2024
Analysis of HER2 expression changes from breast primary to brain metastases and the impact of HER2-low expression on overall survival
Pereslete A, Hughes M, Martin A, Files J, Nguyen K, Buckley L, Patel A, Moore A, Winer E, Dillon D, Li T, Tolaney S, Lin N, Sammons S. Analysis of HER2 expression changes from breast primary to brain metastases and the impact of HER2-low expression on overall survival. Neuro-Oncology 2024, noae163. PMID: 39211994, DOI: 10.1093/neuonc/noae163.Peer-Reviewed Original ResearchHER2-low expressionHER2-lowMetastatic breast cancerHER2-positiveHER2 expressionHER2-0Primary tumorBrain metastasesEstrogen receptorBreast cancerHER2-positive primary tumorsASCO-CAP guidelinesNCI-designated centersMultivariate survival analysisCox proportional hazards modelsAntibody-drug conjugatesProportional hazards modelActive antibody-drug conjugateASCO-CAPHER2 gainHER2 statusInferior survivalOverall survivalIntracranial activityRetrospective analysis
2022
The oral selective estrogen receptor degrader GDC-0810 (ARN-810) in postmenopausal women with hormone receptor-positive HER2-negative (HR + /HER2 −) advanced/metastatic breast cancer
Bardia A, Mayer I, Winer E, Linden H, Ma C, Parker B, Bellet M, Arteaga C, Cheeti S, Gates M, Chang C, Fredrickson J, Spoerke J, Moore H, Giltnane J, Friedman L, Chow Maneval E, Chan I, Jhaveri K. The oral selective estrogen receptor degrader GDC-0810 (ARN-810) in postmenopausal women with hormone receptor-positive HER2-negative (HR + /HER2 −) advanced/metastatic breast cancer. Breast Cancer Research And Treatment 2022, 197: 319-331. PMID: 36401732, PMCID: PMC9823088, DOI: 10.1007/s10549-022-06797-9.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerSelective estrogen receptor degraderDose escalationESR1 mutationsPostmenopausal womenBreast cancerEstrogen receptorCombination treatmentNon-complete response/non-progressive diseaseAdvanced/Metastatic Breast CancerOral selective estrogen receptor degraderPreliminary anti-tumor activityESR1 mutation statusPhase 2 dosePlasma ctDNA samplesCommon adverse eventsNon-progressive diseaseDose-limiting toxicityHormone-releasing hormoneSelective estrogen receptorAnti-tumor activityStable diseaseAdverse eventsPartial responseProgressive 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
2019
Correction: 18F-Fluoroestradiol PET/CT Measurement of Estrogen Receptor Suppression during a Phase I Trial of the Novel Estrogen Receptor-Targeted Therapeutic GDC-0810: Using an Imaging Biomarker to Guide Drug Dosage in Subsequent Trials
Wang Y, Ayres KL, Goldman DA, Dickler MN, Bardia A, Mayer IA, Winer E, Fredrickson J, Arteaga CL, Baselga J, Manning HC, Mahmood U, Ulaner GA. Correction: 18F-Fluoroestradiol PET/CT Measurement of Estrogen Receptor Suppression during a Phase I Trial of the Novel Estrogen Receptor-Targeted Therapeutic GDC-0810: Using an Imaging Biomarker to Guide Drug Dosage in Subsequent Trials. Clinical Cancer Research 2019, 25: 1435-1435. PMID: 30770494, DOI: 10.1158/1078-0432.ccr-18-4266.Peer-Reviewed Original Research
2018
Acquired HER2 mutations in ER+ metastatic breast cancer confer resistance to estrogen receptor–directed therapies
Nayar U, Cohen O, Kapstad C, Cuoco MS, Waks AG, Wander SA, Painter C, Freeman S, Persky NS, Marini L, Helvie K, Oliver N, Rozenblatt-Rosen O, Ma CX, Regev A, Winer EP, Lin NU, Wagle N. Acquired HER2 mutations in ER+ metastatic breast cancer confer resistance to estrogen receptor–directed therapies. Nature Genetics 2018, 51: 207-216. PMID: 30531871, DOI: 10.1038/s41588-018-0287-5.Peer-Reviewed Original ResearchConceptsHER2 mutationsEstrogen receptorBreast cancerClinical resistance mechanismsMainstay of treatmentMetastatic breast cancerReceptor-directed therapyCDK6 inhibitor palbociclibPre-existing mutationsMetastatic settingEstrogen independenceInhibitor palbociclibPrimary tumorMetastatic biopsiesInhibitor neratinibTherapyPatientsER mutationsCancerTamoxifenResistance mechanismsDistinct mechanismsMutationsConfer resistanceBiopsyCDK4/6 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
Neratinib Efficacy and Circulating Tumor DNA Detection of HER2 Mutations in HER2 Nonamplified Metastatic Breast Cancer
X. C, Bose R, Gao F, Freedman RA, Telli ML, Kimmick G, Winer E, Naughton M, Goetz MP, Russell C, Tripathy D, Cobleigh M, Forero A, Pluard TJ, Anders C, Niravath PA, Thomas S, Anderson J, Bumb C, Banks KC, Lanman RB, Bryce R, Lalani AS, Pfeifer J, Hayes DF, Pegram M, Blackwell K, Bedard PL, Al-Kateb H, Ellis MJC. Neratinib Efficacy and Circulating Tumor DNA Detection of HER2 Mutations in HER2 Nonamplified Metastatic Breast Cancer. Clinical Cancer Research 2017, 23: 5687-5695. PMID: 28679771, PMCID: PMC6746403, DOI: 10.1158/1078-0432.ccr-17-0900.Peer-Reviewed Original ResearchConceptsClinical benefit rateProgression-free survivalMetastatic breast cancerStable diseaseCtDNA sequencingMedian progression-free survivalSingle-arm phase II trialCommon adverse eventsPhase II trialClinical trial participationPromising preclinical dataClin Cancer ResTumor-positive casesVariant allele frequencyProphylactic loperamideSecondary endpointsII trialPartial responseAdverse eventsTrial participationPreclinical dataBenefit rateBreast cancerWeek 4Estrogen receptor
2013
Personalized medicine in breast cancer: tamoxifen, endoxifen, and CYP2D6 in clinical practice
Ruddy KJ, Desantis SD, Gelman RS, Wu AH, Punglia RS, Mayer EL, Tolaney SM, Winer EP, Partridge AH, Burstein HJ. Personalized medicine in breast cancer: tamoxifen, endoxifen, and CYP2D6 in clinical practice. Breast Cancer Research And Treatment 2013, 141: 421-427. PMID: 24062210, DOI: 10.1007/s10549-013-2700-1.Peer-Reviewed Original ResearchConceptsEndoxifen levelsEndocrine therapyBreast cancerCYP2D6 genotypeAdjuvant tamoxifenTamoxifen metabolismOptimal adjuvant endocrine therapyAlternative endocrine therapyBaseline whole bloodAdjuvant endocrine therapyMedical record reviewActual treatment decisionsPoor metabolizer genotypeCytochrome P450 2D6Record reviewClinical evidenceTreatment recommendationsTherapy recommendationsTreatment decisionsEstrogen receptorHormonal treatmentStage IClinical practicePatientsTamoxifen
2012
The natural history of hormone receptor-positive breast cancer.
Lim E, Metzger-Filho O, Winer EP. The natural history of hormone receptor-positive breast cancer. Oncology 2012, 26: 688-94, 696. PMID: 22957400.Peer-Reviewed Original ResearchConceptsBreast cancerEstrogen receptorLate relapseProgesterone receptorHormone receptor-positive breast cancerAdjuvant anti-estrogen therapyHR-positive breast cancerReceptor-positive breast cancerNatural historyHormone receptorsAnti-estrogen therapyLong natural historyPredictors of responseBreast cancer subtypesHuman breast tumorsSignificant clinical challengePatient tumor samplesTranslational research strategiesCurrent clinical strategiesAntiestrogen therapyRelapse patternsPreclinical modelsClinical challengeTreatment resistanceTumor relapseClinicopathologic features, patterns of recurrence, and survival among women with triple‐negative breast cancer in the National Comprehensive Cancer Network
Lin NU, Vanderplas A, Hughes ME, Theriault RL, Edge SB, Wong Y, Blayney DW, Niland JC, Winer EP, Weeks JC. Clinicopathologic features, patterns of recurrence, and survival among women with triple‐negative breast cancer in the National Comprehensive Cancer Network. Cancer 2012, 118: 5463-5472. PMID: 22544643, PMCID: PMC3611659, DOI: 10.1002/cncr.27581.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptor 2Triple-negative tumorsHR-positive/HER2-negative tumorsHER2-negative tumorsTriple-negative subtypePatterns of recurrenceEstrogen receptorProgesterone receptorClinicopathologic featuresBreast cancerNational Comprehensive Cancer Network centersNational Comprehensive Cancer NetworkHigher body mass indexEpidermal growth factor receptor 2Triple-negative breast cancerLymph node involvementComprehensive Cancer NetworkGrowth factor receptor 2Triple-negative cancersRisk of deathBody mass indexAbnormal screening mammogramBreast cancer subtypesHigher tumor classificationFactor receptor 2
2011
P1-08-05: Age and Survival in Women with Early Stage Breast Cancer: An Analysis Controlling for Tumor Subtype.
Partridge A, Hughes M, Ottesen R, Wong Y, Edge S, Theriault R, Blayney D, Niland J, Winer E, Weeks J, Tamimi R. P1-08-05: Age and Survival in Women with Early Stage Breast Cancer: An Analysis Controlling for Tumor Subtype. Cancer Research 2011, 71: p1-08-05-p1-08-05. DOI: 10.1158/0008-5472.sabcs11-p1-08-05.Peer-Reviewed Original ResearchMultivariate Cox proportional hazards modelEarly-stage breast cancerCox proportional hazards modelStage breast cancerProportional hazards modelBreast cancerEstrogen receptorYoung womenProgesterone receptorStratified analysisOlder womenHazards modelTumor subtypesYounger ageBreast cancer-specific survivalHER-2/neu statusCancer-specific survivalER-positive diseaseIndependent risk factorEarly breast cancerER-negative diseaseAge 40 yearsBreast cancer recurrenceEfficacy of therapyBreast cancer biologyAdjuvant chemotherapy in luminal breast cancers
Lim E, Winer EP. Adjuvant chemotherapy in luminal breast cancers. The Breast 2011, 20: s128-s131. PMID: 22015279, DOI: 10.1016/s0960-9776(11)70309-5.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsAntineoplastic Agents, HormonalBiomarkersBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleHumansMiddle AgedNeoplasm StagingNeoplasms, Hormone-DependentPrognosisRandomized Controlled Trials as TopicReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRisk AssessmentSurvival AnalysisTreatment OutcomeConceptsAdjuvant endocrine therapyLuminal breast cancerEndocrine therapyBreast cancerEstrogen receptorAdjuvant chemotherapyProgesterone receptorHER2-negative breast cancerER-positive breast tumorsAddition of chemotherapyER-positive diseaseER-positive tumorsUse of chemotherapySubset of patientsSubgroup of patientsER-negative tumorsAdditional therapyCytotoxic chemotherapyEndocrine sensitivityClinicians' estimationTherapeutic responseFavorable outcomeCurrent biomarkersChemotherapyBreast tumors
2009
Tolerability and efficacy of 500 mg fulvestrant in postmenopausal women with estrogen receptor (ER)+ advanced breast cancer
Come S, Parker L, Wulf G, Kuter I, Ryan P, Tkaczuk K, Borges V, Kasper H, Gelman R, Winer E. Tolerability and efficacy of 500 mg fulvestrant in postmenopausal women with estrogen receptor (ER)+ advanced breast cancer. Journal Of Clinical Oncology 2009, 27: 1050-1050. DOI: 10.1200/jco.2009.27.15_suppl.1050.Peer-Reviewed Original ResearchClinical benefit rateStable diseasePartial responseComplete responseEstrogen receptorEndocrine therapyMedian timeBreast cancerEvaluable metastatic breast cancerFirst-line metastatic settingInjection site discomfortAdjuvant endocrine therapyAdjuvant endocrine treatmentPhase II studyTreatment-related toxicityMetastatic breast cancerAdvanced diseaseEndocrine treatmentMetastatic settingPostmenopausal patientsPrimary endpointRECIST criteriaVisceral metastasesII studyPostmenopausal womenClinicopathological features and sites of recurrence according to breast cancer subtype in the National Comprehensive Cancer Network (NCCN)
Lin N, Vanderplas A, Hughes M, Theriault R, Edge S, Wong Y, Blayney D, Niland J, Winer E, Weeks J. Clinicopathological features and sites of recurrence according to breast cancer subtype in the National Comprehensive Cancer Network (NCCN). Journal Of Clinical Oncology 2009, 27: 543-543. DOI: 10.1200/jco.2009.27.15_suppl.543.Peer-Reviewed Original ResearchNational Comprehensive Cancer NetworkSite of recurrenceBreast cancer subtypesClinicopathological featuresProgesterone receptorEstrogen receptorStage ICancer subtypesInvasive ductal histologyExtensive intraductal componentComprehensive Cancer NetworkPatterns of recurrenceFuture clinical trialsMultiple breast cancer subtypesStandard immunohistochemical markersDuctal histologyLymphovascular invasionNode positivityIntraductal componentHER2 statusTN tumorsClinical trialsBreast cancerSubtype distributionImmunohistochemical markers
2006
The impact of tumor progesterone receptor status on optimal adjuvant endocrine therapy for postmenopausal patients with early‐stage breast cancer
Punglia RS, Kuntz KM, Winer EP, Weeks JC, Burstein HJ. The impact of tumor progesterone receptor status on optimal adjuvant endocrine therapy for postmenopausal patients with early‐stage breast cancer. Cancer 2006, 106: 2576-2582. PMID: 16703595, DOI: 10.1002/cncr.21919.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAgedAged, 80 and overAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsChemotherapy, AdjuvantCross-Over StudiesDecision Support TechniquesDisease-Free SurvivalDrug Administration ScheduleFemaleHumansMarkov ChainsMiddle AgedModels, StatisticalModels, TheoreticalNeoplasm StagingOdds RatioPostmenopauseRandomized Controlled Trials as TopicReceptors, ProgesteroneTamoxifenTime FactorsTreatment OutcomeConceptsDisease-free survivalAromatase inhibitorsProgesterone receptorEstrogen receptorOptimal adjuvant endocrine therapyEarly-stage breast cancerAdjuvant endocrine therapyNode-positive groupProgesterone receptor statusRandomized clinical trialsSequential treatmentBreast cancer tumorsAI monotherapyAI therapyBiologic subsetsDFS ratesAdjuvant therapyEndocrine therapyPostmenopausal patientsPostmenopausal womenSequential therapyUpfront treatmentLymph nodesReceptor statusPR expressionNCCN Task Force Report: Adjuvant Therapy for Breast Cancer.
Carlson RW, Brown E, Burstein HJ, Gradishar WJ, Hudis CA, Loprinzi C, Mamounas EP, Perez EA, Pritchard K, Ravdin P, Recht A, Somlo G, Theriault RL, Winer EP, Wolff AC, _ _. NCCN Task Force Report: Adjuvant Therapy for Breast Cancer. Journal Of The National Comprehensive Cancer Network 2006, 4 Suppl 1: s1-26. PMID: 16507275, DOI: 10.6004/jnccn.2006.2001.Peer-Reviewed Original ResearchConceptsNational Comprehensive Cancer NetworkBreast cancer treatment guidelinesCancer treatment guidelinesAdjuvant therapyBreast cancerTreatment guidelinesAdjuvant therapy recommendationsQuantitative estrogen receptorComprehensive Cancer NetworkEstrogen receptor levelsPositive breast cancerEndocrine therapyPostmenopausal womenMenopausal statusTask ForcePredictive factorsGuideline panelHER2 statusBiologic markersAromatase inhibitorsTherapy recommendationsReceptor levelsEstrogen receptorHER2/Cancer Network