2022
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).
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
Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial
Tolaney SM, Tayob N, Dang C, Yardley DA, Isakoff SJ, Valero V, Faggen M, Mulvey T, Bose R, Hu J, Weckstein D, Wolff AC, Reeder-Hayes K, Rugo HS, Ramaswamy B, Zuckerman D, Hart L, Gadi VK, Constantine M, Cheng K, Briccetti F, Schneider B, Garrett AM, Marcom K, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu M, Ruddy K, Zheng Y, Rosenberg SM, Gelber RD, Trippa L, Barry W, DeMeo M, Burstein H, Partridge A, Winer EP, Krop I. Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial. Journal Of Clinical Oncology 2021, 39: 2375-2385. PMID: 34077270, DOI: 10.1200/jco.20.03398.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalT-DM1Breast cancerStage IStage I HER2-positive breast cancerHER2-positive breast cancerHuman epidermal growth factor receptorAdjuvant T-DM1Co-primary objectivesDisease-free survivalPatient-reported outcomesEpidermal growth factor receptorGrowth factor receptorProtocol therapyAnalysis populationTrastuzumab emtansineClinical trialsRelevant toxicityPatientsFactor receptorLess toxicityWeeksTrastuzumabCancerPaclitaxel
2018
Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: ASCO Clinical Practice Guideline Update
Ramakrishna N, Temin S, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Giordano SH, Kirshner JJ, Krop IE, Levinson J, Modi S, Patt DA, Perlmutter J, Winer EP, Lin NU. Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: ASCO Clinical Practice Guideline Update. Journal Of Clinical Oncology 2018, 36: jco.2018.79.271. PMID: 29939840, DOI: 10.1200/jco.2018.79.2713.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptorAdvanced breast cancerBrain metastasesBreast cancerEpidermal growth factor receptorGrowth factor receptorSystemic therapyLocal therapyAdvanced human epidermal growth factor receptorASCO Clinical Practice Guideline UpdateHER2-positive advanced breast cancerClinical Practice Guideline UpdateAppropriate local therapyBest supportive careWhole brain radiotherapyProgression-free survivalSize of metastasesFactor receptorExpert panelPresence of symptomsRoutine magnetic resonanceOutcomes of interestStrong quality evidenceMagnetic resonance imagingAdvocacy experts
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
Trastuzumab Plus Adjuvant Chemotherapy for Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Planned Joint Analysis of Overall Survival From NSABP B-31 and NCCTG N9831
Perez EA, Romond EH, Suman VJ, Jeong JH, Sledge G, Geyer CE, Martino S, Rastogi P, Gralow J, Swain SM, Winer EP, Colon-Otero G, Davidson NE, Mamounas E, Zujewski JA, Wolmark N. Trastuzumab Plus Adjuvant Chemotherapy for Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Planned Joint Analysis of Overall Survival From NSABP B-31 and NCCTG N9831. Journal Of Clinical Oncology 2014, 32: 3744-3752. PMID: 25332249, PMCID: PMC4226805, DOI: 10.1200/jco.2014.55.5730.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptorOverall survivalBreast cancerEpidermal growth factor receptorGrowth factor receptorNCCTG N9831NSABP BEarly-Stage Human Epidermal Growth Factor ReceptorHER2-positive operable breast cancerNational Surgical Adjuvant BreastLarge adjuvant trialsOperable breast cancerAddition of trastuzumabAnti-HER2 agentsFactor receptorSurvival end pointsBreast cancer resultsDFS ratesOverall DFSAdjuvant BreastAdjuvant chemotherapyAdjuvant trialsOS ratesMedian timePatient subgroupsA phase II study of eribulin mesylate in combination with trastuzumab and pertuzumab in patients (pts) with metastatic, human epidermal growth factor receptor 2-positive breast cancer.
Freedman R, Luis I, Barry W, Krop I, Wagle N, Lowe A, Galler S, Sohl J, Isakoff S, Tung N, Winer E, Lin N. A phase II study of eribulin mesylate in combination with trastuzumab and pertuzumab in patients (pts) with metastatic, human epidermal growth factor receptor 2-positive breast cancer. Journal Of Clinical Oncology 2014, 32: tps668-tps668. DOI: 10.1200/jco.2014.32.15_suppl.tps668.Peer-Reviewed Original ResearchRecommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: American Society of Clinical Oncology Clinical Practice Guideline
Ramakrishna N, Temin S, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Giordano SH, Gonzalez-Angulo AM, Kirshner JJ, Krop I, Levinson J, Modi S, Patt DA, Perez EA, Perlmutter J, Winer EP, Lin NU. Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: American Society of Clinical Oncology Clinical Practice Guideline. Journal Of Clinical Oncology 2014, 32: 2100-2108. PMID: 24799487, PMCID: PMC6366342, DOI: 10.1200/jco.2013.54.0955.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBrain NeoplasmsBreast NeoplasmsComorbidityConsensusCranial IrradiationDisease ManagementEvidence-Based MedicineFemaleHealth Status DisparitiesHealthcare DisparitiesHumansRadiosurgeryReceptor, ErbB-2Societies, MedicalTreatment OutcomeUnited StatesConceptsMagnetic resonance imagingHuman epidermal growth factor receptorAdvanced breast cancerBrain metastasesBreast cancerEpidermal growth factor receptorGrowth factor receptorSystemic therapyLocal therapyAdvanced human epidermal growth factor receptorHER2-positive advanced breast cancerClinical Oncology Clinical Practice GuidelineExpert consensus-based recommendationsOncology Clinical Practice GuidelineConsensus-based processRoutine magnetic resonance imagingAppropriate local therapyBest supportive careWhole brain radiotherapySize of metastasesFactor receptorClinical practice guidelinesPresence of symptomsConsensus-based recommendationsAmerican Society
2010
Chemotherapy Agents in Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Time to Step Out of the Limelight
Lin NU, Winer EP. Chemotherapy Agents in Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Time to Step Out of the Limelight. Journal Of Clinical Oncology 2010, 29: 251-253. PMID: 21149664, DOI: 10.1200/jco.2010.32.5290.Peer-Reviewed Original Research
2009
Use of BIBW 2992, a Novel Irreversible EGFR/HER1 and HER2 Tyrosine Kinase Inhibitor To Treat Patients with HER2-Positive Metastatic Breast Cancer after Failure of Treatment with Trastuzumab.
Hickish T, Wheatley D, Lin N, Carey L, Houston S, Mendelson D, Solca F, Uttenreuther-Fischer M, Jones H, Winer E. Use of BIBW 2992, a Novel Irreversible EGFR/HER1 and HER2 Tyrosine Kinase Inhibitor To Treat Patients with HER2-Positive Metastatic Breast Cancer after Failure of Treatment with Trastuzumab. Cancer Research 2009, 69: 5060-5060. DOI: 10.1158/0008-5472.sabcs-09-5060.Peer-Reviewed Original ResearchHER2-positive metastatic breast cancerEpidermal growth factor receptorPhase II studyMetastatic breast cancerBIBW 2992Partial responseBreast cancerGrowth factor receptorII studyEastern Cooperative Oncology Group performance statusSingle-arm phase II studyHER2-positive breast cancer patientsTrastuzumab-resistant cell linesHER2-positive breast cancerHER2 tyrosine kinase inhibitorAdequate organ functionCutaneous adverse eventsEarly clinical responseObjective response rateFactor receptorBreast cancer patientsFailure of treatmentTyrosine kinase inhibitorsEligible patientsMeasurable diseaseRefining Therapy for Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: T Stands for Trastuzumab, Tumor Size, and Treatment Strategy
Burstein HJ, Winer EP. Refining Therapy for Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: T Stands for Trastuzumab, Tumor Size, and Treatment Strategy. Journal Of Clinical Oncology 2009, 27: 5671-5673. PMID: 19884535, DOI: 10.1200/jco.2009.24.2222.Peer-Reviewed Original Research
2008
Phase II Trial of Lapatinib for Brain Metastases in Patients With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer
Lin NU, Carey LA, Liu MC, Younger J, Come SE, Ewend M, Harris GJ, Bullitt E, Van den Abbeele AD, Henson JW, Li X, Gelman R, Burstein HJ, Kasparian E, Kirsch DG, Crawford A, Hochberg F, Winer EP. Phase II Trial of Lapatinib for Brain Metastases in Patients With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer. Journal Of Clinical Oncology 2008, 26: 1993-1999. PMID: 18421051, PMCID: PMC4524351, DOI: 10.1200/jco.2007.12.3588.Peer-Reviewed Original ResearchConceptsEpidermal growth factor receptorNon-CNS sitesPrimary end pointBrain metastasesBreast cancerGrowth factor receptorEnd pointAdverse eventsObjective responseAdvanced human epidermal growth factor receptor 2Human epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorBrain tumor burdenProgressive brain metastasesRefractory brain metastasesCommon adverse eventsSecondary end pointsPhase II trialResponse Evaluation CriteriaEfficacy of lapatinibFactor receptorGrowth factor receptor 2Metastatic brain lesionsPositive breast cancer