2024
Final analysis of the ALTTO trial: adjuvant trastuzumab in sequence or in combination with lapatinib in patients with HER2-positive early breast cancer [BIG 2-06/NCCTG N063D (Alliance)]
de Azambuja E, Piccart-Gebhart M, Fielding S, Townend J, Hillman D, Colleoni M, Roylance R, Kelly C, Lombard J, El-Abed S, Choudhury A, Korde L, Vicente M, Chumsri S, Rodeheffer R, Ellard S, Wolff A, Holtschmidt J, Lang I, Untch M, Boyle F, Xu B, Werutsky G, Tujakowski J, Huang C, Baruch N, Bliss J, Ferro A, Gralow J, Kim S, Kroep J, Krop I, Kuemmel S, McConnell R, Moscetti L, Knop A, van Duijnhoven F, Gomez H, Cameron D, Di Cosimo S, Gelber R, Moreno-Aspitia A. Final analysis of the ALTTO trial: adjuvant trastuzumab in sequence or in combination with lapatinib in patients with HER2-positive early breast cancer [BIG 2-06/NCCTG N063D (Alliance)]. ESMO Open 2024, 9: 103938. PMID: 39418883, PMCID: PMC11532431, DOI: 10.1016/j.esmoop.2024.103938.Peer-Reviewed Original ResearchDisease-free survivalHER2-positive early breast cancerEarly breast cancerOverall survivalALTTO trialBreast cancerFollow-upMetastatic HER2-positive breast cancerDual anti-HER2 blockadeAnti-human epidermal growth factor receptor 2HER2-positive breast cancerEpidermal growth factor receptor 2Lapatinib to trastuzumabAnti-HER2 therapyAnti-HER2 blockadeTreatment groupsOutcomes of patientsAdjuvant trastuzumabOpen-labelAdjuvant chemotherapyPrimary endpointSecondary endpointsEfficacy analysisMulticenter studyAnti-HER2Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer.
Jhaveri K, Accordino M, Bedard P, Cervantes A, Gambardella V, Hamilton E, Italiano A, Kalinsky K, Krop I, Oliveira M, Schmid P, Saura C, Turner N, Varga A, Cheeti S, Hilz S, Hutchinson K, Jin Y, Royer-Joo S, Peters U, Shankar N, Schutzman J, Juric D. Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer. Journal Of Clinical Oncology 2024, 42: 3947-3956. PMID: 39236276, DOI: 10.1200/jco.24.00110.Peer-Reviewed Original ResearchTreatment-related adverse eventsDrug-drug interactionsPreliminary antitumor activityEndocrine therapyStudy treatmentHuman epidermal growth factor receptor 2-negativeBreast cancerTreatment-related adverse event ratesLack of drug-drug interactionsConfirmed objective response rateLocally advanced/metastatic breast cancerCirculating tumor DNA analysisEffect of study treatmentPK drug-drug interactionsAntitumor activityObjective response ratePhase I/Ib studyHormone receptor-positiveProgression-free survivalAdvanced/metastatic breast cancerTumor DNA analysisBiomarkers of responseMetastatic breast cancerYears of ageReceptor-positiveA Pooled Analysis of Trastuzumab Deruxtecan in Patients With HER2-Positive Metastatic Breast Cancer With Brain Metastases
André F, Cortés J, Curigliano G, Modi S, Li W, Park Y, Chung W, Kim S, Yamashita T, Pedrini J, Im S, Tseng L, Harbeck N, Krop I, Nakatani S, Tecson K, Ashfaque S, Egorov A, Hurvitz S. A Pooled Analysis of Trastuzumab Deruxtecan in Patients With HER2-Positive Metastatic Breast Cancer With Brain Metastases. Annals Of Oncology 2024 PMID: 39241960, DOI: 10.1016/j.annonc.2024.08.2347.Peer-Reviewed Original ResearchHER2-positive metastatic breast cancerBlinded independent central reviewMetastatic breast cancerBrain metastasesT-DXdOverall survivalCNS-PFSTrastuzumab deruxtecanBreast cancerCentral nervous system progression-free survivalIntracranial responsePooled analysisIntracranial objective response rateSafety of trastuzumab deruxtecanSystemic progression-free survivalObjective response rateORR of patientsProgression-free survivalDuration of responseFood and Drug Administration criteriaIndependent central reviewUS Food and Drug Administration criteriaCompare treatmentsExploratory pooled analysisBM statusAdjuvant Trastuzumab Emtansine Versus Paclitaxel Plus Trastuzumab for Stage I Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: 5-Year Results and Correlative Analyses From ATEMPT
Tarantino P, Tayob N, Villacampa G, Dang C, Yardley D, Isakoff S, Valero V, Faggen M, Mulvey T, Bose R, Weckstein D, Wolff A, Reeder-Hayes K, Rugo H, Ramaswamy B, Zuckerman D, Hart L, Gadi V, Constantine M, Cheng K, Garrett A, Marcom P, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz R, Rimawi M, Abramson V, Pohlmann P, Van Poznak C, Forero-Torres A, Liu M, Ruddy K, Waks A, DeMeo M, Burstein H, Partridge A, Dell'Orto P, Russo L, Krause E, Newhouse D, Kurt B, Mittendorf E, Schneider B, Prat A, Winer E, Krop I, Tolaney S, Investigators T, Barroso-Sousa R, Curigliano G, DiLullo M, Hui W, Kirkup C, Viale G, Zheng Y. Adjuvant Trastuzumab Emtansine Versus Paclitaxel Plus Trastuzumab for Stage I Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: 5-Year Results and Correlative Analyses From ATEMPT. Journal Of Clinical Oncology 2024, 42: 3652-3665. PMID: 38935923, PMCID: PMC11527383, DOI: 10.1200/jco.23.02170.Peer-Reviewed Original ResearchInvasive disease-free survivalRecurrence-free intervalAdjuvant T-DM1T-DM1Long-term outcomesBreast cancerStage I HER2-positive breast cancerInvasive disease-free survival eventsLong-term outcomes of patientsBreast cancer-specific survivalHER2-positive breast cancerAdjuvant trastuzumab emtansinePredictors of thrombocytopeniaRisk scoreT-DM1 armCancer-specific survivalHormone receptor statusHigh-risk tumorsDisease-free survivalMedian follow-upClinically relevant toxicitiesRisk of recurrenceOutcomes of patientsHER2 immunohistochemical scoresTH armPhase Ib dose-escalation trial of taselisib (GDC-0032) in combination with HER2-directed therapies in patients with advanced HER2+ breast cancer
Grinshpun A, Ren S, Graham N, DeMeo M, Wrabel E, Carter J, Tayob N, Pereslete A, Hamilton E, Juric D, Mayer E, Tolaney S, Krop I, Metzger O. Phase Ib dose-escalation trial of taselisib (GDC-0032) in combination with HER2-directed therapies in patients with advanced HER2+ breast cancer. ESMO Open 2024, 9: 103465. PMID: 38833970, PMCID: PMC11179085, DOI: 10.1016/j.esmoop.2024.103465.Peer-Reviewed Original ResearchProgression-free survivalMaximal tolerated doseHER2+ breast cancerAdverse eventsBreast cancerT-DM1Cohort AHuman epidermal growth factor receptor 2-positiveEpidermal growth factor receptor 2-positiveHER2+) breast cancerMedian progression-free survivalAll-grade adverse eventsAssociated with significant toxicityCirculating tumor DNA analysisDevelopment of acquired resistanceHER2-directed regimensHER2-directed therapyAnti-HER2 therapyHER2-targeted therapyPhase Ib studyTumor DNA analysisPI3KDose escalationImprove disease controlOral inhibitorTucatinib-trastuzumab-capecitabine for treatment of leptomeningeal metastasis in HER2+ breast cancer: TBCRC049 phase 2 study results.
O'Brien B, Murthy R, Berry D, Singareeka Raghavendra A, Gule-Monroe M, Johnson J, Schwartz-Gomez J, Topletz-Erickson A, Lobbous M, Melisko M, Morikawa A, Ferguson S, de Groot J, Krop I, Valero V, Rimawi M, Wolff A, Tripathy D, Lin N, Stringer-Reasor E. Tucatinib-trastuzumab-capecitabine for treatment of leptomeningeal metastasis in HER2+ breast cancer: TBCRC049 phase 2 study results. Journal Of Clinical Oncology 2024, 42: 2018-2018. DOI: 10.1200/jco.2024.42.16_suppl.2018.Peer-Reviewed Original ResearchHER2+ breast cancerLeptomeningeal metastasesPatient-reported outcomesBreast cancerObjective responseClinical examCSF cytologyEvidence of clinically meaningful benefitHER2-targeted tyrosine kinase inhibitorsMedian time to CNS progressionMetastatic HER2+ breast cancerKarnofsky performance status >Treatment of leptomeningeal metastasesAbnormal CSF cytologyPerformance status >Targeted neurological deficitsMDASI-BTPhase 2 studyTyrosine kinase inhibitorsClinically meaningful benefitPre-specified timepointsPreliminary efficacy dataCNS progressionMedian OSCNS metastasesTBCRC 048 (olaparib expanded) expansion cohorts: Phase 2 study of olaparib monotherapy in patients (pts) with metastatic breast cancer (MBC) with germline (g) mutations in PALB2 or somatic (s) mutations in BRCA1 or BRCA2.
Tung N, Robson M, Nanda R, Li T, Vinayak S, Shah P, Khoury K, Kimmick G, Santa-Maria C, Brufsky A, DeMeo M, Vieira J, Carey L, Wulf G, Domchek S, Krop I, Wolff A, Winer E, Garber J. TBCRC 048 (olaparib expanded) expansion cohorts: Phase 2 study of olaparib monotherapy in patients (pts) with metastatic breast cancer (MBC) with germline (g) mutations in PALB2 or somatic (s) mutations in BRCA1 or BRCA2. Journal Of Clinical Oncology 2024, 42: 1021-1021. DOI: 10.1200/jco.2024.42.16_suppl.1021.Peer-Reviewed Original ResearchProgression-free survivalDuration of responseMetastatic breast cancerClinical benefit rateTriple-negative breast cancerMedian duration of responseMedian progression-free survivalMutant allele frequencyExpansion cohortHER2-negativeHER2-positiveCohort 2aNon-respondersBreast cancerEarly due to slow enrollmentMetastatic chemotherapy regimensResponse to olaparibPhase 2 studyPhase II trialKaplan-Meier methodPredictors of responseCohort of womenWilcoxon rank sum testRank sum testBRCA1mPrevalence and dynamics of circulating tumor DNA (ctDNA) among patients (pts) with HER2+ breast cancer (BC) receiving neoadjuvant paclitaxel/trastuzumab/pertuzumab (THP) in the DAPHNe trial.
Waks A, Tarantino P, Li T, Ogayo E, Rahman T, DiLullo M, El-Refai S, Abbott C, Boyle S, Chen R, Desai N, Spring L, Tung N, King T, Krop I, Tayob N, Mittendorf E, Tolaney S, Winer E, Parsons H. Prevalence and dynamics of circulating tumor DNA (ctDNA) among patients (pts) with HER2+ breast cancer (BC) receiving neoadjuvant paclitaxel/trastuzumab/pertuzumab (THP) in the DAPHNe trial. Journal Of Clinical Oncology 2024, 42: 588-588. DOI: 10.1200/jco.2024.42.16_suppl.588.Peer-Reviewed Original ResearchMinimal residual diseaseResidual cancer burdenBreast cancerResidual diseaseDynamics of circulating tumor DNAMinimal residual disease dataRCB 0RCB IIResidual cancer burden-IDetect minimal residual diseaseQuantify minimal residual diseaseResidual cancer burden scoreHER2+ breast cancerAdjuvant systemic therapyClinical stage IINode-negative tumorsHER2 + BCMedian follow-upPlasma samplesBreast cancer recurrenceImmediately post-operativelyLong-term outcomesAssociated with elevated riskCtDNA-positiveT3/T4 tumorsETHAN: A phase II study comparing different endocrine therapies for male breast cancer.
Leone J, Ruddy K, Rashid N, Giordano S, Gupta G, Hilsenbeck S, Gucalp A, Walsh E, Sukumar J, Makhlin I, Ortiz-Perez T, Spanheimer P, Calhoun B, Wolff A, Krop I, Thompson A. ETHAN: A phase II study comparing different endocrine therapies for male breast cancer. Journal Of Clinical Oncology 2024, 42: tps632-tps632. DOI: 10.1200/jco.2024.42.16_suppl.tps632.Peer-Reviewed Original ResearchResidual cancer burdenMale breast cancerPreoperative endocrine prognostic indexTranslational Breast Cancer Research ConsortiumBreast cancerEndocrine therapyKi-67Patient-reported outcomesNeoadjuvant phaseArm BAromatase inhibitorsHuman epidermal growth factor receptor 2 (HER2)-negative breast cancerOutcome of endocrine therapyResidual cancer burden indexWindow phaseCyclin-dependent kinase 4/6Ki-67 reductionHormone receptor-positivePhase II studyInflammatory breast cancerLack of clinical trialsPhase II trialHR+/HER2- breast cancerAnti-cancer therapyStandard of careAnalysis of drug-related interstitial lung disease (ILD) inpatients (pts) treated with datopotamab deruxtecan (Dato-DXd).
Sands J, Lisberg A, Bardia A, Shimizu T, Ahn M, Paz-Ares L, Meric-Bernstam F, Kitazono S, Krop I, Girard N, Pons Tostivint E, Heist R, Cornelissen R, Pistilli B, Lee K, Howarth P, Gu W, Fairhurst R, Khan S, Okamoto I. Analysis of drug-related interstitial lung disease (ILD) inpatients (pts) treated with datopotamab deruxtecan (Dato-DXd). Journal Of Clinical Oncology 2024, 42: 8623-8623. DOI: 10.1200/jco.2024.42.16_suppl.8623.Peer-Reviewed Original ResearchNon-small cell lung cancerInterstitial lung diseaseDrug-related interstitial lung diseaseInterstitial lung disease incidenceBreast cancerTumor typesCases of interstitial lung diseaseCell lung cancerSolid tumor typesDuration of treatmentMultiple tumor typesAntibody drug conjugatesCheckpoint inhibitorsDrug interruptionDose reductionDrug withdrawalSolid tumorsAdverse eventsTumor indicationsLung cancerPooled analysisClinical dataLung diseasePT subgroupAdjudication committeePooled analysis by best confirmed response to trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ metastatic breast cancer (mBC) from DESTINY-Breast-01, -02, and -03.
Saura C, Cortés J, Modi S, Kim S, Hamilton E, Hurvitz S, Krop I, Curigliano G, Iwata H, Im S, Herbolsheimer P, Karnoub M, Gambhire D, Egorov A, Andre F. Pooled analysis by best confirmed response to trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ metastatic breast cancer (mBC) from DESTINY-Breast-01, -02, and -03. Journal Of Clinical Oncology 2024, 42: 1023-1023. DOI: 10.1200/jco.2024.42.16_suppl.1023.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsHER2+ metastatic breast cancerProgression-free survivalMetastatic breast cancerComplete responsePartial responseT-DXdOverall survivalPooled analysisInterstitial lung disease (ILD)/pneumonitisStable disease (SD)/progressive diseaseProlonged progression-free survivalDuration of responseIndependent central reviewNumerically lower ratesLonger treatment durationMetastatic settingRECIST v1.1Trastuzumab deruxtecanOS outcomesCentral reviewAdverse eventsBreast cancerTreatment durationDrug-relatedOutcomes with trastuzumab deruxtecan (T-DXd) by HER2 status and line of treatment in a large real-world database of patients with metastatic breast cancer.
Tarantino P, Lee D, Foldi J, Soulos P, Gross C, Grinda T, Winer E, Lin N, Krop I, Tolaney S, Lustberg M, Sammons S. Outcomes with trastuzumab deruxtecan (T-DXd) by HER2 status and line of treatment in a large real-world database of patients with metastatic breast cancer. Journal Of Clinical Oncology 2024, 42: 1077-1077. DOI: 10.1200/jco.2024.42.16_suppl.1077.Peer-Reviewed Original ResearchReal-world progression-free survivalLines of therapyMetastatic breast cancerMedian real-world progression-free survivalT-DXdHER2+Overall survivalHER2-lowHER2- patientsBreast cancerHER2- metastatic breast cancerTreat metastatic breast cancerProgression-free survivalKaplan-Meier methodLines of treatmentDatabase of patientsRetrospective observational studyClinical trial settingHER2 casesIHC 0Trastuzumab deruxtecanHR statusHER2 statusTriple-negativeMedian ageTrastuzumab 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 survival186P Exploratory pooled safety analysis of trastuzumab deruxtecan (T-DXd) in patients With HER2+ or HER2-low unresectable and/or metastatic breast cancer (mBC) in DESTINY-Breast trials
Park Y, Jacot W, Hurvitz S, Modi S, Yamashita T, Xu B, Tokunaga E, Wang X, Lee K, Iwata H, Krop I, André F, Harbeck N, Rugo H, Mathias E, Pasteiner W, Karnoub M, Ashfaque S, Cheng Y, Kim S. 186P Exploratory pooled safety analysis of trastuzumab deruxtecan (T-DXd) in patients With HER2+ or HER2-low unresectable and/or metastatic breast cancer (mBC) in DESTINY-Breast trials. ESMO Open 2024, 9: 103208. DOI: 10.1016/j.esmoop.2024.103208.Peer-Reviewed Original Research188P A health-related quality-of-life (HRQoL) analysis from DESTINY-Breast04: Trastuzumab deruxtecan (T-DXd) vs capecitabine (CAP) in patients (Pts) with hormone receptor-positive (HR+), HER2-low metastatic breast cancer (mBC)
Ueno N, Cottone F, Dunton K, Cardoso F, Yamashita T, Losada M, Niikura N, Zagouri F, Sohn J, Gombos A, Im S, Pierga J, Krop I, Hashimoto Y, Kim J, Gori S, Jacot W, Bauer R, Aguilar C, Modi S. 188P A health-related quality-of-life (HRQoL) analysis from DESTINY-Breast04: Trastuzumab deruxtecan (T-DXd) vs capecitabine (CAP) in patients (Pts) with hormone receptor-positive (HR+), HER2-low metastatic breast cancer (mBC). ESMO Open 2024, 9: 103210. DOI: 10.1016/j.esmoop.2024.103210.Peer-Reviewed Original Research182MO 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 ResearchDatopotamab 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 durationClinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan
Heist R, Sands J, Bardia A, Shimizu T, Lisberg A, Krop I, Yamamoto N, Kogawa T, Al-Hashimi S, Fung S, Galor A, Pisetzky F, Basak P, Lau C, Meric-Bernstam F. Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan. Cancer Treatment Reviews 2024, 125: 102720. PMID: 38502995, DOI: 10.1016/j.ctrv.2024.102720.Peer-Reviewed Original ResearchNon-small cell lung cancerTriple-negative breast cancerTrophoblast cell surface antigen 2Antibody drug conjugatesAdverse eventsHR+/HER2- BCDelivery of cytotoxic agents to tumor cellsBreast cancerCytotoxic agents to tumor cellsTopoisomerase I inhibitor payloadAgents to tumor cellsInterstitial lung disease/pneumonitisInfusion-related reactionsSolid tumor indicationsPhase I studyCell lung cancerNovel antibody drug conjugatesSystemic therapySafety profileSolid tumorsTumor indicationsTumor cellsLung cancerClinical managementClinical trialsAnalytical validation of HER2DX genomic test for early-stage HER2-positive breast cancer
Marín-Aguilera M, Jares P, Sanfeliu E, Villacampa G, Hernández-lllán E, Martínez-Puchol A, Shankar S, González-Farré B, Waks A, Brasó-Maristany F, Pardo F, Manning D, Abery J, Curaba J, Moon L, Gordon O, Galván P, Wachirakantapong P, Castillo O, Nee C, Blasco P, Senevirathne T, Sirenko V, Martínez-Sáez O, Aguirre A, Krop I, Li Z, Spellman P, Filho O, Polyak K, Michaels P, Puig-Butillé J, Vivancos A, Matito J, Buckingham W, Perou C, Villagrasa-González P, Prat A, Parker J, Paré L. Analytical validation of HER2DX genomic test for early-stage HER2-positive breast cancer. ESMO Open 2024, 9: 102903. PMID: 38452436, PMCID: PMC10937240, DOI: 10.1016/j.esmoop.2024.102903.Peer-Reviewed Original ResearchConceptsEarly-stage HER2-positive breast cancerHER2-positive breast cancerTumor cell contentBreast cancerRecurrence riskEarly-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancerHuman epidermal growth factor receptor 2 (HER2)-positive breast cancerLow tumor cell contentBreast cancer recurrence riskERBB2 mRNA expressionFormalin-fixed paraffin-embedded (FFPE) tumor tissuesPost-neoadjuvant therapyCancer recurrence riskFFPE tumor samplesGenomic testingReagent lotsMessenger RNAProtocol variationsRNA extraction kitsFFPE tumorsHER2DXCell contentTumor samplesIntratumoral variabilityTumor tissuesHER2 heterogeneity and treatment response-associated profiles in HER2-positive breast cancer in the NCT02326974 clinical trial
Li Z, Filho O, Viale G, dell'Orto P, Russo L, Goyette M, Kamat A, Yardley D, Abramson V, Arteaga C, Spring L, Chiotti K, Halsey C, Waks A, King T, Lester S, Bellon J, Winer E, Spellman P, Krop I, Polyak K. HER2 heterogeneity and treatment response-associated profiles in HER2-positive breast cancer in the NCT02326974 clinical trial. Journal Of Clinical Investigation 2024, 134: e176454. PMID: 38300710, PMCID: PMC10977978, DOI: 10.1172/jci176454.Peer-Reviewed Original ResearchPathological complete responseHER2-positive breast cancerHER2 heterogeneityBreast cancerEarly-stage HER2-positive breast cancerHER2-targeted therapyPre-treatment tumorsErbB signalingHER2-targeted antibodiesBasal-like featuresHER2 protein levelsStratification of patientsNational Cancer InstituteNeoadjuvant trialsComplete responseResidual tumorT-DM1Copy number heterogeneityTrastuzumab emtansineERBB2 mRNAImmune infiltrationDownstream pathway componentsClinical challengeClinical trialsTumor