2021
Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03)
Gnant M, Dueck AC, Frantal S, Martin M, Burstein HJ, Greil R, Fox P, Wolff AC, Chan A, Winer EP, Pfeiler G, Miller KD, Colleoni M, Suga JM, Rubovsky G, Bliss JM, Mayer IA, Singer CF, Nowecki Z, Hahn O, Thomson J, Wolmark N, Amillano K, Rugo HS, Steger GG, de Aránguiz B, Haddad TC, Perelló A, Bellet M, Fohler H, Filho O, Jallitsch-Halper A, Solomon K, Schurmans C, Theall KP, Lu DR, Tenner K, Fesl C, DeMichele A, Mayer EL, groups and investigators O. Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03). Journal Of Clinical Oncology 2021, 40: 282-293. PMID: 34874182, PMCID: PMC10476784, DOI: 10.1200/jco.21.02554.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease ProgressionDisease-Free SurvivalFemaleHumansMastectomyMiddle AgedNeoadjuvant TherapyNeoplasm StagingPiperazinesProgression-Free SurvivalProspective StudiesProtein Kinase InhibitorsPyridinesTime FactorsConceptsHormone receptor-positive breast cancerInvasive disease-free survivalReceptor-positive breast cancerAdjuvant endocrine therapyCancer-free survivalEndocrine therapyEarly breast cancerBreast cancerAdjuvant palbociclibPALLAS trialEnd pointEarly hormone receptor-positive breast cancerBreast cancer-free survivalDistant recurrence-free survivalHuman epidermal growth factor receptorProtocol-defined analysisStandard endocrine therapyPrimary end pointSecondary end pointsAdvanced breast cancerDisease-free survivalNew safety signalsRecurrence-free survivalEvent end pointsCyclin-dependent kinase 4
2020
Phase 2 study of buparlisib (BKM120), a pan-class I PI3K inhibitor, in patients with metastatic triple-negative breast cancer
Garrido-Castro AC, Saura C, Barroso-Sousa R, Guo H, Ciruelos E, Bermejo B, Gavilá J, Serra V, Prat A, Paré L, Céliz P, Villagrasa P, Li Y, Savoie J, Xu Z, Arteaga CL, Krop IE, Solit DB, Mills GB, Cantley LC, Winer EP, Lin NU, Rodon J. Phase 2 study of buparlisib (BKM120), a pan-class I PI3K inhibitor, in patients with metastatic triple-negative breast cancer. Breast Cancer Research 2020, 22: 120. PMID: 33138866, PMCID: PMC7607628, DOI: 10.1186/s13058-020-01354-y.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsClass I Phosphatidylinositol 3-KinasesDisease ProgressionFemaleHigh-Throughput Nucleotide SequencingHumansMiddle AgedMorpholinesNeoplasm MetastasisPatient SafetyProtein Kinase InhibitorsProteomicsResponse Evaluation Criteria in Solid TumorsSurvival RateTreatment OutcomeTriple Negative Breast NeoplasmsConceptsTriple-negative breast cancerProgression-free survivalPan-class I PI3K inhibitorMetastatic triple-negative breast cancerStable diseasePhase 2 studyBreast cancerOverall survivalPI3K inhibitorsPI3K pathwayPartial responseComplete responseClinical benefitSingle-arm phase 2 studyTriple-negative metastatic breast cancerMedian progression-free survivalK inhibitorsClinical benefit rateEfficacy of buparlisibK pathwayFrequent adverse eventsMedian overall survivalPercent of patientsMetastatic breast cancerSubset of patientsIntracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial
Lin NU, Borges V, Anders C, Murthy RK, Paplomata E, Hamilton E, Hurvitz S, Loi S, Okines A, Abramson V, Bedard PL, Oliveira M, Mueller V, Zelnak A, DiGiovanna MP, Bachelot T, Chien AJ, O’Regan R, Wardley A, Conlin A, Cameron D, Carey L, Curigliano G, Gelmon K, Loibl S, Mayor J, McGoldrick S, An X, Winer EP. Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial. Journal Of Clinical Oncology 2020, 38: 2610-2619. PMID: 32468955, PMCID: PMC7403000, DOI: 10.1200/jco.20.00775.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerBrain metastasesProgression-free survivalRisk of deathBreast cancerOverall survivalControl armCNS-PFSIntracranial efficacyIntracranial progressionBaseline brain magnetic resonance imagingHuman epidermal growth factor receptor 2Intracranial objective response rateEpidermal growth factor receptor 2Brain magnetic resonance imagingMedian CNS-PFSRECIST 1.1 criteriaMedian overall survivalObjective response rateGrowth factor receptor 2Positive breast cancerFactor receptor 2Magnetic resonance imagingHER2CLIMB trialImproved antitumor activity
2017
Long-term outcomes for neoadjuvant versus adjuvant chemotherapy in early breast cancer: meta-analysis of individual patient data from ten randomised trials
Group E, Asselain B, Barlow W, Bartlett J, Bergh J, Bergsten-Nordström E, Bliss J, Boccardo F, Boddington C, Bogaerts J, Bonadonna G, Bradley R, Brain E, Braybrooke J, Broet P, Bryant J, Burrett J, Cameron D, Clarke M, Coates A, Coleman R, Coombes R, Correa C, Costantino J, Cuzick J, Danforth D, Davidson N, Davies C, Davies L, Di Leo A, Dodwell D, Dowsett M, Duane F, Evans V, Ewertz M, Fisher B, Forbes J, Ford L, Gazet J, Gelber R, Gettins L, Gianni L, Gnant M, Godwin J, Goldhirsch A, Goodwin P, Gray R, Hayes D, Hill C, Ingle J, Jagsi R, Jakesz R, James S, Janni W, Liu H, Liu Z, Lohrisch C, Loibl S, MacKinnon L, Makris A, Mamounas E, Mannu G, Martín M, Mathoulin S, Mauriac L, McGale P, McHugh T, Morris P, Mukai H, Norton L, Ohashi Y, Olivotto I, Paik S, Pan H, Peto R, Piccart M, Pierce L, Poortmans P, Powles T, Pritchard K, Ragaz J, Raina V, Ravdin P, Read S, Regan M, Robertson J, Rutgers E, Scholl S, Slamon D, Sölkner L, Sparano J, Steinberg S, Sutcliffe R, Swain S, Taylor C, Tutt A, Valagussa P, van de Velde C, van der Hage J, Viale G, von Minckwitz G, Wang Y, Wang Z, Wang X, Whelan T, Wilcken N, Winer E, Wolmark N, Wood W, Zambetti M, Zujewski J. Long-term outcomes for neoadjuvant versus adjuvant chemotherapy in early breast cancer: meta-analysis of individual patient data from ten randomised trials. The Lancet Oncology 2017, 19: 27-39. PMID: 29242041, PMCID: PMC5757427, DOI: 10.1016/s1470-2045(17)30777-5.Peer-Reviewed Original ResearchConceptsBreast-conserving therapyEarly breast cancerNeoadjuvant chemotherapyAdjuvant chemotherapyIndividual patient dataLocal recurrenceBreast cancerSame chemotherapyDistant recurrenceTumor characteristicsTumor responsePartial clinical responseYear local recurrencePatient dataBreast cancer deathsHigher local recurrenceBreast-conserving surgeryClinical tumor responseUK Medical Research CouncilBreast cancer mortalityLong-term outcomesFrequent local recurrenceLog-rank methodBritish Heart FoundationThird of women
2016
Perils of the Pathologic Complete Response
Rose BS, Winer EP, Mamon HJ. Perils of the Pathologic Complete Response. Journal Of Clinical Oncology 2016, 34: 3959-3962. PMID: 27551115, DOI: 10.1200/jco.2016.68.1718.Peer-Reviewed Original Research
2015
Genomic Characterization of Brain Metastases Reveals Branched Evolution and Potential Therapeutic Targets
Brastianos PK, Carter SL, Santagata S, Cahill DP, Taylor-Weiner A, Jones RT, Van Allen EM, Lawrence MS, Horowitz PM, Cibulskis K, Ligon KL, Tabernero J, Seoane J, Martinez-Saez E, Curry WT, Dunn IF, Paek SH, Park SH, McKenna A, Chevalier A, Rosenberg M, Barker FG, Gill CM, Van Hummelen P, Thorner AR, Johnson BE, Hoang MP, Choueiri TK, Signoretti S, Sougnez C, Rabin MS, Lin NU, Winer EP, Stemmer-Rachamimov A, Meyerson M, Garraway L, Gabriel S, Lander ES, Beroukhim R, Batchelor TT, Baselga J, Louis DN, Getz G, Hahn WC. Genomic Characterization of Brain Metastases Reveals Branched Evolution and Potential Therapeutic Targets. Cancer Discovery 2015, 5: 1164-1177. PMID: 26410082, PMCID: PMC4916970, DOI: 10.1158/2159-8290.cd-15-0369.Peer-Reviewed Original ResearchConceptsBrain metastasesPrimary tumorPrimary biopsiesRegional lymph node metastasisLymph node metastasisPI3K/Akt/mTORRegional lymph nodesPotential therapeutic targetPrimary tumor biopsiesPrimary tumor samplesAkt/mTORDistinct genetic alterationsWhole-exome sequencingExtracranial metastasesLymph nodesNode metastasisDismal prognosisActionable alterationsMetastasis sitesInformative alterationsIndividualized therapyTherapeutic targetMetastasisPrimary siteEGFR inhibitors
2014
Phase III Study of Iniparib Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin in Patients With Metastatic Triple-Negative Breast Cancer
O'Shaughnessy J, Schwartzberg L, Danso MA, Miller KD, Rugo HS, Neubauer M, Robert N, Hellerstedt B, Saleh M, Richards P, Specht JM, Yardley DA, Carlson RW, Finn RS, Charpentier E, Garcia-Ribas I, Winer EP. Phase III Study of Iniparib Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin in Patients With Metastatic Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2014, 32: 3840-3847. PMID: 25349301, DOI: 10.1200/jco.2014.55.2984.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBenzamidesCarboplatinDeoxycytidineDisease ProgressionDisease-Free SurvivalFemaleGemcitabineHumansKaplan-Meier EstimateMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingProportional Hazards ModelsRisk FactorsTime FactorsTreatment OutcomeTriple Negative Breast NeoplasmsUnited StatesConceptsMetastatic triple-negative breast cancerProgression-free survivalTriple-negative breast cancerCoprimary end pointsOverall survivalBreast cancerRandomized phase II trialEnd pointStage IV/Clinical benefit ratePhase II trialPhase III studyPhase III trialsStandard of careWarrants further evaluationLack of treatmentCarboplatin areaITT populationPrevious chemotherapyPrior chemotherapyII trialIII studyIII trialsSurvival benefitSafety profileCirculating Tumor Cells and Response to Chemotherapy in Metastatic Breast Cancer: SWOG S0500
Smerage JB, Barlow WE, Hortobagyi GN, Winer EP, Leyland-Jones B, Srkalovic G, Tejwani S, Schott AF, O'Rourke MA, Lew DL, Doyle GV, Gralow JR, Livingston RB, Hayes DF. Circulating Tumor Cells and Response to Chemotherapy in Metastatic Breast Cancer: SWOG S0500. Journal Of Clinical Oncology 2014, 32: 3483-3489. PMID: 24888818, PMCID: PMC4209100, DOI: 10.1200/jco.2014.56.2561.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerFirst-line chemotherapyMedian overall survivalDays of therapyOverall survivalInitial therapyBreast cancerTumor cellsTrial of patientsMore effective treatmentsEvaluable patientsStandard chemotherapyPrimary outcomeArm APoor prognosisPrognostic significanceCytotoxic therapyAlternative chemotherapyEffective treatmentChemotherapyPatientsTherapyEarly switchingPersistent increaseMonthsPhase I trial of olaparib in combination with cisplatin for the treatment of patients with advanced breast, ovarian and other solid tumors
Balmaña J, Tung N, Isakoff S, Graña B, Ryan P, Saura C, Lowe E, Frewer P, Winer E, Baselga J, Garber J. Phase I trial of olaparib in combination with cisplatin for the treatment of patients with advanced breast, ovarian and other solid tumors. Annals Of Oncology 2014, 25: 1656-1663. PMID: 24827126, DOI: 10.1093/annonc/mdu187.Peer-Reviewed Original ResearchConceptsAdvanced solid tumorsSolid tumorsBRCA1/2 mutationsDay 1Overall objective response rateBID days 1Grade 3 neutropeniaObjective response ratePhase I trialTreatment of patientsGermline BRCA1/2 mutationsColony-stimulating factorWarrants further investigationAdvanced breastHematologic supportMeasurable diseaseOral olaparibAdverse eventsI trialTreatment cohortsLipase elevationCisplatin dosesFrequent gradePreliminary efficacyStandard treatment
2013
International guidelines for management of metastatic breast cancer (MBC) from the European School of Oncology (ESO)–MBC Task Force: Surveillance, staging, and evaluation of patients with early-stage and metastatic breast cancer
Lin NU, Thomssen C, Cardoso F, Cameron D, Cufer T, Fallowfield L, Francis PA, Kyriakides S, Pagani O, Senkus E, Costa A, Winer EP, Force E. International guidelines for management of metastatic breast cancer (MBC) from the European School of Oncology (ESO)–MBC Task Force: Surveillance, staging, and evaluation of patients with early-stage and metastatic breast cancer. The Breast 2013, 22: 203-210. PMID: 23601761, DOI: 10.1016/j.breast.2013.03.006.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkers, TumorBreast NeoplasmsDisease ProgressionFemaleHumansMammographyNeoplasm MetastasisNeoplasm StagingPopulation SurveillanceConceptsMetastatic breast cancerEarly-stage breast cancerBreast cancerTumor markersRisk/benefit ratioEuropean Breast Cancer ConferenceEarly-stage patientsEvaluation of patientsInitiation of treatmentProgression of diseaseSpecific BC subtypesTask ForceQuality of lifeType of treatmentEndocrine therapyMetastatic diseaseMetastatic involvementSystemic therapyBC subtypesPhysical examinationClinical trialsCancer ConferencePatientsClinical practiceInternational guidelines
2012
TBCRC 001: Randomized Phase II Study of Cetuximab in Combination With Carboplatin in Stage IV Triple-Negative Breast Cancer
Carey LA, Rugo HS, Marcom PK, Mayer EL, Esteva FJ, Ma CX, Liu MC, Storniolo AM, Rimawi MF, Forero-Torres A, Wolff AC, Hobday TJ, Ivanova A, Chiu WK, Ferraro M, Burrows E, Bernard PS, Hoadley KA, Perou CM, Winer EP. TBCRC 001: Randomized Phase II Study of Cetuximab in Combination With Carboplatin in Stage IV Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2012, 30: 2615-2623. PMID: 22665533, PMCID: PMC3413275, DOI: 10.1200/jco.2010.34.5579.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCarboplatinCetuximabDisease ProgressionFemaleHumansMiddle AgedNeoplasm StagingReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSignal TransductionSurvival AnalysisTreatment OutcomeConceptsTriple-negative breast cancerMetastatic triple-negative breast cancerOverall survivalResponse rateBreast cancerEpidermal growth factor receptorMost triple-negative breast cancersRandomized phase II trialBasal-like molecular subtypeBasal-like breast cancerEGFR pathwayArchival tissuePhase II studyPrimary end pointDays of therapyPhase II trialStrong preclinical dataEGFR antibody cetuximabFresh tumor tissueCombination cetuximabConcomitant therapyGrowth factor receptorCarboplatin regimenDisease stabilizationII trialA 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
2010
Poly(ADP-Ribose) Polymerase Inhibition: “Targeted” Therapy for Triple-Negative Breast Cancer
Anders CK, Winer EP, Ford JM, Dent R, Silver DP, Sledge GW, Carey LA. Poly(ADP-Ribose) Polymerase Inhibition: “Targeted” Therapy for Triple-Negative Breast Cancer. Clinical Cancer Research 2010, 16: 4702-4710. PMID: 20858840, PMCID: PMC2948607, DOI: 10.1158/1078-0432.ccr-10-0939.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsBreast NeoplasmsDisease ProgressionEnzyme InhibitorsFemaleHumansPoly(ADP-ribose) Polymerase InhibitorsConceptsTriple-negative breast cancerBreast cancerPARP inhibitorsClinical trialsAdvanced triple-negative breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2PARP inhibitionAdvanced breast cancerGrowth factor receptor 2Clinico-pathologic featuresPositive breast cancerNovel therapeutic classFactor receptor 2Mechanism of actionPreclinical rationalePreclinical modelsNovel agentsReceptor 2CancerTherapeutic classesPolymerase inhibitorsPolymerase inhibitionDNA repairInhibitors
2008
Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer
Dickler MN, Cobleigh MA, Miller KD, Klein PM, Winer EP. Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer. Breast Cancer Research And Treatment 2008, 115: 115-121. PMID: 18496750, DOI: 10.1007/s10549-008-0055-9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAnthracyclinesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineCohort StudiesDeoxycytidineDisease ProgressionErbB ReceptorsErlotinib HydrochlorideFemaleFluorouracilHumansMiddle AgedNeoplasm MetastasisProtein Kinase InhibitorsQuinazolinesTaxoidsConceptsAdvanced breast cancerSafety of erlotinibBreast cancerCohort 1 patientsCohort 2 patientsResults One patientCommon adverse eventsPhase II studyAdvanced stage diseaseMetastatic breast cancerBreast cancer patientsPrimary endpointSecondary endpointsAdverse eventsII studyPartial responseMedian timePredictive factorsCancer patientsErlotinib treatmentCohort 2Cohort 1Design MulticenterOne patientDry skinFifteen-year median follow-up results after neoadjuvant doxorubicin, followed by mastectomy, followed by adjuvant cyclophosphamide, methotrexate, and fluorouracil (CMF) followed by radiation for stage III breast cancer: a phase II trial (CALGB 8944)
Kimmick G, Cirrincione C, Duggan D, Bhalla K, Robert N, Berry D, Norton L, Lemke S, Henderson I, Hudis C, Winer E, On Behalf of the Cancer and Leukemia Group B. Fifteen-year median follow-up results after neoadjuvant doxorubicin, followed by mastectomy, followed by adjuvant cyclophosphamide, methotrexate, and fluorouracil (CMF) followed by radiation for stage III breast cancer: a phase II trial (CALGB 8944). Breast Cancer Research And Treatment 2008, 113: 479-490. PMID: 18306034, PMCID: PMC4217205, DOI: 10.1007/s10549-008-9943-2.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCombined Modality TherapyCyclophosphamideDisease ProgressionDoxorubicinFemaleFluorouracilFollow-Up StudiesHumansMastectomyMethotrexateMiddle AgedNeoadjuvant TherapyNeoplasm StagingRadiotherapy, AdjuvantSurvival AnalysisConceptsStage III breast cancerBreast cancerNeoadjuvant doxorubicinClinical responseLymph nodesClinical stage III breast cancerAdequate organ functionClinical response rateComplete clinical responseInvolved lymph nodesPositive lymph nodesAdvanced breast cancerPathologic complete responsePhase II trialHazard of deathLong-term resultsLong-term survivalAdjuvant chemotherapyAdjuvant cyclophosphamideMedian followII trialNeoadjuvant treatmentMultimodality treatmentOverall survivalComplete response
2007
Trastuzumab plus vinorelbine or taxane chemotherapy for HER2‐overexpressing metastatic breast cancer: The trastuzumab and vinorelbine or taxane study
Burstein HJ, Keshaviah A, Baron AD, Hart RD, Lambert‐Falls R, Marcom PK, Gelman R, Winer EP. Trastuzumab plus vinorelbine or taxane chemotherapy for HER2‐overexpressing metastatic breast cancer: The trastuzumab and vinorelbine or taxane study. Cancer 2007, 110: 965-972. PMID: 17614302, DOI: 10.1002/cncr.22885.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlopeciaAnemiaAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsConstipationDisease ProgressionDrug Administration ScheduleFatigueFemaleHumansKaplan-Meier EstimateMiddle AgedNauseaNeoplasm MetastasisPaclitaxelProspective StudiesReceptor, ErbB-2TrastuzumabTreatment OutcomeVinblastineVinorelbineConceptsMetastatic breast cancerBreast cancerTrastuzumab armEpisodes of cardiotoxicityFirst-line therapyDermatologic toxicitiesEvaluable patientsPrior chemotherapyVinorelbine therapyAdvanced diseaseChemotherapy regimenEligible patientsGastrointestinal toxicityPoor accrualTaxane chemotherapyTaxane therapyMore anemiaMedian timeTrastuzumab treatmentFluid retentionDisease progressionChemotherapy agentsTreatment decisionsVinorelbineSide effectsPhase II study of CT-2103 as first- or second-line chemotherapy in patients with metastatic breast cancer: unexpected incidence of hypersensitivity reactions
Lin NU, Parker LM, Come SE, Burstein HJ, Haldoupis M, Ryabin N, Gelman R, Winer EP, Shulman LN. Phase II study of CT-2103 as first- or second-line chemotherapy in patients with metastatic breast cancer: unexpected incidence of hypersensitivity reactions. Investigational New Drugs 2007, 25: 369-375. PMID: 17345004, DOI: 10.1007/s10637-007-9034-y.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerHypersensitivity reactionsEfficacy of CTBreast cancerPrior linesPatient populationGrade 3HER2-negative metastatic breast cancerSmall studyHER2-negative breast cancerTrue drug allergyPhase II studySecond-line chemotherapyPercent of womenNovel conjugatesAdjuvant settingConjugated paclitaxelEighteen womenIntravenous CTMetastatic treatmentPrior chemotherapyRoutine premedicationDrug allergyII studyObjective response
2006
Rebeccamycin analog for refractory breast cancer: A randomized phase II trial of dosing schedules
Burstein HJ, Overmoyer B, Gelman R, Silverman P, Savoie J, Clarke K, Dumadag L, Younger J, Ivy P, Winer EP. Rebeccamycin analog for refractory breast cancer: A randomized phase II trial of dosing schedules. Investigational New Drugs 2006, 25: 161-164. PMID: 16969707, DOI: 10.1007/s10637-006-9007-6.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerDifferent treatment schedulesBreast cancerTreatment scheduleAdjuvant chemotherapyArm 2Arm 1Response rateAnthracycline-based adjuvant chemotherapyRefractory advanced breast cancerRandomized phase II trialPrior chemotherapy regimensRefractory breast cancerModest clinical activityPhase II trialPrimary study endpointMetastatic breast cancerCentral venous accessAnemia 5Eligible patientsMeasurable diseaseNausea/Prior chemotherapyStable diseaseChemotherapy regimens
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