2019
Ribociclib Plus Trastuzumab in Advanced HER2-Positive Breast Cancer: Results of a Phase 1b/2 Trial
Goel S, Pernas S, Tan-Wasielewski Z, Barry WT, Bardia A, Rees R, Andrews C, Tahara RK, Trippa L, Mayer EL, Winer EP, Spring LM, Tolaney SM. Ribociclib Plus Trastuzumab in Advanced HER2-Positive Breast Cancer: Results of a Phase 1b/2 Trial. Clinical Breast Cancer 2019, 19: 399-404. PMID: 31235441, DOI: 10.1016/j.clbc.2019.05.010.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerAdvanced HER2-positive breast cancerProgression-free survivalBreast cancerAdverse eventsObjective responseGrade 3 adverse eventsGrade 4/5 adverse eventsHormone receptor-positive diseaseMedian progression-free survivalAnti-HER2 combinationClinical benefit rateHER2-negative diseasePhase 1b/2 studyPhase 1b/2 trialPrior therapy linesReceptor-positive diseaseAnti-HER2 therapyNew safety concernsCyclin-dependent kinase 4Stable diseaseExpansion cohortMetastatic settingPrior linesQTc prolongation
2017
A mouse-human phase I co-clinical trial of taselisib in combination with TDM1 in advanced HER2-positive breast cancer (MBC).
Metzger Filho O, Goel S, Barry W, Hamilton E, Tolaney S, Yardley D, Rees R, Demeo M, Mills C, Hafner M, Winer E, Zhao J, Krop I. A mouse-human phase I co-clinical trial of taselisib in combination with TDM1 in advanced HER2-positive breast cancer (MBC). Journal Of Clinical Oncology 2017, 35: 1030-1030. DOI: 10.1200/jco.2017.35.15_suppl.1030.Peer-Reviewed Original ResearchPhase Ib studyT-DM1Co-clinical trialsIb studyAdvanced HER2-positive breast cancerT-DM1-resistant cellsHER2-positive breast cancerPR/CRAcceptable safety profileAnti-HER2 therapyPI3K blockadePre-clinical experimentsConfirmed responsesMedian PFSPJP prophylaxisMedian durationMedian agePIK3CA H1047RPIK3CA statusSafety profilePneumocystis pneumoniaHER2 expressionClinical resultsMammary carcinomaBreast cancer
2014
Long-Term Follow-Up After Preoperative Trastuzumab and Chemotherapy for HER2-Overexpressing Breast Cancer
Mayer EL, Gropper AB, Harris L, Gold JM, Parker L, Kuter I, Come S, Najita JS, Guo H, Winer EP, Burstein HJ. Long-Term Follow-Up After Preoperative Trastuzumab and Chemotherapy for HER2-Overexpressing Breast Cancer. Clinical Breast Cancer 2014, 15: 24-30. PMID: 25205424, DOI: 10.1016/j.clbc.2014.07.010.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleFollow-Up StudiesHumansMastectomyMiddle AgedNeoadjuvant TherapyPreoperative PeriodReceptor, ErbB-2TrastuzumabTreatment OutcomeUp-RegulationConceptsHER2-positive breast cancerLong-term outcomesBreast cancerSymptomatic cardiotoxicityNeoadjuvant chemotherapyCardiotoxic agentsAdvanced HER2-positive breast cancerAnthracycline-based adjuvant chemotherapyFavorable long-term survivalPhase II neoadjuvant trialBreast cancer-related deathsHER2-positive diseaseMinimal late toxicityPaclitaxel/trastuzumabTreatment-related toxicityLong-term efficacyCancer-related deathLong-term survivalLong-term RFSAdjuvant chemotherapyEligible patientsLate cardiotoxicityNeoadjuvant HER2Neoadjuvant trastuzumabNeoadjuvant trials
2013
Pertuzumab: Optimizing HER2 Blockade
Metzger-Filho O, Winer EP, Krop I. Pertuzumab: Optimizing HER2 Blockade. Clinical Cancer Research 2013, 19: 5552-5556. PMID: 23942091, DOI: 10.1158/1078-0432.ccr-13-0518.Peer-Reviewed Original ResearchConceptsBreast cancerAdvanced HER2-positive breast cancerHER2-positive breast cancerRecombinant humanized monoclonal antibodyAddition of pertuzumabTrastuzumab/pertuzumabPhase III studyProgression-free survivalFirst-line treatmentMetastatic breast cancerRisk of mortalityHumanized monoclonal antibodyHeterodimerization of HER2EGF receptorMechanism of actionHER2 blockadeIII studyClinical dataHER familyHER2-HER3 heterodimersPertuzumabDrug AdministrationMonoclonal antibodiesU.S. FoodHER2-HER3Clinicopathological Features Among Patients With Advanced Human Epidermal Growth Factor–2-Positive Breast Cancer With Prolonged Clinical Benefit to First-Line Trastuzumab-Based Therapy: A Retrospective Cohort Study
Vaz-Luis I, Seah D, Olson EM, Wagle N, Metzger-Filho O, Sohl J, Litsas G, Burstein HJ, Krop IE, Winer EP, Lin NU. Clinicopathological Features Among Patients With Advanced Human Epidermal Growth Factor–2-Positive Breast Cancer With Prolonged Clinical Benefit to First-Line Trastuzumab-Based Therapy: A Retrospective Cohort Study. Clinical Breast Cancer 2013, 13: 254-263. PMID: 23829891, PMCID: PMC4084778, DOI: 10.1016/j.clbc.2013.02.010.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Agents, HormonalBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, LobularChemotherapy, AdjuvantFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingPractice Patterns, Physicians'PrognosisReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRetrospective StudiesSurvival RateTamoxifenYoung AdultConceptsTrastuzumab-based therapyFirst-line trastuzumab-based therapyAdvanced HER2-positive breast cancerHER2-positive breast cancerAdjuvant trastuzumabBreast cancerClinicopathological featuresClinical benefitC-statisticHuman epidermal growth factor-2-positive breast cancerTreatment durationPredictive valueHormone receptor-positive tumorsLong-term clinical benefitPrevious adjuvant trastuzumabTreatment duration groupsRetrospective cohort studyDisease-free intervalHormone receptor positivityReceptor-positive tumorsDuration of treatmentMagnitude of benefitLow predictive valueLogistic regression modelsDifferent logistic regression models