2019
TBCRC 022: A Phase II Trial of Neratinib and Capecitabine for Patients With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases
Freedman RA, Gelman RS, Anders CK, Melisko ME, Parsons HA, Cropp AM, Silvestri K, Cotter CM, Componeschi KP, Marte JM, Connolly RM, Moy B, Van Poznak CH, Blackwell KL, Puhalla SL, Jankowitz RC, Smith KL, Ibrahim N, Moynihan TJ, O’Sullivan C, Nangia J, Niravath P, Tung N, Pohlmann PR, Burns R, Rimawi MF, Krop IE, Wolff AC, Winer EP, Lin NU, . TBCRC 022: A Phase II Trial of Neratinib and Capecitabine for Patients With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases. Journal Of Clinical Oncology 2019, 37: jco.18.01511. PMID: 30860945, PMCID: PMC6494354, DOI: 10.1200/jco.18.01511.Peer-Reviewed Original ResearchConceptsCNS objective response rateObjective response rateHER2-positive breast cancer brain metastasesBreast cancer brain metastasesCancer brain metastasesBrain metastasesBreast cancerCommon grade 3 toxicitiesHER2-positive brain metastasesMedian progression-free survivalHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorEfficacy of HER2Non-CNS progressionGrade 3 toxicityPrimary end pointPhase II trialProgression-free survivalGrowth factor receptor 2Positive breast cancerProgressive neurologic signsEvidence-based treatmentsFactor receptor 2Epidermal growth factor receptor
2013
Phase II trial of carboplatin (C) and bevacizumab (BEV) in patients (pts) with breast cancer brain metastases (BCBM).
Lin N, Gelman R, Younger W, Sohl J, Freedman R, Sorensen A, Bullitt E, Harris G, Morganstern D, Schneider B, Krop I, Winer E. Phase II trial of carboplatin (C) and bevacizumab (BEV) in patients (pts) with breast cancer brain metastases (BCBM). Journal Of Clinical Oncology 2013, 31: 513-513. DOI: 10.1200/jco.2013.31.15_suppl.513.Peer-Reviewed Original ResearchBreast cancer brain metastasesCNS responseDay 1CNS objective response rateNon-target lesionsObjective response rateAnti-edema effectCancer brain metastasesPhase II trialProgressive neurologic signsStandard brain MRINon-CNS diseasesMultiple tumor typesPrior lapatinibPrior trastuzumabRECIST 1.0Steroid dosePrimary endpointProtocol therapyBrain metastasesFirst doseII trialCNS lesionsOverall survivalPartial response