2009
Multicenter Phase II Study of Lapatinib in Patients with Brain Metastases from HER2-Positive Breast Cancer
Lin N, Diéras V, Paul D, Lossignol D, Christodoulou C, Stemmler H, Roché H, Liu M, Greil R, Ciruelos E, Loibl S, Gori S, Wardley A, Yardley D, Brufsky A, Blum J, Rubin S, Dharan B, Steplewski K, Zembryki D, Oliva C, Roychowdhury D, Paoletti P, Winer E. Multicenter Phase II Study of Lapatinib in Patients with Brain Metastases from HER2-Positive Breast Cancer. Clinical Cancer Research 2009, 15: 1452-1459. PMID: 19228746, DOI: 10.1158/1078-0432.ccr-08-1080.Peer-Reviewed Original ResearchConceptsBrain metastasesBreast cancerObjective responseVolumetric reductionCNS lesionsNeurologic signsCentral nervous system progressionMulticenter phase II studySmall phase 2 trialHER2-positive breast cancerCombination of lapatinibExtra-CNS diseaseProgressive brain metastasesPhase II studyPrimary end pointPhase 2 trialProgression-free survivalThird of patientsProgressive neurologic signsMajor clinical challengeCNS metastasesCranial radiationEligible patientsEvaluable patientsPrior trastuzumab
2007
EGF105084, a phase II study of lapatinib for brain metastases in patients (pts) with HER2+ breast cancer following trastuzumab (H) based systemic therapy and cranial radiotherapy (RT)
Lin N, Dieras V, Paul D, Lossignol D, Christodoulou C, Laessig D, Roché H, Zembryki D, Oliva C, Winer E. EGF105084, a phase II study of lapatinib for brain metastases in patients (pts) with HER2+ breast cancer following trastuzumab (H) based systemic therapy and cranial radiotherapy (RT). Journal Of Clinical Oncology 2007, 25: 1012-1012. DOI: 10.1200/jco.2007.25.18_suppl.1012.Peer-Reviewed Original ResearchNeurological signs/symptomsCNS diseaseCranial radiotherapyBreast cancerBrain metastasesSystemic therapyInitial phase II trialDose of steroidsECOG PS 0Extra-CNS diseaseIndependent radiology reviewProgressive brain metastasesPhase II studyPhase II trialLarge multicenter trialsSigns/symptomsCNS disease progressionAnalysis of efficacyPreliminary dataEligible ptsH therapyPo bidRefractory settingAccrual goalII trialBrain Metastases: The HER2 Paradigm
Lin NU, Winer EP. Brain Metastases: The HER2 Paradigm. Clinical Cancer Research 2007, 13: 1648-1655. PMID: 17363517, DOI: 10.1158/1078-0432.ccr-06-2478.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerCNS diseaseBreast cancerCentral nervous system metastasesExtra-CNS diseaseImportant sanctuary siteNervous system metastasesProportion of patientsTerms of prognosisCNS metastasesCNS progressionBrain metastasesCytotoxic chemotherapySystemic therapyAdvanced cancerTherapeutic challengePrimary diagnosisHistorical controlsTargeted therapyPreventive strategiesSanctuary siteTumor subtypesParticular tumor subtypesPatientsNatural history