2022
Results from the phase 1/2 study of patritumab deruxtecan, a HER3-directed antibody-drug conjugate (ADC), in patients with HER3-expressing metastatic breast cancer (MBC).
Krop I, Masuda N, Mukohara T, Takahashi S, Nakayama T, Inoue K, Iwata H, Toyama T, Yamamoto Y, Hansra D, Takahashi M, Osaki A, Koyama K, Inoue T, Yonekura T, Mostillo J, Ohwada S, Tanaka Y, Sternberg D, Yonemori K. Results from the phase 1/2 study of patritumab deruxtecan, a HER3-directed antibody-drug conjugate (ADC), in patients with HER3-expressing metastatic breast cancer (MBC). Journal Of Clinical Oncology 2022, 40: 1002-1002. DOI: 10.1200/jco.2022.40.16_suppl.1002.Peer-Reviewed Original ResearchMetastatic breast cancerAntibody-drug conjugatesAnti-HER3 monoclonal antibodyInvestigational antibody-drug conjugateTopoisomerase I inhibitor payloadWhite blood cell countDose-finding portionGrade 5 eventsMedian treatment durationPhase 1/2 studyInterstitial lung diseaseBlood cell countMedian study durationECOG PSData cutoffDose expansionCentral adjudicationMetastatic diseaseNeutrophil countPrior linesMedian agePhase 1/2Platelet countSafety profileLung disease
2019
Current Landscape of Immunotherapy in Breast Cancer
Adams S, Gatti-Mays ME, Kalinsky K, Korde LA, Sharon E, Amiri-Kordestani L, Bear H, McArthur HL, Frank E, Perlmutter J, Page DB, Vincent B, Hayes JF, Gulley JL, Litton JK, Hortobagyi GN, Chia S, Krop I, White J, Sparano J, Disis ML, Mittendorf EA. Current Landscape of Immunotherapy in Breast Cancer. JAMA Oncology 2019, 5: 1205-1214. PMID: 30973611, PMCID: PMC8452050, DOI: 10.1001/jamaoncol.2018.7147.Peer-Reviewed Original ResearchImmune checkpoint blockadeBreast cancerForm of immunotherapyLocal ablative therapyRobust predictive biomarkersCancer immunotherapy trialsAppropriate end pointsCombination therapy strategiesAdditional chemotherapeutic agentsCheckpoint blockadeMetastatic diseaseObjective responseImmunotherapy trialsClinical efficacyAblative therapyPredictive biomarkersClinical trialsImmune responseThoughtful study designImmunotherapyBreast tumorsChemotherapeutic agentsNarrative reviewCancerEnd point
2018
Unraveling the clinicopathological features driving the emergence of ESR1 mutations in metastatic breast cancer
Kuang Y, Siddiqui B, Hu J, Pun M, Cornwell M, Buchwalter G, Hughes ME, Wagle N, Kirschmeier P, Jänne PA, Paweletz CP, Lin NU, Krop IE, Barry WT, Winer EP, Brown M, Jeselsohn R. Unraveling the clinicopathological features driving the emergence of ESR1 mutations in metastatic breast cancer. Npj Breast Cancer 2018, 4: 22. PMID: 30083595, PMCID: PMC6072793, DOI: 10.1038/s41523-018-0075-5.Peer-Reviewed Original ResearchMetastatic breast cancerESR1 mutationsBreast cancerMetastatic settingClinicopathological featuresPIK3CA mutationsAromatase inhibitorsER-positive metastatic breast cancerDetailed clinical dataSpecific systemic treatmentMetastatic treatmentDistant recurrenceMetastatic diseaseSystemic treatmentPrimary diseaseEndocrine resistanceCDK4/6 inhibitorsPathological featuresFulvestrant treatmentClinical dataPrior treatmentSignificant associationPatientsCancerPrevalence
2013
Prospective clinical experience with research biopsies in breast cancer patients
Vaz-Luis I, Zeghibe CA, Frank ES, Sohl J, Washington KE, Silverman SG, Fonte JM, Mayer EL, Overmoyer BA, Richardson AL, Krop IE, Winer EP, Lin NU. Prospective clinical experience with research biopsies in breast cancer patients. Breast Cancer Research And Treatment 2013, 142: 203-209. PMID: 24113744, PMCID: PMC3825285, DOI: 10.1007/s10549-013-2717-5.Peer-Reviewed Original ResearchConceptsResearch biopsiesAdverse eventsDisease courseMetastatic samplesDana-Farber Cancer InstituteGrade 2 painGrade 3 painProspective clinical experiencePatient's disease courseSingle institution experienceBreast cancer patientsPerformance of biopsyHigh rateAnalytic cohortFirst recurrenceMetastatic diseaseMost patientsPerformance statusReceptor statusPrimary cancerProspective studyCancer patientsBreast cancerPatientsBiopsyProspective clinical experience with research biopsies in breast cancer patients.
Zeghibe C, Luis I, Frank E, Sohl J, Washington K, Silverman S, Fonte J, Mayer E, Overmoyer B, Richardson A, Krop I, Winer E, Lin N. Prospective clinical experience with research biopsies in breast cancer patients. Journal Of Clinical Oncology 2013, 31: e17574-e17574. DOI: 10.1200/jco.2013.31.15_suppl.e17574.Peer-Reviewed Original ResearchResearch biopsiesAdverse eventsBreast cancerCohort 1Cohort 2Grade 2Dana-Farber Cancer InstituteGrade 2 painGrade 3 painProspective clinical experienceSingle institution experienceTime of diagnosisBreast cancer patientsOngoing prospective studyMajority of ptsAcademic medical centerWithdrew consentAnalytic cohortChart reviewFirst recurrenceMetastatic diseasePerformance statusSevere painInstitution experienceProspective studyClinical and translational results of CALGB 40601: A neoadjuvant phase III trial of weekly paclitaxel and trastuzumab with or without lapatinib for HER2-positive breast cancer.
Carey L, Berry D, Ollila D, Harris L, Krop I, Weckstein D, Henry N, Anders C, Cirrincione C, Winer E, Perou C, Hudis C. Clinical and translational results of CALGB 40601: A neoadjuvant phase III trial of weekly paclitaxel and trastuzumab with or without lapatinib for HER2-positive breast cancer. Journal Of Clinical Oncology 2013, 31: 500-500. DOI: 10.1200/jco.2013.31.15_suppl.500.Peer-Reviewed Original ResearchHER2-positive breast cancerBreast pCR ratePathological complete responsePCR rateCALGB 40601Weekly paclitaxelResidual diseaseBreast cancerStage IIClinical stage IIDose-dense ACPhase III trialsProgression-free survivalHER2-targeted agentsBiomarkers of sensitivityGene copy number abnormalitiesTissue-based studiesEligible patientsNeoadjuvant settingNeoadjuvant studiesTH armPrimary endpointIII trialsMetastatic diseaseComplete responseA phase II study of ixabepilone and trastuzumab for metastatic HER2-positive breast cancer
Tolaney SM, Najita J, Sperinde J, Huang W, Chen WY, Savoie J, Fornier M, Winer EP, Bunnell C, Krop IE. A phase II study of ixabepilone and trastuzumab for metastatic HER2-positive breast cancer. Annals Of Oncology 2013, 24: 1841-1847. PMID: 23559151, PMCID: PMC3690910, DOI: 10.1093/annonc/mdt121.Peer-Reviewed Original ResearchConceptsMetastatic HER2-positive breast cancerHER2-positive breast cancerCombination of ixabepilonePhase II studyBreast cancerII studyMetastatic diseaseCohort 2Cohort 1Treatment-related toxic effectsClinical benefit rateSubsequent-line therapyTrastuzumab-containing regimensMetastatic breast cancerPrior chemotherapyLine therapyBenefit rateOverall RRDay 1PatientsTrastuzumabIxabepiloneCancerTumor biomarkersCohort
2011
P1-17-02: A Phase 1/2 Study of SAR245408 (S08) in Combination with Trastuzumab (T) or Paclitaxel (P) and T in Patients with HER2+ Metastatic Breast Cancer (MBC) Who Progressed on a Previous T-Based Regimen.
Tolaney S, Burris H, Gartner E, Mayer I, Saura C, Maurer M, DeCillis A, Ruiz-Soto R, Lager J, Winer E, Krop I. P1-17-02: A Phase 1/2 Study of SAR245408 (S08) in Combination with Trastuzumab (T) or Paclitaxel (P) and T in Patients with HER2+ Metastatic Breast Cancer (MBC) Who Progressed on a Previous T-Based Regimen. Cancer Research 2011, 71: p1-17-02-p1-17-02. DOI: 10.1158/0008-5472.sabcs11-p1-17-02.Peer-Reviewed Original ResearchPhase 1/2 studyMetastatic breast cancerOverall response rateArm 1Arm 2Epigastric painMulticenter phase 1/2 studyPan-PI3K inhibitorECOG PS 0Preliminary PK dataDose-escalation designAge 55 yrPhase 2 portionDifferent dose levelsPhase 1PI3K pathwayDisease refractoryFemale ptsMost HER2Recurrent HER2MBC patientsMetastatic diseaseAdverse eventsPeripheral neuropathyPS 0Ribavirin Treatment Effects on Breast Cancers Overexpressing eIF4E, a Biomarker with Prognostic Specificity for Luminal B-Type Breast Cancer
Pettersson F, Yau C, Dobocan MC, Culjkovic-Kraljacic B, Retrouvay H, Puckett R, Flores LM, Krop IE, Rousseau C, Cocolakis E, Borden KL, Benz CC, Miller WH. Ribavirin Treatment Effects on Breast Cancers Overexpressing eIF4E, a Biomarker with Prognostic Specificity for Luminal B-Type Breast Cancer. Clinical Cancer Research 2011, 17: 2874-2884. PMID: 21415224, PMCID: PMC3086959, DOI: 10.1158/1078-0432.ccr-10-2334.Peer-Reviewed Original ResearchMeSH KeywordsAntimetabolites, AntineoplasticBiomarkers, TumorBreast NeoplasmsCarcinomaCell Line, TumorCells, CulturedEukaryotic Initiation Factor-4EFemaleGene Expression Regulation, NeoplasticGene Knockdown TechniquesHumansMammary Glands, HumanOrgan SpecificityPrognosisRibavirinRNA, Small InterferingUp-RegulationConceptsDistant metastasis-free survivalBreast cancer cell linesBreast cancerCancer cell linesLuminal B type breast cancerNode-negative breast cancerIntrinsic breast cancer subtypesPoor outcome groupMetastasis-free survivalLuminal B casesSpecific molecular subtypesCell proliferationBreast cancer subtypesCell linesBreast cancer cellsSpecific molecular profilePrognostic specificityMetastatic diseasePrognostic valuePrimary tumorCancer therapeutic strategiesOutcome groupSkin biopsiesMolecular subtypesPatient tumors
2010
Phase I Study of Trastuzumab-DM1, an HER2 Antibody-Drug Conjugate, Given Every 3 Weeks to Patients With HER2-Positive Metastatic Breast Cancer
Krop IE, Beeram M, Modi S, Jones SF, Holden SN, Yu W, Girish S, Tibbitts J, Yi JH, Sliwkowski MX, Jacobson F, Lutzker SG, Burris HA. Phase I Study of Trastuzumab-DM1, an HER2 Antibody-Drug Conjugate, Given Every 3 Weeks to Patients With HER2-Positive Metastatic Breast Cancer. Journal Of Clinical Oncology 2010, 28: 2698-2704. PMID: 20421541, DOI: 10.1200/jco.2009.26.2071.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBiopsy, NeedleBone NeoplasmsBreast NeoplasmsDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesHalf-LifeHumansImmunoconjugatesImmunohistochemistryLiver NeoplasmsLung NeoplasmsMaximum Tolerated DoseMaytansineMiddle AgedNeoplasm StagingPatient SelectionReceptor, ErbB-2Risk AssessmentSurvival AnalysisThrombocytopeniaTrastuzumabTreatment OutcomeConceptsMaximum-tolerated doseAdvanced HER2-positive breast cancerHER2-positive breast cancerTrastuzumab-DM1Breast cancerAdverse eventsCommon drug-related adverse eventsHER2-positive metastatic breast cancerDrug-related adverse eventsHER2 antibody-drug conjugatesClinical benefit rateConfirmed response rateSubstantial clinical activityTrastuzumab-based therapyMetastatic breast cancerHER2-positive cellsAntibody-drug conjugatesMeasurable diseaseNeuropathy eventsElevated transaminasesCardiac effectsDose modificationMetastatic diseaseObjective responseReversible toxicity
2009
A phase II study of ixabepilone plus trastuzumab for metastatic HER2-positive breast cancer.
Tolaney S, Najita J, Chen W, Savoie J, Fornier M, Krop I, Winer E, Bunnell C. A phase II study of ixabepilone plus trastuzumab for metastatic HER2-positive breast cancer. Cancer Research 2009, 69: 3137. DOI: 10.1158/0008-5472.sabcs-3137.Peer-Reviewed Original ResearchMetastatic HER2-positive breast cancerHER2-positive breast cancerCombination of ixabepiloneBreast cancerPartial responseCohort 1Response rateMetastatic diseaseCohort 2Clinical benefit rateHigher cardiac toxicityRefractory breast cancerSubsequent-line therapyTrastuzumab-containing regimensCycles of therapyPhase II studyTreatment-related toxicityCohort of patientsEncouraging response ratesMetastatic breast cancerSame treatment regimenOverall response ratePrior chemotherapyStable diseaseElevated transaminases