Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes (MINDACT)

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ClinicalTrials.gov Identifier: NCT00433589

Recruitment Status : Completed

First Posted : February 12, 2007

Last Update Posted : November 17, 2022

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

Agendia

Breast International Group

Roche Pharma AG

Novartis

Sanofi

Information provided by (Responsible Party):

European Organisation for Research and Treatment of Cancer - EORTC

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Completed
Actual Primary Completion Date :	March 2020
Actual Study Completion Date :	March 2020

Publications of Results:

Viale G, Slaets L, Bogaerts J, Rutgers E, Van't Veer L, Piccart-Gebhart MJ, de Snoo FA, Stork-Sloots L, Russo L, Dell'Orto P, van den Akker J, Glas A, Cardoso F; TRANSBIG Consortium & the MINDACT Investigators. High concordance of protein (by IHC), gene (by FISH; HER2 only), and microarray readout (by TargetPrint) of ER, PgR, and HER2: results from the EORTC 10041/BIG 03-04 MINDACT trial. Ann Oncol. 2014 Apr;25(4):816-823. doi: 10.1093/annonc/mdu026.

Rutgers E, Piccart-Gebhart MJ, Bogaerts J, Delaloge S, Veer LV, Rubio IT, Viale G, Thompson AM, Passalacqua R, Nitz U, Vindevoghel A, Pierga JY, Ravdin PM, Werutsky G, Cardoso F. The EORTC 10041/BIG 03-04 MINDACT trial is feasible: results of the pilot phase. Eur J Cancer. 2011 Dec;47(18):2742-9. doi: 10.1016/j.ejca.2011.09.016. Epub 2011 Nov 1.

Other Publications:

Mook S, Bonnefoi H, Pruneri G, Larsimont D, Jaskiewicz J, Sabadell MD, MacGrogan G, Van't Veer LJ, Cardoso F, Rutgers EJ. Daily clinical practice of fresh tumour tissue freezing and gene expression profiling; logistics pilot study preceding the MINDACT trial. Eur J Cancer. 2009 May;45(7):1201-1208. doi: 10.1016/j.ejca.2009.01.004. Epub 2009 Feb 14.

Cardoso F, Van't Veer L, Rutgers E, Loi S, Mook S, Piccart-Gebhart MJ. Clinical application of the 70-gene profile: the MINDACT trial. J Clin Oncol. 2008 Feb 10;26(5):729-35. doi: 10.1200/JCO.2007.14.3222.

Cardoso F, Piccart-Gebhart M, Van't Veer L, Rutgers E; TRANSBIG Consortium. The MINDACT trial: the first prospective clinical validation of a genomic tool. Mol Oncol. 2007 Dec;1(3):246-51. doi: 10.1016/j.molonc.2007.10.004. Epub 2007 Oct 22.

Mook S, Van't Veer LJ, Rutgers EJ, Piccart-Gebhart MJ, Cardoso F. Individualization of therapy using Mammaprint: from development to the MINDACT Trial. Cancer Genomics Proteomics. 2007 May-Jun;4(3):147-55.

Bogaerts J, Cardoso F, Buyse M, Braga S, Loi S, Harrison JA, Bines J, Mook S, Decker N, Ravdin P, Therasse P, Rutgers E, van 't Veer LJ, Piccart M; TRANSBIG consortium. Gene signature evaluation as a prognostic tool: challenges in the design of the MINDACT trial. Nat Clin Pract Oncol. 2006 Oct;3(10):540-51. doi: 10.1038/ncponc0591.

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

Piccart M, van 't Veer LJ, Poncet C, Lopes Cardozo JMN, Delaloge S, Pierga JY, Vuylsteke P, Brain E, Vrijaldenhoven S, Neijenhuis PA, Causeret S, Smilde TJ, Viale G, Glas AM, Delorenzi M, Sotiriou C, Rubio IT, Kummel S, Zoppoli G, Thompson AM, Matos E, Zaman K, Hilbers F, Fumagalli D, Ravdin P, Knox S, Tryfonidis K, Peric A, Meulemans B, Bogaerts J, Cardoso F, Rutgers EJT. 70-gene signature as an aid for treatment decisions in early breast cancer: updated results of the phase 3 randomised MINDACT trial with an exploratory analysis by age. Lancet Oncol. 2021 Apr;22(4):476-488. doi: 10.1016/S1470-2045(21)00007-3. Epub 2021 Mar 12.

Delaloge S, Piccart M, Rutgers E, Litiere S, van 't Veer LJ, van den Berkmortel F, Brain E, Dudek-Peric A, Gil-Gil M, Gomez P, Hilbers FS, Khalil Z, Knox S, Kuemmel S, Kunz G, Lesur A, Pierga JY, Ravdin P, Rubio IT, Saghatchian M, Smilde TJ, Thompson AM, Viale G, Zoppoli G, Vuylsteke P, Tryfonidis K, Poncet C, Bogaerts J, Cardoso F; MINDACT investigators and the TRANSBIG Consortium. Standard Anthracycline Based Versus Docetaxel-Capecitabine in Early High Clinical and/or Genomic Risk Breast Cancer in the EORTC 10041/BIG 3-04 MINDACT Phase III Trial. J Clin Oncol. 2020 Apr 10;38(11):1186-1197. doi: 10.1200/JCO.19.01371. Epub 2020 Feb 21.

Cardoso F, van't Veer LJ, Bogaerts J, Slaets L, Viale G, Delaloge S, Pierga JY, Brain E, Causeret S, DeLorenzi M, Glas AM, Golfinopoulos V, Goulioti T, Knox S, Matos E, Meulemans B, Neijenhuis PA, Nitz U, Passalacqua R, Ravdin P, Rubio IT, Saghatchian M, Smilde TJ, Sotiriou C, Stork L, Straehle C, Thomas G, Thompson AM, van der Hoeven JM, Vuylsteke P, Bernards R, Tryfonidis K, Rutgers E, Piccart M; MINDACT Investigators. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med. 2016 Aug 25;375(8):717-29. doi: 10.1056/NEJMoa1602253.

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