Evidence

Decentralization of Next-Generation RNA Sequencing-Based MammaPrint® and BluePrint® Kit at University Hospitals Leuven and Curie Institute Paris.

September 9, 2019

PUBLICATION: Transl Oncol. 2019 Sep 9;12(12):1557-1565. doi: 10.1016/j.tranon.2019.08.008. AUTHORS: Slembrouck L., Darrigues L., Laurent C., Mittempergher L., Delahaye L.J., Vanden Bempt I., Vander Borght S., Vliegen L., Sintubin P., Raynal V., Bohec M., Reyes C., Rapinat A., Helsmoortel C., Jongen L., Hoste G., Neven P., Wildiers H., Smeets A., Nevelsteen I., Punie K., Van Nieuwenhuysen E., Han…

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MammaPrint and BluePrint Molecular Diagnostics Using Targeted RNA Next-Generation Sequencing Technology

September 1, 2019

PUBLICATION: Journal of Molecular Diagnostics September 2019 Volume 21, Issue 5, Pages 808–823. AUTHORS: Lorenza Mittempergher, Leonie J.M.J. Delahaye, Anke T. Witteveen, Jacob B. Spangler, Fariet Hassenmahomed, Sammy Mee, Soufiane Mahmoudi, Jiang Chen, Simon Bao, Mireille H.J. Snel, Sandra Leidelmeijer, Naomi Besseling, Anne Bergstrom Lucas, Carlos Pabón-Peña, Sabine C. Linn, Christa Dreezen, Diederik Wehkamp, Bob Y. Chan,…

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Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer: Update of the ASCO Endorsement of the Cancer Care Ontario Guideline

August 1, 2019

PUBLICATION: Journal of Clinical Oncology 37, no. 22 (August 01, 2019) 1965-1977. DOI: 10.1200/JCO.19.00948. AUTHORS: N. Lynn Henry, MD, PhD; Mark R. Somerfield, PhD; Vandana G. Abramson, MD; Nofisat Ismaila, MD; Kimberly H. Allison, MD; Carey K. Anders, MD; Diana T. Chingos, MS, MFA; Andrea Eisen, MD; Bruno L. Ferrari, MD; Thomas H. Openshaw, MD; Patricia A.…

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The Changing Role of Gene-Expression Profiling in the Era of Deescalating Adjuvant Chemotherapy in Early-Stage Breast Cancer

June 17, 2019

PUBLICATION: Ann Surg Oncol (2019) 26: 3495. https://doi.org/10.1245/s10434-019-07511-8. AUTHORS: J.E.C. van Steenhoven, A. Kuijer, K. Schreuder, S.G. Elias, P.J. van Diest, E. van der Wall, S. Siesling, T. van Dalen SUMMARY: A Netherlands Cancer Registry study correlated the increased use of MammaPrint led to decreased chemotherapy use, especially for LN+ and younger women. Read more: Steenhoven et al_2019_Annals…

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2019 ASCO FLEX Poster

June 4, 2019

AUTHORS: Gordan Srkalovic, Adam Brufsky, Jennifer Crozier, Mehran Habibi, Pat Whitworth, Charles Cox, Ian Grady, Nina D’Abreo, Sarah Untch, Erin Yoder, William Audeh, FLEX Investigators Group DESCRIPTION: Clinical Trial in Progress: The FLEX Big Data Platform Explores New Gene Expression Profiles and Investigator-Initiated Protocols in Early Stage Breast Cancer Genomic signatures are revolutionizing the definition,…

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Strong Impact of MammaPrint and BluePrint on Treatment Decisions in Luminal Early Breast Cancer: Results of the WSG-PRIMe Study

June 1, 2019

PUBLICATION: Breast Cancer Res Treat. (2019) 175: 389. https://doi.org/10.1007/s10549-018-05075-x. AUTHORS: R. Wuerstlein, R. Kates, O. Gluz, E.M. Grischke, C. Schem, M. Thill, S. Hasmueller, A. Köhler, B. Otremba, F. Griesinger, C. Schindlbeck, A. Trojan, F. Otto, M. Knauer, R. Pusch, N. Harbeck, WSG-PRIMe investigators in Germany, Austria, Switzerland SUMMARY: MammaPrint and BluePrint test results strongly impacted physicians’ therapy…

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2018 SABCS FLEX Trials in Progress Poster

December 5, 2018

AUTHORS: Adam M. Brufsky, Jennifer A. Crozier, Ian Grady, Thomas Lomis, Pat Whitworth, Esther Rehmus, Gordon Srkalovic, Laura Lee, Peter Blumencranz, Paul Baron, Blanche Mavromatis, Sarah Untch, Lisa Blumencranz, Tina Treece, Erin Yoder, William Audeh. DESCRIPTION: MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles (FLEX) Genomic signatures are…

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Association of 70-Gene Signature Assay Findings With Physicians’ Treatment Guidance for Patients With Early Breast Cancer Classified as Intermediate Risk by the 21-Gene Assay

January 11, 2018

PUBLICATION: JAMA Oncol. 2018; 4(1):e173470. doi:10.1001/jamaoncol.2017.3470. AUTHORS: Michaela Tsai, MD; Shelly Lo, MD; William Audeh, MD; Rubina Qamar, MD; Raye Budway, MD; Ellis Levine, MD; Pat Whitworth, MD; Blanche Mavromatis, MD; Robin Zon, MD; Dwight Oldham, MD; Sarah Untch, MS; Tina Treece, PhD; Lisa Blumencranz, PhD; Hatem Soliman, MD ABSTRACT: Importance: Among patients who undergo the 21-gene assay…

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Use of Molecular Tools to Identify Patients With Indolent Breast Cancers With Ultralow Risk Over 2 Decades

November 2, 2017

PUBLICATION: JAMA Oncol. 2017;3(11):1503-1510. doi:10.1001/jamaoncol.2017.1261. AUTHORS: Laura J. Esserman, MD, MBA; Christina Yau, PhD; Carlie K. Thompson, MD; Laura J. van ‘t Veer, PhD; Alexander D. Borowsky, MD; Katherine A. Hoadley, PhD; Nicholas P. Tobin, PhD; Bo Nordenskjöld, MD, PhD; Tommy Fornander, MD, PhD; Olle Stål, PhD; Christopher C. Benz, MD; Linda S. Lindström, PhD ABSTRACT: Importance: The…

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Tamoxifen Therapy Benefit for Patients with 70-gene Signature High and Low Risk

November 1, 2017

PUBLICATION: Breast Cancer Res Treat (2017) 166: 593. https://doi.org/10.1007/s10549-017-4428-9. AUTHORS: Laura J. van ‘t Veer, Christina Yau, Nancy Y. Yu, Christopher C. Benz, Bo Nordenskjöld, Tommy Fornander, Olle Stål, Laura J. Esserman, Linda Sofie Lindström SUMMARY: 20yr BCSS and 10yr DMFS analysis of MammaPrint High Risk vs Low Risk patients in the STO trial. Read more: van’t Veer…

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Copy Number Profiling of MammaPrint Genes Reveals Association with the Prognosis of Breast Cancer Patients

September 22, 2017

PUBLICATION: J Breast Cancer. 2017 Sep;20(3):246-253. English. Published online Sep 22, 2017. https://doi.org/10.4048/jbc.2017.20.3.246 AUTHORS: Areej Fatima, Fomaz Tariq, Muhammad Faraz Arshad Malik, Muhammad Qasim, and Farhan Haq SUMMARY: DNA copy number variations (CNVs) in realtion to MammaPrint 70-genes (cell line and TCGA data). Read more: Copy Number Profiling of MammaPrint…_Fatima et al_Journal of Breast Cancer 2017  

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Impact of 70-Gene Signature Use on Adjuvant Chemotherapy Decisions in Patients With Estrogen Receptor–Positive Early Breast Cancer: Results of a Prospective Cohort Study

August 20, 2017

PUBLICATION: Journal of Clinical Oncology 35, no. 24 (August 20, 2017) 2814-2819. DOI: 10.1200/JCO.2016.70.3959. AUTHORS: Anne Kuijer, Marieke Straver, Bianca den Dekker, Annelotte C.M. van Bommel, Sjoerd G. Elias, Carolien H. Smorenburg, Jelle Wesseling, Sabine C. Linn, Emiel J.Th. Rutgers, Sabine Siesling, and Thijs van Dalen SUMMARY: Prospective, observational Dutch study with ER-positive, early-stage breast cancer, 70-GS use…

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Characterisation of Multifocal Breast Cancer Using the 70-gene Signature in Clinical Low-Risk Patients Enrolled in the EORTC 10041/BIG 03-04 MINDACT Trial.

July 2, 2017

PUBLICATION: European Journal of Cancer. July 2017, Volume 79, Pages 98–105. AUTHORS: K.C. Aalders, A. Kuijerb, M.E. Straver, L. Slaets, S. Litiere, G. Viale, L.J. van’t Veer, A.M. Glas, M. Delorenzi, T. van Dalen, K. Tryfonidis, M.J. Piccart, F. Cardoso, E.J. Rutgers on behalf of the TRANSBIG Consortium and the MINDACT Investigators SUMMARY: 

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A Breast Cancer Gene Signature for Indolent Disease

July 1, 2017

PUBLICATION: Breast Cancer Res Treat. 2017 Oct;117(3):483-95. doi: 10.1007/s10549-008-0191-2. Epub 2008 Sep 26. AUTHORS: Leonie J.M.J. Delahaye, Caroline A. Drukker, Christa Dreezen, Anke Witteveen, Bob Chan, Mireille Snel, Inès J. Beumer, Rene Bernards, M. William Audeh, Laura J. van’t Veer, Annuska M. Glas SUMMARY: An Ultralow Risk development paper. In an independent validation cohort, we show that patients…

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Prognostic Value of MammaPrint® in Invasive Lobular Breast Cancer

December 11, 2016

PUBLICATION: Biomark Insights. 2016; 11: 139–146. doi: 10.4137/BMI.S38435 AUTHORS: Inès J. Beumer, Marion Persoon, Anke Witteveen, Christa Dreezen, Suet-Feung Chin, Stephen-John Sammut, Mireille Snel, Carlos Caldas, Sabine Linn, Laura J. van ’t Veer, Rene Bernards, and Annuska M. Glas SUMMARY: Pooled analysis. Study results validate MammaPrint as an independent factor for breast cancer patients with early-stage invasive lobular…

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Genomic Profiling of Breast Cancer in African-American Women Using MammaPrint.

August 27, 2016

PUBLICATION: Breast Cancer Res Treat (2016) 159: 481. https://doi.org/10.1007/s10549-016-3949-y09. AUTHORS: Raquel A. Nunes, Lynette Wray, Mihriye Mete, Pia Herbolsheimer, Karen L. Smith, Lana Bijelic, Marc E. Boisvert, Sandra M. Swain SUMMARY: We evaluated gene expression in tumors from AAF presenting with early stage or locally advanced breast cancer using MammaPrint, BluePrint (molecular subtype) and TargetPrint, correlated with OncotypeDX…

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70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer

August 25, 2016

PUBLICATION: N Engl J Med 2016; 375:717-729; DOI: 10.1056/NEJMoa1602253. AUTHORS: Fatima Cardoso, M.D., Laura J. van’t Veer, Ph.D., Jan Bogaerts, Ph.D., Leen Slaets, Ph.D., Giuseppe Viale, M.D., Suzette Delaloge, M.D., Jean-Yves Pierga, M.D., Ph.D., Etienne Brain, M.D., Ph.D., Sylvain Causeret, M.D., Mauro DeLorenzi, Ph.D., Annuska M. Glas, Ph.D., Vassilis Golfinopoulos, M.D., Ph.D., et al., for the MINDACT…

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MINDACT Supplementary Appendix NEJM 2016

August 15, 2016

SUPPLEMENTARY APPENDIX: This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Cardoso F., van’t Veer L.J., Bogaerts J., et al. 70-Gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med 2016;375:717-29. DOI: 10.1056/NEJMoa1602253.   Read more: MINDACT Supplementary Appendix_NEJM 2016…

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Breast Cancer: Determining the Genetic Profile from Ultrasound-Guided Percutaneous Biopsy Specimens Obtained During Diagnostic Workups

June 14, 2016

PUBLICATION: Radiología (English Edition) Volume 58, Issue 3, May–June 2016, Pages 214-220. AUTHORS: J.A. López Ruiz, I.Zabalza Estévez, J.A. Mieza Arana SUMMARY: Small study demonstrating feasbility of MP on FFPE core biopsies -13 patients. Read more: López Ruiz et al_2016_Radiología_Breast Cancer: Determining the Genetic Profile…  

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Cáncer de Mama: Determinación del Perfil Genético a Partir de la Biopsia Percutánea Ecoguiada Diagnóstica

June 1, 2016

PUBLICATION: Radiología; Vol. 58. Issue 3. pages 214-220 (May-June 2016) AUTHORS: J.A. López Ruiza, I. Zabalza Estévezb, J.A. Mieza Aranac PUBLICATION TITLE (English): Breast cancer: determining the genetic profile from ultrasound-guided percutaneous biopsy specimens obtained during the diagnostic workups ABSTRACT: Objectives: To evaluate the possibility of determining the genetic profile of primary malignant tumors of the breast from specimens…

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Equivalence of MammaPrint Array Types in Clinical Trials and Diagnostics

March 22, 2016

PUBLICATION: Breast Cancer Res Treat (2016) 156: 279. https://doi.org/10.1007/s10549-016-3764-5 AUTHORS: Inès Beumer, Anke Witteveen, Leonie Delahaye, Diederik Wehkamp, Mireille Snel, Christa Dreezen, John Zheng, Arno Floore, Guido Brink, Bob Chan, Sabine Linn, Rene Bernards, Laura van ’t Veer, Annuska Glas SUMMARY: Here we demonstrate the equivalence and reproducibility of the MammaPrint test on both customized certified array types,…

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Application of a 70-Gene Expression Profile to Japanese Breast Cancer Patients

March 1, 2015

PUBLICATION: Breast Care 2015;10:118-122 https://doi.org/10.1159/000376562. AUTHORS: Shimizu H., Horimoto Y., Arakawa A., Sonoue H., Kurata M., Kosaka T., Nakai K., Himuro T., Tokuda E., Takahashi Y., Taira F., Ito M., Abe I., Senuma K., Stork-Sloots L., de Snoo F., Saito M. SUMMARY: Of 38 cases judged to be at intermediate risk based on the St Gallen 2007 Consensus,…

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Gene Expression Profiling to Predict the Risk of Locoregional Recurrence in Breast Cancer: A Pooled Analysis

November 24, 2014

PUBLICATION: Breast Cancer Res Treat (2014) 148: 599. https://doi.org/10.1007/s10549-014-3188-z. AUTHORS: C.A. Drukker, S.G. Elias, M.V. Nijenhuis, J. Wesseling, H. Bartelink, P. Elkhuizen, B. Fowble, P.W. Whitworth, R.R. Patel, F.A. de Snoo, L.J. van ’t Veer, P.D. Beitsch, E.J. Th. Rutgers SUMMARY: After a median follow-up of 8.96 years with 87 LRRs, patients with a high-risk 70-gene signature (n…

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Genomic Profile of Breast Cancer: Cost-Effectiveness Analysis from the Spanish National Healthcare System Perspective

September 12, 2014

PUBLICATION: Expert Rev Pharmacoecon Outcomes Res. 2014 Dec;14(6):889-99. doi: 10.1586/14737167.2014.957185. Epub 2014 Sep 12. AUTHORS: Seguí M.Á., Crespo C., Cortés J., Lluch A., Brosa M., Becerra V., Chiavenna S.M., Gracia A. SUMMARY: A 70-gene signature showed a life expectancy of 23.55 years at lifetime. Life expectancy was lower for 21-gene assay and online algorithm, with associated quality-adjusted life…

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The Multigene Signature MammaPrint Impacts on Multidisciplinary Team Decisions in ER+, HER2− Early Breast Cancer

August 26, 2014

PUBLICATION: British Journal of Cancer, volume 111, pages 837–842 (26 August 2014). AUTHORS: R. Exner, Z. Bago-Horvath, R. Bartsch, M. Mittlboeck, V.P. Retèl, F. Fitzal, M. Rudas, C. Singer, G. Pfeiler, M. Gnant, R. Jakesz, P. Dubsky SUMMARY: According to MammaPrint (MP), 76% were low risk. In over a third of patients, discordance between clinical and molecular risk…

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European Inter-Institutional Impact Study of MammaPrint

August 1, 2014

PUBLICATION: The Breast August 2014, Volume 23, Issue 4, Pages 423–428 AUTHORS: P.G. Cusumano, D. Generali, E. Ciruelos, L. Manso, I. Ghanem, E. Lifrange, G. Jerusalem, J. Klaase, F. de Snoo, L. Stork-Sloots, L. Dekker-Vroling, M. Lutke Holzik SUMMARY: Using MammaPrint, chemotherapy treatment advice for ER+/HER2- breast cancer patients was changed in 37% of patients by the Dutch,…

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Optimized Outcome Prediction in Breast Cancer by Combining the 70-Gene Signature with Clinical Risk Prediction Algorithms

June 1, 2014

PUBLICATION: Breast Cancer Res Treat. 2014 Jun;145(3):697-705. doi: 10.1007/s10549-014-2954-2. Epub 2014 Apr 24. AUTHORS: C.A. Drukker, M.V. Nijenhuis, J.M. Bueno-de-Mesquita, V.P. Retèl, W.H. van Harten, H. van Tinteren, J. Wesseling, M.K. Schmidt, L.J. van’t Veer, G.S. Sonke, E.J. T. Rutgers, M.J. van de Vijver, S.C. Linn SUMMARY: In this cohort, the PREDICT plus tool in combination with the…

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Risk Estimations and Treatment Decisions in Early Stage Breast Cancer: Agreement Among Oncologists and the Impact of the 70-Gene Signature

April 1, 2014

PUBLICATION: Eur J Cancer. 2014 Apr;50(6):1045-54. doi: 10.1016/j.ejca.2014.01.016. Epub 2014 Feb 13. AUTHORS: Drukker C.A., van den Hout H.C., Sonke G.S., Brain E., Bonnefoi H., Cardoso F., Goldhirsch A., Harbeck N., Honkoop A.H., Koornstra R.H., van Laarhoven H.W., Portielje J.E., Schneeweiss A., Smorenburg C.H., Stouthard J., Linn S.C., Schmidt M.K. SUMMARY: Adding the 70-gene signature result significantly increased…

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MammaPrint Molecular Diagnostics on Formalin-Fixed, Paraffin-Embedded Tissue

March 1, 2014

PUBLICATION: J Mol Diagn. 2014 Mar;16(2):190-7. doi: 10.1016/j.jmoldx.2013.10.008. Epub 2013 Dec 28. AUTHORS: Anna Sapino, Paul Roepman, Sabine C. Linn, Mireille H.J. Snel, Leonie J.M.J. Delahaye, Jeroen van den Akker, Annuska M. Glas, Iris M. Simon, Neil Barth, Femke A. de Snoo, Laura J. van ’t Veer, Luca Molinaro, Els M.J.J. Berns, Jelle Wesseling, Lee B. Riley,…

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Mammographic Screening Detects Low-Risk Tumor Biology Breast Cancers

February 2, 2014

PUBLICATION: Breast Cancer Res Treat. 2014 Feb;144(1):103-11. doi: 10.1007/s10549-013-2830-5. Epub 2014 Jan 28.7 AUTHORS: Drukker C.A., Schmidt M.K., Rutgers E.J., Cardoso F., Kerlikowske K., Esserman L.J., van Leeuwen F.E., Pijnappel R.M., Slaets L., Bogaerts J., Van’t Veer L.J. SUMMARY: Among the screen-detected cancers, 32 % had a 70-gene signature high-risk and 68 % a low-risk tumor, of which…

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Long-Term Impact of the 70-Gene Signature on Breast Cancer Outcome

February 1, 2014

PUBLICATION: Breast Cancer Res Treat. 2014 Feb;143(3):587-92. doi: 10.1007/s10549-013-2831-4. Epub 2014 Jan 21. AUTHORS: Drukker C.A., van Tinteren H., Schmidt M.K., Rutgers E.J., Bernards R., van de Vijver M.J., Van’t Veer L.J. SUMMARY: MammaPrint showed a significant absolute difference in DMFS and OS at 25 years between the patients with a low-risk 70-gene signature (60.4 and 57.3 %…

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Prospective Cost-Effectiveness Analysis of Genomic Profiling in Breast Cancer

December 1, 2013

PUBLICATION: European Journal of Cancer. December 2013, Volume 49, Issue 18, Pages 3773–3779 AUTHORS: V.P. Retèl, M.A. Jooreb, C.A. Drukker, J.M. Bueno-de-Mesquita, M. Knauer, H. van Tinteren, S.C. Linn, W.H. van Harten SUMMARY: The total health care costs per patient were €26,786 for the 70-gene and €29,187 for AO. The quality adjusted life years yielded 12.49 and 11.88,…

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Performance Characteristics of the MammaPrint® Breast Cancer Diagnostic Gene Signature

October 17, 2013

PUBLICATION: PERSONALIZED MEDICINE VOL. 10, NO. 8 | 17 Oct 2013 https://doi.org/10.2217/pme.13.88 AUTHORS: Leonie J.M. Delahaye, Diederik Wehkamp, Arno N. Floore, Rene Bernards, Laura J. van‘t Veer & Annuska M. Glas SUMMARY: Here we study these performance characteristics of the MammaPrint® (Agendia NV, Amsterdam, The Netherlands) 70-gene signature using the US FDA-recommended guidelines, as well as predetermined acceptance…

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Potential Impact of the 70-gene Signature in the Choice of Adjuvant Systemic Treatment for ER Positive, HER2 Negative Tumors: a Single Institution Experience

August 1, 2013

PUBLICATION: Breast. 2013 Aug;22(4):419-24. doi: 10.1016/j.breast.2013.03.013. Epub 2013 May 3. AUTHORS: Torrisi R., Garcia-Etienne C.A., Losurdo A., Morenghi E., Di Tommaso L., Gatzemeier W., Sagona A., Fernandes B., Rossetti C., Eboli M., Rubino A., Barbieri E., Andreoli C., Orefice S., Gandini C., Rota S., Zuradelli M., Masci G., Santoro A., Tinterri C. SUMMARY: MammaPrint (MP) results would have…

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MammaPrint Pre-Screen Algorithm (MPA) Reduces Chemotherapy in Patients with Early-Stage Breast Cancer

July 3, 2013

PUBLICATION: S Afr Med J. 2013 Jul 3;103(8):522-6. doi: 10.7196/samj.7223. AUTHORS: Grant K.A., Apffelstaedt J.P., Wright C.A., Myburgh E., Pienaar R., De Klerk M., Kotze M.J. SUMMARY: The 70-gene profile classifies approximately 40% of early-stage breast cancer patients as low-risk compared with 15% using conventional criteria. In comparison, more than 60% were shown to be low risk with…

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Association Between Genomic Recurrence Risk and Well-Being Among Breast Cancer Patients

June 18, 2013

PUBLICATION: BMC Cancer. 2013 Jun 18;13:295. doi: 10.1186/1471-2407-13-295. AUTHORS: Retèl V.P., Groothuis-Oudshoorn C.G., Aaronson N.K., Brewer N.T., Rutgers E.J., van Harten W.H. SUMMARY: Based on MINDACT: Women (n = 347, response rate 62%) reported high satisfaction with and a good understanding of the GEP information they received. Read more: Retèl et al_2013_BMC Cancer_Association Between Genomic Recurrence Risk…  

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Multigene Assays and Molecular Markers in Breast Cancer: Systematic Review of Health Economic Analyses

June 1, 2013

PUBLICATION: Breast Cancer Res Treat. 2013 Jun;139(3):621-37. doi: 10.1007/s10549-013-2559-1. Epub 2013 May 31. AUTHORS: Rouzier R., Pronzato P., Chéreau E., Carlson J., Hunt B., Valentine W.J. SUMMARY: Systematic Review: The review identified 29 publications that reported evaluations of two assays: Oncotype DX(®) and MammaPrint. Studies of both tests provided evidence that their routine use was cost saving or…

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A Prospective Evaluation of a Breast Cancer Prognosis Signature in the Observational RASTER Study

January 13, 2013

PUBLICATION: Int J Cancer. 2013 Aug 15;133(4):929-36. doi: 10.1002/ijc.28082. Epub 2013 Mar 4. AUTHORS: Drukker C.A., Bueno-de-Mesquita J.M., Retèl V.P., van Harten W.H., van Tinteren H., Wesseling J., Roumen R.M., Knauer M., van’t Veer L.J., Sonke G.S., Rutgers E.J., van de Vijver M.J., Linn S.C. SUMMARY: A prospective community based observational study, the 5-year DRFI probabilities confirmed the…

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MammaPrint Feasibility in a Large Tertiary Urban Medical Center: An Initial Experience

December 31, 2012

PUBLICATION: Scientifica (Cairo). 2012; 2012: 942507. Published online 2012 Dec 31. doi: 10.6064/2012/942507. AUTHORS: C. Francisco Espinel, Shaughn Keating, Hanina Hibshoosh, Bret Taback, Kathie-Ann Joseph, Mahmoud El-Tamer, and Sheldon Feldman SUMMARY: This study indicates that using MP/TP assay is feasible in a tertiary care center but there may be utility in limiting MP testing to patients with tumors…

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Additional Value of the 70-gene Signature and Levels of ER and PR for the Prediction of Outcome in Tamoxifen-Treated, ER-Positive Breast Cancer

December 1, 2012

PUBLICATION: The Breast. 2012 Dec;21(6):769-78. doi: 10.1016/j.breast.2012.04.010. Epub 2012 Jun 26. AUTHORS: Kok M., Koornstra R.H., Mook S., Hauptmann M., Fles R., Jansen M.P., Berns E.M., Linn S.C., Van ‘t Veer L.J. SUMMARY: In the series analysed, the 70-gene signature was mainly a prognostic factor, while ER and PR levels were mainly associated with outcome after tamoxifen. Combination…

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Lobular Histology and Response to Neoadjuvant Chemotherapy in Invasive Breast Cancer

November 1, 2012

PUBLICATION: Breast Cancer Res Treat. 2012 Nov;136(1):35-43. doi: 10.1007/s10549-012-2233-z. Epub 2012 Sep 8. AUTHORS: Lips E.H., Mukhtar R.A., Yau C., de Ronde J.J., Livasy C., Carey L.A., Loo C.E., Vrancken-Peeters M.J., Sonke G.S., Berry D.A., Van’t Veer L.J., Esserman L.J., Wesseling J., Rodenhuis S., Shelley Hwang E.; I-SPY TRIAL Investigators. SUMMARY: Expression subtyping, particularly the NKI 70-gene signature,…

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Economic Evaluation of the 70-gene Prognosis-Signature (MammaPrint®) in Hormone Receptor-Positive, Lymph Node-Negative, Human Epidermal Growth Factor Receptor Type 2-Negative Early Stage Breast Cancer in Japan

June 1, 2012

PUBLICATION: Breast Cancer Res Treat. 2012 Jun;133(2):759-68. doi: 10.1007/s10549-012-1979-7. AUTHORS: Kondo M., Hoshi S.L., Ishiguro H., Toi M. SUMMARY: The introduction of the assay into Japanese practice of ER+, LN−, HER2− ESBC treatment by including it to Japan’s social health insurance benefit package has a reasonable chance to be judged as cost-effective and may be justified as an…

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Cost Effectiveness of Gene Expression Profiling for Early Stage Breast Cancer: a Decision-Analytic Mode

February 22, 2012

PUBLICATION: Cancer. 2012 Oct 15;118(20):5163-70. doi: 10.1002/cncr.27443. Epub 2012 Feb 22. AUTHORS: Yang M., Rajan S., Issa A.M. SUMMARY: The model suggested that MammaPrint is a more cost‐effective GEP test compared with Oncotype DX at a threshold willingness‐to‐pay of $50,000 per QALY. Read more: Yang et al_2012_Cancer_Cost Effectiveness of Gene Expression  

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Head-to-Head Comparison of the 70-gene Signature Versus the 21-Gene Assay: Cost-Effectiveness and the Effect of Compliance

January 1, 2012

PUBLICATION: Breast Cancer Res Treat. 2012 Jan;131(2):627-36. doi: 10.1007/s10549-011-1769-7. Epub 2011 Sep 24. AUTHORS: Retèl V.P., Joore M.A., van Harten W.H. SUMMARY: The 21-gene has the highest probability of being cost-effective when focusing on cost/LY, while focusing on cost/QALY, the 70-gene signature was most cost-effective. Read more: Breast Cancer Res Treat_Retel et al_The 21-gene has the highest probability…

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Impact of Mammographic Screening on the Detection of Good and Poor Prognosis Breast Cancers

December 2, 2011

PUBLICATION: Breast Cancer Res Treat. 2011 Dec;130(3):725-34. doi: 10.1007/s10549-011-1748-z. Epub 2011 Sep 4. AUTHORS: Esserman L.J., Shieh Y., Rutgers E.J., Knauer M., Retèl V.P., Mook S., Glas A.M., Moore D.H., Linn S., van Leeuwen F.E., van ‘t Veer L.J. SUMMARY:  In women aged 49-60, the time period of diagnosis significantly affects the proportion of cancers that were…

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The EORTC 10041/BIG 03-04 MINDACT Trial is Feasible: Results of the Pilot Phase

December 1, 2011

PUBLICATION: European Journal of Cancer, December 2011, Volume 47, Issue 18, Pages 2742–2749. AUTHORS: Emiel Rutgers, Martine J. Piccart-Gebhart, Jan Bogaerts, Suzette Delaloge, Laura Van ‘t Veer, Isabel Teresa Rubio, Giuseppe Viale, Alastair M. Thompson, Rodolfo Passalacqua, Ulrike Nitz, Anita Vindevoghel, Jean-Yves Pierga, Peter M. Ravdin, Gustavo Werutsky, Fatima Cardoso SUMMARY: The logistically complex MINDACT trial is feasible…

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Use of a Genomic Test (MammaPrint™) in Daily Clinical Practice to Assist in Risk Stratification of Young Breast Cancer Patients

March 1, 2011

PUBLICATION: Arch Gynecol Obstet (2011) 283: 597. https://doi.org/10.1007/s00404-010-1454-9. AUTHORS: Kunz, G. SUMMARY: 44 patients had MammaPrint results and were eligible for the analysis. The results revealed a low risk result in 29 patients and a high risk result in 15 patients. Read more: Kunz_2011_Arch Gynecol Obstet._Use of a Genomic Test  

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Gene Expression Profiles from Formalin Fixed Paraffin Embedded Breast Cancer Tissue are Largely Comparable to Fresh Frozen Matched Tissue

February 11, 2011

PUBLICATION: PLoS One. 2011 Feb 11;6(2):e17163. doi: 10.1371/journal.pone.0017163. AUTHORS: Mittempergher L., de Ronde J.J., Nieuwland M., Kerkhoven R.M., Simon I., Rutgers E.J., Wessels L.F., Van’t Veer L.J. SUMMARY: We demonstrate that data generated from FFPE material with the DASL assay, if properly processed, are comparable to data extracted from the FF counterpart. Specifically, gene expression profiles for a…

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Cost-effectiveness of 70-gene MammaPrint Signature in Node-Negative Breast Cancer

December 21, 2010

PUBLICATION: Am J Manag Care. 2010 Dec 1;16(12):e333-42. AUTHORS: Chen E., Tong K.B., Malin J.L. SUMMARY: 70-gene signature reclassified 29% of patients and spared 10% of patients from chemotherapy. Results of this modeling analysis suggest that treatment guided by 70-gene signature may be associated with a decrease in chemotherapy use and an increase in life expectancy when applied…

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Identification of a Low-Risk Subgroup of HER-2-Positive Breast Cancer by the 70-gene Prognosis Signature

December 7, 2010

PUBLICATION: Br J Cancer. 2010 Dec 7; 103(12): 1788–1793. Published online 2010 Nov 16. doi: 10.1038/sj.bjc.6605916. AUTHORS: M. Knauer, F. Cardoso, J. Wesseling, P.L. Bedard, S.C. Linn, E.J.T. Rutgers, and L.J. van’t Veer SUMMARY: Pooled analysis: In the group of 89 chemotherapy-naive patients, after a median follow-up of 7.4 years, 35 (39%) distant recurrences and 29 (33%) breast…

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Comparison of MammaPrint and TargetPrint Results with Clinical Parameters in German Patients with Early Stage Breast Cancer

December 1, 2010

PUBLICATION: Int J Mol Med. 2010 Dec;26(6):837-43. AUTHORS: Gevensleben H., Göhring U.J., Büttner R., Heukamp L.C., Kunz G., Dimpfl T., Jackisch C., Ortmann O., Albert U.S., Bender R., De Snoo F., Krijgsman O., Glas A.M., Ergönenc Y.H., Vogel C., Dykgers A., Langwieder C., Rees M., Anzeneder T. SUMMARY: Thirty-two percent of patients (19/59) with a poor prognosis-signature identified…

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Biological Functions of the Genes in the MammaPrint® Breast Cancer Profile Reflect the Hallmarks of Cancer

November 24, 2010

PUBLICATION: Biomarker Insights. 2010 Nov 28;5:129-38. doi: 10.4137/BMI.S6184. AUTHORS: Tian S., Roepman P., Van’t Veer L.J., Bernards R., de Snoo F., Glas A.M. SUMMARY: The study included 3090 clinical low-risk patients with unifocal and 238 patients with multifoGenes in the MammaPrint gene signature comprehensively measure the six hallmarks of cancer-related biology. This finding establishes a link between a…

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MammaPrint® Translating Research into a Diagnostic Test

September 7, 2010

PUBLICATION: Molecular Diagnostics: The Key in Personalized Cancer Medicine 2010; pg. 26; Chapter 7 AUTHORS: Annuska M. Glas, Leonie Delahaye, Oscar Krijgsman SUMMARY: Book Chapter: This chapter describes all important critical steps being met for the implementation of a multi-marker microarray (MammaPrint®) as a routine diagnostic tool. Read more: MammaPrint Translating Research into a Diagnostic Test… Glas_Molecular Diagnostics:…

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Cost-effectiveness of the 70-gene Signature Versus St. Gallen Guidelines and Adjuvant Online for Early Breast Cancer

May 2, 2010

PUBLICATION: Eur J Cancer. 2010 May;46(8):1382-91. doi: 10.1016/j.ejca.2010.02.035. Epub 2010 Mar 30. AUTHORS: Retèl V.P., Joore M.A., Knauer M., Linn S.C., Hauptmann M., Harten W.H. SUMMARY: Pooled analysis: he 70-gene has the highest probability of being cost-effective for a willingness to pay for a QALY higher than euro12.000. Sankt Gallen showed the highest survival rates compared to the…

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Metastatic Potential of T1 Breast Cancer Can Be Predicted by the 70-gene MammaPrint Signature

May 1, 2010

PUBLICATION: Ann Surg Oncol. 2010 May;17(5):1406-13. doi: 10.1245/s10434-009-0902-x. Epub 2010 Jan 22. AUTHORS: Mook S., Knauer M., Bueno-de-Mesquita J.M., Retel V.P., Wesseling J., Linn S.C., Van’t Veer L.J., Rutgers E.J. SUMMARY: The 10-year distant metastasis-free (DMFS) and breast cancer specific survival (BCSS) probabilities were 87% (SE 2%) and 91% (SE 2%), respectively, for the good prognosis-signature group (n…

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The Predictive Value of the 70-Gene Signature for Adjuvant Chemotherapy in Early Breast Cancer

March 5, 2010

PUBLICATION: Breast Cancer Res Treat. 2010 Apr;120(3):655-61. doi: 10.1007/s10549-010-0814-2. AUTHORS: Knauer M., Mook S., Rutgers E.J., Bender R.A., Hauptmann M., van de Vijver M.J., Koornstra R.H., Bueno-de-Mesquita J.M., Linn S.C., van ‘t Veer L.J. ABSTRACT: Multigene assays have been developed and validated to determine the prognosis of breast cancer. In this study, we assessed the additional predictive value…

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The 70-gene Signature as a Response Predictor for Neoadjuvant Chemotherapy in Breast Cancer

February 1, 2010

PUBLICATION: Breast Cancer Res Treat. 2010 Feb;119(3):551-8. doi: 10.1007/s10549-009-0333-1. Epub 2009 Feb 13. AUTHORS: Straver M.E., Glas A.M., Hannemann J., Wesseling J., van de Vijver M.J., Rutgers E.J., Vrancken Peeters M.J., van Tinteren H., Van’t Veer L.J., Rodenhuis S. SUMMARY: 144 (86%) were having a poor and 23 (14%) a good prognosis-signature. None of the good prognosis-signature patients…

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Clinical Utility of the 70-gene MammaPrint Profile in a Japanese Population

January 27, 2010

PUBLICATION: Japanese Journal of Clinical Oncology, Volume 40, Issue 6, June 2010, Pages 508–512, https://doi.org/10.1093/jjco/hyp195. AUTHORS: Makoto Ishitobi, Teodora E. Goranova, Yoshifumi Komoike, Kazuyoshi Motomura, Hiroki Koyama, Annuska M. Glas, Ellen van Lienen, Hideo Inaji, Laura J. Van’t Veer, Kikuya Kato SUMMARY: A small observational study in a Japanese Cohort -102 patients: 20% Low Risk / 80% High…

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Validation of 70-gene Prognosis Signature in Node-Negative Breast Cancer

October 14, 2009

PUBLICATION: Breast Cancer Res Treat. 2009 Oct;117(3):483-95. doi: 10.1007/s10549-008-0191-2. Epub 2008 Sep 26. AUTHORS: Bueno-de-Mesquita J.M., Linn S.C., Keijzer R., Wesseling J., Nuyten D.S., van Krimpen C., Meijers C., de Graaf P.W., Bos M.M., Hart A.A., Rutgers E.J., Peterse J.L., Halfwerk H., de Groot R., Pronk A., Floore A.N., Glas A.M., Van’t Veer L.J., van de Vijver…

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The 70-gene Prognosis Signature Predicts Early Metastasis in Breast Cancer Patients Between 55 and 70 Years of Age

October 13, 2009

PUBLICATION: Ann Oncol. 2010 Apr;21(4):717-22. doi: 10.1093/annonc/mdp388. Epub 2009 Oct 13. AUTHORS: Mook S., Schmidt M.K., Weigelt B., Kreike B., Eekhout I., van de Vijver M.J., Glas A.M., Floore A., Rutgers E.J., van ‘t Veer L.J. SUMMARY: The 70-gene prognosis signature predicts early metastasis in breast cancer patients between 55 and 70 years of age. Read more: 70-gene…

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Gene Expression Profiling in Breast Cancer – Design of a Pooled Database to Address Open Questions

October 1, 2009

PUBLICATION: Eur Surg (2009) 41: 221. https://doi.org/10.1007/s10353-009-0487-4. AUTHORS: M. Knauer, E. Wenzl, E.J.T. Rutgers, S.C. Linn, L.J. van’t Veer SUMMARY: A pooled database was constructed containing clinical, pathological and microarray data of 1696 patients. The database will be used to study the performance of the 70-gene profile in patients with small-sized T1 tumors. Read more: Knauer et al_2009_European…

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A Gene Expression Profile for Detection of Sufficient Tumour Cells in Breast Tumour Tissue: Microarray Diagnosis Eligibility

August 1, 2009

PUBLICATION: BMC Med Genomics. 2009 Aug 12;2:52. doi: 10.1186/1755-8794-2-52. AUTHORS: Roepman P., Schuurman A., Delahaye L.J., Witteveen A.T., Floore A.N., Glas A.M. SUMMARY: The developed 13-gene profile provides an objective tool for assessment whether a breast cancer sample contains sufficient tumour cells for microarray diagnostics. Read more: A Gene-Expression Profile… Roepman et al_BMC Medical Genomics 2009  

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The 70-gene Prognosis-Signature Predicts Disease Outcome in Breast Cancer Patients with 1-3 Positive Lymph Nodes in an Independent Validation Study

July 27, 2009

PUBLICATION: Breast Cancer Res Treat. 2009 Jul;116(2):295-302. doi: 10.1007/s10549-008-0130-2. Epub 2008 Jul 27. AUTHORS: Mook S., Schmidt M.K., Viale G., Pruneri G., Eekhout I., Floore A., Glas A.M., Bogaerts J., Cardoso F., Piccart-Gebhart M.J., Rutgers E.T., Van’t Veer L.J.; TRANSBIG Consortium. SUMMARY: Among 1-3 LN+ patients, the 10-year distant metastasis-free (DMFS) and breast cancer specific survival (BCSS) probabilities…

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Daily Clinical Practice of Fresh Tumour Tissue Freezing and Gene Expression Profiling; Logistics Pilot Study Preceding the MINDACT Trial

May 1, 2009

PUBLICATION: Eur J Cancer. 2009 May;45(7):1201-1208. doi: 10.1016/j.ejca.2009.01.004. Epub 2009 Feb 14. AUTHORS: Mook S., Bonnefoi H., Pruneri G., Larsimont D., Jaskiewicz J., Sabadell M.D., MacGrogan G., Van’t Veer L.J., Cardoso F., Rutgers E.J. SUMMARY: Tumour samples were obtained in 60 of 64 patients. Among the 60 samples, 11 contained insufficient tumour cells (

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Constructive Technology Assessment (CTA) as a Tool in Coverage with Evidence Development: The Case of the 70-gene Prognosis Signature for Breast Cancer Diagnostics

January 24, 2009

PUBLICATION: Int J Technol Assess Health Care. 2009 Jan;25(1):73-83. doi: 10.1017/S0266462309090102. AUTHORS: Retèl V.P., Bueno-de-Mesquita J.M., Hummel M.J., van de Vijver M.J., Douma K.F., Karsenberg K., van Dam F.S., van Krimpen C., Bellot F.E., Roumen R.M., Linn S.C., van Harten W.H. SUMMARY: Differences in speed of implementation and influenced treatment decisions were seen. Impact on patients seems especially…

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Clinical Application of the 70-gene Profile: The MINDACT Trial

February 11, 2008

PUBLICATION: J Clin Oncol. 2008 Feb 10;26(5):729-35. doi: 10.1200/JCO.2007.14.3222. AUTHORS: Cardoso F., Van’t Veer L., Rutgers E., Loi S., Mook S., Piccart-Gebhart M.J. SUMMARY: Its prospective validation is currently ongoing through the MINDACT (Microarray in Node-Negative Disease May Avoid Chemotherapy) trial, a 6,000-patient randomized, multicentric trial. This article reviews the several steps in the development of the profile…

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Analysis of the MammaPrint Breast Cancer Assay in a Predominantly Postmenopausal Cohort.

February 10, 2008

PUBLICATION: Clin Cancer Res. 2008 May 15;14(10):2988-93. doi: 10.1158/1078-0432.CCR-07-4723. AUTHORS: Wittner B.S., Sgroi D.C., Ryan P.D., Bruinsma T.J., Glas A.M., Male A., Dahiya S., Habin K., Bernards R., Haber D.A., Van’t Veer L.J., Ramaswamy S. SUMMARY: The MammaPrint assay was originally designed to identify younger breast cancer patients at low risk for distant metastasis, who might consequently be…

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Use of 70-gene Signature to Predict Prognosis of Patients with Node-Negative Breast Cancer: A Prospective Community-Based Feasibility Study (RASTER)

December 8, 2007

PUBLICATION: Lancet Oncol. 2007 Dec;8(12):1079-1087. doi: 10.1016/S1470-2045(07)70346-7. Epub 2007 Nov 26. AUTHORS: Bueno-de-Mesquita J.M., van Harten W.H., Retel V.P., van’t Veer L.J., van Dam F.S., Karsenberg K., Douma K.F., van Tinteren H., Peterse J.L., Wesseling J., Wu T.S., Atsma D., Rutgers E.J., Brink G., Floore A.N., Glas A.M., Roumen R.M., Bellot F.E., van Krimpen C., Rodenhuis S.,…

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Robust Interlaboratory Reproducibility of a Gene Expression Signature Measurement Consistent with the Needs of a New Generation of Diagnostic Tools

June 7, 2007

PUBLICATION: BMC Genomics. 2007 Jun 7;8:148. AUTHORS: Ach R.A., Floore A., Curry B., Lazar V., Glas A.M., Pover R., Tsalenko A., Ripoche H., Cardoso F., d’Assignies M.S., Bruhn L., Van’t Veer L.J. SUMMARY: Despite this variation, measurement of one particular breast cancer gene expression signature in three different laboratories was found to be highly robust, showing a high…

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Converting a Breast Cancer Microarray Signature into a High-Throughput Diagnostic Test

October 30, 2006

PUBLICATION: BMC Genomics. 2006 Oct 30;7:278. AUTHORS: Glas A.M., Floore A., Delahaye L.J., Witteveen A.T., Pover R.C., Bakx N., Lahti-Domenici J.S., Bruinsma T.J., Warmoes M.O., Bernards R., Wessels L.F., Van’t Veer L.J. SUMMARY: In this report, we demonstrate for the first time that microarray technology can be used as a reliable diagnostic tool. The data clearly demonstrate the…

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Gene Expression Profiles of Primary Breast Carcinomas from Patients at High-Risk for Local Recurrence After Breast-Conserving Therapy

October 1, 2006

PUBLICATION: Clin Cancer Res. 2006 Oct 1;12(19):5705-12. AUTHORS: Kreike B., Halfwerk H., Kristel P., Glas A., Peterse H., Bartelink H., van de Vijver M.J. SUMMARY: No significant differences in gene expression between primary breast cancer tumors in patients with or without local recurrence after BCT were identified. Furthermore, analyses of primary tumors and local recurrences show a preservation…

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Validation and Clinical Utility of a 70-Gene Prognostic Signature for Women with Node-Negative Breast Cancer

September 6, 2006

PUBLICATION: J Natl Cancer Inst. 2006 Sep 6;98(17):1183-92. AUTHORS: Buyse M., Loi S., van’t Veer L., Viale G., Delorenzi M., Glas A.M., d’Assignies M.S., Bergh J., Lidereau R., Ellis P., Harris A., Bogaerts J., Therasse P., Floore A., Amakrane M., Piette F., Rutgers E., Sotiriou C., Cardoso F., Piccart M.J.; TRANSBIG Consortium. SUMMARY: The 70-gene signature outperformed the…

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Molecular Portraits and 70-gene Prognosis Signature Are Preserved Throughout the Metastatic Process of Breast Cancer

October 5, 2005

PUBLICATION: Cancer Res. 2005 Oct 15;65(20):9155-8. AUTHORS: Weigelt B., Hu Z., He X., Livasy C., Carey L.A., Ewend M.G., Glas A.M., Perou C.M., Van’t Veer L.J. SUMMARY: Furthermore, our data imply that poor prognosis breast carcinomas classified either by the intrinsic gene set or the 70 prognosis genes represent distinct disease entities that seem sustained throughout the metastatic…

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Gene Expression Profiling of Breast Cancer: A New Tumor Marker

March 10, 2005

PUBLICATION: Journal of Clinical Oncology March 10, 2005 23:8, 1631-1635 AUTHORS: Laura J. van’t Veer, Soonmyung Paik, Daniel F. Hayes SUMMARY: A review of genomic signatures and the genomic landscape. Read more: van’t Veer et al_2005_Journal of Clinical Oncology._Gene Expression Profiling  

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A Gene-Expression Signature as a Predictor of Survival in Breast Cancer

December 19, 2002

PUBLICATION: N Engl J Med. 2002 Dec 19;347(25):1999-2009. AUTHORS: van de Vijver M.J., He Y.D., van’t Veer L.J., Dai H., Hart A.A., Voskuil D.W., Schreiber G.J., Peterse J.L., Roberts C., Marton M.J., Parrish M., Atsma D., Witteveen A., Glas A., Delahaye L., van der Velde T., Bartelink H., Rodenhuis S., Rutgers E.T., Friend S.H., Bernards R. SUMMARY: Among…

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Gene Expression Profiling Predicts Clinical Outcome of Breast Cancer

January 31, 2002

PUBLICATION: Nature. 2002 Jan 31;415(6871):530-6. AUTHORS: van ‘t Veer L.J., Dai H., van de Vijver M.J., He Y.D., Hart A.A., Mao M., Peterse H.L., van der Kooy K., Marton M.J., Witteveen A.T., Schreiber G.J., Kerkhoven R.M., Roberts C., Linsley P.S., Bernards R., Friend S.H. SUMMARY: Development of MammaPrint from 98 tumors, to 78 (non-BRCA). his gene expression profile…

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