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Association of Event-Free and Distant Recurrence-Free Survival With Individual-Level Pathologic Complete Response in Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer: Three-Year Follow-up Analysis for the I-SPY2 Adaptively Randomized Clinical Trial.
I-SPY2 Trial Consortium; Yee D, DeMichele AM, Yau C, Isaacs C, Symmans WF, Albain KS, Chen YY, Krings G, Wei S, Harada S, Datnow B, Fadare O, Klein M, Pambuccian S, Chen B, Adamson K, Sams S, Mhawech-Fauceglia P, Magliocco A, Feldman M, Rendi M, Sattar H, Zeck J, Ocal IT, Tawfik O, LeBeau LG, Sahoo S, Vinh T, Chien AJ, Forero-Torres A, Stringer-Reasor E, Wallace AM, Pusztai L, Boughey JC, Ellis ED, Elias AD, Lu J, Lang JE, Han HS, Clark AS, Nanda R, Northfelt DW, Khan QJ, Viscusi RK, Euhus DM, Edmiston KK, Chui SY, Kemmer K, Park JW, Liu MC, Olopade O, Leyland-Jones B, Tripathy D, Moulder SL, Rugo HS, Schwab R, Lo S, Helsten T, Beckwith H, Haugen P, Hylton NM, Van't Veer LJ, Perlmutter J, Melisko ME, Wilson A, Peterson G, Asare AL, Buxton MB, Paoloni M, Clennell JL, Hirst GL, Singhrao R, Steeg K, Matthews JB, Asare SM, Sanil A, Berry SM, Esserman LJ, Berry DA. I-SPY2 Trial Consortium, et al. Among authors: leyland jones b. JAMA Oncol. 2020 Sep 1;6(9):1355-1362. doi: 10.1001/jamaoncol.2020.2535. JAMA Oncol. 2020. PMID: 32701140 Free PMC article. Clinical Trial.
The Neoadjuvant Model Is Still the Future for Drug Development in Breast Cancer.
DeMichele A, Yee D, Berry DA, Albain KS, Benz CC, Boughey J, Buxton M, Chia SK, Chien AJ, Chui SY, Clark A, Edmiston K, Elias AD, Forero-Torres A, Haddad TC, Haley B, Haluska P, Hylton NM, Isaacs C, Kaplan H, Korde L, Leyland-Jones B, Liu MC, Melisko M, Minton SE, Moulder SL, Nanda R, Olopade OI, Paoloni M, Park JW, Parker BA, Perlmutter J, Petricoin EF, Rugo H, Symmans F, Tripathy D, van't Veer LJ, Viscusi RK, Wallace A, Wolf D, Yau C, Esserman LJ. DeMichele A, et al. Clin Cancer Res. 2015 Jul 1;21(13):2911-5. doi: 10.1158/1078-0432.CCR-14-1760. Epub 2015 Feb 24. Clin Cancer Res. 2015. PMID: 25712686 Free PMC article.
Assessment of Residual Cancer Burden and Event-Free Survival in Neoadjuvant Treatment for High-risk Breast Cancer: An Analysis of Data From the I-SPY2 Randomized Clinical Trial.
Symmans WF, Yau C, Chen YY, Balassanian R, Klein ME, Pusztai L, Nanda R, Parker BA, Datnow B, Krings G, Wei S, Feldman MD, Duan X, Chen B, Sattar H, Khazai L, Zeck JC, Sams S, Mhawech-Fauceglia P, Rendi M, Sahoo S, Ocal IT, Fan F, LeBeau LG, Vinh T, Troxell ML, Chien AJ, Wallace AM, Forero-Torres A, Ellis E, Albain KS, Murthy RK, Boughey JC, Liu MC, Haley BB, Elias AD, Clark AS, Kemmer K, Isaacs C, Lang JE, Han HS, Edmiston K, Viscusi RK, Northfelt DW, Khan QJ, Leyland-Jones B, Venters SJ, Shad S, Matthews JB, Asare SM, Buxton M, Asare AL, Rugo HS, Schwab RB, Helsten T, Hylton NM, van 't Veer L, Perlmutter J, DeMichele AM, Yee D, Berry DA, Esserman LJ. Symmans WF, et al. Among authors: leyland jones b. JAMA Oncol. 2021 Nov 1;7(11):1654-1663. doi: 10.1001/jamaoncol.2021.3690. JAMA Oncol. 2021. PMID: 34529000 Free PMC article. Clinical Trial.
Residual cancer burden after neoadjuvant chemotherapy and long-term survival outcomes in breast cancer: a multicentre pooled analysis of 5161 patients.
Yau C, Osdoit M, van der Noordaa M, Shad S, Wei J, de Croze D, Hamy AS, Laé M, Reyal F, Sonke GS, Steenbruggen TG, van Seijen M, Wesseling J, Martín M, Del Monte-Millán M, López-Tarruella S; I-SPY 2 Trial Consortium; Boughey JC, Goetz MP, Hoskin T, Gould R, Valero V, Edge SB, Abraham JE, Bartlett JMS, Caldas C, Dunn J, Earl H, Hayward L, Hiller L, Provenzano E, Sammut SJ, Thomas JS, Cameron D, Graham A, Hall P, Mackintosh L, Fan F, Godwin AK, Schwensen K, Sharma P, DeMichele AM, Cole K, Pusztai L, Kim MO, van 't Veer LJ, Esserman LJ, Symmans WF. Yau C, et al. Lancet Oncol. 2022 Jan;23(1):149-160. doi: 10.1016/S1470-2045(21)00589-1. Epub 2021 Dec 11. Lancet Oncol. 2022. PMID: 34902335 Free PMC article.
Developing safety criteria for introducing new agents into neoadjuvant trials.
DeMichele A, Berry DA, Zujewski J, Hunsberger S, Rubinstein L, Tomaszewski JE, Kelloff G, Perlmutter J, Buxton M, Lyandres J, Albain KS, Benz C, Chien AJ, Haluska P, Leyland-Jones B, Liu MC, Munster P, Olopade O, Park JW, Parker BA, Pusztai L, Tripathy D, Rugo H, Yee D, Esserman L. DeMichele A, et al. Clin Cancer Res. 2013 Jun 1;19(11):2817-23. doi: 10.1158/1078-0432.CCR-12-2620. Epub 2013 Mar 7. Clin Cancer Res. 2013. PMID: 23470967 Free PMC article. Review.
Adaptive trials in the neoadjuvant setting: a model to safely tailor care while accelerating drug development.
Yee D, Haddad T, Albain K, Barker A, Benz C, Boughey J, Buxton M, Chien AJ, DeMichele A, Dilts D, Elias A, Haluska P, Hogarth M, Hu A, Hytlon N, Kaplan HG, Kelloff GG, Khan Q, Lang J, Leyland-Jones B, Liu M, Nanda R, Northfelt D, Olopade OI, Park J, Parker B, Parkinson D, Pearson-White S, Perlmutter J, Pusztai L, Symmans F, Rugo H, Tripathy D, Wallace A, Wholley D, Van't Veer L, Berry DA, Esserman L. Yee D, et al. J Clin Oncol. 2012 Dec 20;30(36):4584-6; author reply 4588-9. doi: 10.1200/JCO.2012.44.1022. Epub 2012 Nov 19. J Clin Oncol. 2012. PMID: 23169510 No abstract available.
The Genomic Grade Assay Compared With Ki67 to Determine Risk of Distant Breast Cancer Recurrence.
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. Ignatiadis M, et al. JAMA Oncol. 2016 Feb;2(2):217-24. doi: 10.1001/jamaoncol.2015.4377. JAMA Oncol. 2016. PMID: 26633571 Clinical Trial.
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