2024
Datopotamab Deruxtecan in Advanced or Metastatic HR+/HER2– and Triple-Negative Breast Cancer: Results From the Phase I TROPION-PanTumor01 Study
Bardia A, Krop I, Kogawa T, Juric D, Tolcher A, Hamilton E, Mukohara T, Lisberg A, Shimizu T, Spira A, Tsurutani J, Damodaran S, Papadopoulos K, Greenberg J, Kobayashi F, Zebger-Gong H, Wong R, Kawasaki Y, Nakamura T, Meric-Bernstam F. Datopotamab Deruxtecan in Advanced or Metastatic HR+/HER2– and Triple-Negative Breast Cancer: Results From the Phase I TROPION-PanTumor01 Study. Journal Of Clinical Oncology 2024, 42: 2281-2294. PMID: 38652877, PMCID: PMC11210948, DOI: 10.1200/jco.23.01909.Peer-Reviewed Original ResearchTriple-negative BCHR+/HER2- BCBreast cancerHormone receptor-positive/human epidermal growth factor receptor 2-negativeAll-causality treatment-emergent adverse eventsMedian duration of responseTopoisomerase I inhibitor payloadTreatment-emergent adverse eventsBlinded independent central reviewTriple-negative breast cancerDose-expansion studyProgression-free survivalDuration of responsePhase III studyIndependent central reviewTreating solid tumorsPrimary study objectiveAntibody-drug conjugatesDose escalationData cutoffTriple-negativeBC cohortEvaluation of antitumor activityIII studiesMedian duration
2023
186O Patient-reported outcomes (PROs) from DESTINY-Breast02, a randomized phase III study of trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC) in patients (pts) with HER2–positive (HER2+) metastatic breast cancer (mBC)
Fehm T, Cottone F, Dunton K, André F, Krop I, Park Y, De Laurentiis M, Miyoshi Y, Armstrong A, Borrego M, Yerushalmi R, Duhoux F, Takano T, Lu W, Livings C, Egorov A, Kim S. 186O Patient-reported outcomes (PROs) from DESTINY-Breast02, a randomized phase III study of trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC) in patients (pts) with HER2–positive (HER2+) metastatic breast cancer (mBC). ESMO Open 2023, 8: 101375. DOI: 10.1016/j.esmoop.2023.101375.Peer-Reviewed Original Research
2021
42O Biomarker analysis from KAITLIN, a randomised phase III study of adjuvant trastuzumab emtansine (TDM-1; K) plus pertuzumab (P) versus trastuzumab (H) plus taxane (T) plus P after anthracyclines (AC) for high-risk HER2-positive early breast cancer (EBC)
Metzger O, Lambertini C, Krop I, Phillips G, Perou C, Symmans F, Melero I, Harbeck N, Winer E, Im S, Barrios C, Bonnefoi H, Gralow J, Ellis P, Gianni L, Toi M, Swain S, Boulet T, Song C, de Haas S. 42O Biomarker analysis from KAITLIN, a randomised phase III study of adjuvant trastuzumab emtansine (TDM-1; K) plus pertuzumab (P) versus trastuzumab (H) plus taxane (T) plus P after anthracyclines (AC) for high-risk HER2-positive early breast cancer (EBC). Annals Of Oncology 2021, 32: s37-s38. DOI: 10.1016/j.annonc.2021.03.056.Peer-Reviewed Original Research
2020
Primary analysis of KAITLIN: A phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC).
Harbeck N, Im S, Barrios C, Bonnefoi H, Gralow J, Toi M, Ellis P, Gianni L, Swain S, Im Y, De Laurentiis M, Nowecki Z, Shah J, Boulet T, Liu H, Macharia H, Trask P, Song C, Winer E, Krop I. Primary analysis of KAITLIN: A phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC). Journal Of Clinical Oncology 2020, 38: 500-500. DOI: 10.1200/jco.2020.38.15_suppl.500.Peer-Reviewed Original ResearchHER2-positive early breast cancerInvasive disease-free survivalEarly breast cancerPatient-reported outcomesCo-primary endpointsStandard of careT-DM1ITT populationOverall survivalAnthracycline-based chemotherapyOpen-label studyDisease-free survivalPhase III studyWeeks of surgeryHigh-risk populationChemotherapy-associated toxicityAdjuvant taxanesConcurrent trastuzumabEndocrine therapySecondary endpointsAdjuvant radiotherapyAdjuvant therapyIII studyNodal statusMore patients3O Mutation analysis of circulating tumour DNA from baseline and study discontinuation samples in SANDPIPER, a phase III study of taselisib or placebo with fulvestrant in oestrogen receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA-mutant advanced breast cancer
Jacot W, Savage H, Dent S, Cortés J, Im Y, Dieras V, Harbeck N, Krop I, Chen J, Sokol E, Schimmoller F, Hsu J, De Laurentiis M, Wilson T. 3O Mutation analysis of circulating tumour DNA from baseline and study discontinuation samples in SANDPIPER, a phase III study of taselisib or placebo with fulvestrant in oestrogen receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA-mutant advanced breast cancer. Annals Of Oncology 2020, 31: s16. DOI: 10.1016/j.annonc.2020.03.139.Peer-Reviewed Original Research
2019
Genomic correlates of response to adjuvant trastuzumab (H) and pertuzumab (P) in HER2+ breast cancer (BC): Biomarker analysis of the APHINITY trial.
Krop I, Paulson J, Campbell C, Kiermaier A, Andre F, Fumagalli D, de Haas S, Salgado R, Denkert C, Loibl S, Bailey A, Lewis Phillips G, Frank E, Piccart M, Viale G, Loi S. Genomic correlates of response to adjuvant trastuzumab (H) and pertuzumab (P) in HER2+ breast cancer (BC): Biomarker analysis of the APHINITY trial. Journal Of Clinical Oncology 2019, 37: 1012-1012. DOI: 10.1200/jco.2019.37.15_suppl.1012.Peer-Reviewed Original ResearchTumor-Infiltrating LymphocytesBreast cancerBetter prognosisComprehensive biomarker analysisPhase III studyInteraction p valueCase-control designBiomarker analysisHigher mRNA expressionAnthracycline useAPHINITY trialAdjuvant trastuzumabChemotherapy typeIII studyImmune signaturesNodal statusImmune markersInfiltrating lymphocytesClinical parametersPoor prognosisPredictive biomarkersTIL analysisBetter outcomesPAM50 subtypesPrognosis197TiP Phase III study of [fam-] trastuzumab deruxtecan vs investigator’s choice in T-DM1-pretreated HER2+ breast cancer
André F, Shahidi J, Lee C, Wang K, Krop I. 197TiP Phase III study of [fam-] trastuzumab deruxtecan vs investigator’s choice in T-DM1-pretreated HER2+ breast cancer. Annals Of Oncology 2019, 30: iii63. DOI: 10.1093/annonc/mdz100.048.Peer-Reviewed Original Research
2015
Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Metastatic Breast Cancer Previously Treated With Chemotherapy and 2 or More HER2-Targeted Agents
Yardley DA, Krop IE, LoRusso PM, Mayer M, Barnett B, Yoo B, Perez EA. Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Metastatic Breast Cancer Previously Treated With Chemotherapy and 2 or More HER2-Targeted Agents. The Cancer Journal 2015, 21: 357-364. PMID: 26389758, DOI: 10.1097/ppo.0000000000000144.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsBreast Neoplasms, MaleComorbidityFemaleHumansMaleMaytansineMiddle AgedMolecular Targeted TherapyNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingReceptor, ErbB-2RetreatmentTrastuzumabTreatment OutcomeConceptsMetastatic breast cancerObjective response rateAdvanced breast cancerBreast cancerT-DM1Measurable diseaseAdverse eventsTrastuzumab emtansineGrade 3Investigator-assessed objective response rateHER2-positive metastatic breast cancerResponse ratePositive metastatic breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Grade adverse eventsNew safety signalsPhase III studyGrowth factor receptor 2Significant cardiovascular diseaseVentricular ejection fractionPlatelet count decreaseSimilar patient populationsRoutine clinical practiceFactor receptor 2
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-HER3
2012
Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane.
Pegram M, Blackwell K, Miles D, Bianchi G, Krop I, Welslau M, Baselga J, Oh D, Dieras V, Guardino E, Olsen S, Fang L, Lu M, Verma S. Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane. Journal Of Clinical Oncology 2012, 30: 98-98. DOI: 10.1200/jco.2012.30.27_suppl.98.Peer-Reviewed Original ResearchMetastatic breast cancerT-DM1End pointProgressive diseaseAdverse eventsCytotoxic agent DM1Primary end pointUnexpected safety signalsPalmar-plantar erythrodysesthesiaPhase III studyFinal PFS analysisRefractory HER2Prior therapyBaseline demographicsIII studyMedian durationRandomized studyPlantar erythrodysesthesiaUnmanageable toxicityDisease characteristicsAdvanced BCTrastuzumab emtansineNovel therapiesSafety signalsBreast cancerPrimary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane.
Blackwell K, Miles D, Gianni L, Krop I, Welslau M, Baselga J, Pegram M, Oh D, Dieras V, Olsen S, Fang L, Lu M, Guardino E, Verma S. Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane. Journal Of Clinical Oncology 2012, 30: lba1-lba1. DOI: 10.1200/jco.2012.30.18_suppl.lba1.Peer-Reviewed Original ResearchMetastatic breast cancerT-DM1End pointProgressive diseaseAdverse eventsCytotoxic agent DM1Primary end pointUnexpected safety signalsPalmar-plantar erythrodysesthesiaPhase III studyFinal PFS analysisRefractory HER2Prior therapyBaseline demographicsIII studyMedian durationRandomized studyPlantar erythrodysesthesiaUnmanageable toxicityDisease characteristicsAdvanced BCTrastuzumab emtansineNovel therapiesSafety signalsBreast cancerPrimary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane.
Blackwell K, Miles D, Gianni L, Krop I, Welslau M, Baselga J, Pegram M, Oh D, Dieras V, Olsen S, Fang L, Lu M, Guardino E, Verma S. Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane. Journal Of Clinical Oncology 2012, 30: lba1-lba1. DOI: 10.1200/jco.2012.30.15_suppl.lba1.Peer-Reviewed Original Research