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Standardized Definitions for Efficacy End Points in Neoadjuvant Breast Cancer Clinical Trials: NeoSTEEP.
Litton JK, Regan MM, Pusztai L, Rugo HS, Tolaney SM, Garrett-Mayer E, Amiri-Kordestani L, Basho RK, Best AF, Boileau JF, Denkert C, Foster JC, Harbeck N, Jacene HA, King TA, Mason G, O'Sullivan CC, Prowell TM, Richardson AL, Sepulveda KA, Smith ML, Tjoe JA, Turashvili G, Woodward WA, Butler LP, Schwartz EI, Korde LA. Litton JK, et al. J Clin Oncol. 2023 Sep 20;41(27):4433-4442. doi: 10.1200/JCO.23.00435. Epub 2023 Jul 11. J Clin Oncol. 2023. PMID: 37433103 Free PMC article.
Why do phase III clinical trials in oncology fail so often?
Amiri-Kordestani L, Fojo T. Amiri-Kordestani L, et al. J Natl Cancer Inst. 2012 Apr 18;104(8):568-9. doi: 10.1093/jnci/djs180. Epub 2012 Apr 6. J Natl Cancer Inst. 2012. PMID: 22491346 No abstract available.
Assessing cardiac safety in oncology drug development.
Seltzer JH, Gintant G, Amiri-Kordestani L, Singer J, Koplowitz LP, Moslehi JJ, Barac A, Yu AF. Seltzer JH, et al. Am Heart J. 2019 Aug;214:125-133. doi: 10.1016/j.ahj.2019.04.010. Epub 2019 May 4. Am Heart J. 2019. PMID: 31202099 Free PMC article. Review. No abstract available.
US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments.
Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. Wedam SB, et al. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9. J Clin Oncol. 2018. PMID: 29522361 Free PMC article.
National Cancer Institute Breast Cancer Steering Committee Working Group Report on Meaningful and Appropriate End Points for Clinical Trials in Metastatic Breast Cancer.
Seidman AD, Bordeleau L, Fehrenbacher L, Barlow WE, Perlmutter J, Rubinstein L, Wedam SB, Hershman DL, Hayes JF, Butler LP, Smith ML, Regan MM, Beaver JA, Amiri-Kordestani L, Rastogi P, Zujewski JA, Korde LA. Seidman AD, et al. J Clin Oncol. 2018 Nov 10;36(32):3259-3268. doi: 10.1200/JCO.18.00242. Epub 2018 Sep 13. J Clin Oncol. 2018. PMID: 30212295 Free PMC article.
91 results