BR21

Canadian Cancer Trials Group - Tumour Bank
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BR21 Details
Status: Closed
Activation Date: 2001AUG14
Closing Date: 2003JAN31
Phase: III

Description: A Randomized Placebo Controlled Study of OSI-774 (Tarceva) in Patients with Incurable Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease

Eligibility: Incurable stage IIIB/IV non-small cell lung cancer who have failed at least one prior regimen, but no more than two prior regimens for advanced or metastatic disease.

Objective: To compare overall survival; secondary endpoints include progression-free survival, response rates, duration of response, toxicity and tolerability, QoL QLQ C30 + QLQ LC13: all patients, tissue EGFR versus outcome and response, OSI-744 trough PK.

Participation: Not limited

Primary Publication Show

Other Publications Show

Year: 2005
Title: Erlotinib in Lung Cancer - Molecular and clinical predictors of outcome
Authors: Tsao M;Sakurada A;Cutz J;Zhu C;Kamel-Reid S;Squire J;Lorimer I;Zhang T;Liu N;Daneshmand M;Marrano P;da Cunha Santos G;Lagarde A;Richardson F;Seymour L;Whitehead M;Ding K;Pater J;Shepherd FA;
Reference: New England Journal of Medicine 2005 Jul 14; 353 (2)
Link:

Year: 2005
Title: Molecular analysis of the epidermal growth factor receptor gene and protein expression in patients treated with erlotinib in National Cancer Institute of Canada Clinical Trials Group trial BR.21
Authors: Tsao MS;Sakurada A;Lorimer I;Cutz J;Kamel-Reid S;Squire J;Ding K;Frank R;Seymour L;Shepherd F;
Reference: Proceedings of the American Society of Clinical Oncology 2005 May 13; 23 (16S Part 1, abstr 7007)
Link: http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=34&abstractID=31926

Year: 2006
Title: An analysis of the prognostic and predictive importance of K-ras mutation status in the National Cancer Institute of Canada Clinical Trials Group BR.21 study of erlotinib versus placebo in the treatment of non-small cell lung cancer
Authors: Tsao M;Zhu C;Sakurada A;Zhang T;Whitehead M;Kamel-Reid S;Ding K;Seymour L;Shepherd F;
Reference: Journal of Clinical Oncology 2006 Jun 2 ; 24 (18s Part 1, abstr 7005)
Link: http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=40&abstractID=34061

Year: 2006
Title: Smoking history and epidermal growth factor receptor expression as predictors of survival benefit from erlotinib for patients with non-small-cell lung cancer in the National Cancer Institute of Canada Clinical Trials Group study BR.21
Authors: Clark GM;Zborowski DM;Santabarbara P;Ding K;Whitehead M;Seymour L;Shepherd FA;
Reference: Clinical Lung Cancer 2006 May ; 7 (6)
Link:

Year: 2006
Title: Clinical utility of epidermal growth factor receptor expression for selecting patients with advanced non-small cell lung cancer for treatment with erlotinib
Authors: Clark GM;Zborowski DM;Culbertson JL;Whitehead M;Savoie M;Seymour L;Shepherd FA;
Reference: Journal of Thoracic Oncology 2006 Oct 1 ; 1 (8)
Link:

Year: 2007
Title: Updated molecular analyses of exons 19 and 21 of the epidermal growth factor receptor gene and codons 12 and 13 of the KRAS gene in non-small cell lung cancer patients treated with erlotinib in National Cancer Institute of Canada Clinical Trials Group BR.21
Authors: Shepherd FA;Ding K;Sakurada A;da Cunha Santos G;Zhu C;Seymour L;Whitehead M;Kamel-Reid S;Squire J;Tsao MS;
Reference: Journal of Clinical Oncology 2007 Jun 1 ; 25 (18s Part 1, abstr 7571)
Link:

Year: 2007
Title: Predictors of benefit from targeted therapy: lessons learned from the EGFR inhibitor story
Authors: Tsao M;
Reference: Making Connections: A Canadian Cancer Research Conference Celebrating NCIC's 60th Anniversary 2007 Nov 15; ( )
Link:

Year: 2008
Title: Validation of treatment induced specific adverse effect as a predictor of treatment benefit: a case study of NCIC CTG BR21
Authors: Ding K;Pater J;Whitehead M;Seymour L;Shepherd FA;
Reference: Contemporary Clinical Trials 2008 Jul ; 29 (4)
Link:

Year: 2008
Title: Role of KRAS and EGFR as biomarkers of response to erlotinib in National Cancer Institute of Canada Clinical Trials Group study BR.21
Authors: Zhu C;da Cunha Santos G;Ding K;Sakurada A;Cutz J;Liu N;Zhang T;Marrano P;Whitehead M;Squire JA;Kamel-Reid S;Seymour L;Shepherd FA;Tsao M;
Reference: Journal of Clinical Oncology 2008 Sep 10; 26 (26)
Link:

Year: 2009
Title: TGF-a and amphiregulin levels in non-small cell lung cancer patients treated with erlotinib/placebo in the National Cancer Institute of Canada Clinical Trials Group NCIC CTG) BR.21
Authors: Goss GD;Addison C;Shepherd F;Seymour L;Le Maitre A;Ding K;
Reference: Journal of Clinical Oncology 2009 May 29; 27 (15s Part 1, abstr 11023)
Link: http://meetinglibrary.asco.org/content/32967-65

Year: 2009
Title: Baseline TGF- and amphiregulin levels in non small cell lung cancer patients treated with erlotinib or placebo in the NCIC Clinical Trials Group BR.21 clinical trial
Authors: Bradbury PA;Addison CL;Goss G;Shepherd FA;Seymour L;Le Maitre A;Ding K;
Reference: Journal of Thoracic Oncology 2009 Sep 1 ; 4 (9 suppl 1, abstr PD9.2.4)
Link:

Year: 2009
Title: Comparison of E-cadherin IHC status with clinical outcomes from erlotinib in the non small cell lung cancer clinical trial NCIC CTG BR.21
Authors: Richardson F;Young D;Wolf J;Sennello G;Wacker B;Davies A;
Reference: Journal of Thoracic Oncology 2009 Sep 1 ; 4 (9 suppl 1, abstr PD7.2.5)
Link:

Year: 2009
Title: A novel algorithm for the EGFR fluorescence in situ hybridization (FISH) assay in non-small cell lung cancer: an analysis of the NCIC Clinical Trials Group Study BR.21
Authors: da Cunha Santos G;Ding K;Cutz J;Le Maitre A;Squire JA;Shepherd FA;Tsao MS;Seymour L;
Reference: Journal of Thoracic Oncology 2009 Sep 1 ; 4 (9 suppl 1, abstr P3.171)
Link:

Year: 2010
Title: Plasma transforming growth factor a and amphiregulin protein levels in NCIC Clinical Trials Group BR.21
Authors: Addison CL;Ding K;Zhao H;Le Maitre A;Goss GD;Seymour L;Tsao M;Shepherd FA;Bradbury PA;
Reference: Journal of Clinical Oncology 2010 Dec 20; 28 (36)
Link: http://jco.ascopubs.org/content/28/36/5247.abstract?cmpid=jco_etoc_20December2010

Year: 2010
Title: EGFR and ABCG2 polymorphisms as prognostic and predictive markers in the NCIC CTG BR.21 trial of single-agent erlotinib in advanced non-small cell lung cancer
Authors: Liu G;Cheng D;Le Maitre A;Liu N;Chen Z;Seymour L;Ding K;Shepherd FA;Tsao MS;
Reference: Journal of Clinical Oncology 2010 Jun 4 ; 28 (15s, abstr 7538)
Link: http://meetinglibrary.asco.org/content/48780-74

Year: 2012
Title: Pharmacogenetic Analysis of BR.21, a Placebo-Controlled Randomized Phase III Clinical Trial of Erlotinib in Advanced Non-small Cell Lung Cancer
Authors: Liu G;Cheng D;Ding K;Le Maitre A;Liu N;Patel D;Chen Z;Seymour L;Shepherd FA;Tsao MS;
Reference: Journal of Thoracic Oncology 2012 Feb 1 ; 7 (2)
Link: http://journals.lww.com/jto/Fulltext/2012/02000/Pharmacogenetic_Analysis_of_BR_21,_a.8.aspx

Year: 2012
Title: Prognostic and Predictive Role of the VeriStrat Plasma Test in Patients with Advanced Non-Small-Cell Lung Cancer Treated with Erlotinib or Placebo in the NCIC Clinical Trials Group BR.21 Trial
Authors: Carbone DP;Ding K;Roder H;Grigorieva J;Roder J;Tsao MS;Seymour L;Shepherd FA;
Reference: Journal of Thoracic Oncology 2012 Nov 1 ; 7 (11)
Link: http://journals.lww.com/jto/Abstract/2012/11000/Prognostic_and_Predictive_Role_of_the_VeriStrat.6.aspx

Inventory
Hide Tissue Samples

Disease Site	Trial Code	Patients Accrued	Patients - Blocks	Patients - Slides	Patients - Blocks and/or Slides
LUNG	BR21	731	270	432	438

Hide TMA Samples

(Core size is 0.6 mm)

Disease Site	Trial Code	Patients Accrued	TMA Blocks	Patients on TMA Blocks
LUNG	BR21	731	0	0

Hide Fluid Samples

Disease Site	Trial Code	Patients Accrued	Patients - Whole Blood	Patients - Cellular Component of Blood	Patients - DNA extracted from Blood	Patients - RNA extracted from Blood	Patients - Plasma	Patients - Serum	Patients - Urine	Patients - Buccal
LUNG	BR21	731	0	0	0	0	728	1	0	0