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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. Among authors: kelloff gg. 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.
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.
What evidence do we need for biomarker qualification?
Leptak C, Menetski JP, Wagner JA, Aubrecht J, Brady L, Brumfield M, Chin WW, Hoffmann S, Kelloff G, Lavezzari G, Ranganathan R, Sauer JM, Sistare FD, Zabka T, Wholley D. Leptak C, et al. Sci Transl Med. 2017 Nov 22;9(417):eaal4599. doi: 10.1126/scitranslmed.aal4599. Sci Transl Med. 2017. PMID: 29167393 Review.