2019
A phase II study of cabozantinib alone or in combination with trastuzumab in breast cancer patients with brain metastases
Leone JP, Duda DG, Hu J, Barry WT, Trippa L, Gerstner ER, Jain RK, Tan S, Lawler E, Winer EP, Lin NU, Tolaney SM. A phase II study of cabozantinib alone or in combination with trastuzumab in breast cancer patients with brain metastases. Breast Cancer Research And Treatment 2019, 179: 113-123. PMID: 31541381, DOI: 10.1007/s10549-019-05445-z.Peer-Reviewed Original ResearchConceptsBreast cancer brain metastasesObjective response rateCNS objective response ratePhase II studyCohort 2Cohort 1BCBM patientsBrain metastasesII studyCohort 3Central nervous system (CNS) objective response rateMost common grade 3/4 adverse eventsCommon grade 3/4 adverse eventsSingle-arm phase II studyGrade 3/4 adverse eventsSecondary objectiveTolerability of cabozantinibWhole brain radiationCancer brain metastasesProgression-free survivalBreast cancer patientsTumor blood volumeCabozantinib 60RECIST 1.1STie-2
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
2011
A Phase II Study of Sagopilone (ZK 219477; ZK-EPO) in Patients With Breast Cancer and Brain Metastases
Freedman RA, Bullitt E, Sun L, Gelman R, Harris G, Ligibel JA, Krop IE, Partridge AH, Eisenberg E, Winer EP, Lin NU. A Phase II Study of Sagopilone (ZK 219477; ZK-EPO) in Patients With Breast Cancer and Brain Metastases. Clinical Breast Cancer 2011, 11: 376-383. PMID: 21697017, PMCID: PMC3773692, DOI: 10.1016/j.clbc.2011.03.024.Peer-Reviewed Original ResearchConceptsMedian progression-free survivalProgression-free survivalObjective response ratePhase II studyBrain metastasesChallenging clinical problemBreast cancerCentral nervous systemII studyOverall survivalMagnetic resonance angiographyClinical problemCentral nervous system (CNS) objective response rateResponse rateCNS objective response rateCommon grade 3 toxicitiesProgressive metastatic breast cancerBreast cancer brain metastasesProgressive CNS diseaseGrade 3 toxicityRecurrent brain metastasesWhole brain radiotherapyCancer brain metastasesMetastatic breast cancerHigh-resolution magnetic resonance angiography