2021
ALEXANDRA/IMpassion030: A phase 3 study of standard adjuvant chemotherapy with or without atezolizumab in patients with early-stage triple-negative breast cancer.
Saji S, McArthur H, Ignatiadis M, Bailey A, El-Abed S, Brandao M, Metzger O, Lai C, Guillaume S, Fumagalli D, Agbor-tarh D, Seiller A, Xifro R, Honvault V, Viale G, DuFrane C, Barata T, Winer E, Gelber R, Piccart-Gebhart M. ALEXANDRA/IMpassion030: A phase 3 study of standard adjuvant chemotherapy with or without atezolizumab in patients with early-stage triple-negative breast cancer. Journal Of Clinical Oncology 2021, 39: tps597-tps597. DOI: 10.1200/jco.2021.39.15_suppl.tps597.Peer-Reviewed Original ResearchTriple-negative breast cancerInvasive disease-free survivalEarly-stage triple-negative breast cancerPD-L1Breast cancerAdjuvant chemotherapyStage triple-negative breast cancerMetastatic triple-negative breast cancerPD-L1 negative tumorsF. Hoffmann-La Roche LtdBreast International GroupOperable stage IIRandomized phase 3Same chemotherapy regimenStandard adjuvant chemotherapyCentral pathology reviewDisease-free survivalPD-L1 statusPhase 3 studyPhase 3 trialType of surgeryNegative breast cancerQuality of lifeAtezolizumab 1200Weekly paclitaxelGenomic features of rapid versus late relapse in triple negative breast cancer
Zhang Y, Asad S, Weber Z, Tallman D, Nock W, Wyse M, Bey JF, Dean KL, Adams EJ, Stockard S, Singh J, Winer EP, Lin NU, Jiang YZ, Ma D, Wang P, Shi L, Huang W, Shao ZM, Cherian M, Lustberg MB, Ramaswamy B, Sardesai S, VanDeusen J, Williams N, Wesolowski R, Obeng-Gyasi S, Sizemore GM, Sizemore ST, Verschraegen C, Stover DG. Genomic features of rapid versus late relapse in triple negative breast cancer. BMC Cancer 2021, 21: 568. PMID: 34006255, PMCID: PMC8130400, DOI: 10.1186/s12885-021-08320-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultBiomarkers, TumorChemotherapy, AdjuvantDatasets as TopicDisease-Free SurvivalDNA Copy Number VariationsFemaleFollow-Up StudiesGene Expression ProfilingGene Expression Regulation, NeoplasticHumansLogistic ModelsMastectomyMiddle AgedModels, GeneticMutationNeoadjuvant TherapyNeoplasm Recurrence, LocalPrognosisRisk AssessmentTime FactorsTriple Negative Breast NeoplasmsConceptsLate relapseRapid relapseImmune signaturesBreast cancerAnti-tumor CD8 T cellsBackgroundTriple-negative breast cancerTriple-negative breast cancerCD8 T cellsTumor mutation burdenIndependent validation cohortNegative breast cancerFisher's exact testPearson's chi-squared testChi-squared testLogistic regression modelsLuminal signaturePrimary TNBCTNBC subsetImmune subsetsClinical featuresValidation cohortWhole-genome copy numberPrimary tumorM1 macrophagesT cells
2020
Response to neoadjuvant chemotherapy and the 21-gene breast recurrence score in young women with estrogen receptor-positive early breast cancer.
Sella T, Gelber S, Poorvu P, Kim H, Guzman Arocho Y, Collins L, Ruddy K, Tamimi R, Peppercorn J, Schapira L, Borges V, Come S, Warner E, Snow C, Jakubowski D, Russell C, Winer E, Rosenberg S, Partridge A. Response to neoadjuvant chemotherapy and the 21-gene breast recurrence score in young women with estrogen receptor-positive early breast cancer. Journal Of Clinical Oncology 2020, 38: 514-514. DOI: 10.1200/jco.2020.38.15_suppl.514.Peer-Reviewed Original ResearchPathologic complete responseBreast Recurrence ScoreNeoadjuvant chemotherapyBreast cancerRecurrence scoreBreast Cancer StudyYoung womenHER2- BCEstrogen receptor-positive early breast cancerHER-2 negative breast cancerReceptor-positive early breast cancerYoung Women's Breast Cancer StudyNeoadjuvant endocrine therapyResidual invasive tumorEarly breast cancerPost-menopausal womenNegative breast cancerHigh gradeLogistic regression modelingAdjuvant chemotherapyDuctal histologyPgR negativityEndocrine therapyNeoadjuvant therapyProspective cohortABC 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 aspirin141P Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple negative breast cancer
Schmid P, Haiderali A, Mejia J, Guo Z, Zhou X, Martin-Nguyen A, Cortés J, Winer E. 141P Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple negative breast cancer. Annals Of Oncology 2020, 31: s65-s66. DOI: 10.1016/j.annonc.2020.03.242.Peer-Reviewed Original ResearchTBCRC 031: Randomized Phase II Study of Neoadjuvant Cisplatin Versus Doxorubicin-Cyclophosphamide in Germline BRCA Carriers With HER2-Negative Breast Cancer (the INFORM trial).
Tung N, Arun B, Hacker MR, Hofstatter E, Toppmeyer DL, Isakoff SJ, Borges V, Legare RD, Isaacs C, Wolff AC, Marcom PK, Mayer EL, Lange PB, Goss AJ, Jenkins C, Krop IE, Winer EP, Schnitt SJ, Garber JE. TBCRC 031: Randomized Phase II Study of Neoadjuvant Cisplatin Versus Doxorubicin-Cyclophosphamide in Germline BRCA Carriers With HER2-Negative Breast Cancer (the INFORM trial). Journal Of Clinical Oncology 2020, 38: 1539-1548. PMID: 32097092, PMCID: PMC8462533, DOI: 10.1200/jco.19.03292.Peer-Reviewed Original ResearchConceptsHER2-negative breast cancerTriple-negative breast cancerResidual cancer burden scoreBreast cancerDoxorubicin-cyclophosphamideRisk ratioStage IPathologic complete response rateHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Single-agent cisplatinComplete response ratePhase II studyPhase II trialGrowth factor receptor 2Positive breast cancerNegative breast cancerFactor receptor 2CT1-3II trialII studyNodal involvementPCR rateNegative diseasePathologic response
2019
LBA21 KEYNOTE-119: Phase III study of pembrolizumab (pembro) versus single-agent chemotherapy (chemo) for metastatic triple negative breast cancer (mTNBC)
Cortés J, Lipatov O, Im S, Gonçalves A, Lee K, Schmid P, Tamura K, Testa L, Witzel I, Ohtani S, Zambelli S, Harbeck N, André F, Dent R, Zhou X, Karantza V, Mejia J, Winer E. LBA21 KEYNOTE-119: Phase III study of pembrolizumab (pembro) versus single-agent chemotherapy (chemo) for metastatic triple negative breast cancer (mTNBC). Annals Of Oncology 2019, 30: v859-v860. DOI: 10.1093/annonc/mdz394.010.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerCombined positive scoreSubsidiary of MerckGerman Study GroupDohme Corp.Merck SharpSeattle GeneticsGrade 3Study groupOpen-label phase III studyPD-L1 combined positive scoreEnd pointTriple-negative breast cancerDaiichi SankyoF. Hoffman-La RochePrior systemic treatmentPrimary end pointSecondary end pointsSingle-agent chemotherapyPhase III studyHigh-grade toxicityNegative breast cancerPD-L1 enrichmentTreatment effectsBristol-Myers Squibb289TiP ALEXANDRA/IMpassion030: A phase III study of standard adjuvant chemotherapy with or without atezolizumab in early stage triple negative breast cancer
Ignatiadis M, McArthur H, Bailey A, Martinez J, de Azambuja E, Metzger O, Lai C, Franzoi M, Goulioti T, Daly F, Bouhlel A, Balta V, Maetens M, Viale G, André B, DuFRane C, Nguyen D, Gelber R, Piccart M, Winer E. 289TiP ALEXANDRA/IMpassion030: A phase III study of standard adjuvant chemotherapy with or without atezolizumab in early stage triple negative breast cancer. Annals Of Oncology 2019, 30: v97. DOI: 10.1093/annonc/mdz240.112.Peer-Reviewed Original ResearchTriple-negative breast cancerInvasive disease-free survivalEarly-stage triple-negative breast cancerStage triple-negative breast cancerBreast International GroupNegative breast cancerBreast cancerAdjuvant chemotherapyPD-L1Seattle GeneticsRoche/GenentechMetastatic triple-negative breast cancerRoche-GenentechJules BordetOperable stage IIRandomized phase 3Same chemotherapy regimenStandard adjuvant chemotherapyCentral pathology reviewDisease-free survivalPD-L1 statusPhase 3 trialPhase III studyLymph node statusPD-L1 antibodiesAggressive Subsets of Metastatic Triple Negative Breast Cancer
Singh J, Asad S, Zhang Y, Nock W, Adams E, Damicis A, Ramaswamy B, Williams N, Parsons HA, Adalsteinsson VA, Winer EP, Lin NU, Partridge AH, Overmoyer B, Stover DG. Aggressive Subsets of Metastatic Triple Negative Breast Cancer. Clinical Breast Cancer 2019, 20: e20-e26. PMID: 31631016, DOI: 10.1016/j.clbc.2019.06.012.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerInflammatory breast cancerTriple-negative breast cancerWorse overall survivalYounger patientsOverall survivalBreast cancerIBC groupMetastatic breast cancer subtypesYounger groupFrequent lung metastasisMedian overall survivalSite of metastasisSingle-institution cohortNegative breast cancerBreast cancer subtypesClinicopathologic characteristicsMetastatic diagnosisMetastatic sitesWorse prognosisLung metastasesPoor prognosisSurvival outcomesPrimary diagnosisAggressive subsetABC 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 eventsPassion for immune checkpoint blockade in triple negative breast cancer: Comment on the IMpassion130 study
Kok M, Winer EP, Loi S. Passion for immune checkpoint blockade in triple negative breast cancer: Comment on the IMpassion130 study. Annals Of Oncology 2019, 30: 13-16. PMID: 30351400, DOI: 10.1093/annonc/mdy473.Peer-Reviewed Original Research
2015
Impact of Neoadjuvant Chemotherapy in Stage II–III Triple Negative Breast Cancer on Eligibility for Breast-conserving Surgery and Breast Conservation Rates
Golshan M, Cirrincione CT, Sikov WM, Berry DA, Jasinski S, Weisberg TF, Somlo G, Hudis C, Winer E, Ollila DW. Impact of Neoadjuvant Chemotherapy in Stage II–III Triple Negative Breast Cancer on Eligibility for Breast-conserving Surgery and Breast Conservation Rates. Annals Of Surgery 2015, 262: 434-439. PMID: 26222764, PMCID: PMC4710511, DOI: 10.1097/sla.0000000000001417.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinChemotherapy, AdjuvantDisease-Free SurvivalDoxorubicinFemaleHumansMastectomy, SegmentalMaximum Tolerated DoseMiddle AgedNeoadjuvant TherapyNeoplasm InvasivenessNeoplasm StagingPaclitaxelPatient SelectionPrognosisProspective StudiesSurvival AnalysisTreatment OutcomeTriple Negative Breast NeoplasmsYoung AdultConceptsNeoadjuvant systemic therapyBreast-conserving therapyTriple-negative breast cancerNegative breast cancerSuccessful breast-conserving therapyBCT candidatesBreast cancerStage IIAddition of carboplatinBCT-eligible patientsRandomized phase IIBreast conservation ratesTumor-free marginsBCT eligibilityNeoadjuvant paclitaxelNeoadjuvant chemotherapySystemic therapySurgical outcomesSurgical choiceTumor regressionPatient's discretionFactorial trialPatientsAbsolute increaseCancerTailoring adjuvant chemotherapy regimens for patients with triple negative breast cancer
Stover DG, Winer EP. Tailoring adjuvant chemotherapy regimens for patients with triple negative breast cancer. The Breast 2015, 24: s132-s135. PMID: 26255198, DOI: 10.1016/j.breast.2015.07.032.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerBreast cancerAdjuvant chemotherapyHigh-risk triple negative breast cancerLong-term outcome dataAnthracycline-taxane combinationsBRCA mutation carriersStandard of careNegative breast cancerPoor prognosis subtypeAdjuvant settingStandard regimensToxic regimensMetastatic settingCytotoxic chemotherapySystemic therapyImmune infiltratesTumor characteristicsMutation carriersOutcome dataWarrants further considerationStage ISpecific subgroupsChemotherapyCancer
2014
TBCRC 018: phase II study of iniparib in combination with irinotecan to treat progressive triple negative breast cancer brain metastases
Anders C, Deal AM, Abramson V, Liu MC, Storniolo AM, Carpenter JT, Puhalla S, Nanda R, Melhem-Bertrandt A, Lin NU, Kelly Marcom P, Van Poznak C, Stearns V, Melisko M, Smith JK, Karginova O, Parker J, Berg J, Winer EP, Peterman A, Prat A, Perou CM, Wolff AC, Carey LA. TBCRC 018: phase II study of iniparib in combination with irinotecan to treat progressive triple negative breast cancer brain metastases. Breast Cancer Research And Treatment 2014, 146: 557-566. PMID: 25001612, PMCID: PMC4112043, DOI: 10.1007/s10549-014-3039-y.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBenzamidesBrain NeoplasmsCamptothecinDrug-Related Side Effects and Adverse ReactionsFemaleHumansIrinotecanMiddle AgedNeoplasm StagingReceptor, ErbB-2Survival AnalysisTriple Negative Breast NeoplasmsVascular Endothelial Growth Factor AConceptsTriple-negative breast cancerClinical benefit rateBrain metastasesOverall survivalResponse rateTriple negative breast cancer brain metastasisCommon grade 3/4 adverse eventsAdvanced triple-negative breast cancerGrade 3/4 adverse eventsIntracranial clinical benefit rateBreast cancer brain metastasesGrade 3/4 diarrheaIntracranial response ratesProgressive brain metastasesMedian overall survivalPhase II studyPrimary end pointCancer brain metastasesHalf of patientsHealth-related qualityBRCA germline mutationsTreatment-refractory diseaseBlood-brain barrierNegative breast cancerGermline BRCA1/2 status
2011
PD05-07: Prospective Validation and Characterization of HER2 Positive Circulating Tumor Cells in Patients with HER2 Negative Metastatic Breast Cancer.
Olson E, Flores L, Najita J, Curley C, Jeong J, Murray K, Savoie J, Winer E, Krop I. PD05-07: Prospective Validation and Characterization of HER2 Positive Circulating Tumor Cells in Patients with HER2 Negative Metastatic Breast Cancer. Cancer Research 2011, 71: pd05-07-pd05-07. DOI: 10.1158/0008-5472.sabcs11-pd05-07.Peer-Reviewed Original ResearchHER2-positive CTCsMetastatic breast cancerHER2-negative metastatic breast cancerNegative metastatic breast cancerHER2-negative CTCsER-positive diseasePositive CTCsBreast cancerDetectable CTCsLobular histologyPositive diseaseNegative CTCsHER2 amplificationProspective validationHER2-Positive Circulating Tumor CellsHER2-negative breast cancerCEP17 ratioTumor cellsInitial screeningMajority of ptsNegative breast cancerHER2/CEP17 ratioCirculating Tumor CellsDuctal histologyBaseline characteristics
2010
Does Neoadjuvant Bevacizumab Increase Surgical Complications in Breast Surgery?
Golshan M, Garber JE, Gelman R, Tung N, Smith BL, Troyan S, Greenberg CC, Winer EP, Ryan P. Does Neoadjuvant Bevacizumab Increase Surgical Complications in Breast Surgery? Annals Of Surgical Oncology 2010, 18: 733-737. PMID: 20882415, DOI: 10.1245/s10434-010-1366-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsChemotherapy, AdjuvantCisplatinCombined Modality TherapyFemaleHumansMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalNeoplasm StagingPostoperative ComplicationsReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSentinel Lymph Node BiopsySurvival RateTreatment OutcomeConceptsTriple-negative breast cancerSingle-arm trialNeoadjuvant cisplatinPostoperative complicationsBreast cancerTwo-sided Fisher's exact testExpander/implantsSafety of bevacizumabOperable breast cancerDefinitive local therapyBreast cancer surgeryNegative breast cancerFisher's exact testBackgroundNeoadjuvant chemotherapyNeoadjuvant settingNeoadjuvant therapyProtocol therapySurgical complicationsLocal therapyRelated complicationsCancer surgeryCisplatin therapyBreast surgeryComplicationsPatients
2009
Surgical Complications and the Use of Neoadjuvant Bevacizumab.
Golshan M, Garber J, Gelman R, Tung N, Smith B, Troyan S, Greenberg C, Winer E, Ryan P. Surgical Complications and the Use of Neoadjuvant Bevacizumab. Cancer Research 2009, 69: 43-43. DOI: 10.1158/0008-5472.sabcs-09-43.Peer-Reviewed Original ResearchTriple-negative breast cancerDefinitive local therapyPhase II trialPostoperative complicationsNeoadjuvant cisplatinDefinitive surgeryII trialWound breakdownLocal therapyMedian ageBreast cancerSingle-arm phase II trialArm phase II trialTwo-sided Fisher's exact testClinical stage IIDose-dense ACSafety of bevacizumabOperable breast cancerBreast cancer surgerySingle-arm trialNegative breast cancerFisher's exact testCycles cisplatinNeoadjuvant bevacizumabNeoadjuvant settingNeoadjuvant cisplatin and bevacizumab in triple negative breast cancer (TNBC): Safety and efficacy
Ryan P, Tung N, Isakoff S, Golshan M, Richardson A, Corben A, Smith B, Gelman R, Winer E, Garber J. Neoadjuvant cisplatin and bevacizumab in triple negative breast cancer (TNBC): Safety and efficacy. Journal Of Clinical Oncology 2009, 27: 551-551. DOI: 10.1200/jco.2009.27.15_suppl.551.Peer-Reviewed Original ResearchTriple-negative breast cancerClinical partial responseClinical complete responseNeoadjuvant cisplatinNeoadjuvant therapyPulmonary embolismBreast cancerStable diseaseProgressive diseasePathological responseHearing lossWeeks x 4 cyclesTreatment of TNBCSingle-arm phase II trialArm phase II trialCycles of bevacizumabEfficacy of bevacizumabGrade 4 toxicityComplete pathological responseAddition of bevacizumabPhase II trialMetastatic breast cancerEfficacy of chemotherapyNegative breast cancerTissue-based assays