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 carcinoma
2011
P3-16-05: A Phase II Trial Expansion Cohort of the PARP Inhibitor Veliparib (ABT888) and Temozolomide in BRCA1/2 Associated Metastatic Breast Cancer.
Isakoff S, Overmoyer B, Tung N, Gelman R, Habin K, Qian J, Giranda V, Shepherd S, Garber J, Ellisen L, Winer E, Goss P. P3-16-05: A Phase II Trial Expansion Cohort of the PARP Inhibitor Veliparib (ABT888) and Temozolomide in BRCA1/2 Associated Metastatic Breast Cancer. Cancer Research 2011, 71: p3-16-05-p3-16-05. DOI: 10.1158/0008-5472.sabcs11-p3-16-05.Peer-Reviewed Original ResearchMetastatic breast cancerClinical benefit ratePrior platinum treatmentExpansion cohortResponse rateBenefit ratePlatinum treatmentPo bidPrior platinumMedian PFSAdditional patientsOriginal cohortBreast cancerCommon grade 3/4 toxicitiesSingle-arm phase II trialArm phase II trialBreast cancer xenograft modelPARP inhibitor veliparibPrior adjuvant chemotherapySafety of temozolomideGrade 3/4 toxicitiesPhase II studyFirst-line therapyPhase II trialOverall response rate
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
2006
Phase II trial of lapatinib for brain metastases in patients with HER2+ breast cancer
Lin N, Carey L, Liu M, Younger J, Come S, Bullitt E, Van Den Abbeele A, Li X, Hochberg F, Winer E. Phase II trial of lapatinib for brain metastases in patients with HER2+ breast cancer. Journal Of Clinical Oncology 2006, 24: 503-503. DOI: 10.1200/jco.2006.24.18_suppl.503.Peer-Reviewed Original ResearchBrain metastasesBreast cancerObjective responsePrimary endpointCNS lesionsCNS diseaseCentral nervous system metastasesVolumetric declinesCentral radiology reviewProgressive brain metastasesNervous system metastasesPhase II trialEfficacy of lapatinibMetastatic breast cancerFDG-PET scansMean age 52Analysis of QOLCommon AEsEligible patientsMeasurable diseasePo bidII trialPrior radiationRECIST criteriaSecondary endpoints