2021
Phase I study of JAK1/2 inhibitor ruxolitinib with weekly paclitaxel for the treatment of HER2-negative metastatic breast cancer
Lynce F, Williams JT, Regan MM, Bunnell CA, Freedman RA, Tolaney SM, Chen WY, Mayer EL, Partridge AH, Winer EP, Overmoyer B. Phase I study of JAK1/2 inhibitor ruxolitinib with weekly paclitaxel for the treatment of HER2-negative metastatic breast cancer. Cancer Chemotherapy And Pharmacology 2021, 87: 673-679. PMID: 33585999, DOI: 10.1007/s00280-021-04245-x.Peer-Reviewed Original ResearchConceptsHER2-negative metastatic breast cancerMetastatic breast cancerBreast cancerWeekly paclitaxelAdvanced diseaseHormone receptor-positive diseaseTriple-negative breast cancerGrade 4/5 toxicitiesMost frequent toxicitiesPhase 2 doseWeekly paclitaxel 80Receptor-positive diseaseDose-escalation designJAK1/2 inhibitor ruxolitinibCombination of ruxolitinibBreast cancer cellsOral ruxolitinibPaclitaxel 80PurposePreclinical studiesChemotherapy regimensFrequent toxicitiesProtocol therapyMethodsEligible patientsThirteen patientsVisceral disease
2020
Acquired FGFR and FGF Alterations Confer Resistance to Estrogen Receptor (ER) Targeted Therapy in ER+ Metastatic Breast Cancer
Mao P, Cohen O, Kowalski KJ, Kusiel JG, Buendia-Buendia JE, Cuoco MS, Exman P, Wander SA, Waks AG, Nayar U, Chung J, Freeman S, Rozenblatt-Rosen O, Miller VA, Piccioni F, Root DE, Regev A, Winer EP, Lin NU, Wagle N. Acquired FGFR and FGF Alterations Confer Resistance to Estrogen Receptor (ER) Targeted Therapy in ER+ Metastatic Breast Cancer. Clinical Cancer Research 2020, 26: 5974-5989. PMID: 32723837, DOI: 10.1158/1078-0432.ccr-19-3958.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBreast NeoplasmsCell Line, TumorDrug Resistance, NeoplasmExome SequencingFemaleFibroblast Growth Factor 3FulvestrantGene Expression Regulation, NeoplasticHumansMCF-7 CellsMiddle AgedMutationNeoplasm MetastasisPiperazinesProtein Kinase InhibitorsPyridinesReceptor, Fibroblast Growth Factor, Type 1Receptor, Fibroblast Growth Factor, Type 2Receptors, EstrogenXenograft Model Antitumor AssaysConceptsMetastatic breast cancerEstrogen receptorBreast cancerFGFR pathwaySelective estrogen receptor degraderCDK4/6 inhibitor palbociclibBreast cancer cellsMAPK pathwayWhole-exome sequencingResistant cell linesMAPK pathway inhibitorsFulvestrant resistanceInhibitor palbociclibDrug combinationsFGFR inhibitorsTherapyPathway inhibitorMEK inhibitorsConfer resistanceCancer cellsCancerInsulin receptorGenes/pathwaysBiopsyCell lines
2018
CDK4/6 inhibition in breast cancer: current practice and future directions
Pernas S, Tolaney SM, Winer EP, Goel S. CDK4/6 inhibition in breast cancer: current practice and future directions. Therapeutic Advances In Medical Oncology 2018, 10: 1758835918786451. PMID: 30038670, PMCID: PMC6050811, DOI: 10.1177/1758835918786451.Peer-Reviewed Original ResearchCDK4/6 inhibitorsBreast cancerNovel immune-based therapiesPositive breast cancer patientsER-positive breast cancerProgression-free survivalImmune-based therapiesBreast cancer patientsCancer cell cycle arrestClinical trial resultsSelective CDK4/6 inhibitorsNormal breast epitheliumCyclin-dependent kinase 4Breast cancer cellsCyclin D/cyclin-dependent kinase 4Cancer cell cycleEndocrine therapyCDK4/6 pathwayCDK4/6 inhibitionCancer patientsCell cycle arrestClinical dataEstrogen receptorPreclinical studiesBreast epithelium
2017
A Phase Ib Study of Alpelisib (BYL719), a PI3Kα-Specific Inhibitor, with Letrozole in ER+/HER2− Metastatic Breast Cancer
Mayer IA, Abramson VG, Formisano L, Balko JM, Estrada MV, Sanders ME, Juric D, Solit D, Berger MF, Won HH, Li Y, Cantley LC, Winer E, Arteaga CL. A Phase Ib Study of Alpelisib (BYL719), a PI3Kα-Specific Inhibitor, with Letrozole in ER+/HER2− Metastatic Breast Cancer. Clinical Cancer Research 2017, 23: 26-34. PMID: 27126994, PMCID: PMC5085926, DOI: 10.1158/1078-0432.ccr-16-0134.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBiomarkers, TumorBreast NeoplasmsCell Line, TumorDNA Mutational AnalysisFemaleHumansIn Situ Hybridization, FluorescenceLetrozoleMaximum Tolerated DoseMiddle AgedMutationNeoplasm MetastasisNeoplasm StagingNitrilesPhosphatidylinositol 3-KinasesPhosphoinositide-3 Kinase InhibitorsReceptor, ErbB-2Receptor, Fibroblast Growth Factor, Type 1Receptors, EstrogenThiazolesTreatment OutcomeTriazolesConceptsMaximum-tolerated doseBreast cancer cellsEndocrine therapyClinical benefitCommon drug-related adverse eventsDrug-related adverse eventsMutant breast cancer cellsBreast cancer refractoryPIK3CA mutation statusPIK3CA-mutated tumorsClinical benefit ratePhase Ib studyPI3K catalytic subunit p110αDose-limiting toxicityCancer cellsSelective oral inhibitorOverexpression of FGFR1Combination of letrozoleSynergistic antitumor activityCatalytic subunit p110αCancer refractoryFGFR1/2 amplificationMetastatic ERAdverse eventsObjective response
2009
A phase I study of an autologous GM-CSF-secreting breast cancer vaccine.
Anderson K, Hodi F, Sasada T, Canning C, Hassett M, Mayer E, Hannagan K, Wong J, Colson Y, Shoji B, Najita J, Sibani S, LaBaer J, Winer E, Dranoff G. A phase I study of an autologous GM-CSF-secreting breast cancer vaccine. Cancer Research 2009, 69: 4124. DOI: 10.1158/0008-5472.sabcs-4124.Peer-Reviewed Original ResearchBreast cancer vaccinesGM-CSFAutologous GM-CSFCancer vaccinesLung cancerSkin biopsiesImmune responseECOG performance status 0Antigen-specific immune responsesLocal injection site reactionsPerformance status 0Anti-tumor immunityInjection site reactionsMetastatic breast cancerMalignant pleural effusionReplication-defective adenoviral vectorMultiple tumor modelsGM-CSF secretionBreast cancer cellsTumor cell yieldGranulocyte-macrophage colonyAutologous vaccinationMeasurable diseasePrior chemotherapyStable disease
2007
HER2 and Response to Paclitaxel in Node-Positive Breast Cancer
Hayes DF, Thor AD, Dressler LG, Weaver D, Edgerton S, Cowan D, Broadwater G, Goldstein LJ, Martino S, Ingle JN, Henderson IC, Norton L, Winer EP, Hudis CA, Ellis MJ, Berry DA. HER2 and Response to Paclitaxel in Node-Positive Breast Cancer. New England Journal Of Medicine 2007, 357: 1496-1506. PMID: 17928597, DOI: 10.1056/nejmoa071167.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptor type 2Node-positive breast cancerAddition of paclitaxelEstrogen receptor statusHER2 positivityBreast cancerAdjuvant chemotherapyDoxorubicin dosesAdjuvant anthracycline-based chemotherapyEpidermal growth factor receptor type 2HER2-positive breast cancerFactor receptor type 2CB11 monoclonal antibodyCycles of paclitaxelAnthracycline-based chemotherapyAdministration of paclitaxelReceptor type 2Breast cancer cellsAdjuvant treatmentHazard ratioClinical outcomesPositive cancersHER2 amplificationImmunohistochemical analysisCyclophosphamide