Adaptive Randomization of Neratinib in Early Breast Cancer
Park JW, Liu MC, Yee D, Yau C, van 't Veer LJ, Symmans WF, Paoloni M, Perlmutter J, Hylton NM, Hogarth M, DeMichele A, Buxton MB, Chien AJ, Wallace AM, Boughey JC, Haddad TC, Chui SY, Kemmer KA, Kaplan HG, Isaacs C, Nanda R, Tripathy D, Albain KS, Edmiston KK, Elias AD, Northfelt DW, Pusztai L, Moulder SL, Lang JE, Viscusi RK, Euhus DM, Haley BB, Khan QJ, Wood WC, Melisko M, Schwab R, Helsten T, Lyandres J, Davis SE, Hirst GL, Sanil A, Esserman LJ, Berry DA. Adaptive Randomization of Neratinib in Early Breast Cancer. New England Journal Of Medicine 2016, 375: 11-22. PMID: 27406346, PMCID: PMC5259558, DOI: 10.1056/nejmoa1513750.Peer-Reviewed Original ResearchConceptsPathological complete responseComplete responseBreast cancerNeoadjuvant therapyStandard chemotherapyHuman epidermal growth factor receptor 2 (HER2) statusEpidermal growth factor receptor 2 statusBiomarker signaturesSerial magnetic resonance imagingI-SPY 2 TRIALTyrosine kinase inhibitor neratinibClinical stage IIPrimary end pointHormone receptor statusPhase 2 trialPhase 3 trialStandard neoadjuvant chemotherapyEarly breast cancerMultiple new agentsAdaptive randomizationNegative breast cancerConfirmatory phase 3 trialPhase 3 testingExperimental groupMagnetic resonance imagingAdaptive Randomization of Veliparib–Carboplatin Treatment in Breast Cancer
Rugo HS, Olopade OI, DeMichele A, Yau C, van 't Veer LJ, Buxton MB, Hogarth M, Hylton NM, Paoloni M, Perlmutter J, Symmans WF, Yee D, Chien AJ, Wallace AM, Kaplan HG, Boughey JC, Haddad TC, Albain KS, Liu MC, Isaacs C, Khan QJ, Lang JE, Viscusi RK, Pusztai L, Moulder SL, Chui SY, Kemmer KA, Elias AD, Edmiston KK, Euhus DM, Haley BB, Nanda R, Northfelt DW, Tripathy D, Wood WC, Ewing C, Schwab R, Lyandres J, Davis SE, Hirst GL, Sanil A, Berry DA, Esserman LJ. Adaptive Randomization of Veliparib–Carboplatin Treatment in Breast Cancer. New England Journal Of Medicine 2016, 375: 23-34. PMID: 27406347, PMCID: PMC5259561, DOI: 10.1056/nejmoa1513749.Peer-Reviewed Original ResearchConceptsPathological complete responseHuman epidermal growth factor receptor 2Triple-negative breast cancerStandard therapyComplete responseBreast cancerBiomarker subtypesExperimental regimensEpidermal growth factor receptor 2I-SPY 2Triple-negative populationCompletion of chemotherapyPrimary end pointPhase 3 trialStandard neoadjuvant chemotherapyGrowth factor receptor 2HER2-negative tumorsAdaptive randomizationBiomarker signaturesTumor volume changesFactor receptor 2Phase 2Carboplatin groupNeoadjuvant trialsNeoadjuvant chemotherapy