2024
Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial
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, Egorov A, Kim S. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial. The Lancet Oncology 2024, 25: 614-625. PMID: 38697155, DOI: 10.1016/s1470-2045(24)00128-1.Peer-Reviewed Original ResearchConceptsTreatment of physician's choiceMetastatic breast cancerTreatment of physician's choice groupPatient-reported outcomesPhysician's choice groupTrastuzumab deruxtecan groupTrastuzumab deruxtecanPhase 3 trialHER2-positiveBreast cancerGlobal health statusPhysician's choiceEORTC QLQ-C30 global health statusPatient-reported outcome variablesOpen-labelQLQ-C30 global health statusTrastuzumab emtansineDefinitive deteriorationMedian time to definitive deteriorationHER2-positive metastatic breast cancerEastern Cooperative Oncology Group performance statusTreatment durationBlinded independent central reviewQuality of lifeProgression-free survival182MO Trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC) in patients (pts) with HER2+ metastatic breast cancer (mBC) previously treated with trastuzumab emtansine (T-DM1): Updated overall survival (OS) results of the randomized phase III DESTINY-breast (DB-)02 study
Kim S, André F, Takano T, Fehm T, Park Y, Lee J, Borges G, Kaplan M, Kaczmarek E, Guarneri V, Yonemori K, Pluard T, Prat A, Paterson F, Oakman C, Nakatani S, Ashfaque S, Lu W, Egorov A, Krop I. 182MO Trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC) in patients (pts) with HER2+ metastatic breast cancer (mBC) previously treated with trastuzumab emtansine (T-DM1): Updated overall survival (OS) results of the randomized phase III DESTINY-breast (DB-)02 study. ESMO Open 2024, 9: 103204. DOI: 10.1016/j.esmoop.2024.103204.Peer-Reviewed Original Research
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 ResearchTrastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trial
André F, Hee Park Y, Kim S, Takano T, Im S, Borges G, Lima J, Aksoy S, Gavila Gregori J, De Laurentiis M, Bianchini G, Roylance R, Miyoshi Y, Armstrong A, Sinha R, Ruiz Borrego M, Lim E, Ettl J, Yerushalmi R, Zagouri F, Duhoux F, Fehm T, Gambhire D, Cathcart J, Wu C, Chu C, Egorov A, Krop I. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trial. The Lancet 2023, 401: 1773-1785. PMID: 37086745, DOI: 10.1016/s0140-6736(23)00725-0.Peer-Reviewed Original ResearchConceptsHER2-positive metastatic breast cancerMetastatic breast cancerPhysician's choice groupTreatment-emergent adverse eventsBlinded independent central reviewPhase 3 trialProgression-free survivalTrastuzumab deruxtecanIndependent central reviewBreast cancerPhysician's choiceAdverse eventsCentral reviewTrastuzumab emtansineEastern Cooperative Oncology Group performance statusCommon treatment-emergent adverse eventsHigher treatment-emergent adverse eventsMedian progression-free survivalPositive metastatic breast cancerFavorable benefit-risk profilePalmar-plantar erythrodysaesthesiaInterstitial lung diseaseBenefit-risk profileAntibody-drug conjugatesChoice group
2017
Trastuzumab emtansine versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer (TH3RESA): final overall survival results from a randomised open-label phase 3 trial
Krop IE, Kim SB, Martin AG, LoRusso PM, Ferrero JM, Badovinac-Crnjevic T, Hoersch S, Smitt M, Wildiers H. Trastuzumab emtansine versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer (TH3RESA): final overall survival results from a randomised open-label phase 3 trial. The Lancet Oncology 2017, 18: 743-754. PMID: 28526538, DOI: 10.1016/s1470-2045(17)30313-3.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsBreast Neoplasms, MaleBridged-Ring CompoundsChemotherapy-Induced Febrile NeutropeniaDiarrheaEarly Termination of Clinical TrialsFemaleHemorrhageHumansLapatinibMaleMaytansineMiddle AgedNeoplasm MetastasisNeutropeniaPractice Patterns, Physicians'QuinazolinesReceptor, ErbB-2RetreatmentSurvival RateTaxoidsThrombocytopeniaTrastuzumabConceptsHER2-positive advanced breast cancerPhysician's choice groupAdvanced breast cancerWorse adverse eventsProgression-free survivalOverall survivalTrastuzumab emtansineAdverse eventsOverall survival analysisBreast cancerPhysician's choiceTH3RESA trialGrade 3Eastern Cooperative Oncology Group performance statusInvestigator-assessed progression-free survivalOpen-label phase 3 trialHER2-positive metastatic breast cancerSurvival analysisFinal overall survival analysisFinal overall survival resultsAdequate organ functionCommon grade 3Permuted block randomisationTrastuzumab emtansine treatmentSecond interim analysis
2016
315TiP HERMIONE: A phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician's choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and T-DM1
Castan J, Verma S, Hurvitz S, Krop I, Tripathy D, Yardley D, Dionne M, Reynolds J, Wickham T, Molnar I, Miller K. 315TiP HERMIONE: A phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician's choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and T-DM1. Annals Of Oncology 2016, 27: vi99. DOI: 10.1093/annonc/mdw365.94.Peer-Reviewed Original ResearchHERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician’s choice plus trastuzumab in patients with previously treated, anthracycline-naïve, HER2-positive, locally advanced/metastatic breast cancer
Miller K, Cortes J, Hurvitz SA, Krop IE, Tripathy D, Verma S, Riahi K, Reynolds JG, Wickham TJ, Molnar I, Yardley DA. HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician’s choice plus trastuzumab in patients with previously treated, anthracycline-naïve, HER2-positive, locally advanced/metastatic breast cancer. BMC Cancer 2016, 16: 352. PMID: 27259714, PMCID: PMC4893300, DOI: 10.1186/s12885-016-2385-z.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerProgression-free survivalPhase 2 trialMetastatic breast cancerBreast cancerDisease progressionOverall survivalMM-302Physician's choiceInvestigator-assessed progression-free survivalMetastatic HER2-positive breast cancerRandomized phase 2 trialEpidermal growth factor receptor 2Anthracycline-naïve patientsBackgroundHuman epidermal growth factor receptor 2Objective response rateGrowth factor receptor 2Positive breast cancerAdo-trastuzumab emtansineKey inclusion criteriaFactor receptor 2Quality of lifeOS ratesRECIST v1.1Refractory HER2HERMIONE: A Phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician’s choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and ado-trastuzumab emtansine (T-DM1).
Miller K, Cortes J, Hurvitz S, Krop I, Tripathy D, Verma S, Dionne M, Campbell K, Reynolds J, Wickham T, Molnar I, Yardley D. HERMIONE: A Phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician’s choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and ado-trastuzumab emtansine (T-DM1). Journal Of Clinical Oncology 2016, 34: tps631-tps631. DOI: 10.1200/jco.2016.34.15_suppl.tps631.Peer-Reviewed Original Research
2015
HERMIONE: A Phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician’s choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and ado-trastuzumab emtansine (T-DM1).
Miller K, Cortes J, Hurvitz S, Krop I, Tripathy D, Verma S, Riahi K, Reynolds J, Wickham T, Molnar I, Yardley D. HERMIONE: A Phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician’s choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and ado-trastuzumab emtansine (T-DM1). Journal Of Clinical Oncology 2015, 33: tps641-tps641. DOI: 10.1200/jco.2015.33.15_suppl.tps641.Peer-Reviewed Original Research
2014
Relationship between tumor biomarkers (BM) and efficacy in TH3RESA, a phase 3 study of trastuzumab emtansine (T-DM1) versus treatment of physician’s choice (TPC) in HER2-positive advanced breast cancer (BC) previously treated with trastuzumab and lapatinib.
Kim S, Wildiers H, Krop I, Leung A, Trudeau C, Yu R, de Haas S, Gonzalez-Martin A. Relationship between tumor biomarkers (BM) and efficacy in TH3RESA, a phase 3 study of trastuzumab emtansine (T-DM1) versus treatment of physician’s choice (TPC) in HER2-positive advanced breast cancer (BC) previously treated with trastuzumab and lapatinib. Journal Of Clinical Oncology 2014, 32: 605-605. DOI: 10.1200/jco.2014.32.15_suppl.605.Peer-Reviewed Original ResearchTrastuzumab emtansine versus treatment of physician's choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial
Krop IE, Kim SB, González-Martín A, LoRusso PM, Ferrero JM, Smitt M, Yu R, Leung AC, Wildiers H, collaborators O. Trastuzumab emtansine versus treatment of physician's choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial. The Lancet Oncology 2014, 15: 689-699. PMID: 24793816, DOI: 10.1016/s1470-2045(14)70178-0.Peer-Reviewed Original ResearchConceptsHER2-positive advanced breast cancerPhysician's choice groupWorse adverse eventsAdvanced breast cancerProgression-free survivalInterim overall survival analysisPhase 3 trialTrastuzumab emtansineAdverse eventsOverall survival analysisBreast cancerPhysician's choiceGrade 3Investigator-assessed progression-free survivalSurvival analysisBlock randomisation schemeCytotoxic agent DM1Previous taxane therapySerious adverse eventsWeb response systemMetastatic breast cancerEffective therapeutic optionPopulation of patientsFinal PFS analysisChoice group