2017
CMET-25. PROGRESSION-FREE SURVIVAL (PFS) AND SITE OF FIRST PROGRESSION IN HER2+ METASTATIC BREAST CANCER PATIENTS WITH OR WITHOUT BRAIN METASTASES: A POOLED ANALYSIS OF TUCATINIB PHASE I STUDIES
Hamilton E, Moulder S, Ferrario C, Conlin A, Krop I, Chamberlain M, Gray T, Borges V. CMET-25. PROGRESSION-FREE SURVIVAL (PFS) AND SITE OF FIRST PROGRESSION IN HER2+ METASTATIC BREAST CANCER PATIENTS WITH OR WITHOUT BRAIN METASTASES: A POOLED ANALYSIS OF TUCATINIB PHASE I STUDIES. Neuro-Oncology 2017, 19: vi44-vi44. PMCID: PMC5692086, DOI: 10.1093/neuonc/nox168.173.Peer-Reviewed Original ResearchProgression-free survivalBaseline brain metastasesMetastatic breast cancerBrain metastasesMedian progression-free survivalMetastatic breast cancer patientsPhase 1b studyProgressive brain metastasesStable brain metastasesSite of relapseIncidence of progressionSignificant neurologic morbidityUntreated brain metastasesBreast cancer patientsTyrosine kinase inhibitorsBM cohortHER2 therapyHER2CLIMB trialPrior HER2Neurologic morbidityDurable responsesFirst progressionSystemic metastasesCombination therapyPatient cohortA 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
2016
Efficacy results of a phase 1b study of ONT-380, a CNS-penetrant TKI, in combination with T-DM1 in HER2+ metastatic breast cancer (MBC), including patients (pts) with brain metastases.
Borges V, Ferrario C, Aucoin N, Falkson C, Khan Q, Krop I, Welch S, Bedard P, Conlin A, Chaves J, Walker L, Hamilton E. Efficacy results of a phase 1b study of ONT-380, a CNS-penetrant TKI, in combination with T-DM1 in HER2+ metastatic breast cancer (MBC), including patients (pts) with brain metastases. Journal Of Clinical Oncology 2016, 34: 513-513. DOI: 10.1200/jco.2016.34.15_suppl.513.Peer-Reviewed Original Research
2014
A phase 1b study of ONT-380, an oral HER2-specific inhibitor, combined with ado-trastuzumab emtansine (T-DM1), in HER2+ metastatic breast cancer (MBC).
Borges V, Hamilton E, Yardley D, Moulder S, Hortobagyi G, Walker L, Krop I. A phase 1b study of ONT-380, an oral HER2-specific inhibitor, combined with ado-trastuzumab emtansine (T-DM1), in HER2+ metastatic breast cancer (MBC). Journal Of Clinical Oncology 2014, 32: tps662-tps662. DOI: 10.1200/jco.2014.32.15_suppl.tps662.Peer-Reviewed Original Research