2024
Analytical 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
2021
Impact of HER2 heterogeneity on treatment response of early-stage HER2-positive breast cancer: phase II neoadjuvant clinical trial of T-DM1 combined with pertuzumab
Filho OM, Viale G, Stein S, Trippa L, Yardley DA, Mayer IA, Abramson VG, Arteaga CL, Spring LM, Waks AG, Wrabel E, DeMeo MK, Bardia A, Dell'Orto P, Russo L, King TA, Polyak K, Michor F, Winer EP, Krop IE. Impact of HER2 heterogeneity on treatment response of early-stage HER2-positive breast cancer: phase II neoadjuvant clinical trial of T-DM1 combined with pertuzumab. Cancer Discovery 2021, 11: candisc.1557.2020. PMID: 33941592, PMCID: PMC8598376, DOI: 10.1158/2159-8290.cd-20-1557.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerHER2 heterogeneityBreast cancerEarly-stage HER2-positive breast cancerHER2-positive early-stage breast cancerTherapeutic resistancePathologic complete response rateEarly-stage breast cancerNeoadjuvant clinical trialsComplete response rateSubset of patientsHER2 therapyPretreatment biopsiesEvaluable casesCure rateT-DM1Trastuzumab emtansineClinical trialsTreatment strategiesTreatment responseTreatment selectionResponse rateRelated commentaryTherapyIssue feature
2018
HER2-enriched subtype and ERBB2 mRNA as predictors of pathological complete response following trastuzumab and lapatinib without chemotherapy in early-stage HER2-positive breast cancer: A combined analysis of TBCRC006/023 and PAMELA trials.
Prat A, De Angelis C, Pascual T, Gutierrez C, Llombart-Cussac A, Wang T, Cortes J, Rexer B, Veeraraghavan J, Forero-Torres A, Wolff A, Morales S, Krop I, Pavlick A, Bermejo B, Hilsenbeck S, Oliveira M, Schiff R, Osborne C, Rimawi M. HER2-enriched subtype and ERBB2 mRNA as predictors of pathological complete response following trastuzumab and lapatinib without chemotherapy in early-stage HER2-positive breast cancer: A combined analysis of TBCRC006/023 and PAMELA trials. Journal Of Clinical Oncology 2018, 36: 509-509. DOI: 10.1200/jco.2018.36.15_suppl.509.Peer-Reviewed Original ResearchEarly-stage HER2-positive breast cancerHER2-positive breast cancerPathological complete responseComplete responseBreast cancerERBB2 mRNAChemotherapyTrastuzumabHER2CancerSubtypes
2012
Cardiac safety in a phase II study of trastuzumab emtansine (T-DM1) following anthracycline-based chemotherapy as adjuvant or neoadjuvant therapy for early-stage HER2-positive breast cancer.
Dang C, Gianni L, Romieu G, Dirix L, Campone M, Citron M, Zamagni C, Krop I, Xu N, Smitt M, Suter T. Cardiac safety in a phase II study of trastuzumab emtansine (T-DM1) following anthracycline-based chemotherapy as adjuvant or neoadjuvant therapy for early-stage HER2-positive breast cancer. Journal Of Clinical Oncology 2012, 30: 532-532. DOI: 10.1200/jco.2012.30.15_suppl.532.Peer-Reviewed Original ResearchEarly-stage HER2-positive breast cancerLeft ventricular ejection fractionHER2-positive breast cancerAnthracycline-based chemotherapyPhase II studyT-DM1Breast cancerCardiac eventsII studyCardiac safetyInterim analysisDoxorubicin/cyclophosphamideOpen-label studyPrevious phase IIVentricular systolic dysfunctionSignificant cardiac eventsVentricular ejection fractionT-DM1 treatmentCo-primary endpointsPhase IICardiac AEsNeoadjuvant settingNeoadjuvant therapySystolic dysfunctionAdverse events