2024
Neratinib and Ado-Trastuzumab-Emtansine for Pre-treated and Untreated HER2-positive Breast Cancer Brain Metastases: Translational Breast Cancer Research Consortium Trial 022
Freedman R, Heiling H, Li T, Trapani D, Tayob N, Smith K, Davis R, Pereslete A, DeMeo M, Cotter C, Chen W, Parsons H, Santa-Maria C, Van Poznak C, Moy B, Brufsky A, Melisko M, O’Sullivan C, Ashai N, Rauf Y, Nangia J, Burns R, Savoie J, Wolff A, Winer E, Rimawi M, Krop I, Lin N. Neratinib and Ado-Trastuzumab-Emtansine for Pre-treated and Untreated HER2-positive Breast Cancer Brain Metastases: Translational Breast Cancer Research Consortium Trial 022. Annals Of Oncology 2024 PMID: 38977064, DOI: 10.1016/j.annonc.2024.07.245.Peer-Reviewed Original ResearchHER2-positive breast cancer brain metastasesBreast cancer brain metastasesT-DM1Ado-trastuzumab emtansineCentral nervous systemOverall survivalCNS objective response rateEfficacy of neratinibT-DM1 exposureObjective response rateCancer brain metastasesPhase II studyMedian OSRANO-BMBrain MetastasesSlow accrualIntracranial activityII studyPrimary endpointPreclinical dataCohort 4Response assessmentTreatment optionsNeratinibPatients
2017
Neratinib Efficacy and Circulating Tumor DNA Detection of HER2 Mutations in HER2 Nonamplified Metastatic Breast Cancer
X. C, Bose R, Gao F, Freedman RA, Telli ML, Kimmick G, Winer E, Naughton M, Goetz MP, Russell C, Tripathy D, Cobleigh M, Forero A, Pluard TJ, Anders C, Niravath PA, Thomas S, Anderson J, Bumb C, Banks KC, Lanman RB, Bryce R, Lalani AS, Pfeifer J, Hayes DF, Pegram M, Blackwell K, Bedard PL, Al-Kateb H, Ellis MJC. Neratinib Efficacy and Circulating Tumor DNA Detection of HER2 Mutations in HER2 Nonamplified Metastatic Breast Cancer. Clinical Cancer Research 2017, 23: 5687-5695. PMID: 28679771, PMCID: PMC6746403, DOI: 10.1158/1078-0432.ccr-17-0900.Peer-Reviewed Original ResearchConceptsClinical benefit rateProgression-free survivalMetastatic breast cancerStable diseaseCtDNA sequencingMedian progression-free survivalSingle-arm phase II trialCommon adverse eventsPhase II trialClinical trial participationPromising preclinical dataClin Cancer ResTumor-positive casesVariant allele frequencyProphylactic loperamideSecondary endpointsII trialPartial responseAdverse eventsTrial participationPreclinical dataBenefit rateBreast cancerWeek 4Estrogen receptor
2015
Phase II study of tivantinib (ARQ 197) in patients with metastatic triple-negative breast cancer
Tolaney SM, Tan S, Guo H, Barry W, Van Allen E, Wagle N, Brock J, Larrabee K, Paweletz C, Ivanova E, Janne P, Overmoyer B, Wright JJ, Shapiro GI, Winer EP, Krop IE. Phase II study of tivantinib (ARQ 197) in patients with metastatic triple-negative breast cancer. Investigational New Drugs 2015, 33: 1108-1114. PMID: 26123926, PMCID: PMC4608248, DOI: 10.1007/s10637-015-0269-8.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerPhase 2 studyProgression-free survivalBreast cancerPartial responseSingle-arm phase 2 studyResults 22 patientsPhase II studyDaily oral dosingOverall response rateRecent preclinical dataMechanism of actionTivantinib monotherapyMetastatic settingAdverse eventsII studyMethods PatientsPrior linesPreclinical dataOral dosingTivantinibPatientsMET expressionResponse rate
2001
New Combinations with Herceptin® in Metastatic Breast Cancer
Winer E, Burstein H. New Combinations with Herceptin® in Metastatic Breast Cancer. Oncology 2001, 61: 50-57. PMID: 11694788, DOI: 10.1159/000055402.Peer-Reviewed Original ResearchMeSH KeywordsAnastrozoleAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicCyclophosphamideDeoxycytidineDoxorubicinDrug InteractionsDrug SynergismEpirubicinFemaleFluorouracilGemcitabineHeart DiseasesHematologic DiseasesHumansMethotrexateNeoplasm MetastasisNitrilesOrganoplatinum CompoundsPaclitaxelTamoxifenThiotepaTrastuzumabTreatment OutcomeTriazolesVinblastineVinorelbineConceptsMetastatic breast cancerBreast cancerHormonal agentsSide effectsHER2-positive metastatic breast cancerPivotal phase III trialsHER2-positive breast cancerSingle-agent vinorelbineCombination of trastuzumabPhase II trialPhase III trialsMajor side effectsPossible side effectsHormonal therapyII trialIII trialsCombination regimensPreclinical dataClinical trialsMost womenBetter outcomesTrastuzumabCancerTrialsLiposomal formulation