2022
Cardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trial
Barroso-Sousa R, Tarantino P, Tayob N, Dang C, Yardley DA, Isakoff SJ, Valero V, Faggen M, Mulvey T, Bose R, Hu J, Weckstein D, Wolff AC, Reeder-Hayes K, Rugo HS, Ramaswamy B, Zuckerman D, Hart L, Gadi VK, Constantine M, Cheng K, Briccetti F, Schneider B, Garrett AM, Marcom K, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu M, Ruddy KJ, Zheng Y, Rosenberg SM, Gelber RD, Trippa L, Barry W, DeMeo M, Burstein H, Partridge A, Winer EP, Krop I, Tolaney SM. Cardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trial. Npj Breast Cancer 2022, 8: 18. PMID: 35173164, PMCID: PMC8850608, DOI: 10.1038/s41523-022-00385-2.Peer-Reviewed Original ResearchLeft ventricular ejection fractionHER2-positive breast cancerAdjuvant T-DM1Adjuvant trastuzumab emtansineT-DM1Adverse eventsCardiac outcomesTrastuzumab emtansineBreast cancerStage I HER2-positive breast cancerAsymptomatic left ventricular ejection fractionBaseline left ventricular ejection fractionAnthracycline-free regimensAsymptomatic LVEF declineResidual invasive diseaseT-DM1 armCardiac adverse eventsVentricular systolic dysfunctionSignificant adverse eventsVentricular ejection fractionBody mass indexFavorable toxicity profilePotential therapeutic optionBreast Cancer StudyAdjuvant paclitaxel
2016
Cardiac Outcomes of Patients Receiving Adjuvant Weekly Paclitaxel and Trastuzumab for Node-Negative, ERBB2-Positive Breast Cancer
Dang C, Guo H, Najita J, Yardley D, Marcom K, Albain K, Rugo H, Miller K, Ellis M, Shapira I, Wolff AC, Carey LA, Moy B, Groarke J, Moslehi J, Krop I, Burstein HJ, Hudis C, Winer EP, Tolaney SM. Cardiac Outcomes of Patients Receiving Adjuvant Weekly Paclitaxel and Trastuzumab for Node-Negative, ERBB2-Positive Breast Cancer. JAMA Oncology 2016, 2: 1-8. PMID: 26539793, PMCID: PMC5654518, DOI: 10.1001/jamaoncol.2015.3709.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalDrug Administration ScheduleFemaleHumansMiddle AgedNeoplasm StagingPaclitaxelReceptor, ErbB-2Risk AssessmentRisk FactorsStroke VolumeTime FactorsTrastuzumabTreatment OutcomeUnited StatesVentricular Dysfunction, LeftVentricular Function, LeftYoung AdultConceptsErbB2-positive breast cancerAsymptomatic LVEF declineCardiac toxic effectsLVEF declineBreast cancerPatients LVEFGrade 3Early-stage human epidermal growth factor receptor 2Asymptomatic left ventricular ejection fraction declineLeft ventricular ejection fraction declineVentricular ejection fraction declineHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Adjuvant weekly paclitaxelCardiac safety dataEjection fraction declineMedian patient ageVentricular systolic dysfunctionTrastuzumab-based treatmentWeeks of chemotherapyGrowth factor receptor 2Positive breast cancerLife-saving therapyFactor receptor 2Single-group study
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
2011
P2-18-02: Cardiac Outcomes of Patients on Adjuvant Weekly Paclitaxel (T) and Trastuzumab (H) for Node Negative, HER2 Positive Breast Cancer (BCA).
Dang C, Tolaney S, Najita J, Gelman R, Yardley D, Marcom K, Albain K, Rugo H, Miller K, Ellis M, Shapira I, Wolff A, Carey L, Vahdat L, Burdette-Radoux S, Budd T, Krop I, Burstein H, Hudis C, Winer E. P2-18-02: Cardiac Outcomes of Patients on Adjuvant Weekly Paclitaxel (T) and Trastuzumab (H) for Node Negative, HER2 Positive Breast Cancer (BCA). Cancer Research 2011, 71: p2-18-02-p2-18-02. DOI: 10.1158/0008-5472.sabcs11-p2-18-02.Peer-Reviewed Original ResearchLeft ventricular ejection fractionCongestive heart failureHER2-positive breast cancerBenefit of chemotherapyPositive breast cancerBreast cancerHeart failureHigh-risk node-negative breast cancerIncidence of CHFSerial left ventricular ejection fractionSymptomatic congestive heart failureNode-negative breast cancerAdjuvant weekly paclitaxelAnthracycline-based treatmentNode-negative groupNode-negative populationVentricular systolic dysfunctionPhase II studyDisease-free survivalVentricular ejection fractionLVEF monitoringLVEF recoveryWeekly paclitaxelPrimary endpointProtocol therapy