HERAKEYDESIGNELEMENTS,RESULTSANDFUTURE.ppt

HERA:KEYDESIGNELEMENTS,RESULTSANDFUTUREPLANSNSABP17SEPTEMBER2005BrianLeyland-JonesMindaDeGunzbergProfessorofOncology,McGillUniversity,Montreal,CanadaArandomizedthree-armmulti-parisonof:1yeartrastuzumab2yearstrastuzumabornotrastuzumabinwomenwithHER-pletedadjuvantchemotherapyFIRSTRESULTSOFTHEHERATRIALASCO,ScientificSession,May16,%EASTERNEUROPE:11%JAPAN12%ENTRAL&%ACCRUAL:5090WOMEN478centersfrom39countries(2002-2005)OUNTRIESSOUTHAFRICAAUSTRALIA–NEWZEALANDHERATRIALDESIGNWomenwithHER2POSITIVEinvasivebreastcancerIHC3+orFISH+centrallyconfirmedSurgery+(neo)adjuvantchemotherapy(CT)radiotherapyStratificationNodalstatus,adjuvantCTregimen,herapy,age,regionRandomizationTrastuzumab8mg/kg6mg/kg3weeklyx2yearsTrastuzumab8mg/kg6mg/pletionofallchemoandradiationtherapyTrastuzumabadministeredonaq3weeklyscheduleTheonlytrialaskinga durationquestion(byincludinga2yeararm)Largeproportion(one-third)ofnodenegativepatientsKEYINCLUSIONCRITERIACentrallyconfirmedHER-2overexpressionoramplificationNode-positiveor(sentinel)node-negativewithpleted4cyclesofapproved(neo)adjuvantchemotherapyregimenBaselineLVEF55%(EchoorMUGA)KnownhormonereceptorstatusPrimaryendpoint:DFSSecondaryendpoints:RFS,DDFS,OS,rual:4482HR=(power80%2sided=)foreachpairwisetest(1yvsnilor2yvsnil)Oneinterimefficacyanalysis(n=475events)Oneprimarycoreanalysis(n=951events)n=300 n=600 n=900ptsStoppingrule:4%absoluteincreaseinprimarycardiaceventsHERAFLOWCHART5090Womenenrolled5081withavailabledata1yearmedianfollow-up2ytrastuzumabN=1694EfficacyAnalysisN=3387N=16771ytrastuzumabN=1736ObservationSafetyAnalysisN=3413N=3N=20N=26ObservationN=16931ytrastuzumabN=1694PATIENT/TUMORCHARACTERISTICSAge(%)<35y35-49y50-59y60ymissingObservation(n=1693)1yeartrastuzumab(n=1694)Adjuvantchemotherapy(%)Anthracyclines+taxanesNoanthracyclines,