2021
SYST-06. PHASE II TRIAL OF PAXALISIB (GDC-0084) IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM)
Leone J, Tayob N, Pereslete A, Ligibel J, Parsons H, Bi W, Zhao J, Winer E, Lin N. SYST-06. PHASE II TRIAL OF PAXALISIB (GDC-0084) IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM). Neuro-Oncology Advances 2021, 3: iv9-iv9. DOI: 10.1093/noajnl/vdab112.034.Peer-Reviewed Original ResearchBreast cancer brain metastasesObjective response rateCohort BCohort ACNS metastasesPrimary endpointHER2-positive breast cancer brain metastasesNeuro-Oncology Brain Metastases criteriaCentral nervous system metastasesHER2-positive breast cancerPatient-derived xenografts (PDX) modelsPhase II cohortNervous system metastasesPhase II studyCancer brain metastasesPhase II trialPI3K/Akt/mTORPatient-reported outcomesPI3KBrain-penetrant inhibitorAkt/mTORMetastasis (TNM) criteriaBrain metastasesII trialMetastasis resectionHow we treat HER2-positive brain metastases
Stavrou E, Winer EP, Lin NU. How we treat HER2-positive brain metastases. ESMO Open 2021, 6: 100256. PMID: 34482180, PMCID: PMC8424223, DOI: 10.1016/j.esmoop.2021.100256.Peer-Reviewed Original ResearchConceptsHER2-positive brain metastasesHuman epidermal growth factor 2Brain metastasesAdvanced diseaseBreast cancerCentral nervous system metastasesHER2-positive breast cancerEpidermal growth factor 2Nervous system metastasesExperienced multidisciplinary teamSurvival of patientsCentral nervous system activitySite of diseaseNervous system activityUnique clinical challengesAssociated morbiditySystemic therapyGrowth factor 2Clinical challengeReview of agentsClinical scenariosMultidisciplinary teamMetastasisSystem activityDisease
2019
TRLS-03. PHASE II TRIAL OF GDC-0084 IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM)
Leone J, Trippa L, Milisits L, Andrews C, Ligibel J, Parsons H, Bi W, Zhao J, Winer E, Lin N. TRLS-03. PHASE II TRIAL OF GDC-0084 IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM). Neuro-Oncology Advances 2019, 1: i9-i9. PMCID: PMC7213424, DOI: 10.1093/noajnl/vdz014.036.Peer-Reviewed Original ResearchBreast cancer brain metastasesObjective response rateCohort BCohort ACNS metastasesPrimary endpointHER2-positive breast cancer brain metastasesNeuro-Oncology Brain Metastases criteriaCentral nervous system metastasesHER2-positive breast cancerPatient-derived xenografts (PDX) modelsPhase II cohortNervous system metastasesPhase II studyCancer brain metastasesPhase II trialPI3K/Akt/mTORPatient-reported outcomesPI3KBrain-penetrant inhibitorAkt/mTORCombination of GDCMetastasis (TNM) criteriaBrain metastasesII trialPembrolizumab monotherapy for previously untreated, PD-L1-positive, metastatic triple-negative breast cancer: cohort B of the phase II KEYNOTE-086 study
Adams S, Loi S, Toppmeyer D, Cescon DW, De Laurentiis M, Nanda R, Winer EP, Mukai H, Tamura K, Armstrong A, Liu MC, Iwata H, Ryvo L, Wimberger P, Rugo HS, Tan AR, Jia L, Ding Y, Karantza V, Schmid P. Pembrolizumab monotherapy for previously untreated, PD-L1-positive, metastatic triple-negative breast cancer: cohort B of the phase II KEYNOTE-086 study. Annals Of Oncology 2019, 30: 405-411. PMID: 30475947, DOI: 10.1093/annonc/mdy518.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerPositive metastatic triple-negative breast cancerTreatment-related adverse eventsTriple-negative breast cancerDisease control rateObjective response rateFirst-line therapyProgression-free survivalAdverse eventsPD-L1Stable diseasePembrolizumab monotherapyOverall survivalCohort BControl rateBreast cancerResponse ratePD-L1 combined positive scoreCentral nervous system metastasesGrade 4 adverse eventsMedian progression-free survivalStandard first-line treatmentEnd pointGrade 3 severityManageable safety profile
2018
A phase II study of atezolizumab (Atezo) combined with pertuzumab (P) and high-dose trastuzumab (H) for the treatment of central nervous system (CNS) metastases in patients with Her2-positive (HER2+) metastatic breast cancer (MBC).
Barroso-Sousa R, Barry W, Kumthekar P, Guo H, Silvestri K, Krop I, Winer E, Tolaney S, Lin N. A phase II study of atezolizumab (Atezo) combined with pertuzumab (P) and high-dose trastuzumab (H) for the treatment of central nervous system (CNS) metastases in patients with Her2-positive (HER2+) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2018, 36: tps1100-tps1100. DOI: 10.1200/jco.2018.36.15_suppl.tps1100.Peer-Reviewed Original Research
2013
TBCRC 018: Phase II study of iniparib plus chemotherapy to treat triple-negative breast cancer (TNBC) central nervous system (CNS) metastases (mets).
Anders C, Deal A, Abramson V, Liu M, Storniolo A, Carpenter J, Puhalla S, Nanda R, Melhem-Bertrandt A, Lin N, Marcom P, Van Poznak C, Stearns V, Melisko M, Smith J, Karginova O, Winer E, Perou C, Wolff A, Carey L. TBCRC 018: Phase II study of iniparib plus chemotherapy to treat triple-negative breast cancer (TNBC) central nervous system (CNS) metastases (mets). Journal Of Clinical Oncology 2013, 31: 515-515. DOI: 10.1200/jco.2013.31.15_suppl.515.Peer-Reviewed Original ResearchQuality of lifeBlood-brain barrierResponse rateCommon grade 3/4 adverse eventsCentral nervous system metastasesGrade 3/4 adverse eventsClinical benefit rateNervous system metastasesPhase II studyTumor response rateKaplan-Meier methodWhole brain RTHalf of womenBetter response rateSmall molecule anti-cancer agentTopoisomerase I inhibitorAdvanced TNBCCorrelative endpointsEligible ptsGermline BRCA1/2Measurable lesionsMedian TTPRadiation-naïveAnti-cancer agentsPrimary endpoint
2007
Brain Metastases: The HER2 Paradigm
Lin NU, Winer EP. Brain Metastases: The HER2 Paradigm. Clinical Cancer Research 2007, 13: 1648-1655. PMID: 17363517, DOI: 10.1158/1078-0432.ccr-06-2478.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerCNS diseaseBreast cancerCentral nervous system metastasesExtra-CNS diseaseImportant sanctuary siteNervous system metastasesProportion of patientsTerms of prognosisCNS metastasesCNS progressionBrain metastasesCytotoxic chemotherapySystemic therapyAdvanced cancerTherapeutic challengePrimary diagnosisHistorical controlsTargeted therapyPreventive strategiesSanctuary siteTumor subtypesParticular tumor subtypesPatientsNatural history
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
2005
Isolated central nervous system metastases in patients with HER2-overexpressing advanced breast cancer treated with first-line trastuzumab-based therapy
Burstein HJ, Lieberman G, Slamon DJ, Winer EP, Klein P. Isolated central nervous system metastases in patients with HER2-overexpressing advanced breast cancer treated with first-line trastuzumab-based therapy. Annals Of Oncology 2005, 16: 1772-1777. PMID: 16150805, DOI: 10.1093/annonc/mdi371.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCentral Nervous System NeoplasmsCyclophosphamideDisease ProgressionDoxorubicinFemaleFollow-Up StudiesGene AmplificationHumansIn Situ Hybridization, FluorescencePaclitaxelPrevalenceReceptor, ErbB-2Survival RateTime FactorsTrastuzumabVinblastineVinorelbineConceptsTrastuzumab-based therapyMetastatic breast cancerHER2-overexpressing metastatic breast cancerCentral nervous system metastasesNervous system metastasesBreast cancerCNS progressionCNS metastasesFirst-line trastuzumab-based therapyHER2-positive metastatic breast cancerMulticenter phase II trialAdvanced breast cancerFirst-line treatmentPhase II trialPhase III studyTrastuzumab-based treatmentPrimary breast cancerHER2 gene amplificationGene amplificationMeasurable diseaseCNS recurrenceII trialIII studyMetastatic diseasePatient survival
2003
Central nervous system metastases in women who receive trastuzumab‐based therapy for metastatic breast carcinoma
Bendell JC, Domchek SM, Burstein HJ, Harris L, Younger J, Kuter I, Bunnell C, Rue M, Gelman R, Winer E. Central nervous system metastases in women who receive trastuzumab‐based therapy for metastatic breast carcinoma. Cancer 2003, 97: 2972-2977. PMID: 12784331, DOI: 10.1002/cncr.11436.Peer-Reviewed Original ResearchConceptsPercent of patientsMetastatic breast carcinomaTrastuzumab-based therapyCentral nervous system metastasesCentral nervous system diseaseNervous system metastasesCNS diseaseNervous system diseasesBreast carcinomaBrain metastasesCNS metastasesLeptomeningeal involvementSystem diseasesDisease sitesMore brain metastasesParenchymal brain metastasesProgressive CNS diseaseFirst-line therapyTime of diagnosisMedian survival periodBlood-brain barrierNew treatment strategiesStable diseaseMetastatic diseasePharmacy records