2024
RNA-Seq based gene expression profiling of baseline and on-treatment breast tumors to predict response to HER2-directed therapy, without chemotherapy (TBCRC026).
Hennessy M, Fernández A, Huang C, Cimino-Mathews A, Denbow R, Abramson V, Rimawi M, Specht J, Storniolo A, Valero V, Vaklavas C, Winer E, Krop I, Wolff A, Wahl R, Thompson E, Stearns V, Perou C, Carey L, Connolly R. RNA-Seq based gene expression profiling of baseline and on-treatment breast tumors to predict response to HER2-directed therapy, without chemotherapy (TBCRC026). Journal Of Clinical Oncology 2024, 42: 530-530. DOI: 10.1200/jco.2024.42.16_suppl.530.Peer-Reviewed Original ResearchRelapse-free survivalB cell signaturesGene expression signaturesHER2-directed therapyPET/CT parametersER-negativeHER2 subtypeClinical outcomesEarly stage HER2-positive breast cancerResponse to HER2-directed therapyAssociated with lack of responseHER2-positive breast cancerGene expression changesUnivariate logistic regression analysisHER2-positive cohortIncreased immune signalingMetabolic changesAssociated with pCRNatural killer cellsNested Cox modelsLogistic regression analysisWilcoxon signed-rank testHER2 ampliconFDG-PET/CTHER2- tumorsAssociation of higher baseline stress and pain with clinical outcomes: Secondary analysis from Alliance A011502.
Gandhi S, Ballman K, Holmes M, Visvanathan K, Symington B, Carvan M, Matyka C, Weiss A, Winer E, Razaq W, Carey L, Partridge A, Chen W. Association of higher baseline stress and pain with clinical outcomes: Secondary analysis from Alliance A011502. Journal Of Clinical Oncology 2024, 42: 11016-11016. DOI: 10.1200/jco.2024.42.16_suppl.11016.Peer-Reviewed Original ResearchInvasive disease-free survivalBrief Pain InventoryPerceived Stress ScaleOverall survivalPittsburgh Sleep Quality IndexMultivariate Cox modelClinical outcomesBreast cancerCESD-RClinical trialsAssociated with worse clinical outcomesDouble-blind clinical trialCox modelBrief Pain Inventory scoresHormone receptor statusDisease-free survivalEpidemiologic Studies Depression Scale-RevisedCenter for Epidemiologic Studies Depression Scale-RevisedHigher Perceived Stress ScaleBody mass indexNonmetastatic breast cancerSleep qualityCESD-R scoresPerceived Stress Scale scoresPittsburgh Sleep Quality Index score
2023
Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study
Schmid P, Lipatov O, Im S, Goncalves A, Muñoz-Couselo E, Lee K, Tamura K, Testa L, Witzel I, Ohtani S, Turner N, Zambelli S, Harbeck N, Andre F, Dent R, Mejia J, Zhou X, Haiderali A, Nguyen A, Cortes J, Winer E. Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study. European Journal Of Cancer 2023, 195: 113393. PMID: 37976633, DOI: 10.1016/j.ejca.2023.113393.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerCombined positive scoreMetastatic triple-negative breast cancerPD-L1 combined positive scoreHealth-related qualityBreast cancerQLQ-C30 functional scalesTumor PD-L1 expressionGHS/QoLNausea/vomitingPD-L1 expressionStart of treatmentHRQoL resultsEligible patientsHRQoL analysisOverall survivalSystemic therapyClinical outcomesFunctional scalesPhysician's choicePatientsChemotherapyFirst onsetCountry guidelinesMedian TTD190MO Association of 18-Gene expression profile (GEP) with clinical outcomes in patients with metastatic triple-negative breast cancer (mTNBC) treated with pembrolizumab (Pembro) or chemotherapy (Chemo) in KEYNOTE-119
Cortés J, Lipatov O, Im S, Gonçalves A, Lee K, Schmid P, Tamura K, Testa L, Ohtani S, Harbeck N, Loi S, Salgado R, Lunceford J, Karantza V, Mejia J, Cristescu R, Nebozhyn M, Jelinic P, Huang L, Winer E. 190MO Association of 18-Gene expression profile (GEP) with clinical outcomes in patients with metastatic triple-negative breast cancer (mTNBC) treated with pembrolizumab (Pembro) or chemotherapy (Chemo) in KEYNOTE-119. ESMO Open 2023, 8: 101379. DOI: 10.1016/j.esmoop.2023.101379.Peer-Reviewed Original ResearchAssociation Between Biomarkers and Clinical Outcomes of Pembrolizumab Monotherapy in Patients With Metastatic Triple-Negative Breast Cancer: KEYNOTE-086 Exploratory Analysis
Loi S, Salgado R, Schmid P, Cortes J, Cescon D, Winer E, Toppmeyer D, Rugo H, De Laurentiis M, Nanda R, Iwata H, Awada A, Tan A, Sun Y, Karantza V, Wang A, Huang L, Saadatpour A, Cristescu R, Yearley J, Lunceford J, Jelinic P, Adams S. Association Between Biomarkers and Clinical Outcomes of Pembrolizumab Monotherapy in Patients With Metastatic Triple-Negative Breast Cancer: KEYNOTE-086 Exploratory Analysis. JCO Precision Oncology 2023, 7: e2200317. PMID: 37099733, DOI: 10.1200/po.22.00317.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerClinical outcomesPembrolizumab monotherapyPD-L1Metastatic diseaseGEP signaturesBreast cancerStromal tumor-infiltrating lymphocytesT-cell-inflamed gene expression profileExploratory biomarker analysisMore systemic therapiesPD-L1 CPSTumor PD-L1PD-L1 statusTumor-infiltrating lymphocytesImproved clinical outcomesTumor mutational burdenSignature 3Mutational signature 3Cohort BDifferentiation 8Systemic therapyCohort ACombined cohort
2022
Surrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer
Conforti F, Pala L, Bagnardi V, De Pas T, Colleoni M, Buyse M, Hortobagyi G, Gianni L, Winer E, Loibl S, Cortes J, Piccart M, Wolff AC, Viale G, Gelber RD. Surrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer. JAMA Oncology 2022, 8: 1668-1675. PMID: 36201176, DOI: 10.1001/jamaoncol.2022.3755.Peer-Reviewed Original ResearchConceptsSurrogate end pointsPathologic complete responseEarly breast cancerBreast cancerEnd pointComplete responseClinical outcomesClinical benefitEvent-free survival dataLong-term patient outcomesReliable surrogate end pointsTrial levelPatient clinical benefitPatients' clinical outcomesAccelerated approval processNeoadjuvant RCTNeoadjuvant therapyPatient survivalClinical trialsDrug regulatory policyEffective therapyPathological responsePatient outcomesPatient levelDrug effectsCirculating Tumor DNA and Late Recurrence in High-Risk Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer
Lipsyc-Sharf M, de Bruin EC, Santos K, McEwen R, Stetson D, Patel A, Kirkner GJ, Hughes ME, Tolaney SM, Partridge AH, Krop IE, Knape C, Feger U, Marsico G, Howarth K, Winer EP, Lin NU, Parsons HA. Circulating Tumor DNA and Late Recurrence in High-Risk Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer. Journal Of Clinical Oncology 2022, 40: 2408-2419. PMID: 35658506, PMCID: PMC9467679, DOI: 10.1200/jco.22.00908.Peer-Reviewed Original ResearchConceptsMinimal residual diseaseWhole-exome sequencingClinical recurrenceMetastatic recurrenceBreast cancerEarly-stage hormone receptor-positive breast cancerHormone receptor-positive breast cancerTumor tissueHigh-risk stage IIReceptor-positive breast cancerTumor DNAHuman epidermal growth factor receptorDistant metastatic recurrenceHormone receptor positiveMRD-positive patientsPlasma samplesTime of consentPrimary tumor tissuesSufficient tumor tissueEpidermal growth factor receptorAdjuvant settingGrowth factor receptorLocal recurrenceClinical outcomesDistant metastasisCirculating tumor DNA (ctDNA) and late recurrence in high-risk, hormone receptor–positive, HER2-negative breast cancer (CHiRP).
Lipsyc-Sharf M, De Bruin E, Santos K, McEwen R, Stetson D, Patel A, Kirkner G, Hughes M, Tolaney S, Krop I, Knape C, Feger U, Marsico G, Howarth K, Winer E, Lin N, Parsons H. Circulating tumor DNA (ctDNA) and late recurrence in high-risk, hormone receptor–positive, HER2-negative breast cancer (CHiRP). Journal Of Clinical Oncology 2022, 40: 103-103. DOI: 10.1200/jco.2022.40.16_suppl.103.Peer-Reviewed Original ResearchMinimal residual diseaseDistant metastatic recurrenceAdjuvant endocrine therapyWhole-exome sequencingEndocrine therapyMetastatic recurrenceClinical outcomesBreast cancerHormone receptor-positive breast cancerPlasma samplesTumor tissueHER2-negative breast cancerReceptor-positive breast cancerTumor DNACtDNA detectionRegular surveillance imagingStage 3 diseaseCurative intent chemotherapyTime of consentPrimary tumor tissuesCurrent practice standardsSufficient tumor tissueLiquid biopsy testsAdjuvant settingCtDNA dynamics
2021
PD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel–Treated Advanced Triple-Negative Breast Cancer
Rugo HS, Loi S, Adams S, Schmid P, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Winer EP, Kockx MM, Peeters D, Chui SY, Lin JC, Nguyen-Duc A, Viale G, Molinero L, Emens LA. PD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel–Treated Advanced Triple-Negative Breast Cancer. Journal Of The National Cancer Institute 2021, 113: 1733-1743. PMID: 34097070, PMCID: PMC8634452, DOI: 10.1093/jnci/djab108.Peer-Reviewed Original ResearchConceptsNab-paclitaxelPD-L1Metastatic triple-negative breast cancer patientsAdvanced triple-negative breast cancerAnalytical concordanceTriple-negative breast cancer patientsTriple-negative breast cancerDouble-positive casesCombined positive scorePD-L1 statusPD-L1 assaysBreast cancer patientsSingle positive caseMore patientsSP263 assaysClinical outcomesClinical benefitCancer patientsClinical activityBreast cancerSP142SP263PatientsPhase IIIPositive scoreTemporal and spatial topography of cell proliferation in cancer.
Kabraji S, Gaglia G, Argyropoulou D, Dai Y, Wang S, Bergholz J, Coy S, Lin J, Jeselsohn R, Metzger O, Winer E, Dillon D, Zhao J, Sorger P, Santagata S. Temporal and spatial topography of cell proliferation in cancer. Journal Of Clinical Oncology 2021, 39: 3122-3122. DOI: 10.1200/jco.2021.39.15_suppl.3122.Peer-Reviewed Original ResearchCell cycle stateCancer cellsBreast cancerTumor-infiltrating immune cellsDisease-free survivalCell cycle protein expressionCell proliferationDormant cancer cellsCancer cell proliferationQuiescent cancer cellsCycle stateCancer stem cellsSame primary tumorNeoadjuvant therapyProliferative cancer cellsAdjuvant therapyClinical outcomesColorectal cancerPrimary tumorImmune cellsUntreated tumorsDiverse tumor typesUnique tumorProliferation indexProliferative indexThe impact of tumor epithelial and microenvironmental heterogeneity on treatment responses in HER2-positive breast cancer
Janiszewska M, Stein S, Filho O, Eng J, Kingston NL, Harper NW, Rye IH, Alečković M, Trinh A, Murphy KC, Marangoni E, Cristea S, Oakes B, Winer EP, Krop I, Russnes HG, Spellman PT, Bucher E, Hu Z, Chin K, Gray JW, Michor F, Polyak K. The impact of tumor epithelial and microenvironmental heterogeneity on treatment responses in HER2-positive breast cancer. JCI Insight 2021, 6: e147617. PMID: 33886505, PMCID: PMC8262355, DOI: 10.1172/jci.insight.147617.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBreast NeoplasmsClass I Phosphatidylinositol 3-KinasesDNA Copy Number VariationsDrug Resistance, NeoplasmEpithelial CellsFemaleFibroblastsHumansMacrophagesMiddle AgedMutationNeoplasm TransplantationReceptor, ErbB-2TrastuzumabTumor MicroenvironmentVesicular Transport ProteinsConceptsBreast cancerTherapeutic resistanceHuman epidermal growth factor receptor 2HER2-positive breast cancerEpidermal growth factor receptor 2Patient-derived xenograft modelsLymphatic vessel endothelial hyaluronan receptorHER2-targeted therapiesGrowth factor receptor 2Impact of tumorFibroblastic reticular cellsFactor receptor 2Tumor epithelial cellsIntratumor heterogeneityDivergent cellular phenotypesResistance-conferring mutationsClinical outcomesPIK3CA mutationsTreatment responseClinical challengeDifferent therapiesFrequency of cellsXenograft modelReceptor 2Stromal determinants
2020
Effect of Exercise or Metformin on Biomarkers of Inflammation in Breast and Colorectal Cancer: A Randomized Trial
Brown JC, Zhang S, Ligibel JA, Irwin ML, Jones LW, Campbell N, Pollak MN, Sorrentino A, Cartmel B, Harrigan M, Tolaney SM, Winer EP, Ng K, Abrams TA, Sanft T, Douglas PS, Hu FB, Fuchs CS, Meyerhardt JA. Effect of Exercise or Metformin on Biomarkers of Inflammation in Breast and Colorectal Cancer: A Randomized Trial. Cancer Prevention Research 2020, 13: 1055-1062. PMID: 32859615, PMCID: PMC7718298, DOI: 10.1158/1940-6207.capr-20-0188.Peer-Reviewed Original ResearchConceptsHs-CRPColorectal cancerPhysical activityHigh-sensitivity C-reactive proteinLow baseline physical activitySurvivors of breastTrial product estimandBaseline physical activityBiomarkers of inflammationC-reactive proteinMeasures of inflammationImproved clinical outcomesEffects of exerciseType 2 diabetesCombination of exerciseStandard therapyClinical outcomesCancer recurrenceObservational studyTreatment groupsInflammation outcomesMetforminIL6Factorial trialInflammationTumour mutational burden and clinical outcomes with first-line atezolizumab and nab-paclitaxel in triple-negative breast cancer: Exploratory analysis of the phase III IMpassion130 trial
Emens L, Molinero L, Adams S, Rugo H, Schneeweiss A, Diéras V, Iwata H, Barrios C, Nechaeva M, Winer E, Chang C, Chui S, Schmid P, Loi S. Tumour mutational burden and clinical outcomes with first-line atezolizumab and nab-paclitaxel in triple-negative breast cancer: Exploratory analysis of the phase III IMpassion130 trial. Annals Of Oncology 2020, 31: s360-s361. DOI: 10.1016/j.annonc.2020.08.398.Peer-Reviewed Original ResearchAssociation of tumor mutational burden (TMB) and clinical outcomes with pembrolizumab (pembro) versus chemotherapy (chemo) in patients with metastatic triple-negative breast cancer (mTNBC) from KEYNOTE-119.
Winer E, Lipatov O, Im S, Goncalves A, Muñoz-Couselo E, Lee K, Schmid P, Testa L, Witzel I, Ohtani S, Lunceford J, Karantza V, Mejia J, Cristescu R, Aurora-Garg D, Jelinic P, Huang L, Cortes J. Association of tumor mutational burden (TMB) and clinical outcomes with pembrolizumab (pembro) versus chemotherapy (chemo) in patients with metastatic triple-negative breast cancer (mTNBC) from KEYNOTE-119. Journal Of Clinical Oncology 2020, 38: 1013-1013. DOI: 10.1200/jco.2020.38.15_suppl.1013.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerTumor mutational burdenMut/MbClinical outcomesTriple-negative breast cancerChemo-treated patientsPrior systemic treatmentThird-line settingOverall study populationNumber of patientsTwo-sided p valuePD-L1 enrichmentReceiver operator characteristic analysisEstimates of efficacyOperator characteristic analysisP-valueFoundationOne CDxBaseline characteristicsMetastatic diseaseSystemic treatmentPotential positive associationTreatment armsClinical benefitCox regressionBreast cancer
2017
Seven-year (yr) follow-up of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC).
Tolaney S, Barry W, Guo H, Dillon D, Dang C, Yardley D, Moy B, Marcom P, Albain K, Rugo H, Ellis M, Shapira I, Wolff A, Carey L, Overmoyer B, Partridge A, Hudis C, Krop I, Burstein H, Winer E. Seven-year (yr) follow-up of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC). Journal Of Clinical Oncology 2017, 35: 511-511. DOI: 10.1200/jco.2017.35.15_suppl.511.Peer-Reviewed Original ResearchBreast cancer-specific survivalDisease-free survivalRecurrence-free intervalBreast cancerDistant recurrenceOverall survivalTumor sizeNew contralateral breast cancerHER2-positive breast cancerNode-negative HER2Cancer-specific survivalPhase II studyContralateral breast cancerAdjuvant paclitaxelAPT trialNodal micrometastasisPrimary endpointProtocol therapyAdjuvant therapyDFS eventsII studyDisease recurrenceRegional recurrenceSpecific survivalClinical outcomes
2015
Phase II Study of Lapatinib in Combination With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: Clinical Outcomes and Predictive Value of Early [18F]Fluorodeoxyglucose Positron Emission Tomography Imaging (TBCRC 003)
Lin NU, Guo H, Yap JT, Mayer IA, Falkson CI, Hobday TJ, Dees EC, Richardson AL, Nanda R, Rimawi MF, Ryabin N, Najita JS, Barry WT, Arteaga CL, Wolff AC, Krop IE, Winer EP, Van den Abbeele AD. Phase II Study of Lapatinib in Combination With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: Clinical Outcomes and Predictive Value of Early [18F]Fluorodeoxyglucose Positron Emission Tomography Imaging (TBCRC 003). Journal Of Clinical Oncology 2015, 33: 2623-2631. PMID: 26169615, PMCID: PMC4534525, DOI: 10.1200/jco.2014.60.0353.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCohort StudiesFemaleFluorodeoxyglucose F18HumansLapatinibMiddle AgedNeoplasm MetastasisPositron-Emission TomographyQuinazolinesReceptor, ErbB-2TrastuzumabTreatment OutcomeConceptsMetastatic breast cancerHuman epidermal growth factor receptorClinical benefit rateEpidermal growth factor receptorObjective response rateProgression-free survivalGrowth factor receptorClinical outcomesWeek 1Cohort 2Benefit rateCohort 1Breast cancerFactor receptorPredictive valueResponse rateConfirmed objective response rateMedian progression-free survivalEnd pointPhase II studyPrimary end pointSecondary end pointsSelection of patientsToxicity of chemotherapyPET/CTGenomic Analysis Reveals That Immune Function Genes Are Strongly Linked to Clinical Outcome in the North Central Cancer Treatment Group N9831 Adjuvant Trastuzumab Trial
Perez EA, Thompson EA, Ballman KV, Anderson SK, Asmann YW, Kalari KR, Eckel-Passow JE, Dueck AC, Tenner KS, Jen J, Fan JB, Geiger XJ, McCullough AE, Chen B, Jenkins RB, Sledge GW, Winer EP, Gralow JR, Reinholz MM. Genomic Analysis Reveals That Immune Function Genes Are Strongly Linked to Clinical Outcome in the North Central Cancer Treatment Group N9831 Adjuvant Trastuzumab Trial. Journal Of Clinical Oncology 2015, 33: 701-708. PMID: 25605861, PMCID: PMC4334774, DOI: 10.1200/jco.2014.57.6298.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalDNA, NeoplasmFemaleGene Expression Regulation, NeoplasticGenomicsHumansKaplan-Meier EstimateMiddle AgedMolecular Targeted TherapyProportional Hazards ModelsReceptor, ErbB-2TranscriptomeTrastuzumabConceptsRelapse-free survivalImmune function genesAdjuvant trastuzumab trialsArm BTrastuzumab trialsHazard ratioArm AHuman epidermal growth factor receptorClinicopathologic risk factorsProportional hazard ratiosEpidermal growth factor receptorGrowth factor receptorAdjuvant trastuzumabC patientsCombination chemotherapyClinical outcomesRisk factorsBreast cancerPatientsTrastuzumabPredictive signatureFunction genesChemotherapyGene enrichmentFactor receptor
2014
Association of genomic analysis of immune function genes and clinical outcome in the NCCTG (Alliance) N9831 adjuvant trastuzumab trial.
Perez E, Thompson E, Anderson S, Asmann Y, Kalari K, Eckel-Passow J, Dueck A, Tenner K, Jen J, Fan J, Geiger X, McCullough A, Chen B, Zschunke M, Jenkins R, Sledge G, Winer E, Gralow J, Reinholz M, Ballman K. Association of genomic analysis of immune function genes and clinical outcome in the NCCTG (Alliance) N9831 adjuvant trastuzumab trial. Journal Of Clinical Oncology 2014, 32: 509-509. DOI: 10.1200/jco.2014.32.15_suppl.509.Peer-Reviewed Original Research
2012
Human epidermal growth factor receptor-2-positive breast cancer: does estrogen receptor status define two distinct subtypes?
Vaz-Luis I, Winer EP, Lin NU. Human epidermal growth factor receptor-2-positive breast cancer: does estrogen receptor status define two distinct subtypes? Annals Of Oncology 2012, 24: 283-291. PMID: 23022997, PMCID: PMC3551479, DOI: 10.1093/annonc/mds286.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerHER2-positive diseaseEstrogen receptor statusBreast cancerReceptor statusClinical outcomesEpidermal growth factor receptor 2 overexpressionHuman epidermal growth factor receptor 2 (HER2) overexpressionDistinct subtypesFuture clinical trialsEfficacy of therapyMetastatic settingNeoadjuvant therapyMetastatic diseaseER statusSurvival outcomesClinical trialsPatterns of disseminationTherapyCancerDiseaseSubstantial minorityOutcomesSubtypesHeterogeneous entitySix Cycles of Doxorubicin and Cyclophosphamide or Paclitaxel Are Not Superior to Four Cycles As Adjuvant Chemotherapy for Breast Cancer in Women With Zero to Three Positive Axillary Nodes: Cancer and Leukemia Group B 40101
Shulman LN, Cirrincione CT, Berry DA, Becker HP, Perez EA, O'Regan R, Martino S, Atkins JN, Mayer E, Schneider CJ, Kimmick G, Norton L, Muss H, Winer EP, Hudis C. Six Cycles of Doxorubicin and Cyclophosphamide or Paclitaxel Are Not Superior to Four Cycles As Adjuvant Chemotherapy for Breast Cancer in Women With Zero to Three Positive Axillary Nodes: Cancer and Leukemia Group B 40101. Journal Of Clinical Oncology 2012, 30: 4071-4076. PMID: 22826271, PMCID: PMC3494835, DOI: 10.1200/jco.2011.40.6405.Peer-Reviewed Original ResearchConceptsRelapse-free survivalHuman epidermal growth factor receptor 2Primary breast cancerPositive nodesBreast cancerHazard ratioAdjuvant chemotherapyChemotherapy regimenEstrogen receptor/progesterone receptorPrimary efficacy end pointEpidermal growth factor receptor 2Dose-dense fashionDoxorubicin/cyclophosphamideAdjusted hazard ratioCycles of doxorubicinEfficacy end pointOperable breast cancerPositive axillary nodesER/PgRGrowth factor receptor 2Factor receptor 2Chemotherapy regimensAxillary nodesMenopausal statusClinical outcomes