe Empana

given: Jean-Philippe

name: Department of Cardiology, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA (R.L., J.K.P., J.K.).

family: Levine

full_name: Ryan Levine

given: Ryan

name: Microbiology, Immunology, and Transplantation and of Nephrology(M.N.), University Hospitals Leuven, Katholieke Universiteit Leuven, Belgium.

name: Renal Transplantation (M.N.), University Hospitals Leuven, Katholieke Universiteit Leuven, Belgium.

family: Naesens

full_name: Maarten Naesens

given: Maarten

family: Patel

full_name: Jigneh K. Patel

given: Jigneh K.

family: Jouven

full_name: Xavier Jouven

given: Xavier

family: Kobashigawa

full_name: Jon Kobashigawa

given: Jon

publisher: Ovid Technologies (Wolters Kluwer Health)

lead_sponsor: Paris Translational Research Center for Organ Transplantation

location_facility:
Jon Kobashigawa
Maarten Naesens
Paris Transplant Group


title: In Vivo Determination of Knee Kinematics for Subjects Having a Zimmer-Biomet Persona PCR or PS TKA

acronym: PCR PS TKA

summary: 25 subjects implanted with a Zimmer-Biomet Posterior Cruciate Retaining (PCR) total knee arthroplasty (TKA) and 25 subjects implanted with a Zimmer-Biomet Posterior Stabilizing (PS) TKA will be asked to perform stepping up and deep knee bend activities while under fluoroscopic surveillance (x-ray video). The movements between the two different types of TKAs will be compared.

time_perspective: Retrospective

ipd_sharing_description: Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.

lead_sponsor: The University of Tennessee, Knoxville

location_facility: The Institute for Locomotion, Aix-Marseille University, Hopital Sainte-Marguerite


title: A Phase 1, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of TRK-950 Given Intravenously in Patients With Advanced Solid Tumors

summary:
To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent
To establish the dose of TRK-950 recommended for future phase 2 studies

lead_sponsor: Toray Industries, Inc

location_facility:
Mayo Clinic
Centre Léon Bérard
HonorHealth Research Institute

intervention_type: Biological


title: An Open-Label Multicenter Phase 1 Study of E7046 in Subjects With Selected Advanced Malignancies

summary: This is an open label, multicenter, Phase 1 study of E7046 to assess the safety and tolerability of E7046 and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of E7046.

ReferenceCitation: Hong DS, Parikh A, Shapiro GI, Varga A, Naing A, Meric-Bernstam F, Ataman Ö, Reyderman L, Binder TA, Ren M, Liu M, Dayal S, Siu AY, Sachdev P, Xu L, Bhagawati-Prasad V, Tchakov I, Ooi CE, Bao X, Marabelle A. First-in-human phase I study of immunomodulatory E7046, an antagonist of PGE(2)-receptor E-type 4 (EP4), in patients with advanced cancers. J Immunother Cancer. 2020 Jun;8(1). pii: e000222. doi: 10.1136/jitc-2019-000222.

family: Hong

full_name: David S Hong

given: David S

family: Parikh

full_name: Aparna Parikh

given: Aparna

family: Shapiro

full_name: Geoffrey I Shapiro

given: Geoffrey I

family: Varga

full_name: Andrea Varga

given: Andrea

family: Naing

full_name: Aung Naing

given: Aung

family: Meric-Bernstam

full_name: Funda Meric-Bernstam

given: Funda

family: Ataman

full_name: Özlem Ataman

given: Özlem

family: Reyderman

full_name: Larisa Reyderman

given: Larisa

family: Binder

full_name: Terri A Binder

given: Terri A

family: Ren

full_name: Min Ren

given: Min

family: Liu

full_name: Mingjie Liu

given: Mingjie

family: Dayal

full_name: Satish Dayal

given: Satish

family: Siu

full_name: Amy Y Siu

given: Amy Y

family: Sachdev

full_name: Pallavi Sachdev

given: Pallavi

family: Xu

full_name: Lucy Xu

given: Lucy

family: Bhagawati-Prasad

full_name: Vijay Bhagawati-Prasad

given: Vijay

family: Tchakov

full_name: Ilian Tchakov

given: Ilian

family: Ooi

full_name: Chean Eng Ooi

given: Chean Eng

family: Bao

full_name: Xingfeng Bao

given: Xingfeng

family: Marabelle

full_name: Aurelien Marabelle

given: Aurelien

currency_apc_doaj: USD

journal_name: Journal for ImmunoTherapy of Cancer

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

title: First-in-human phase I study of immunomodulatory E7046, an antagonist of PGE2-receptor E-type 4 (EP4), in patients with advanced cancers