2020
Phase I dose-escalation trial of tucatinib in combination with trastuzumab in patients with HER2-positive breast cancer brain metastases
Filho O, Leone JP, Li T, Tan-Wasielewski Z, Trippa L, Barry WT, Younger J, Lawler E, Walker L, Freedman RA, Tolaney SM, Krop I, Winer EP, Lin NU. Phase I dose-escalation trial of tucatinib in combination with trastuzumab in patients with HER2-positive breast cancer brain metastases. Annals Of Oncology 2020, 31: 1231-1239. PMID: 32461105, DOI: 10.1016/j.annonc.2020.05.014.Peer-Reviewed Original ResearchConceptsClinical benefit rateHER2-positive brain metastasesAlanine aminotransferase elevationCohort ABrain metastasesCohort BAminotransferase elevationBreast cancerHER2-positive breast cancer brain metastasesPhase I dose-escalation trialMedian progression-free survivalBreast cancer brain metastasesCommon dose-limiting toxicityI dose-escalation trialHER2-positive breast cancerCombination of tucatinibSecondary end pointsCancer brain metastasesDose-escalation trialProgression-free survivalDose-limiting toxicityMetastatic breast cancerBrain radiationObjective responseIntracranial activity
2018
Safety and pharmacokinetics of MM-302, a HER2-targeted antibody–liposomal doxorubicin conjugate, in patients with advanced HER2-positive breast cancer: a phase 1 dose-escalation study
Munster P, Krop IE, LoRusso P, Ma C, Siegel BA, Shields AF, Molnár I, Wickham TJ, Reynolds J, Campbell K, Hendriks BS, Adiwijaya BS, Geretti E, Moyo V, Miller KD. Safety and pharmacokinetics of MM-302, a HER2-targeted antibody–liposomal doxorubicin conjugate, in patients with advanced HER2-positive breast cancer: a phase 1 dose-escalation study. British Journal Of Cancer 2018, 119: 1086-1093. PMID: 30361524, PMCID: PMC6219487, DOI: 10.1038/s41416-018-0235-2.Peer-Reviewed Original ResearchConceptsOverall response rateAdverse eventsMM-302Breast cancerAdvanced HER2-positive breast cancerPhase 1 dose-escalation studyPhase 1 dose-escalation trialGrade 3/4 adverse eventsHER2-positive breast cancerAnthracycline-naïve patientsResultsSixty-nine patientsCommon adverse eventsDose-escalation studyDose-escalation trialPalmar-plantar erythrodysesthesiaMetastatic breast cancerFebrile neutropeniaMucosal inflammationPromising efficacyResponse rateTrastuzumabQ3wPatientsMonotherapyNeutropenia
2014
Phase I dose-escalation trial of ONT-380 in combination with trastuzumab in participants with brain metastases from HER2+ breast cancer.
Metzger-Filho O, Barry W, Krop I, Younger W, Lawler E, Winer E, Lin N. Phase I dose-escalation trial of ONT-380 in combination with trastuzumab in participants with brain metastases from HER2+ breast cancer. Journal Of Clinical Oncology 2014, 32: tps660-tps660. DOI: 10.1200/jco.2014.32.15_suppl.tps660.Peer-Reviewed Original Research