2023
Effect of a telephone-based weight loss intervention (WLI) on weight at 12-months in women with early breast cancer: Results from the Breast Cancer Weight Loss (BWEL) trial.
Ligibel J, Ballman K, McCall L, Goodwin P, Weiss A, Delahanty L, Alfano C, Crane T, Neuhouser M, Spears P, Hershman D, Paskett E, Hopkins J, Bernstein V, Stearns V, White J, Wadden T, Winer E, Partridge A, Carey L. Effect of a telephone-based weight loss intervention (WLI) on weight at 12-months in women with early breast cancer: Results from the Breast Cancer Weight Loss (BWEL) trial. Journal Of Clinical Oncology 2023, 41: 12001-12001. DOI: 10.1200/jco.2023.41.16_suppl.12001.Peer-Reviewed Original ResearchWeight loss interventionBody mass indexEarly breast cancerWeight loss trialBreast cancerHealth educationTumor factorsWeight lossLoss trialHER2-negative breast cancerInvasive disease-free survivalTelephone-based health coachingBreast cancer ptsBaseline body weightDisease-free survivalMeaningful weight lossMonths of diagnosisPoor prognostic factorTime of diagnosisBreast cancer patientsSignificant weight lossMultivariable regression modelsRace/ethnicityCancer ptsEligible pts
2022
ASO Visual Abstract: Expanding Staging Criteria in T1–2N0 Hormone Receptor-Positive Breast Cancer Patients Enrolled in TAILORx
Kantor O, Burstein HJ, King TA, Shak S, Russell CA, Giuliano AE, Hortobagyi GN, Winer EP, Korde LA, Sparano JA, Mittendorf EA. ASO Visual Abstract: Expanding Staging Criteria in T1–2N0 Hormone Receptor-Positive Breast Cancer Patients Enrolled in TAILORx. Annals Of Surgical Oncology 2022, 29: 8024-8025. DOI: 10.1245/s10434-022-12294-6.Peer-Reviewed Original ResearchExpanding the Staging Criteria for T1-2N0 Hormone-Receptor Positive Breast Cancer Patients Enrolled in TAILORx
Kantor O, Burstein HJ, King TA, Shak S, Russell CA, Giuliano AE, Hortobagyi GN, Winer EP, Korde LA, Sparano JA, Mittendorf EA. Expanding the Staging Criteria for T1-2N0 Hormone-Receptor Positive Breast Cancer Patients Enrolled in TAILORx. Annals Of Surgical Oncology 2022, 29: 8016-8023. PMID: 35900648, DOI: 10.1245/s10434-022-12225-5.Peer-Reviewed Original ResearchConceptsRecurrence-free intervalBreast cancer patientsRecurrence scoreTAILORx trialEndocrine therapyCancer patientsHormone receptor-positive breast cancer patientsBackgroundThe American Joint CommitteePositive breast cancer patientsCurrent AJCC staging systemHuman epidermal growth factor receptorBreast Recurrence ScoreKaplan-Meier methodAmerican Joint CommitteeAJCC staging systemEpidermal growth factor receptorGrowth factor receptorMedian followT1-2N0T3 diseasePrognostic stagingStaging systemStaging criteriaBreast cancerResultsThe study
2021
The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention
Delahanty LM, Wadden TA, Goodwin PJ, Alfano CM, Thomson CA, Irwin ML, Neuhouser ML, Crane TE, Frank E, Spears PA, Gillis BP, Hershman DL, Paskett ED, Hopkins J, Bernstein V, Stearns V, White J, Hudis C, Winer EP, Carey L, Partridge AH, Ligibel JA. The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention. Obesity 2021, 30: 28-38. PMID: 34932888, PMCID: PMC9186690, DOI: 10.1002/oby.23287.Peer-Reviewed Original ResearchConceptsWeight loss interventionWeight loss trialLifestyle interventionHealth education materialsWeight lossLoss trialPhysical activityInvasive disease-free survivalDisease-free survivalBreast cancer patientsBreast cancer diagnosisCare of thousandsEducation materialsBaseline weightCancer outcomesCancer patientsHealth coachesCancer recurrenceBreast cancerCaloric restrictionStage IITrialsCancer diagnosisInterventionWomenPhase II trial of veliparib and temozolomide in metastatic breast cancer patients with and without BRCA1/2 mutations
Xu J, Keenan TE, Overmoyer B, Tung NM, Gelman RS, Habin K, Garber JE, Ellisen LW, Winer EP, Goss PE, Yeap BY, Chabner BA, Isakoff SJ. Phase II trial of veliparib and temozolomide in metastatic breast cancer patients with and without BRCA1/2 mutations. Breast Cancer Research And Treatment 2021, 189: 641-651. PMID: 34417675, DOI: 10.1007/s10549-021-06292-7.Peer-Reviewed Original ResearchConceptsObjective response rateClinical benefit rateProgression-free survivalMedian progression-free survivalMetastatic breast cancer patientsPhase II trialMetastatic breast cancerBreast cancer patientsBRCA1/2 carriersBreast cancerExpansion cohortII trialPrimary endpointPrimary cohortCancer patientsBenefit rateBRCA1/2 mutationsDay 1Longer median progression-free survivalSingle-arm phase II trialCommon grade 3Doses of veliparibPlatinum-naïve patientsPrior platinum therapyBRCA mutation carriersCustomizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021
Burstein HJ, Curigliano G, Thürlimann B, Weber WP, Poortmans P, Regan MM, Senn HJ, Winer EP, Gnant M, Conference P, Aebi S, André F, Barrios C, Bergh J, Bonnefoi H, Morales D, Brucker S, Burstein H, Cameron D, Cardoso F, Carey L, Chua B, Ciruelos E, Colleoni M, Curigliano G, Delaloge S, Denkert C, Dubsky P, Ejlertsen B, Fitzal F, Francis P, Galimberti V, Mahmoud H, Garber J, Gnant M, Gradishar W, Gulluoglu B, Harbeck N, Huang C, Huober J, Ilbawi A, Jiang Z, Johnston S, Lee E, Loibl S, Morrow M, Partridge A, Piccart M, Poortmans P, Prat A, Regan M, Rubio I, Rugo H, Rutgers E, Sedlmayer F, Semiglazov V, Senn H, Shao Z, Spanic T, Tesarova P, Thürlimann B, Tjulandin S, Toi M, Trudeau M, Turner N, Luis I, Viale G, Watanabe T, Weber W, Winer E, Xu B. Customizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021. Annals Of Oncology 2021, 32: 1216-1235. PMID: 34242744, PMCID: PMC9906308, DOI: 10.1016/j.annonc.2021.06.023.Peer-Reviewed Original ResearchConceptsEarly-stage breast cancerBreast cancerSystemic therapyEarly breast cancerTime of diagnosisBreast cancer patientsInternational consensus guidelinesBreast cancer riskRadiation oncology providersBreast cancer diagnosisNeoadjuvant therapyMultidisciplinary careOncology providersClinical featuresConsensus guidelinesCancer patientsPatient preferencesTreatment recommendationsTreatment responseCancer riskClinical careClinical informationConsensus conferenceEarly breast cancer diagnosisPatient experiencePD-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 score
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 analysisSerial Analysis of Circulating Tumor Cells in Metastatic Breast Cancer Receiving First-Line Chemotherapy
Magbanua MJM, Hendrix LH, Hyslop T, Barry WT, Winer EP, Hudis C, Toppmeyer D, Carey LA, Partridge AH, Pierga JY, Fehm T, Vidal-Martínez J, Mavroudis D, Garcia-Saenz JA, Stebbing J, Gazzaniga P, Manso L, Zamarchi R, Antelo ML, De Mattos-Arruda L, Generali D, Caldas C, Munzone E, Dirix L, Delson AL, Burstein HJ, Qadir M, Ma C, Scott JH, Bidard FC, Park JW, Rugo HS. Serial Analysis of Circulating Tumor Cells in Metastatic Breast Cancer Receiving First-Line Chemotherapy. Journal Of The National Cancer Institute 2020, 113: 443-452. PMID: 32770247, PMCID: PMC8023821, DOI: 10.1093/jnci/djaa113.Peer-Reviewed Original ResearchConceptsProgression-free survivalFirst-line chemotherapyOverall survivalBaseline CTCsCTC statusPrognostic groupsInferior progression-free survivalMetastatic breast cancer patientsFuture prospective clinical trialsNovel prognostic groupsMetastatic breast cancerProspective clinical trialsRisk stratification strategiesBreast cancer patientsCourse of treatmentMore effective treatmentsUndetectable CTCsMBC patientsHazard ratioPoor outcomePrognostic significanceCox regressionCancer patientsClinical trialsCTC measurementWeathering the Storm: Managing Older Adults With Breast Cancer Amid COVID-19 and Beyond
Freedman RA, Sedrak MS, Bellon JR, Block CC, Lin NU, King TA, Minami C, VanderWalde N, Jolly TA, Muss HB, Winer EP. Weathering the Storm: Managing Older Adults With Breast Cancer Amid COVID-19 and Beyond. Journal Of The National Cancer Institute 2020, 113: 355-359. PMID: 32449757, PMCID: PMC7313961, DOI: 10.1093/jnci/djaa079.Peer-Reviewed Original ResearchConceptsOlder patientsBreast cancerSevere acute respiratory syndrome coronavirus 2 exposureTreatment-related toxicityMultidisciplinary treatment approachBreast cancer patientsUnique clinical considerationsCOVID-19Chemotherapy toxicityMetastatic diseaseTreatment delayCancer patientsFunctional statusCare considerationsTreatment decisionsFunctional declineTherapeutic benefitTreatment prioritiesClinical considerationsTreatment approachesPatientsOlder adultsCOVID-19 pandemicCancerToxicityABC trial (A011502): A randomized phase III double-blinded placebo-controlled trial of aspirin as adjuvant therapy breast cancer.
Chen W, Winer E, Ballman K, Partridge A, Carey L, Carvan M, Matyka C, Openshaw T, Visvanathan K, Symington B, Holmes M. ABC trial (A011502): A randomized phase III double-blinded placebo-controlled trial of aspirin as adjuvant therapy breast cancer. Journal Of Clinical Oncology 2020, 38: tps600-tps600. DOI: 10.1200/jco.2020.38.15_suppl.tps600.Peer-Reviewed Original ResearchInvasive disease-free survivalAspirin usersCardiovascular diseaseBreast cancerHER2-negative breast cancer patientsBlinded placebo-controlled trialHER2-negative breast cancerNegative breast cancer patientsRandomized phase IIIRegular aspirin usersPlacebo-controlled trialDisease-free survivalHormone receptor statusDouble-blinded fashionMonths of diagnosisBreast cancer survivorsTime of presentationBody mass indexBreast cancer patientsTherapy-Breast CancerBreast cancer survivalMultiple epidemiologic studiesNegative breast cancerAnti-tumor effectsDaily aspirinTBCRC 048: A phase II study of olaparib monotherapy in metastatic breast cancer patients with germline or somatic mutations in DNA damage response (DDR) pathway genes (Olaparib Expanded).
Tung N, Robson M, Ventz S, Santa-Maria C, Marcom P, Nanda R, Shah P, Ballinger T, Yang E, Melisko M, Brufsky A, Vinayak S, Demeo M, Jenkins C, Domchek S, Wulf G, Krop I, Wolff A, Winer E, Garber J. TBCRC 048: A phase II study of olaparib monotherapy in metastatic breast cancer patients with germline or somatic mutations in DNA damage response (DDR) pathway genes (Olaparib Expanded). Journal Of Clinical Oncology 2020, 38: 1002-1002. DOI: 10.1200/jco.2020.38.15_suppl.1002.Peer-Reviewed Original ResearchReversion and non-reversion mechanisms of resistance to PARP inhibitor or platinum chemotherapy in BRCA1/2-mutant metastatic breast cancer
Waks AG, Cohen O, Kochupurakkal B, Kim D, Dunn CE, Buendia J, Wander S, Helvie K, Lloyd MR, Marini L, Hughes ME, Freeman SS, Ivy SP, Geradts J, Isakoff S, LoRusso P, Adalsteinsson VA, Tolaney SM, Matulonis U, Krop IE, D’Andrea A, Winer EP, Lin NU, Shapiro GI, Wagle N. Reversion and non-reversion mechanisms of resistance to PARP inhibitor or platinum chemotherapy in BRCA1/2-mutant metastatic breast cancer. Annals Of Oncology 2020, 31: 590-598. PMID: 32245699, PMCID: PMC7946408, DOI: 10.1016/j.annonc.2020.02.008.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerPlatinum chemotherapyDNA-damaging therapyMechanisms of resistanceBreast cancerMetastatic breast cancer patientsBreast cancer patientsTumor DNA sequencingNovel sequence alterationsWhole-exome sequencingDNA-damaging therapiesTreatment failureCancer patientsFunctional statusDisease progressionTumor biopsiesClinical cohortImmunohistochemical stainingSubsequent linesBRCA1/2 mutationsTherapeutic benefitPatientsUseful biomarkerFunctional assessmentTumor sections
2019
A phase II study of cabozantinib alone or in combination with trastuzumab in breast cancer patients with brain metastases
Leone JP, Duda DG, Hu J, Barry WT, Trippa L, Gerstner ER, Jain RK, Tan S, Lawler E, Winer EP, Lin NU, Tolaney SM. A phase II study of cabozantinib alone or in combination with trastuzumab in breast cancer patients with brain metastases. Breast Cancer Research And Treatment 2019, 179: 113-123. PMID: 31541381, DOI: 10.1007/s10549-019-05445-z.Peer-Reviewed Original ResearchConceptsBreast cancer brain metastasesObjective response rateCNS objective response ratePhase II studyCohort 2Cohort 1BCBM patientsBrain metastasesII studyCohort 3Central nervous system (CNS) objective response rateMost common grade 3/4 adverse eventsCommon grade 3/4 adverse eventsSingle-arm phase II studyGrade 3/4 adverse eventsSecondary objectiveTolerability of cabozantinibWhole brain radiationCancer brain metastasesProgression-free survivalBreast cancer patientsTumor blood volumeCabozantinib 60RECIST 1.1STie-2Phase II trial of AKT inhibitor MK-2206 in patients with advanced breast cancer who have tumors with PIK3CA or AKT mutations, and/or PTEN loss/PTEN mutation
Xing Y, Lin NU, Maurer MA, Chen H, Mahvash A, Sahin A, Akcakanat A, Li Y, Abramson V, Litton J, Chavez-MacGregor M, Valero V, Piha-Paul SA, Hong D, Do KA, Tarco E, Riall D, Eterovic AK, Wulf GM, Cantley LC, Mills GB, Doyle LA, Winer E, Hortobagyi GN, Gonzalez-Angulo AM, Meric-Bernstam F. Phase II trial of AKT inhibitor MK-2206 in patients with advanced breast cancer who have tumors with PIK3CA or AKT mutations, and/or PTEN loss/PTEN mutation. Breast Cancer Research 2019, 21: 78. PMID: 31277699, PMCID: PMC6612080, DOI: 10.1186/s13058-019-1154-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBiomarkersBreast NeoplasmsClass I Phosphatidylinositol 3-KinasesDrug MonitoringFemaleHeterocyclic Compounds, 3-RingHigh-Throughput Nucleotide SequencingHumansImmunohistochemistryMiddle AgedMutationNeoplasm MetastasisNeoplasm StagingProtein Kinase InhibitorsProto-Oncogene Proteins c-aktTreatment OutcomeConceptsObjective response ratePeripheral blood mononuclear cellsPlatelet-rich plasmaAdvanced breast cancerPhase II trialPre-treatment biopsiesBreast cancerAKT inhibitor MKAKT1 mutationsPTEN lossII trialPIK3CA mutationsPIK3CA/AKT1 mutationsAdvanced breast cancer patientsInhibitor MKTriple-negative breast cancerMethodsThe primary endpointPIK3CA/AKT1Common adverse eventsPre-treated patientsProgression-free survivalResultsTwenty-seven patientsBreast cancer patientsBlood mononuclear cellsPTEN mutationsClinical significance of circulating tumor cells (CTCs) in hormone receptor-positive (HR+) metastatic breast cancer (MBC) patients (pts) receiving letrozole (Let) or Let plus bevacizumab (Bev): CALGB 40503 (Alliance).
Magbanua M, Oleksandr Savenkov O, Asmus E, Ballman K, Scott J, Park J, Dickler M, Partridge A, Carey L, Winer E, Rugo H. Clinical significance of circulating tumor cells (CTCs) in hormone receptor-positive (HR+) metastatic breast cancer (MBC) patients (pts) receiving letrozole (Let) or Let plus bevacizumab (Bev): CALGB 40503 (Alliance). Journal Of Clinical Oncology 2019, 37: 1049-1049. DOI: 10.1200/jco.2019.37.15_suppl.1049.Peer-Reviewed Original ResearchProgression-free survivalOverall survivalCTC statusHormone receptor-positive metastatic breast cancer patientsPredictive valueLonger median progression-free survivalImproved progression-free survivalMedian progression-free survivalMetastatic breast cancer patientsWorse progression-free survivalAddition of BevFirst-line therapyCox regression analysisEarly breast cancerInitiation of treatmentBreast cancer patientsPotential predictive valueML of bloodMetastatic diseaseMultivariable analysisCancer patientsClinical significanceBreast cancerUS FDATumor cellsABC trial (A011502): A randomized phase III double-blinded placebo controlled trial of aspirin as adjuvant therapy breast cancer.
Chen W, Winer E, Ballman K, Partridge A, Carey L, Carvan M, Matyka C, Visvanathan K, Symington B, Holmes M. ABC trial (A011502): A randomized phase III double-blinded placebo controlled trial of aspirin as adjuvant therapy breast cancer. Journal Of Clinical Oncology 2019, 37: tps599-tps599. DOI: 10.1200/jco.2019.37.15_suppl.tps599.Peer-Reviewed Original ResearchInvasive disease-free survivalAspirin usersCardiovascular diseaseBreast cancerHER2-negative breast cancer patientsHER2-negative breast cancerNegative breast cancer patientsRandomized phase IIIRegular aspirin usersTrial of aspirinDisease-free survivalHormone receptor statusDouble-blinded fashionMonths of diagnosisBreast cancer survivorsTime of presentationBody mass indexBreast cancer patientsTherapy-Breast CancerBreast cancer survivalMultiple epidemiologic studiesNegative breast cancerAnti-tumor effectsDaily aspirinIDFS events
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
Immune biomarkers and treatment (tx) outcome in hormone receptor-positive (HR+) breast cancer (BC) patients (pts) treated with preoperative chemotherapy (preop chemo) plus bevacizumab (bev).
Waks A, Barry W, Gjini E, Dillon D, Rodig S, Brock J, Baltay M, Savoie J, Stover D, Winer E, Krop I, Tolaney S. Immune biomarkers and treatment (tx) outcome in hormone receptor-positive (HR+) breast cancer (BC) patients (pts) treated with preoperative chemotherapy (preop chemo) plus bevacizumab (bev). Journal Of Clinical Oncology 2017, 35: e12134-e12134. DOI: 10.1200/jco.2017.35.15_suppl.e12134.Peer-Reviewed Original ResearchTumor-infiltrating lymphocytesTPD-L1Miller-PaynePathologic responseImmune biomarkersHormone receptor-positive breast cancer patientsReceptor-positive breast cancer patientsPanCancer Immune Profiling PanelResidual cancer burden scorePathologic complete responsePD-L1 expressionBreast cancer patientsPD-L1 scoresImmune Profiling PanelImportant clinical implicationsPreoperative chemotherapyComplete responseProspective trialTumor-immune interactionsBurden scoreCancer patientsImmune microenvironmentUnadjusted analysesTumor gradeTreatment outcomesFrailty and long-term mortality of older breast cancer patients: CALGB 369901 (Alliance)
Mandelblatt JS, Cai L, Luta G, Kimmick G, Clapp J, Isaacs C, Pitcher B, Barry W, Winer E, Sugarman S, Hudis C, Muss H, Cohen HJ, Hurria A. Frailty and long-term mortality of older breast cancer patients: CALGB 369901 (Alliance). Breast Cancer Research And Treatment 2017, 164: 107-117. PMID: 28364214, PMCID: PMC5479131, DOI: 10.1007/s10549-017-4222-8.Peer-Reviewed Original ResearchConceptsOlder breast cancer patientsLong-term mortalityBreast cancer patientsCancer patientsHormonal therapyRobust patientsFrailty indexBreast cancer-specific mortalityDeficit-accumulation frailty indexAbsolute mortality differencePurposeBreast cancer patientsAdjusted hazard ratioCancer-specific mortalityBreast cancer deathsInvasive breast cancerBreast cancer mortalityAdjusted hazardFrailty categoriesCause mortalityFrail patientsMore chemotherapyFrailty statusHazard ratioOlder patientsClinical factors