2017
A randomized, double-blinded, controlled study of tucatinib (ONT-380) vs. placebo in combination with capecitabine (C) and trastuzumab (Tz) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (mBC) (HER2CLIMB).
Anders C, Murthy R, Hamilton E, Borges V, Cameron D, Carey L, Müller V, Curigliano G, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pivot X, Pegram M, Slamon D, Hurvitz S, Tsai M, Winer E. A randomized, double-blinded, controlled study of tucatinib (ONT-380) vs. placebo in combination with capecitabine (C) and trastuzumab (Tz) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (mBC) (HER2CLIMB). Journal Of Clinical Oncology 2017, 35: tps1107-tps1107. DOI: 10.1200/jco.2017.35.15_suppl.tps1107.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast carcinomaBrain metsIndependent data monitoring committeeClinical benefit ratePhase 1b studyDuration of responseIndependent central reviewPrimary study objectiveData monitoring committeeCNS progressionEGFR agentsPo bidBrain metastasesAdult patientsObjective responseOverall survivalCentral reviewStudy treatmentT-DM1CNS therapyTrastuzumab emtansineBenefit rateSelective small molecule inhibitorsBreast carcinomaTBCRC 022: Phase II trial of neratinib + capecitabine for patients (Pts) with human epidermal growth factor receptor 2 (HER2+) breast cancer brain metastases (BCBM).
Freedman R, Gelman R, Melisko M, Anders C, Moy B, Blackwell K, Connolly R, Niravath P, Van Poznak C, Puhalla S, Farooq S, Cropp A, Cotter C, Liu M, Krop I, Nangia J, Tung N, Wolff A, Winer E, Lin N. TBCRC 022: Phase II trial of neratinib + capecitabine for patients (Pts) with human epidermal growth factor receptor 2 (HER2+) breast cancer brain metastases (BCBM). Journal Of Clinical Oncology 2017, 35: 1005-1005. DOI: 10.1200/jco.2017.35.15_suppl.1005.Peer-Reviewed Original ResearchBreast cancer brain metastasesObjective response rateCombination of neratinibCentral nervous system (CNS) objective response rateCNS objective response rateNeurologic signs/symptomsGrade 3 toxicityGrade 4 toxicityMedian age 51Cancer brain metastasesPhase II trialSigns/symptomsEvidence-based treatmentsNon-CNS lesionsCNS progressionPrior lapatinibPrior WBRTPrimary endpointProtocol therapyBrain metastasesII trialCNS lesionsNew lesionsMedian numberBrain MRI
2013
Clinical outcomes and treatment practice patterns of patients with HER2-positive metastatic breast cancer in the post-trastuzumab era
Olson EM, Najita JS, Sohl J, Arnaout A, Burstein HJ, Winer EP, Lin NU. Clinical outcomes and treatment practice patterns of patients with HER2-positive metastatic breast cancer in the post-trastuzumab era. The Breast 2013, 22: 525-531. PMID: 23352568, PMCID: PMC3713786, DOI: 10.1016/j.breast.2012.12.006.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCentral Nervous System NeoplasmsCohort StudiesDisease-Free SurvivalFemaleFollow-Up StudiesHumansKaplan-Meier EstimateLiver NeoplasmsLung NeoplasmsMiddle AgedPractice Patterns, Physicians'PrognosisProportional Hazards ModelsReceptor, ErbB-2Retrospective StudiesTrastuzumabTreatment OutcomeConceptsHER2-positive metastatic breast cancerMetastatic breast cancerMedian overall survivalTrastuzumab-based therapyOverall survivalHazard ratioMedian durationBreast cancerCox proportional hazards modelCentral nervous system diseasePost-trastuzumab eraTreatment practice patternsHER2-positive patientsKaplan-Meier methodologyLog-rank testPatterns of careLine of treatmentNervous system diseasesProportional hazards modelTime of deathCNS metastasesCNS progressionMetastatic settingFirst recurrenceShorter OS
2008
Sites of distant recurrence and clinical outcomes in patients with metastatic triple‐negative breast cancer
Lin NU, Claus E, Sohl J, Razzak AR, Arnaout A, Winer EP. Sites of distant recurrence and clinical outcomes in patients with metastatic triple‐negative breast cancer. Cancer 2008, 113: 2638-2645. PMID: 18833576, PMCID: PMC2835546, DOI: 10.1002/cncr.23930.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerBreast cancerCNS metastasesMedian survivalMetastatic diagnosisSystemic diseaseCentral nervous system recurrenceDana-Farber Cancer InstituteInitial metastatic diagnosisProgressive CNS diseaseOutcomes of patientsNew treatment strategiesRace-adjusted ratesCNS progressionBrain metastasesCNS involvementCNS recurrenceDistant recurrenceMetastatic presentationCNS lesionsClinical outcomesPathology recordsCNS diseaseAggressive subtype
2007
Brain 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
2005
Isolated central nervous system metastases in patients with HER2-overexpressing advanced breast cancer treated with first-line trastuzumab-based therapy
Burstein HJ, Lieberman G, Slamon DJ, Winer EP, Klein P. Isolated central nervous system metastases in patients with HER2-overexpressing advanced breast cancer treated with first-line trastuzumab-based therapy. Annals Of Oncology 2005, 16: 1772-1777. PMID: 16150805, DOI: 10.1093/annonc/mdi371.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCentral Nervous System NeoplasmsCyclophosphamideDisease ProgressionDoxorubicinFemaleFollow-Up StudiesGene AmplificationHumansIn Situ Hybridization, FluorescencePaclitaxelPrevalenceReceptor, ErbB-2Survival RateTime FactorsTrastuzumabVinblastineVinorelbineConceptsTrastuzumab-based therapyMetastatic breast cancerHER2-overexpressing metastatic breast cancerCentral nervous system metastasesNervous system metastasesBreast cancerCNS progressionCNS metastasesFirst-line trastuzumab-based therapyHER2-positive metastatic breast cancerMulticenter phase II trialAdvanced breast cancerFirst-line treatmentPhase II trialPhase III studyTrastuzumab-based treatmentPrimary breast cancerHER2 gene amplificationGene amplificationMeasurable diseaseCNS recurrenceII trialIII studyMetastatic diseasePatient survival