2021
Updated Results of TBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathological Complete Response to Pertuzumab and Trastuzumab in Breast Cancer
Connolly RM, Leal JP, Solnes L, Huang CY, Carpenter A, Gaffney K, Abramson V, Carey LA, Liu MC, Rimawi M, Specht J, Storniolo AM, Valero V, Vaklavas C, Krop IE, Winer EP, Camp M, Miller RS, Wolff AC, Cimino-Mathews A, Park BH, Wahl RL, Stearns V. Updated Results of TBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathological Complete Response to Pertuzumab and Trastuzumab in Breast Cancer. Journal Of Clinical Oncology 2021, 39: 2247-2256. PMID: 33999652, PMCID: PMC8260904, DOI: 10.1200/jco.21.00280.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantFemaleFluorodeoxyglucose F18HumansMiddle AgedNeoadjuvant TherapyPositron Emission Tomography Computed TomographyPredictive Value of TestsRadiopharmaceuticalsReceptor, ErbB-2Time FactorsTrastuzumabTreatment OutcomeUnited StatesConceptsPositron emission tomography-computed tomographyFluorodeoxyglucose positron emission tomography-computed tomographyHER2-positive breast cancerEmission tomography-computed tomographyPathologic complete responseTomography-computed tomographyStandardized uptake valueBreast cancerComplete responseUptake valuePercent changeOne-sided type ITumor maximum standardized uptake valueHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Maximum standardized uptake valuePathological complete responseGrowth factor receptor 2Median percent reductionPositive breast cancerTailoring of therapyLean body massReceiver operator characteristic analysisFactor receptor 2Operator characteristic analysisUtility of the 21-Gene Recurrence Score in Node-Positive Breast Cancer.
Laws A, Garrido-Castro A, Poorvu P, Winer E, Mittendorf E, King T. Utility of the 21-Gene Recurrence Score in Node-Positive Breast Cancer. Oncology 2021, 35: 77-84. PMID: 33577165, DOI: 10.46883/onc.2021.3502.0077.Peer-Reviewed Original ResearchConceptsRecurrence scorePositive nodesClinical trialsBreast cancerHER2-negative breast cancerNode-positive breast cancerLarge population-based registryNode-positive populationAdjuvant chemotherapy useChemotherapy-treated patientsClinical practice guidelinesCurrent practice patternsPopulation-based registryMultiple clinical trialsPotential predictive valueADAPT trialAdjuvant chemotherapyChemotherapy useEndocrine therapyPostmenopausal patientsChemotherapy benefitExcellent outcomesPractice patternsPractice guidelinesRetrospective analysis
2020
Clinical Significance of Circulating Tumor Cells in Hormone Receptor–positive Metastatic Breast Cancer Patients who Received Letrozole with or Without Bevacizumab
Magbanua MJM, Savenkov O, Asmus EJ, Ballman KV, Scott JH, Park JW, Dickler M, Partridge A, Carey LA, Winer EP, Rugo HS. Clinical Significance of Circulating Tumor Cells in Hormone Receptor–positive Metastatic Breast Cancer Patients who Received Letrozole with or Without Bevacizumab. Clinical Cancer Research 2020, 26: 4911-4920. PMID: 32586939, PMCID: PMC7501177, DOI: 10.1158/1078-0432.ccr-20-1329.Peer-Reviewed Original ResearchConceptsProgression-free survivalCTC-positive patientsHormone receptor-positive metastatic breast cancer patientsMetastatic breast cancer patientsAddition of bevacizumabBreast cancer patientsOverall survivalCancer patientsPredictive valueMean survival time analysisMedian progression-free survivalWorse progression-free survivalAssociation of CTCsCTC-negative patientsFirst-line settingRisk of progressionCox regression modelPotential predictive valueML of bloodAdditional time pointsCirculating Tumor CellsLetrozole armOS benefitPFS benefitMultivariable analysis
2019
TBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathologic Complete Response to Pertuzumab and Trastuzumab in Breast Cancer
Connolly RM, Leal JP, Solnes L, Huang CY, Carpenter A, Gaffney K, Abramson V, Carey LA, Liu MC, Rimawi M, Specht J, Storniolo AM, Valero V, Vaklavas C, Krop IE, Winer EP, Camp M, Miller RS, Wolff AC, Cimino-Mathews A, Park BH, Wahl RL, Stearns V. TBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathologic Complete Response to Pertuzumab and Trastuzumab in Breast Cancer. Journal Of Clinical Oncology 2019, 37: jco.2018.78.7986. PMID: 30721110, PMCID: PMC6424139, DOI: 10.1200/jco.2018.78.7986.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantFemaleFluorodeoxyglucose F18HumansMiddle AgedNeoadjuvant TherapyNeoplasm StagingPredictive Value of TestsRadiopharmaceuticalsReceptor, ErbB-2Receptors, EstrogenSingle Photon Emission Computed Tomography Computed TomographyTime FactorsTrastuzumabTreatment OutcomeUnited StatesConceptsPathologic complete responseHER2-positive breast cancerPositron emission tomography/Emission tomography/Standardized uptake valueBreast cancerComplete responseTomography/Uptake valueTumor maximum standardized uptake valueOne-sided type IHuman epidermal growth factor receptor 2Stage II/IIIEpidermal growth factor receptor 2Maximum standardized uptake valueCycles of PTGrowth factor receptor 2Median percent reductionPositive breast cancerLean body massFactor receptor 2Significant differencesEvaluable patientsNeoadjuvant pertuzumabPT initiation
2017
Ki67 Proliferation Index as a Tool for Chemotherapy Decisions During and After Neoadjuvant Aromatase Inhibitor Treatment of Breast Cancer: Results From the American College of Surgeons Oncology Group Z1031 Trial (Alliance)
Ellis MJ, Suman VJ, Hoog J, Goncalves R, Sanati S, Creighton CJ, DeSchryver K, Crouch E, Brink A, Watson M, Luo J, Tao Y, Barnes M, Dowsett M, Budd GT, Winer E, Silverman P, Esserman L, Carey L, X. C, Unzeitig G, Pluard T, Whitworth P, Babiera G, Guenther JM, Dayao Z, Ota D, Leitch M, Olson JA, Allred DC, Hunt K. Ki67 Proliferation Index as a Tool for Chemotherapy Decisions During and After Neoadjuvant Aromatase Inhibitor Treatment of Breast Cancer: Results From the American College of Surgeons Oncology Group Z1031 Trial (Alliance). Journal Of Clinical Oncology 2017, 35: jco.2016.69.440. PMID: 28045625, PMCID: PMC5455353, DOI: 10.1200/jco.2016.69.4406.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnastrozoleAndrostadienesAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsClinical Decision-MakingFemaleFollow-Up StudiesHumansKi-67 AntigenLetrozoleMiddle AgedMitotic IndexNeoadjuvant TherapyNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingNitrilesPredictive Value of TestsPrognosisProportional Hazards ModelsReceptors, EstrogenReceptors, ProgesteroneSurvival RateTranscriptomeTriazolesConceptsPreoperative endocrine prognostic indexBreast cancerNeoadjuvant chemotherapyAmerican CollegeEstrogen receptor-positive primary breast cancerNeoadjuvant aromatase inhibitor therapyPathologic complete response rateER-positive breast cancerAromatase inhibitor therapyComplete response rateER-positive tumorsPrimary breast cancerRisk of relapseAromatase inhibitor treatmentKi67 proliferation indexEndocrine monotherapyNeoadjuvant AIsAI therapyPCR ratePostmenopausal womenInhibitor therapyCox modelingOptimal therapyPrognostic indexRelapse risk
2016
Frequency of Germline Mutations in 25 Cancer Susceptibility Genes in a Sequential Series of Patients With Breast Cancer
Tung N, Lin NU, Kidd J, Allen BA, Singh N, Wenstrup RJ, Hartman AR, Winer EP, Garber JE. Frequency of Germline Mutations in 25 Cancer Susceptibility Genes in a Sequential Series of Patients With Breast Cancer. Journal Of Clinical Oncology 2016, 34: 1460-1468. PMID: 26976419, PMCID: PMC4872307, DOI: 10.1200/jco.2015.65.0747.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsAgedAged, 80 and overBreast NeoplasmsFemaleGene Expression ProfilingGene Expression Regulation, NeoplasticGenes, BRCA1Genes, BRCA2Genetic Predisposition to DiseaseGenetic TestingGerm-Line MutationHigh-Throughput Nucleotide SequencingHumansJewsMiddle AgedNeoplasm StagingOvarian NeoplasmsPredictive Value of TestsPrevalenceProspective StudiesRetrospective StudiesRisk FactorsTriple Negative Breast NeoplasmsConceptsCancer predisposition genesTriple-negative breast cancerBreast cancer predisposition genesBreast cancerPredisposition genesGermline mutationsOvarian cancerNext-generation sequencingBRCA1/2 mutationsCancer susceptibility genesSingle cancer centerFamily cancer historyBreast/ovarian cancerOvarian cancer predisposition genesPredictors of mutationsSusceptibility genesSelect patientsSequential patientsAshkenazi Jewish ancestryCancer CenterCancer historyClinical managementFamily historyBreast/ovarian cancer susceptibility geneOvarian cancer susceptibility genes
2011
p53 Expression in Node-Positive Breast Cancer Patients: Results from the Cancer and Leukemia Group B 9344 Trial (159905)
Lara JF, Thor AD, Dressler LG, Broadwater G, Bleiweiss IJ, Edgerton S, Cowan D, Goldstein LJ, Martino S, Ingle JN, Henderson IC, Norton L, Winer EP, Hudis CA, Ellis MJ, Berry DA, Hayes DF, B F. p53 Expression in Node-Positive Breast Cancer Patients: Results from the Cancer and Leukemia Group B 9344 Trial (159905). Clinical Cancer Research 2011, 17: 5170-5178. PMID: 21693655, PMCID: PMC3149770, DOI: 10.1158/1078-0432.ccr-11-0484.Peer-Reviewed Original ResearchConceptsAddition of paclitaxelDoses of doxorubicinOverall survivalP53 protein expressionAdjuvant doxorubicinDose escalationBreast cancerP53 expressionNode-positive breast cancer patientsNode-positive breast cancerEarly-stage breast cancerCycles of cyclophosphamideNode-positive patientsProtein expressionStage II patientsBreast cancer patientsRandomized clinical trialsWorse RFSWorse OSII patientsPredictive factorsWorse prognosisCancer patientsP53 positivityP53 staining
2009
Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial
Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT, Ravdin P, Bugarini R, Baehner FL, Davidson NE, Sledge GW, Winer EP, Hudis C, Ingle JN, Perez EA, Pritchard KI, Shepherd L, Gralow JR, Yoshizawa C, Allred DC, Osborne CK, Hayes DF, America F. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. The Lancet Oncology 2009, 11: 55-65. PMID: 20005174, PMCID: PMC3058239, DOI: 10.1016/s1470-2045(09)70314-6.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials, Phase III as TopicCyclophosphamideDisease-Free SurvivalDoxorubicinFemaleFluorouracilGene Expression ProfilingGene Expression Regulation, NeoplasticGenetic TestingHumansKaplan-Meier EstimateLymphatic MetastasisMiddle AgedPatient SelectionPostmenopausePredictive Value of TestsProportional Hazards ModelsRandomized Controlled Trials as TopicReceptors, EstrogenRecurrenceRetrospective StudiesReverse Transcriptase Polymerase Chain ReactionRisk AssessmentTamoxifenTime FactorsTreatment OutcomeUnited StatesConceptsLow recurrence scorePositive breast cancerAnthracycline-based chemotherapyDisease-free survivalHigh recurrence scoreRecurrence scorePositive nodesBreast cancerPostmenopausal womenRetrospective analysisNode-positive breast cancerTamoxifen-alone groupTamoxifen-treated patientsPhase 3 trialNational Cancer InstituteEffect of recurrenceOverall survivalSpecific survivalSurvival benefitCox regressionHigh riskTreatment groupsCancer InstituteChemotherapyPredictive valueClinical Cancer Advances 2009: Major Research Advances in Cancer Treatment, Prevention, and Screening—A Report From the American Society of Clinical Oncology
Petrelli NJ, Winer EP, Brahmer J, Dubey S, Smith S, Thomas C, Vahdat LT, Obel J, Vogelzang N, Markman M, Sweetenham JW, Pfister D, Kris MG, Schuchter LM, Sawaya R, Raghavan D, Ganz PA, Kramer B. Clinical Cancer Advances 2009: Major Research Advances in Cancer Treatment, Prevention, and Screening—A Report From the American Society of Clinical Oncology. Journal Of Clinical Oncology 2009, 27: 6052-6069. PMID: 19901123, DOI: 10.1200/jco.2009.26.6171.Peer-Reviewed Original ResearchMeSH KeywordsBiomedical ResearchEvidence-Based MedicineFemaleFinancing, GovernmentHealth PolicyHumansMaleMass ScreeningMedical OncologyNeoplasmsPractice Guidelines as TopicPredictive Value of TestsQuality of Health CareQuality of LifeResearch Support as TopicSocieties, MedicalTime FactorsTreatment OutcomeUnited StatesConceptsClinical cancer researchClinical OncologyAmerican SocietyCancer treatmentScreening—A ReportPatients 40 yearsThird of patientsCancer researchCourse of diseaseCancer mortality ratesHealth care accessClinical research programNational Cancer InstituteHigh-quality careClinical research projectsSite of originClinical research enterpriseHigh-quality treatmentPatients' qualityPersonalized cancer medicineASCO'S PRESIDENTCare accessCancer InstituteMortality ratePatient care
2008
Breast surgery in stage IV breast cancer: impact of staging and patient selection on overall survival
Bafford AC, Burstein HJ, Barkley CR, Smith BL, Lipsitz S, Iglehart JD, Winer EP, Golshan M. Breast surgery in stage IV breast cancer: impact of staging and patient selection on overall survival. Breast Cancer Research And Treatment 2008, 115: 7-12. PMID: 18581232, DOI: 10.1007/s10549-008-0101-7.Peer-Reviewed Original ResearchConceptsStage IV breast cancerOverall survivalBreast cancerStage IV breast carcinomaMedian overall survivalDatabase of patientsAdverse predictorsHer2neu statusUnderwent mastectomySurgery groupLiver metastasesMedian survivalMetastatic diseaseBreast surgeryTherapeutic surgeryBreast carcinomaNS groupRetrospective analysisStaging factorsSurgerySurvivalWomenPatientsMultivariate survivalCancerRisk Perceptions and Psychosocial Outcomes of Women With Ductal Carcinoma In Situ: Longitudinal Results From a Cohort Study
Partridge A, Adloff K, Blood E, Dees EC, Kaelin C, Golshan M, Ligibel J, de Moor JS, Weeks J, Emmons K, Winer E. Risk Perceptions and Psychosocial Outcomes of Women With Ductal Carcinoma In Situ: Longitudinal Results From a Cohort Study. Journal Of The National Cancer Institute 2008, 100: 243-251. PMID: 18270338, DOI: 10.1093/jnci/djn010.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAnxietyBreast NeoplasmsCarcinoma, Intraductal, NoninfiltratingCohort StudiesDepressionFemaleHumansLogistic ModelsLongitudinal StudiesMammographyMass ScreeningMassachusettsMiddle AgedNeoplasm Recurrence, LocalOdds RatioPredictive Value of TestsPrognosisQuality of LifeRisk AssessmentRisk FactorsConceptsLocal recurrence rateRecurrence ratePsychosocial outcomesDuctal carcinomaModerate riskCancer-related risksFavorable overall prognosisSystemic recurrence ratesBreast-conserving treatmentBreast cancer riskDCIS diagnosisCohort studyDCIS recurrenceOverall prognosisDisease recurrenceInvasive cancerDCISCancer riskPsychosocial concernsHealth behaviorsEnrollment surveySubstantial anxietyWomenInaccurate perceptionsModerate likelihood
2007
Predictors of Resistance to Preoperative Trastuzumab and Vinorelbine for HER2-Positive Early Breast Cancer
Harris LN, You F, Schnitt SJ, Witkiewicz A, Lu X, Sgroi D, Ryan PD, Come SE, Burstein HJ, Lesnikoski BA, Kamma M, Friedman PN, Gelman R, Iglehart JD, Winer EP. Predictors of Resistance to Preoperative Trastuzumab and Vinorelbine for HER2-Positive Early Breast Cancer. Clinical Cancer Research 2007, 13: 1198-1207. PMID: 17317830, DOI: 10.1158/1078-0432.ccr-06-1304.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDoxorubicinDrug Resistance, NeoplasmFemaleGenes, erbB-2HumansMalePredictive Value of TestsPreoperative CareReceptor, ErbB-2TrastuzumabVinblastineVinorelbineConceptsPathologic complete responsePreoperative trastuzumabBreast cancerClinical responseComplete responseStage II/III breast cancerHER2-positive early breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Clinical complete responseEarly breast cancerGrowth factor receptor 2Estrogen receptor statusPositive breast cancerPredictors of responseBasal-like phenotypeInsulin-like growthFactor receptor 2Predictors of resistanceReceptor membrane expressionExtremes of responseGrowth factor pathwaysLow response rateGrowth factor receptorPreoperative treatment
2006
Molecular subtypes of breast cancer in relation to paclitaxel response and outcomes in women with metastatic disease: results from CALGB 9342
Harris LN, Broadwater G, Lin NU, Miron A, Schnitt SJ, Cowan D, Lara J, Bleiweiss I, Berry D, Ellis M, Hayes DF, Winer EP, Dressler L. Molecular subtypes of breast cancer in relation to paclitaxel response and outcomes in women with metastatic disease: results from CALGB 9342. Breast Cancer Research 2006, 8: r66. PMID: 17129383, PMCID: PMC1797029, DOI: 10.1186/bcr1622.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerTriple-negative tumorsOverall survivalBreast cancerP53 statusNegative tumorsHER2 statusHormone receptorsHormone receptor statusShorter median timeDoses of paclitaxelLonger overall survivalHER2-positive tumorsAfrican American patientsHormone receptor expressionPrimary tumor tissuesAdvanced diseaseMetastatic diseaseShorter OSReceptor statusMedian timeTreatment failureShorter survivalCaucasian patientsPathology reports
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
1998
Testing for the BRCA1 and BRCA2 Breast-Ovarian Cancer Susceptibility Genes
Tengs TO, Winer EP, Paddock S, Aguilar-Chavez O, Berry DA. Testing for the BRCA1 and BRCA2 Breast-Ovarian Cancer Susceptibility Genes. Medical Decision Making 1998, 18: 365-375. PMID: 10372578, DOI: 10.1177/0272989x9801800402.Peer-Reviewed Original ResearchAdultAgedBreast NeoplasmsDecision Support TechniquesFemaleGenes, BRCA1Genes, Tumor SuppressorGenetic Predisposition to DiseaseGenetic TestingHumansIncidenceMarkov ChainsMastectomyMiddle AgedOvarian NeoplasmsOvariectomyPredictive Value of TestsQuality-Adjusted Life YearsRisk AssessmentSurvival AnalysisUnited States