2023
Nodal positivity and systemic therapy among patients with clinical T1–T2N0 human epidermal growth factor receptor‐positive breast cancer: Results from two international cohorts
Weiss A, Martínez‐Sáez O, Waks A, Laws A, McGrath M, Tarantino P, Portnow L, Winer E, Rey M, Tapia M, Prat A, Partridge A, Tolaney S, Cejalvo J, Mittendorf E, King T. Nodal positivity and systemic therapy among patients with clinical T1–T2N0 human epidermal growth factor receptor‐positive breast cancer: Results from two international cohorts. Cancer 2023, 129: 1836-1845. PMID: 36951169, DOI: 10.1002/cncr.34750.Peer-Reviewed Original ResearchMeSH KeywordsAxillaBreast NeoplasmsChemotherapy, AdjuvantFemaleHepatitis CHumansLymph Node ExcisionLymph NodesNeoadjuvant TherapySentinel Lymph Node BiopsyConceptsHER2-positive breast cancerNeoadjuvant chemotherapyUpfront surgeryNodal positivityBreast cancerTumor sizeALND ratesCT1c tumorsTreatment strategiesSmall human epidermal growth factor receptor 2Lymph node dissection ratesReceptor-positive breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Clinical T1-T2Lymph node positiveHER2-positive patientsGrowth factor receptor 2Optimal treatment strategyFactor receptor 2Nodal statusSystemic therapyNode positiveAxillary imagingPositive tumors
2022
Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials
Pagani O, Walley B, Fleming G, Colleoni M, Láng I, Gomez H, Tondini C, Burstein H, Goetz M, Ciruelos E, Stearns V, Bonnefoi H, Martino S, Geyer C, Chini C, Puglisi F, Spazzapan S, Ruhstaller T, Winer E, Ruepp B, Loi S, Coates A, Gelber R, Goldhirsch A, Regan M, Francis P, Group F. Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials. Journal Of Clinical Oncology 2022, 41: 1376-1382. PMID: 36521078, PMCID: PMC10419413, DOI: 10.1200/jco.22.01064.Peer-Reviewed Original ResearchConceptsDistant recurrence-free intervalOvarian function suppressionDisease-free survivalPrimary end pointOverall survivalAdjuvant exemestaneEnd pointBreast cancerReceptor-positive early breast cancerHuman epidermal growth factor receptorClinical trial updateYears of exemestaneOverall survival benefitHigh-risk patientsPremenopausal breast cancerRecurrence-free intervalEarly breast cancerGrade 3 tumorsRisk of recurrenceEpidermal growth factor receptorGrowth factor receptorSOFT trialTreat populationOvarian suppressionPremenopausal womenAdjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT
Francis P, Fleming G, Láng I, Ciruelos E, Bonnefoi H, Bellet M, Bernardo A, Climent M, Martino S, Bermejo B, Burstein H, Davidson N, Geyer C, Walley B, Ingle J, Coleman R, Müller B, Le Du F, Loibl S, Winer E, Ruepp B, Loi S, Colleoni M, Coates A, Gelber R, Goldhirsch A, Regan M, Group F. Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT. Journal Of Clinical Oncology 2022, 41: 1370-1375. PMID: 36493334, PMCID: PMC10419521, DOI: 10.1200/jco.22.01065.Peer-Reviewed Original ResearchConceptsOvarian function suppressionDisease-free survivalAdjuvant endocrine therapyPrimary end pointOverall survivalAdjuvant tamoxifenEndocrine therapyEnd pointBreast cancerHuman epidermal growth factor receptor-2-negative tumoursTamoxifen plus ovarian function suppressionHormone receptor-positive breast cancerReceptor-positive breast cancerClinical trial updateOvarian Function TrialPremenopausal breast cancerHigher baseline riskPrior chemotherapyPremenopausal womenTrial updateClinical trialsBaseline riskMultiple end pointsTamoxifenExemestaneEfficacy of neoadjuvant chemotherapy in male breast cancer compared with female breast cancer
Leone JP, Hassett MJ, Leone J, Tolaney SM, Vallejo CT, Leone BA, Winer EP, Lin NU. Efficacy of neoadjuvant chemotherapy in male breast cancer compared with female breast cancer. Cancer 2022, 128: 3796-3803. PMID: 36069365, PMCID: PMC9826058, DOI: 10.1002/cncr.34448.Peer-Reviewed Original ResearchConceptsPathologic complete responseFive-year OSNeoadjuvant chemotherapyMale breast cancerBreast cancerTumor subtypesOverall survivalIndependent associationEfficacy of NACInitiation of NACHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2National Cancer DatabaseGrowth factor receptor 2Multivariable logistic regressionFemale breast cancerFactor receptor 2HR-/HER2Complete responseMedian timeMultivariable analysisKaplan-MeierCancer DatabaseReceptor 2Logistic regressionTreatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03).
Mayer EL, Fesl C, Hlauschek D, Garcia-Estevez L, Burstein HJ, Zdenkowski N, Wette V, Miller KD, Balic M, Mayer IA, Cameron D, Winer EP, Ponce Lorenzo JJ, Lake D, Pristauz-Telsnigg G, Haddad TC, Shepherd L, Iwata H, Goetz M, Cardoso F, Traina TA, Sabanathan D, Breitenstein U, Ackerl K, Metzger Filho O, Zehetner K, Solomon K, El-Abed S, Theall KP, Lu DR, Dueck A, Gnant M, DeMichele A. Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03). Journal Of Clinical Oncology 2022, 40: 449-458. PMID: 34995105, PMCID: PMC9851679, DOI: 10.1200/jco.21.01918.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleHumansNeoplasm StagingPiperazinesProtein Kinase InhibitorsPyridinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRisk FactorsTime FactorsConceptsInvasive disease-free survivalAdjuvant endocrine therapyHuman epidermal growth factor receptorEndocrine therapyEpidermal growth factor receptorPalbociclib exposureGrowth factor receptorBreast cancerHormone Receptor-Positive/Human Epidermal Growth Factor ReceptorAddition of palbociclibNovel adjuvant treatmentDisease-free survivalEarly breast cancerFactor receptorOral cancer therapyProtocol analysisPALLAS studyAdjuvant treatmentEarly discontinuationAdjuvant studiesDiscontinuation ratesDose modificationAnalysis populationCDK4/6 inhibitorsDrug persistence
2021
Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer: The Phase III KAITLIN Study
Krop IE, Im SA, Barrios C, Bonnefoi H, Gralow J, Toi M, Ellis PA, Gianni L, Swain SM, Im YH, De Laurentiis M, Nowecki Z, Huang CS, Fehrenbacher L, Ito Y, Shah J, Boulet T, Liu H, Macharia H, Trask P, Song C, Winer EP, Harbeck N. Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer: The Phase III KAITLIN Study. Journal Of Clinical Oncology 2021, 40: 438-448. PMID: 34890214, PMCID: PMC8824393, DOI: 10.1200/jco.21.00896.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalOverall populationTrastuzumab emtansineHigh-risk human epidermal growth factor receptorHuman epidermal growth factor receptor 2End pointEpidermal growth factor receptor 2Early breast cancer treatmentHuman epidermal growth factor receptorAnthracycline-based chemotherapyCoprimary end pointsPrimary end pointDisease-free survivalSerious adverse eventsEarly breast cancerGlobal health statusGrowth factor receptor 2Treatment completion ratesStandard of careBreast cancer treatmentFactor receptor 2Epidermal growth factor receptorGrowth factor receptorEndocrine therapyAdverse eventsAdjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03)
Gnant M, Dueck AC, Frantal S, Martin M, Burstein HJ, Greil R, Fox P, Wolff AC, Chan A, Winer EP, Pfeiler G, Miller KD, Colleoni M, Suga JM, Rubovsky G, Bliss JM, Mayer IA, Singer CF, Nowecki Z, Hahn O, Thomson J, Wolmark N, Amillano K, Rugo HS, Steger GG, de Aránguiz B, Haddad TC, Perelló A, Bellet M, Fohler H, Filho O, Jallitsch-Halper A, Solomon K, Schurmans C, Theall KP, Lu DR, Tenner K, Fesl C, DeMichele A, Mayer EL, groups and investigators O. Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03). Journal Of Clinical Oncology 2021, 40: 282-293. PMID: 34874182, PMCID: PMC10476784, DOI: 10.1200/jco.21.02554.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease ProgressionDisease-Free SurvivalFemaleHumansMastectomyMiddle AgedNeoadjuvant TherapyNeoplasm StagingPiperazinesProgression-Free SurvivalProspective StudiesProtein Kinase InhibitorsPyridinesTime FactorsConceptsHormone receptor-positive breast cancerInvasive disease-free survivalReceptor-positive breast cancerAdjuvant endocrine therapyCancer-free survivalEndocrine therapyEarly breast cancerBreast cancerAdjuvant palbociclibPALLAS trialEnd pointEarly hormone receptor-positive breast cancerBreast cancer-free survivalDistant recurrence-free survivalHuman epidermal growth factor receptorProtocol-defined analysisStandard endocrine therapyPrimary end pointSecondary end pointsAdvanced breast cancerDisease-free survivalNew safety signalsRecurrence-free survivalEvent end pointsCyclin-dependent kinase 4Gene expression signatures for tailoring adjuvant chemotherapy of luminal breast cancer: stronger evidence, greater trust
Piccart M, Kalinsky K, Gray R, Barlow W, Poncet C, Cardoso F, Winer E, Sparano J. Gene expression signatures for tailoring adjuvant chemotherapy of luminal breast cancer: stronger evidence, greater trust. Annals Of Oncology 2021, 32: 1077-1082. PMID: 34082017, DOI: 10.1016/j.annonc.2021.05.804.Peer-Reviewed Original ResearchGenomic 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 cellsUpdated 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 analysisClinical Efficacy and Molecular Response Correlates of the WEE1 Inhibitor Adavosertib Combined with Cisplatin in Patients with Metastatic Triple-Negative Breast Cancer
Keenan TE, Li T, Vallius T, Guerriero JL, Tayob N, Kochupurakkal B, Davis J, Pastorello R, Tahara RK, Anderson L, Conway J, He MX, Shannon E, Godin RE, Sorger PK, D'Andrea A, Overmoyer B, Winer EP, Mittendorf EA, Van Allen EM, Shapiro GI, Tolaney SM. Clinical Efficacy and Molecular Response Correlates of the WEE1 Inhibitor Adavosertib Combined with Cisplatin in Patients with Metastatic Triple-Negative Breast Cancer. Clinical Cancer Research 2021, 27: 983-991. PMID: 33257427, PMCID: PMC7887044, DOI: 10.1158/1078-0432.ccr-20-3089.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerObjective response rateTriple-negative breast cancerWEE1 inhibitor adavosertibPrior linesClinical benefitBreast cancerMedian progression-free survivalTreatment-related grade 3One-sided type I errorImmune-infiltrated tumorsPhase II studyProgression-free survivalT cell infiltrationImmune gene expressionPrior chemotherapyStable diseaseProtocol therapyII studyPartial responseAdverse eventsMedian ageClinical efficacyGrade 3Tumor biopsies
2020
Road Map to Safe and Well-Designed De-escalation Trials of Systemic Adjuvant Therapy for Solid Tumors.
Piccart MJ, Hilbers FS, Bliss JM, Caballero C, Frank ES, Renault P, Naït Kaoudjt R, Schumacher E, Spears PA, Regan MM, Gelber RD, Davidson NE, Norton L, Winer EP. Road Map to Safe and Well-Designed De-escalation Trials of Systemic Adjuvant Therapy for Solid Tumors. Journal Of Clinical Oncology 2020, 38: 4120-4129. PMID: 33052755, DOI: 10.1200/jco.20.01382.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsChemotherapy, AdjuvantHumansNeoplasmsRandomized Controlled Trials as TopicConceptsDe-escalation trialsNorth American Breast Cancer GroupBreast International GroupTreatment de-escalation trialsSystemic adjuvant therapySystemic adjuvant treatmentBreast cancer groupNoninferiority trial designAdjuvant trialsAdjuvant therapyAdjuvant treatmentCancer groupDifferent cancer typesPatient insightPatient's perspectiveEffective treatmentConsensus articleTrial designSolid tumorsField of cancerEnd pointFinancial toxicityCancer typesTrialsAdverse effectsOncotype DX testing in node-positive breast cancer strongly impacts chemotherapy use at a comprehensive cancer center
Losk K, Freedman RA, Laws A, Kantor O, Mittendorf EA, Tan-Wasielewski Z, Trippa L, Lin NU, Winer EP, King TA. Oncotype DX testing in node-positive breast cancer strongly impacts chemotherapy use at a comprehensive cancer center. Breast Cancer Research And Treatment 2020, 185: 215-227. PMID: 32939592, DOI: 10.1007/s10549-020-05931-9.Peer-Reviewed Original ResearchMeSH KeywordsBreast NeoplasmsChemotherapy, AdjuvantFemaleGene Expression ProfilingHumansNeoplasm Recurrence, LocalReceptors, EstrogenRiskConceptsRecurrence-free survivalPN1 breast cancerRecurrence scoreChemotherapy useBreast cancerOverall survivalChemotherapy receiptPN1 patientsRS testingUse of RSNode-positive breast cancerOncotype DX recurrence scoreAdjuvant chemotherapy receiptLow genomic riskNode-positive diseaseAdjuvant treatment decisionsLow recurrence scoreShort-term outcomesMultivariate logistic regressionComprehensive cancer centerDX recurrence scoreOncotype DX testingChemotherapy omissionPT1-2N0Upfront surgeryClinical 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 analysisA Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials
Amiri-Kordestani L, Xie D, Tolaney SM, Bloomquist E, Tang S, Ibrahim A, Goldberg KB, Theoret MR, Pazdur R, Sridhara R, Winer EP, Beaver JA. A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials. Annals Of Oncology 2020, 31: 1704-1708. PMID: 32866625, DOI: 10.1016/j.annonc.2020.08.2106.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalEarly breast cancerHER2-positive early breast cancerTH armOverall survivalAdjuvant paclitaxelTrastuzumab trialsReceptor statusLow-risk early breast cancerHuman epidermal growth factor receptor 2Positive early breast cancerPropensity scoreEpidermal growth factor receptor 2De-escalate therapyDisease-free survivalGrowth factor receptor 2Progesterone receptor statusSingle-arm studyEstrogen receptor statusSingle-arm trialPatient-level dataFactor receptor 2Drug Administration analysisCovariates of ageHistorical clinical trials
2019
Adjuvant Chemotherapy for Older Patients With Breast Cancer: When Is the Pain Worth the Gain?
Freedman RA, Winer EP. Adjuvant Chemotherapy for Older Patients With Breast Cancer: When Is the Pain Worth the Gain? Journal Of The National Cancer Institute 2019, 112: 551-552. PMID: 31612212, PMCID: PMC7301071, DOI: 10.1093/jnci/djz192.Peer-Reviewed Original ResearchA phase II feasibility study of palbociclib in combination with adjuvant endocrine therapy for hormone receptor-positive invasive breast carcinoma
Mayer EL, DeMichele A, Rugo HS, Miller K, Waks AG, Come SE, Mulvey T, Jeselsohn R, Overmoyer B, Guo H, Barry WT, Bartlett C, Koehler M, Winer EP, Burstein HJ. A phase II feasibility study of palbociclib in combination with adjuvant endocrine therapy for hormone receptor-positive invasive breast carcinoma. Annals Of Oncology 2019, 30: 1514-1520. PMID: 31250880, DOI: 10.1093/annonc/mdz198.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalEstradiolFeasibility StudiesFemaleFulvestrantHumansMiddle AgedNeoplasm InvasivenessNeoplasm StagingPiperazinesProtein Kinase InhibitorsPyridinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneConceptsEarly breast cancerEndocrine therapyAdjuvant palbociclibBreast cancerHormone receptor-positive/HER2-negative metastatic breast cancerHER2-negative metastatic breast cancerPhase II feasibility studyProlong progression-free survivalRandomized phase III trialAdjuvant endocrine therapyPrimary end pointStage III diseasePhase II trialPhase III trialsProgression-free survivalMetastatic breast cancerYears of therapyStart of treatmentInvasive breast carcinomaEligible patientsFebrile neutropeniaPrior chemotherapyWeeks on/1II trialCumulative incidencePre- and Postoperative Neratinib for HER2-Positive Breast Cancer Brain Metastases: Translational Breast Cancer Research Consortium 022
Freedman RA, Gelman RS, Agar NYR, Santagata S, Randall EC, Lopez B, Connolly RM, Dunn IF, Van Poznak CH, Anders CK, Melisko ME, Silvestri K, Cotter CM, Componeschi KP, Marte JM, Moy B, Blackwell KL, Puhalla SL, Ibrahim N, Moynihan TJ, Nangia J, Tung N, Burns R, Rimawi MF, Krop IE, Wolff AC, Winer EP, Lin NU, Consortium T. Pre- and Postoperative Neratinib for HER2-Positive Breast Cancer Brain Metastases: Translational Breast Cancer Research Consortium 022. Clinical Breast Cancer 2019, 20: 145-151.e2. PMID: 31558424, PMCID: PMC7035200, DOI: 10.1016/j.clbc.2019.07.011.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAntineoplastic Combined Chemotherapy ProtocolsBrainBrain NeoplasmsBreastBreast NeoplasmsChemotherapy, AdjuvantCraniotomyDrug Administration ScheduleFemaleHumansMiddle AgedNeoadjuvant TherapyPilot ProjectsQuinolinesReceptor, ErbB-2Tissue DistributionTreatment OutcomeConceptsCentral nervous system penetrationCerebrospinal fluidBrain metastasesStudy treatmentDisease progressionHER2-positive breast cancer brain metastasesHER2-positive metastatic breast cancerHER2-positive brain metastasesBreast cancer brain metastasesGrade 3 diarrheaCancer brain metastasesMetastatic breast cancerCentral nervous systemResected tumor tissueBlood-based analysesNeratinib monotherapyPostoperative cyclesParenchymal tumorsStudy protocolBreast cancerTumor histopathologyPatientsNervous systemSmall cohortSurgical tissuesRandomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial.
Muss HB, Polley MC, Berry DA, Liu H, Cirrincione CT, Theodoulou M, Mauer AM, Kornblith AB, Partridge AH, Dressler LG, Cohen HJ, Kartcheske PA, Perez EA, Wolff AC, Gralow JR, Burstein HJ, Mahmood AA, Sutton LM, Magrinat G, Parker BA, Hart RD, Grenier D, Hurria A, Jatoi A, Norton L, Hudis CA, Winer EP, Carey L. Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial. Journal Of Clinical Oncology 2019, 37: 2338-2348. PMID: 31339827, PMCID: PMC6900836, DOI: 10.1200/jco.19.00647.Peer-Reviewed Original ResearchConceptsRecurrence-free survivalStandard adjuvant chemotherapyEarly breast cancerAdjuvant chemotherapyAge 65 yearsStandard chemotherapyBreast cancerOlder womenBreast cancer-specific survival ratesSurvival rateHormone receptor-negative diseaseHormone receptor-negative patientsHormone receptor-positive patientsCancer-specific survival ratesPatients age 65 yearsWomen age 65 yearsReceptor-negative patientsReceptor-positive patientsOverall survival benefitPrimary end pointReceptor-negative diseaseOverall survival rateAdaptive Bayesian designNonbreast cancersRFS ratesLocal–regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial)
Bellon JR, Guo H, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Hudis CA, Krop I, Burstein HJ, Winer EP, Tolaney SM. Local–regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial). Breast Cancer Research And Treatment 2019, 176: 303-310. PMID: 31004299, DOI: 10.1007/s10549-019-05238-4.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerLocal-regional recurrenceDisease-free survivalEffective anti-HER2 therapyLRR-free survivalAnti-HER2 therapyBreast-conserving surgeryBreast cancerRadiation therapySystemic therapyHormone receptor-positive tumorsProspective multi-institutional studyHER2-negative diseaseHER2-positive diseaseNegative axillary nodesEffective systemic therapyProspective multicenter trialEarly-stage patientsKaplan-Meier methodReceptor-positive tumorsHER2-positive tumorsMulti-institutional studyFuture investigational effortsAdjuvant trastuzumabProtocol therapy