2022
Phase Ib study of pembrolizumab in combination with trastuzumab emtansine for metastatic HER2-positive breast cancer
Waks AG, Keenan TE, Li T, Tayob N, Wulf GM, Richardson ET, Attaya V, Anderson L, Mittendorf EA, Overmoyer B, Winer EP, Krop IE, Agudo J, Van Allen EM, Tolaney SM. Phase Ib study of pembrolizumab in combination with trastuzumab emtansine for metastatic HER2-positive breast cancer. Journal For ImmunoTherapy Of Cancer 2022, 10: e005119. PMID: 36252998, PMCID: PMC9577940, DOI: 10.1136/jitc-2022-005119.Peer-Reviewed Original ResearchConceptsObjective response rateProgression-free survivalMetastatic breast cancerAdverse eventsBreast cancerT-DM1Immune biomarkersTrastuzumab emtansineHER2-positive metastatic breast cancerMetastatic HER2-positive breast cancerGrade 3 adverse eventsMedian progression-free survivalTreatment-related adverse eventsHuman epidermal growth factor receptor 2Cell death ligand 1HER2-positive breast cancerEpidermal growth factor receptor 2Dose-finding cohortPhase 2 dosePhase Ib studyPhase Ib trialAnti-HER2 therapyDose-limiting toxicityGrowth factor receptor 2Immune checkpoint blockade
2019
Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer
Murthy RK, Loi S, Okines A, Paplomata E, Hamilton E, Hurvitz SA, Lin NU, Borges V, Abramson V, Anders C, Bedard PL, Oliveira M, Jakobsen E, Bachelot T, Shachar SS, Müller V, Braga S, Duhoux FP, Greil R, Cameron D, Carey LA, Curigliano G, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Palanca-Wessels MC, Walker L, Feng W, Winer EP. Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer. New England Journal Of Medicine 2019, 382: 597-609. PMID: 31825569, DOI: 10.1056/nejmoa1914609.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsBreast NeoplasmsCapecitabineConsolidation ChemotherapyDiarrheaDouble-Blind MethodFemaleHumansKaplan-Meier EstimateMiddle AgedOxazolesProgression-Free SurvivalProtein-Tyrosine KinasesPyridinesQuinazolinesReceptor, ErbB-2TrastuzumabConceptsHER2-positive metastatic breast cancerProgression-free survivalPlacebo-combination groupMetastatic breast cancerElevated aminotransferase levelsBrain metastasesBreast cancerOverall survivalAminotransferase levelsMedian progression-free survivalPalmar-plantar erythrodysesthesia syndromeBetter progression-free survivalPositive metastatic breast cancerHuman epidermal growth factor receptor 2End pointEpidermal growth factor receptor 2Common adverse eventsMedian overall survivalObjective response ratePrimary end pointSecondary end pointsGrowth factor receptor 2Overall survival outcomesRisk of diarrheaFactor receptor 2Pre- and Postoperative Neratinib for HER2-Positive Breast Cancer Brain Metastases: Translational Breast Cancer Research Consortium 022
Freedman RA, Gelman RS, Agar NYR, Santagata S, Randall EC, Lopez B, Connolly RM, Dunn IF, Van Poznak CH, Anders CK, Melisko ME, Silvestri K, Cotter CM, Componeschi KP, Marte JM, Moy B, Blackwell KL, Puhalla SL, Ibrahim N, Moynihan TJ, Nangia J, Tung N, Burns R, Rimawi MF, Krop IE, Wolff AC, Winer EP, Lin NU, Consortium T. Pre- and Postoperative Neratinib for HER2-Positive Breast Cancer Brain Metastases: Translational Breast Cancer Research Consortium 022. Clinical Breast Cancer 2019, 20: 145-151.e2. PMID: 31558424, PMCID: PMC7035200, DOI: 10.1016/j.clbc.2019.07.011.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAntineoplastic Combined Chemotherapy ProtocolsBrainBrain NeoplasmsBreastBreast NeoplasmsChemotherapy, AdjuvantCraniotomyDrug Administration ScheduleFemaleHumansMiddle AgedNeoadjuvant TherapyPilot ProjectsQuinolinesReceptor, ErbB-2Tissue DistributionTreatment OutcomeConceptsCentral nervous system penetrationCerebrospinal fluidBrain metastasesStudy treatmentDisease progressionHER2-positive breast cancer brain metastasesHER2-positive metastatic breast cancerHER2-positive brain metastasesBreast cancer brain metastasesGrade 3 diarrheaCancer brain metastasesMetastatic breast cancerCentral nervous systemResected tumor tissueBlood-based analysesNeratinib monotherapyPostoperative cyclesParenchymal tumorsStudy protocolBreast cancerTumor histopathologyPatientsNervous systemSmall cohortSurgical tissues
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 Research69 Chemotherapy and HER2-Directed Therapy for Metastatic Breast Cancer
Waks A, Winer E. 69 Chemotherapy and HER2-Directed Therapy for Metastatic Breast Cancer. 2018, 885-906.e8. DOI: 10.1016/b978-0-323-35955-9.00069-6.Peer-Reviewed Original ResearchMetastatic breast cancerBreast cancerHER2-positive metastatic breast cancerTriple-negative breast cancerTriple-negative diseaseBRCA-deficient breast cancersUnderstanding of treatmentDistinct disease subtypesBrain metastasesOverall survivalSystemic therapyClinical efficacyNovel therapiesDisease subtypesTherapyCancerHER2ChemotherapyImportant advancesImmunotherapyPertuzumabPatientsMetastasisSubtypesDisease
2017
324TiP PATINA: A randomized open label phase III trial to evaluate the efficacy and safety of palbociclib + anti HER2 therapy + endocrine therapy vs anti HER2 therapy + endocrine therapy after induction treatment for hormone receptor positive, HER2-positive metastatic breast cancer
Metzger O, Mandrekar S, Ciruelos E, Loibl S, Valagussa P, Demichele A, Lim E, Tripathy D, Winer E, Huang C, Khoeler M, Carey L, Francis P, Miller K, Goel S, Goetz M, Prat A, Loi S, Krop I, Gianni L. 324TiP PATINA: A randomized open label phase III trial to evaluate the efficacy and safety of palbociclib + anti HER2 therapy + endocrine therapy vs anti HER2 therapy + endocrine therapy after induction treatment for hormone receptor positive, HER2-positive metastatic breast cancer. Annals Of Oncology 2017, 28: v107-v108. DOI: 10.1093/annonc/mdx365.087.Peer-Reviewed Original Research
2014
Phase I/II study of pilaralisib (SAR245408) in combination with trastuzumab or trastuzumab plus paclitaxel in trastuzumab-refractory HER2-positive metastatic breast cancer
Tolaney S, Burris H, Gartner E, Mayer IA, Saura C, Maurer M, Ciruelos E, Garcia AA, Campana F, Wu B, Xu Y, Jiang J, Winer E, Krop I. Phase I/II study of pilaralisib (SAR245408) in combination with trastuzumab or trastuzumab plus paclitaxel in trastuzumab-refractory HER2-positive metastatic breast cancer. Breast Cancer Research And Treatment 2014, 149: 151-161. PMID: 25537644, DOI: 10.1007/s10549-014-3248-4.Peer-Reviewed Original ResearchConceptsHER2-positive metastatic breast cancerMetastatic breast cancerAdverse eventsBreast cancerArm 2Arm 1Phase I/II dose-escalation studyMetastatic HER2-positive breast cancerPhase I/II studyTreatment-related adverse eventsHER2-positive breast cancerTreatment-related gradeAcceptable safety profileDose-escalation studyDose-limiting toxicityDose-escalation designPan-class IEvaluable patientsPaclitaxel armPrior taxanePrior trastuzumabErythematous rashII studyPartial responsePeripheral neuropathy
2013
Human epidermal growth factor receptor 2 (HER2) suppression with the addition of lapatinib to trastuzumab in HER2-positive metastatic breast cancer (HALT: LPT112515).
Lin N, Danso M, David A, Muscato J, Rayson D, Houck W, Ellis C, DeSilvio M, Garofalo A, Levin J, Winer E. Human epidermal growth factor receptor 2 (HER2) suppression with the addition of lapatinib to trastuzumab in HER2-positive metastatic breast cancer (HALT: LPT112515). Journal Of Clinical Oncology 2013, 31: tps664-tps664. DOI: 10.1200/jco.2013.31.15_suppl.tps664.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast cancerBreast cancerOverall survivalMetastatic BCPFS eventsStage II/III breast cancerHigher pathologic complete response rateHER2-positive metastatic breast cancerMedian progression-free survivalPathologic complete response rateLonger progression-free survivalAssociated hazard ratiosClinical benefit rateDual HER2 blockadeStable brain metastasesComplete response rateSecond-line treatmentHormone receptor statusPhase III studyAddition of lapatinibLine of treatmentChemotherapy discontinuationEligible patientsHER2 blockadeA phase II study of bevacizumab in combination with vinorelbine and trastuzumab in HER2-positive metastatic breast cancer
Lin NU, Seah DS, Gelman R, Desantis S, Mayer EL, Isakoff S, DiPiro P, Krop IE, Come SE, Weckstein D, Winer EP, Burstein HJ. A phase II study of bevacizumab in combination with vinorelbine and trastuzumab in HER2-positive metastatic breast cancer. Breast Cancer Research And Treatment 2013, 139: 403-410. PMID: 23645007, DOI: 10.1007/s10549-013-2551-9.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerGrade 3/4 non-hematologic toxicitiesHER2-positive metastatic breast cancerNon-hematologic toxicitiesTreatment-related toxicityBreast cancerCommon treatment-related toxicitiesFirst-line patientsProtocol-based therapySecond-line cohortSecond-line patientsSecond-line settingPhase II studyProportion of patientsCombination of vinorelbineCo-primary endpointsEligible patientsFebrile neutropeniaMedian PFSII studyMedian durationObjective responsePrior linesUnacceptable toxicityMedian ageClinical outcomes and treatment practice patterns of patients with HER2-positive metastatic breast cancer in the post-trastuzumab era
Olson EM, Najita JS, Sohl J, Arnaout A, Burstein HJ, Winer EP, Lin NU. Clinical outcomes and treatment practice patterns of patients with HER2-positive metastatic breast cancer in the post-trastuzumab era. The Breast 2013, 22: 525-531. PMID: 23352568, PMCID: PMC3713786, DOI: 10.1016/j.breast.2012.12.006.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCentral Nervous System NeoplasmsCohort StudiesDisease-Free SurvivalFemaleFollow-Up StudiesHumansKaplan-Meier EstimateLiver NeoplasmsLung NeoplasmsMiddle AgedPractice Patterns, Physicians'PrognosisProportional Hazards ModelsReceptor, ErbB-2Retrospective StudiesTrastuzumabTreatment OutcomeConceptsHER2-positive metastatic breast cancerMetastatic breast cancerMedian overall survivalTrastuzumab-based therapyOverall survivalHazard ratioMedian durationBreast cancerCox proportional hazards modelCentral nervous system diseasePost-trastuzumab eraTreatment practice patternsHER2-positive patientsKaplan-Meier methodologyLog-rank testPatterns of careLine of treatmentNervous system diseasesProportional hazards modelTime of deathCNS metastasesCNS progressionMetastatic settingFirst recurrenceShorter OS
2012
A Phase II Study of Trastuzumab Emtansine in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab, Lapatinib, an Anthracycline, a Taxane, and Capecitabine
Krop IE, LoRusso P, Miller KD, Modi S, Yardley D, Rodriguez G, Guardino E, Lu M, Zheng M, Girish S, Amler L, Winer EP, Rugo HS. A Phase II Study of Trastuzumab Emtansine in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab, Lapatinib, an Anthracycline, a Taxane, and Capecitabine. Journal Of Clinical Oncology 2012, 30: 3234-3241. PMID: 22649126, DOI: 10.1200/jco.2011.40.5902.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAnthracyclinesAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsBridged-Ring CompoundsCapecitabineDeoxycytidineDisease-Free SurvivalFemaleFluorouracilHumansImmunotoxinsLapatinibMaleMaytansineMiddle AgedMolecular Targeted TherapyNeoplasm MetastasisQuinazolinesReceptor, ErbB-2TaxoidsTrastuzumabConceptsHER2-positive metastatic breast cancerHuman epidermal growth factor receptor 2Metastatic breast cancerProgression-free survivalOverall response rateMedian progression-free survivalPhase II studyT-DM1II studyTrastuzumab emtansineBreast cancerResponse rateSingle-arm phase II studyEpidermal growth factor receptor 2Human epidermal growth factor receptorClinical benefit rateHER2-directed therapiesMost adverse eventsGrowth factor receptor 2Single-agent activityHER2-positive tumorsMultiple chemotherapy agentsEffective new treatmentsFactor receptor 2Epidermal growth factor receptorHALT MBC: HER2 suppression with the addition of lapatinib to trastuzumab in HER2-positive metastatic breast cancer (LPT112515).
Lin N, Danso M, David A, Muscato J, Rayson D, Houck W, Ellis C, DeSilvio M, Garofalo A, Nagarwala Y, Winer E. HALT MBC: HER2 suppression with the addition of lapatinib to trastuzumab in HER2-positive metastatic breast cancer (LPT112515). Journal Of Clinical Oncology 2012, 30: tps658-tps658. DOI: 10.1200/jco.2012.30.15_suppl.tps658.Peer-Reviewed Original ResearchHER2-positive metastatic BCSecond-line treatmentMetastatic BCOverall survivalHigher pathologic complete response rateHER2-positive metastatic breast cancerBreast cancer preclinical modelsPathologic complete response rateClinical benefit rateDual HER2 blockadeStable brain metastasesComplete response rateCombination of trastuzumabHormone receptor statusPhase III studyAddition of lapatinibKey eligibility criteriaMetastatic breast cancerLine of treatmentChemotherapy discontinuationHER2 blockadeITT populationMedian PFSStable diseaseBrain metastasesA phase II study of afatinib (BIBW 2992), an irreversible ErbB family blocker, in patients with HER2-positive metastatic breast cancer progressing after trastuzumab
Lin NU, Winer EP, Wheatley D, Carey LA, Houston S, Mendelson D, Munster P, Frakes L, Kelly S, Garcia AA, Cleator S, Uttenreuther-Fischer M, Jones H, Wind S, Vinisko R, Hickish T. A phase II study of afatinib (BIBW 2992), an irreversible ErbB family blocker, in patients with HER2-positive metastatic breast cancer progressing after trastuzumab. Breast Cancer Research And Treatment 2012, 133: 1057-1065. PMID: 22418700, PMCID: PMC3387495, DOI: 10.1007/s10549-012-2003-y.Peer-Reviewed Original ResearchConceptsHER2-positive metastatic breast cancerErbB family blockerMetastatic breast cancerBreast cancer patientsAdverse eventsCancer patientsBreast cancerEastern Cooperative Oncology Group performance statusHER2-positive breast cancer patientsIrreversible ErbB family blockerMedian progression-free survivalTreatment-related adverse eventsPositive breast cancer patientsHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Common Terminology CriteriaMedian overall survivalObjective response ratePhase II studyProgression-free survivalGrowth factor receptor 2Single-arm studyPrior chemotherapy linesPromising clinical activityFactor receptor 2
2011
HER2 suppression with the addition of lapatinib to trastuzumab in HER2-positive metastatic breast cancer (LPT112515).
Lin N, Danso M, David A, Muscato J, Ellis C, Lahiri S, Sessa T, Nagarwala Y, Winer E. HER2 suppression with the addition of lapatinib to trastuzumab in HER2-positive metastatic breast cancer (LPT112515). Journal Of Clinical Oncology 2011, 29: tps113-tps113. DOI: 10.1200/jco.2011.29.15_suppl.tps113.Peer-Reviewed Original ResearchHER2-positive metastatic breast cancerAddition of lapatinibMetastatic breast cancerBreast cancerTrastuzumabResponses to subsequent anti-HER2 therapy after treatment with trastuzumab-DM1 in women with HER2-positive metastatic breast cancer
Olson EM, Lin NU, DiPiro PJ, Najita JS, Krop IE, Winer EP, Burstein HJ. Responses to subsequent anti-HER2 therapy after treatment with trastuzumab-DM1 in women with HER2-positive metastatic breast cancer. Annals Of Oncology 2011, 23: 93-97. PMID: 21531783, PMCID: PMC3276325, DOI: 10.1093/annonc/mdr061.Peer-Reviewed Original ResearchConceptsAnti-HER2 therapyMetastatic breast cancerHER2-positive MBC patientsT-DM1MBC patientsBreast cancerHER2-positive metastatic breast cancerSingle-agent T-DM1Positive metastatic breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Blinded radiology reviewAnti-HER2 agentsGrowth factor receptor 2Kaplan-Meier estimatesFurther clinical benefitFactor receptor 2Protocol therapyMedian durationFurther therapyPartial responseRadiology reviewClinical benefitSubsequent linesMetastatic therapy
2009
Use of BIBW 2992, a Novel Irreversible EGFR/HER1 and HER2 Tyrosine Kinase Inhibitor To Treat Patients with HER2-Positive Metastatic Breast Cancer after Failure of Treatment with Trastuzumab.
Hickish T, Wheatley D, Lin N, Carey L, Houston S, Mendelson D, Solca F, Uttenreuther-Fischer M, Jones H, Winer E. Use of BIBW 2992, a Novel Irreversible EGFR/HER1 and HER2 Tyrosine Kinase Inhibitor To Treat Patients with HER2-Positive Metastatic Breast Cancer after Failure of Treatment with Trastuzumab. Cancer Research 2009, 69: 5060-5060. DOI: 10.1158/0008-5472.sabcs-09-5060.Peer-Reviewed Original ResearchHER2-positive metastatic breast cancerEpidermal growth factor receptorPhase II studyMetastatic breast cancerBIBW 2992Partial responseBreast cancerGrowth factor receptorII studyEastern Cooperative Oncology Group performance statusSingle-arm phase II studyHER2-positive breast cancer patientsTrastuzumab-resistant cell linesHER2-positive breast cancerHER2 tyrosine kinase inhibitorAdequate organ functionCutaneous adverse eventsEarly clinical responseObjective response rateFactor receptorBreast cancer patientsFailure of treatmentTyrosine kinase inhibitorsEligible patientsMeasurable diseaseUse of BIBW 2992, a novel irreversible EGFR/HER2 tyrosine kinase inhibitor (TKI), to treat patients with HER2-positive metastatic breast cancer after failure of treatment with trastuzumab
Hickish T, Wheatley D, Lin N, Carey L, Houston S, Mendelson D, Solca F, Uttenreuther-Fischer M, Jones H, Winer E. Use of BIBW 2992, a novel irreversible EGFR/HER2 tyrosine kinase inhibitor (TKI), to treat patients with HER2-positive metastatic breast cancer after failure of treatment with trastuzumab. Journal Of Clinical Oncology 2009, 27: 1023-1023. DOI: 10.1200/jco.2009.27.15_suppl.1023.Peer-Reviewed Original ResearchHER2-positive metastatic breast cancerPhase II studyMetastatic breast cancerBIBW 2992Tyrosine kinase inhibitorsPartial responseBreast cancerEpidermal growth factor receptorStable diseaseAdverse eventsII studyDisease progressionTumor assessmentOpen-label single-arm phase II studySide effectsEastern Cooperative Oncology Group performance statusSingle-arm phase II studyHER2-positive breast cancer patientsDual epidermal growth factor receptorArm phase II studyTrastuzumab-resistant cell linesEGFR/HER2 tyrosine kinase inhibitorHER2-positive breast cancerHER2 tyrosine kinase inhibitorAdequate organ function
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
Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm.
Burstein HJ, Harris LN, Marcom PK, Lambert-Falls R, Havlin K, Overmoyer B, Friedlander RJ, Gargiulo J, Strenger R, Vogel CL, Ryan PD, Ellis MJ, Nunes RA, Bunnell CA, Campos SM, Hallor M, Gelman R, Winer EP. Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm. Journal Of Clinical Oncology 2003, 21: 2889-95. PMID: 12885806, DOI: 10.1200/jco.2003.02.018.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlgorithmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsDisease ProgressionFemaleHeart DiseasesHumansInfusions, IntravenousMiddle AgedPredictive Value of TestsReceptor, ErbB-2ROC CurveSurvival AnalysisTrastuzumabTreatment OutcomeVinblastineVinorelbineConceptsLeft ventricular ejection fractionMetastatic breast cancerHER2-positive metastatic breast cancerBreast cancerHER2 extracellular domainResponse rateEjection fractionTumor markersNormal left ventricular ejection fractionMulticenter phase II studyMulticenter phase II trialPositive advanced breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Prior adjuvant chemotherapySafety of trastuzumabFirst-line chemotherapyPhase II studySymptomatic heart failureAdvanced breast cancerBaseline ejection fractionFirst-line therapyFirst-line treatmentPhase II trialTrastuzumab-based therapy
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