MINDACT

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

Official title

MINDACT (Microarray In Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy): A Prospective, Randomized Study Comparing the 70-Gene Signature With the Common Clinical-Pathological Criteria in Selecting Patients for Adjuvant Chemotherapy in Breast Cancer With 0 to 3 Positive Nodes

Phase

Phase 3

Status

Completed

Conditions

Breast Cancer

Interventions

anthracycline-based; docetaxel and capecitabine; tamoxifen; Letrozole

Arms

• Chemotherapy randomization: Arm I (anthracycline-based) · Active comparator
• Chemotherapy randomization: Arm II (docetaxel and capecitabine) · Experimental
• Endocrine therapy randomization: Arm I · Active comparator
• Endocrine therapy randomization: Arm II · Experimental
• Treatment decision randomization: Arm I · Active comparator
• Treatment decision randomization: Arm II · Experimental

Enrollment

6,600 (estimated)

Primary outcomes

• Distant metastasis-free survival at 5 years
• Disease-free survival (DFS)
• DFS

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC with Agendia, Breast International Group, Roche Pharma AG, Novartis, Sanofi

Start

Feb 2007

Primary completion

Mar 2020

Results posted

No

Registry record

NCT00433589 · updated Nov 17, 2022

• 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. PubMed 19232484
• 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. PubMed 18258980
• 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. PubMed 19383299
• 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. PubMed 17878518
• 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. PubMed 17019432
• 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. PubMed 24667714
• 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. PubMed 22051734
• Alaeikhanehshir S, Ajayi T, Duijnhoven FH, Poncet C, Olaniran RO, Lips EH, van 't Veer LJ, Delaloge S, Rubio IT, Thompson AM, Cardoso F, Piccart M, Rutgers EJT. Locoregional Breast Cancer Recurrence in the European Organisation for Research and Treatment of Cancer 10041/BIG 03-04 MINDACT Trial: Analysis of Risk Factors Including the 70-Gene Signature. J Clin Oncol. 2024 Apr 1;42(10):1124-1134. doi: 10.1200/JCO.22.02690. Epub 2024 Jan 19. PubMed 38241603
• 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. PubMed 33721561
• 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. PubMed 32083990
• 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. PubMed 27557300