2023
P111 A phase 3, open-label trial of neoadjuvant trastuzumab deruxtecan (T-DXd) monotherapy or T-DXd followed by THP vs ddAC-THP in high-risk HER2-positive early-stage breast cancer (DESTINY-Breast11)
Harbeck N, Boileau J, Modi S, Kelly C, Ohno S, Wu J, Konpa A, Herbolsheimer P, Safdar S, Zhang Y, Pusztai L. P111 A phase 3, open-label trial of neoadjuvant trastuzumab deruxtecan (T-DXd) monotherapy or T-DXd followed by THP vs ddAC-THP in high-risk HER2-positive early-stage breast cancer (DESTINY-Breast11). The Breast 2023, 68: s57. DOI: 10.1016/s0960-9776(23)00228-x.Peer-Reviewed Original ResearchHER2-positive early-stage breast cancerEarly-stage breast cancerOpen-label trialT-DXdBreast cancerPhase 3MonotherapyCancerTrials
2021
Copy number aberration analysis to predict response to neoadjuvant anti-HER2 therapy: results from the NeoALTTO phase III clinical trial.
Venet D, Rediti M, Maetens M, Fumagalli D, Brown DN, Majjaj S, Salgado R, Pusztai L, Harbeck N, El-Abed S, Wang Y, Saura C, Gomez H, Semiglazov VF, de Azambuja E, Huober J, Nuciforo P, Di Cosimo S, Piccart M, Loi S, Rothé F, Sotiriou C. Copy number aberration analysis to predict response to neoadjuvant anti-HER2 therapy: results from the NeoALTTO phase III clinical trial. Clinical Cancer Research 2021, 27: clincanres.1317.2021. PMID: 34321278, DOI: 10.1158/1078-0432.ccr-21-1317.Peer-Reviewed Original ResearchConceptsPathologic complete responseNeoALTTO trialCopy number aberrationsBreast cancerHER2-positive early-stage breast cancerEstrogen receptor-positive subgroupNeoadjuvant anti-HER2 therapyEarly-stage breast cancerHER2-positive breast cancerPhase III clinical trialsAnti-HER2 therapyAnti-HER2 agentsPredictors of responseReceptor-positive subgroupNumber aberration analysisCopy number levelsWarrants further investigationHeterogeneity of responseComplete responseSurvival outcomesWhole cohortClinical trialsImmune processesPatientsSignificant association
2017
Cardiac biomarkers for early detection and prediction of trastuzumab and/or lapatinib-induced cardiotoxicity in patients with HER2-positive early-stage breast cancer: a NeoALTTO sub-study (BIG 1-06)
Ponde N, Bradbury I, Lambertini M, Ewer M, Campbell C, Ameels H, Zardavas D, Di Cosimo S, Baselga J, Huober J, Izquierdo M, Fumagalli D, Bozovic-Spasojevic I, Maetens M, Harbeck N, Pusztai L, Berghorn M, Im YH, Borrego MR, Chen DR, Rodeheffer R, Piccart M, Suter T, de Azambuja E. Cardiac biomarkers for early detection and prediction of trastuzumab and/or lapatinib-induced cardiotoxicity in patients with HER2-positive early-stage breast cancer: a NeoALTTO sub-study (BIG 1-06). Breast Cancer Research And Treatment 2017, 168: 631-638. PMID: 29280043, PMCID: PMC5843537, DOI: 10.1007/s10549-017-4628-3.Peer-Reviewed Original ResearchConceptsAnti-HER2 therapyNT-proBNPBiomarker elevationCardiac toxicityEarly predictorHER2-positive early-stage breast cancerEarly-stage breast cancerAnthracycline-naïve patientsEarly cardiac toxicityLevels of TnTNT-proBNP elevationBrain natriuretic peptideBreast cancer patientsNeoALTTO trialWeekly paclitaxelCardiac dysfunctionTreatment armsCardiac damageNatriuretic peptideCancer patientsCardiac biomarkersBreast cancerPatientsTroponin TAmino-terminal fragmentRNA Sequencing to Predict Response to Neoadjuvant Anti-HER2 Therapy: A Secondary Analysis of the NeoALTTO Randomized Clinical Trial
Fumagalli D, Venet D, Ignatiadis M, Azim HA, Maetens M, Rothé F, Salgado R, Bradbury I, Pusztai L, Harbeck N, Gomez H, Chang TW, Coccia-Portugal MA, Di Cosimo S, de Azambuja E, de la Peña L, Nuciforo P, Brase JC, Huober J, Baselga J, Piccart M, Loi S, Sotiriou C. RNA Sequencing to Predict Response to Neoadjuvant Anti-HER2 Therapy: A Secondary Analysis of the NeoALTTO Randomized Clinical Trial. JAMA Oncology 2017, 3: 227-234. PMID: 27684533, PMCID: PMC5374044, DOI: 10.1001/jamaoncol.2016.3824.Peer-Reviewed Original ResearchEvent-free survivalAnti-HER2 therapyAnti-HER2 agentsErbB2/HER2Genomic grade indexCombination armTreatment armsGene signatureBreast cancerHER2-positive early-stage breast cancerNeoadjuvant anti-HER2 therapyPathologic complete response rateHuman epidermal growth factor receptor 2Early-stage breast cancerEpidermal growth factor receptor 2Candidate predictive markersCycles of fluorouracilDual HER2 blockadeImmune gene signaturesComplete response rateGrowth factor receptor 2Positive breast cancerLong-term outcomesRandomized clinical trialsHigh PCR