2017
TBCRC 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
2016
Translational Breast Cancer Research Consortium (TBCRC) 022: A Phase II Trial of Neratinib for Patients With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases
Freedman RA, Gelman RS, Wefel JS, Melisko ME, Hess KR, Connolly RM, Van Poznak CH, Niravath PA, Puhalla SL, Ibrahim N, Blackwell KL, Moy B, Herold C, Liu MC, Lowe A, Agar NY, Ryabin N, Farooq S, Lawler E, Rimawi MF, Krop IE, Wolff AC, Winer EP, Lin NU. Translational Breast Cancer Research Consortium (TBCRC) 022: A Phase II Trial of Neratinib for Patients With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases. Journal Of Clinical Oncology 2016, 34: 945-952. PMID: 26834058, PMCID: PMC5070554, DOI: 10.1200/jco.2015.63.0343.Peer-Reviewed Original ResearchConceptsObjective response rateWhole brain radiotherapyBrain metastasesBreast cancerHER2-positive breast cancer brain metastasesCNS objective response rateHER2-positive brain metastasesMedian progression-free survivalNeurologic signs/symptomsPrevious whole-brain radiotherapyBreast cancer brain metastasesHuman epidermal growth factor receptor 2HER2-positive breast cancerEpidermal growth factor receptor 2Human epidermal growth factor receptorCNS-directed therapyNon-CNS progressionNon-target lesionsOpen-label trialCancer brain metastasesPhase II trialProgression-free survivalGrowth factor receptor 2Positive breast cancerSigns/symptoms
2009
Presentation of breast cancer in young women
Ruddy K, Gelber S, Tamimi R, Schapira L, Come S, Kereakoglow S, Lin N, Winer E, Partridge A. Presentation of breast cancer in young women. Journal Of Clinical Oncology 2009, 27: 6608-6608. DOI: 10.1200/jco.2009.27.15_suppl.6608.Peer-Reviewed Original ResearchSigns/symptomsMedical attentionBreast cancerYoung womenDiagnostic delayMedian timeExact testInitial signsProspective multicenter cohort studyInitial signs/symptomsLarge modern cohortPotential diagnostic delayMulticenter cohort studyClinical breast examBreast Self-ExamPredictors of delayFisher's exact testCohort studyModern cohortMedian agePatient factorsPoor outcomePrognostic implicationsSystemic symptomsBreast exam
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 trial