2016
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 imaging
2005
Phase II study of tariquidar, a selective P‐glycoprotein inhibitor, in patients with chemotherapy‐resistant, advanced breast carcinoma
Pusztai L, Wagner P, Ibrahim N, Rivera E, Theriault R, Booser D, Symmans FW, Wong F, Blumenschein G, Fleming DR, Rouzier R, Boniface G, Hortobagyi GN. Phase II study of tariquidar, a selective P‐glycoprotein inhibitor, in patients with chemotherapy‐resistant, advanced breast carcinoma. Cancer 2005, 104: 682-691. PMID: 15986399, DOI: 10.1002/cncr.21227.Peer-Reviewed Original ResearchConceptsAdministration of tariquidarP-gp expressionSestamibi scanBreast carcinomaSestamibi uptakeP-gp-positive tumorsTaxane-containing chemotherapy regimensDocetaxel-related toxicitiesLimited clinical activityObjective tumor responsePercent of patientsPhase II studyAdvanced breast carcinomaP-glycoprotein inhibitor tariquidarP-glycoprotein inhibitorsMultidrug resistance modulationP-gp transporterMultidrug resistance inhibitorsSame chemotherapyStable diseaseChemotherapy regimenChemotherapy regimensTaxane chemotherapyClinical responseDose modification