2021
Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer: The Phase III KAITLIN Study
Krop IE, Im SA, Barrios C, Bonnefoi H, Gralow J, Toi M, Ellis PA, Gianni L, Swain SM, Im YH, De Laurentiis M, Nowecki Z, Huang CS, Fehrenbacher L, Ito Y, Shah J, Boulet T, Liu H, Macharia H, Trask P, Song C, Winer EP, Harbeck N. Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer: The Phase III KAITLIN Study. Journal Of Clinical Oncology 2021, 40: 438-448. PMID: 34890214, PMCID: PMC8824393, DOI: 10.1200/jco.21.00896.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalOverall populationTrastuzumab emtansineHigh-risk human epidermal growth factor receptorHuman epidermal growth factor receptor 2End pointEpidermal growth factor receptor 2Early breast cancer treatmentHuman epidermal growth factor receptorAnthracycline-based chemotherapyCoprimary end pointsPrimary end pointDisease-free survivalSerious adverse eventsEarly breast cancerGlobal health statusGrowth factor receptor 2Treatment completion ratesStandard of careBreast cancer treatmentFactor receptor 2Epidermal growth factor receptorGrowth factor receptorEndocrine therapyAdverse events
2009
Topoisomerase IIα Amplification Does Not Predict Benefit From Dose-Intense Cyclophosphamide, Doxorubicin, and Fluorouracil Therapy in HER2-Amplified Early Breast Cancer: Results of CALGB 8541/150013
Harris LN, Broadwater G, Abu-Khalaf M, Cowan D, Thor AD, Budman D, Cirrincione CT, Berry DA, Winer EP, Hudis CA, Hayes DF, Friedman P, Ellis M, Dressler L. Topoisomerase IIα Amplification Does Not Predict Benefit From Dose-Intense Cyclophosphamide, Doxorubicin, and Fluorouracil Therapy in HER2-Amplified Early Breast Cancer: Results of CALGB 8541/150013. Journal Of Clinical Oncology 2009, 27: 3430-3436. PMID: 19470942, PMCID: PMC4979079, DOI: 10.1200/jco.2008.18.4085.Peer-Reviewed Original ResearchMeSH KeywordsAnthracyclinesAntibiotics, AntineoplasticAntigens, NeoplasmAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCyclophosphamideDNA Topoisomerases, Type IIDNA-Binding ProteinsDoxorubicinDrug InteractionsFluorouracilGene AmplificationHumansImmunohistochemistryReceptor, ErbB-2
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 ResearchMeSH KeywordsAdultAgedAntibiotics, AntineoplasticBlood Cell CountBreast NeoplasmsCarbazolesDisease ProgressionDrug Resistance, NeoplasmEndpoint DeterminationFemaleHumansIndolesMiddle AgedConceptsAdvanced 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
2004
Efficacy and safety of liposomal anthracyclines in Phase I/II clinical trials
Alberts DS, Muggia FM, Carmichael J, Winer EP, Jahanzeb M, Venook AP, Skubitz KM, Rivera E, Sparano JA, Dibella NJ, Stewart SJ, Kavanagh JJ, Gabizon AA. Efficacy and safety of liposomal anthracyclines in Phase I/II clinical trials. Seminars In Oncology 2004, 31: 53-90. PMID: 15717738, DOI: 10.1053/j.seminoncol.2004.08.010.Peer-Reviewed Original ResearchMeSH KeywordsAntibiotics, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicDaunorubicinDoxorubicinHumansLiposomesConceptsLiposomal anthracyclinesClinical trialsConventional anthracyclinesLiposomal doxorubicinTumor typesPhase I/II clinical trialsSingle-agent therapyRange of dosesAnthracycline therapyLiposomal daunorubicinAnthracycline treatmentPharmacologic advantageContinuous infusionPatient populationHematologic tumorsClinical dataPreclinical studiesPharmacokinetic profileAnthracyclinesDrug concentrationsCytotoxic agentsTumor cellsPhase ITrialsFurther studiesThe role of the liposomal anthracyclines and other systemic therapies in the management of advanced breast cancer
Robert NJ, Vogel CL, Henderson IC, Sparano JA, Moore MR, Silverman P, Overmoyer BA, Shapiro CL, Park JW, Colbern GT, Winer EP, Gabizon AA. The role of the liposomal anthracyclines and other systemic therapies in the management of advanced breast cancer. Seminars In Oncology 2004, 31: 106-146. PMID: 15717740, DOI: 10.1053/j.seminoncol.2004.09.018.Peer-Reviewed Original ResearchMeSH KeywordsAntibiotics, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClinical Trials as TopicDoxorubicinHumansLiposomesConceptsConventional doxorubicinBreast cancerLiposomal anthracyclinesLiposomal doxorubicinHand-foot syndromeAdvanced breast cancerMultiple phase IIConventional anthracyclinesSystemic therapyProlong survivalStandard dosesContinuous infusionToxicity profileOptimal doseActive drugCytotoxic drugsHigh dosesIntermittent scheduleWeekly scheduleAnthracyclinesNormal tissuesTrastuzumabCancerDoxorubicinNausea
2002
Trastuzumab/chemotherapy combinations in metastatic breast cancer.
Ligibel JA, Winer EP. Trastuzumab/chemotherapy combinations in metastatic breast cancer. Seminars In Oncology 2002, 29: 38-43. PMID: 12138396, DOI: 10.1053/sonc.2002.34054.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerHER2-overexpressing metastatic breast cancerUse of trastuzumabBreast cancerRandomized phase III clinical trialsHER2-overexpressing breast cancerPhase III clinical trialsHER2/neu proteinAdvanced breast cancerFirst-line treatmentForm of chemotherapyHumanized monoclonal antibodyLonger survival durationHigh response rateNew chemotherapy drugsAdjuvant settingChemotherapy combinationsSurvival durationClinical trialsFurther trialsEfficacious treatmentPlatinum agentsSingle agentUS FoodDrug Administration
2001
Liposomal anthracyclines for breast cancer
Sparano J, Winer E. Liposomal anthracyclines for breast cancer. Seminars In Oncology 2001, 28: 32-40. PMID: 11552228, DOI: 10.1016/s0093-7754(01)90197-6.Peer-Reviewed Original ResearchConceptsBreast cancerLiposomal anthracyclinesAdvanced-stage breast cancerStage breast cancerConventional anthracyclinesTLC DLiposomal daunorubicinCardiac toxicityConventional doxorubicinLiposomal doxorubicinPreclinical modelsAnthracyclinesCancer typesCytotoxic agentsNormal tissuesCancerFurther studiesChronic toxicityDoxorubicinTreatmentToxicityLiposomal doxorubicin preparationsAgentsCyclophosphamideVinorelbine
1995
Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer.
Jones S, Winer E, Vogel C, Laufman L, Hutchins L, O'Rourke M, Lembersky B, Budman D, Bigley J, Hohneker J. Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer. Journal Of Clinical Oncology 1995, 13: 2567-74. PMID: 7595708, DOI: 10.1200/jco.1995.13.10.2567.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibiotics, AntineoplasticAntineoplastic AgentsBreast NeoplasmsDisease ProgressionDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHematologic DiseasesHumansInjections, IntravenousMelphalanMiddle AgedProportional Hazards ModelsProspective StudiesQuality of LifeSurvival RateVinblastineVinorelbineConceptsQuality of lifeAdvanced breast cancerCancer-related symptomsTreatment failureBreast cancerALK patientsSurvival rateStabilization of diseaseEfficacy end pointTumor response ratePopulation of patientsMedian survival rateCommon toxicitiesProspective multicenterObjective responseSeptic deathSurvival benefitRandomized comparisonPatient populationPatientsIntergroup differencesTreatment centersResponse rateEnd pointVinorelbine tartrate