2018
Phase II study of ruxolitinib, a selective JAK1/2 inhibitor, in patients with metastatic triple-negative breast cancer
Stover DG, Gil Del Alcazar CR, Brock J, Guo H, Overmoyer B, Balko J, Xu Q, Bardia A, Tolaney SM, Gelman R, Lloyd M, Wang Y, Xu Y, Michor F, Wang V, Winer EP, Polyak K, Lin NU. Phase II study of ruxolitinib, a selective JAK1/2 inhibitor, in patients with metastatic triple-negative breast cancer. Npj Breast Cancer 2018, 4: 10. PMID: 29761158, PMCID: PMC5935675, DOI: 10.1038/s41523-018-0060-z.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerTriple-negative breast cancerPhase II studyBreast cancerII studyObjective responseNon-randomized phase II studyIL-6/JAK2/STAT3Efficacy of ruxolitinibInfrequent grade 3Refractory patient populationPrimary efficacy endpointMetastatic breast cancerInflammatory breast cancerSelective JAK1/2 inhibitorArchival tumor tissueJAK2/STAT3Central immunohistochemistryCommon toxicitiesRECIST 1.1Efficacy endpointPrimary endpointProtocol therapyJAK1/2 inhibitorPatient population
2017
Evaluating the addition of bevacizumab (Bev) to endocrine therapy as first-line treatment for hormone-receptor positive (HR+)/HER2-negative advanced breast cancer (ABC): Pooled-analysis from the LEA (GEICAM/2006-11_GBG51) and CALGB 40503 (Alliance) trials.
Martin M, Loibl S, Hyslop T, de la Haba-Rodriguez J, Aktas B, Cirrincione C, Carrasco E, Mehta K, Barry W, Morales S, Carey L, Garcia Saenz J, Partridge A, Martinez N, Hahn O, Winer E, Guerrero A, Hudis C, Casas M, Dickler M. Evaluating the addition of bevacizumab (Bev) to endocrine therapy as first-line treatment for hormone-receptor positive (HR+)/HER2-negative advanced breast cancer (ABC): Pooled-analysis from the LEA (GEICAM/2006-11_GBG51) and CALGB 40503 (Alliance) trials. Journal Of Clinical Oncology 2017, 35: 1012-1012. DOI: 10.1200/jco.2017.35.15_suppl.1012.Peer-Reviewed Original ResearchProgression-free survivalAdvanced breast cancerRandomized trialsMedian progression-free survivalNegative advanced breast cancerBreast Cancer Research FoundationAddition of BevMultivariable Cox modelAddition of bevacizumabFirst-line treatmentCancer Research FoundationCardiovascular eventsPgR statusSecondary endpointsLiver eventsRecurrent diseaseMedian ageMultivariable analysisTreatment armsPatient populationBreast cancerGrade 3Prolonged benefitCox modelStudy-level differences
2016
Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527
Freedman RA, Foster JC, Seisler DK, Lafky JM, Muss HB, Cohen HJ, Mandelblatt J, Winer EP, Hudis CA, Partridge AH, Carey LA, Cirrincione C, Moreno-Aspitia A, Kimmick G, Jatoi A, Hurria A. Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527. Journal Of Clinical Oncology 2016, 35: 421-431. PMID: 27992272, PMCID: PMC5455700, DOI: 10.1200/jco.2016.69.4182.Peer-Reviewed Original ResearchConceptsOlder patientsMetastatic trialsAdjuvant trialsBreast cancerHormone receptor-negative tumorsBreast cancer treatment trialConclusion Older patientsSystemic therapy trialsReceptor-negative tumorsBreast cancer trialsCancer treatment trialsYears of ageAccrual challengesNeoadjuvant trialsAdjuvant studiesPatient ageTherapy cessationLymph nodesTherapeutic trialsTreatment cessationTumor sizeDisease characteristicsPatient populationTreatment trialsCancer trials
2011
Can Axillary Node Dissection Be Omitted in a Subset of Patients with Low Local and Regional Failure Rates?
Barkley C, Burstein H, Smith B, Bellon J, Wong J, Gadd M, Taghian A, Winer E, Iglehart JD, Harris J, Golshan M. Can Axillary Node Dissection Be Omitted in a Subset of Patients with Low Local and Regional Failure Rates? The Breast Journal 2011, 18: 23-27. PMID: 22017599, DOI: 10.1111/j.1524-4741.2011.01178.x.Peer-Reviewed Original ResearchConceptsPositive sentinel lymph nodesSentinel lymph node biopsySentinel lymph nodesAxillary node dissectionCompletion axillary node dissectionLow-risk patient populationAdjuvant treatment patternMedian patient agePercent of patientsLymph node biopsyStandard of careNodal radiationNode dissectionMicrometastatic diseaseNode biopsyLymph nodesPatient ageTreatment patternsPatient populationBreast cancerClinical dataRadiation therapyPatientsDiseaseMacrometastasis
2010
International Guidelines for Management of Metastatic Breast Cancer: Can Metastatic Breast Cancer Be Cured?
Pagani O, Senkus E, Wood W, Colleoni M, Cufer T, Kyriakides S, Costa A, Winer EP, Cardoso F. International Guidelines for Management of Metastatic Breast Cancer: Can Metastatic Breast Cancer Be Cured? Journal Of The National Cancer Institute 2010, 102: 456-463. PMID: 20220104, PMCID: PMC3298957, DOI: 10.1093/jnci/djq029.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntineoplastic Combined Chemotherapy ProtocolsBone NeoplasmsBreast NeoplasmsCatheter AblationChemotherapy, AdjuvantClinical Trials as TopicCongresses as TopicConsensus Development Conferences as TopicDose-Response Relationship, DrugEarly Detection of CancerEuropeFemaleGene Expression ProfilingHumansImmunosuppressive AgentsInterdisciplinary CommunicationInternational CooperationLiver NeoplasmsLung NeoplasmsNeoplasm StagingNeoplastic Cells, CirculatingObserver VariationPatient Care TeamPatient SelectionPractice Guidelines as TopicRadiotherapy, AdjuvantSurvival RateConceptsMetastatic breast cancerOligometastatic diseaseBreast cancerMetastatic lesionsPrimary tumorEuropean Breast Cancer ConferenceFirst consensus recommendationsOptimal local treatmentRapid disease controlAvailable therapeutic optionsSubset of patientsLong-term outcomesLarge retrospective seriesDetectable metastatic lesionsAttractive therapeutic strategyChemotherapy optionsSurvival benefitSystemic therapyTreatment guidelinesRegional chemotherapyRetrospective seriesTask ForceLung metastasesTherapeutic optionsPatient population
2007
Phase 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
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 ResearchConceptsLiposomal 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 studies
2003
Use of the Peroxisome Proliferator-Activated Receptor (PPAR) γ Ligand Troglitazone as Treatment for Refractory Breast Cancer: A Phase II Study
Burstein HJ, Demetri GD, Mueller E, Sarraf P, Spiegelman BM, Winer EP. Use of the Peroxisome Proliferator-Activated Receptor (PPAR) γ Ligand Troglitazone as Treatment for Refractory Breast Cancer: A Phase II Study. Breast Cancer Research And Treatment 2003, 79: 391-397. PMID: 12846423, DOI: 10.1023/a:1024038127156.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerSerum tumor markersBreast cancerTumor markersTumor differentiationDisease progressionAdvanced breast cancer refractoryElevated serum tumor markersRefractory metastatic breast cancerPeroxisome proliferator-activated receptor γBreast cancer refractoryRefractory breast cancerPhase II studyPercentage of patientsProliferator-activated receptor γDifferent patient populationsCancer refractoryChemotherapy regimenII studyObjective responseSystemic therapyPO QDHormonal regimensHepatic toxicityPatient populationThe aromatase inhibitors as adjuvant therapy for hormone receptor-positive breast cancer.
Ligibel JA, Winer EP. The aromatase inhibitors as adjuvant therapy for hormone receptor-positive breast cancer. Journal Of The National Comprehensive Cancer Network 2003, 1: 215-21. PMID: 19768880, DOI: 10.6004/jnccn.2003.0020.Peer-Reviewed Original ResearchConceptsHormone receptor-positive breast cancerReceptor-positive breast cancerAdjuvant hormonal therapyAromatase inhibitorsAdjuvant settingBreast cancerATAC trialHormonal therapyThird-generation aromatase inhibitor anastrozoleMost postmenopausal womenNew hormonal agentsAromatase inhibitor anastrozoleEarly breast cancerMetastatic breast cancerUse of tamoxifenRelapse-free survivalBreast cancer recurrenceAdjuvant therapyPostmenopausal patientsPostmenopausal womenThromboembolic eventsOverall mortalityHormonal agentsPatient populationUterine cancer
2001
Phase II Evaluation Of Thalidomide In Patients With Metastatic Breast Cancer
Baidas S, Winer E, Fleming G, Harris L, Pluda J, Crawford J, Yamauchi H, Isaacs C, Hanfelt J, Tefft M, Flockhart D, Johnson, Hawkins M, Lippman M, Hayes D. Phase II Evaluation Of Thalidomide In Patients With Metastatic Breast Cancer. Journal Of The Peripheral Nervous System 2001, 6: 65-66. DOI: 10.1046/j.1529-8027.2001.01008-20.x.Peer-Reviewed Original ResearchMetastatic breast cancerWeeks of treatmentProgressive diseaseBreast cancerDose levelsProgressive metastatic breast cancerGrowth factor serum levelsSingle-agent thalidomideFactor serum levelsPhase II evaluationLack of efficacyDifferent patient populationsLow dose levelsAngiogenic growth factorsStable diseaseDry mouthAdverse eventsSkin rashComplete responseSerum levelsPatient populationWeek 16II evaluationGrade 3Patients
2000
Phase II evaluation of thalidomide in patients with metastatic breast cancer.
Baidas S, Winer E, Fleming G, Harris L, Pluda J, Crawford J, Yamauchi H, Isaacs C, Hanfelt J, Tefft M, Flockhart D, Johnson M, Hawkins M, Lippman M, Hayes D. Phase II evaluation of thalidomide in patients with metastatic breast cancer. Journal Of Clinical Oncology 2000, 18: 2710-7. PMID: 10894870, DOI: 10.1200/jco.2000.18.14.2710.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAngiogenesis InhibitorsBreast NeoplasmsDrug Administration ScheduleEndothelial Growth FactorsFemaleFibroblast Growth Factor 2Growth SubstancesHumansLymphokinesMatrix MetalloproteinasesMiddle AgedNeoplasm MetastasisProspective StudiesThalidomideTumor Necrosis Factor-alphaVascular Endothelial Growth Factor AVascular Endothelial Growth FactorsConceptsMetastatic breast cancerWeeks of treatmentProgressive diseaseBreast cancerDose levelsProgressive metastatic breast cancerGrowth factor serum levelsSingle-agent thalidomideFactor serum levelsPhase II evaluationLack of efficacyDifferent patient populationsLow dose levelsAngiogenic growth factorsStable diseaseDry mouthAdverse eventsSkin rashComplete responseSerum levelsPatient populationWeek 16II evaluationGrade 3Patients
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