2022
Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Guideline Update
Giordano SH, Franzoi MAB, Temin S, Anders CK, Chandarlapaty S, Crews JR, Kirshner JJ, Krop IE, Lin NU, Morikawa A, Patt DA, Perlmutter J, Ramakrishna N, Davidson NE. Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Guideline Update. Journal Of Clinical Oncology 2022, 40: 2612-2635. PMID: 35640077, DOI: 10.1200/jco.22.00519.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerBreast cancerSystemic therapyTrastuzumab deruxtecanGuideline recommendationsAdvanced human epidermal growth factor receptorHER2-positive advanced breast cancerProgesterone receptor-positive breast cancerClinical congestive heart failureEvidence-based guideline recommendationsStandard first-line therapyPositive advanced breast cancerLeft ventricular ejection fractionReceptor-positive breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorASCO Guideline UpdateThird-line settingSecond-line treatmentFirst-line therapyFirst-line treatmentTime of progressionAbsence of progressionCongestive heart failureCardiac 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
2018
Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Clinical Practice Guideline Update
Giordano SH, Temin S, Chandarlapaty S, Crews JR, Esteva FJ, Kirshner JJ, Krop IE, Levinson J, Lin NU, Modi S, Patt DA, Perlmutter J, Ramakrishna N, Winer EP, Davidson NE. Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Clinical Practice Guideline Update. Journal Of Clinical Oncology 2018, 36: jco.2018.79.269. PMID: 29939838, DOI: 10.1200/jco.2018.79.2697.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerBreast cancerSystemic therapyTrastuzumab emtansineEstrogen receptor-positive/progesterone receptor-positive breast cancerAdvanced human epidermal growth factor receptorASCO Clinical Practice Guideline UpdateHER2-positive advanced breast cancerProgesterone receptor-positive breast cancerClinical congestive heart failureClinical Practice Guideline UpdateEvidence-based guideline recommendationsStandard first-line therapyPositive advanced breast cancerLeft ventricular ejection fractionReceptor-positive breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorThird-line settingSecond-line treatmentFirst-line therapyFirst-line treatmentProgression-free survivalTime of progression
2015
Adjuvant Paclitaxel and Trastuzumab for Node-Negative, HER2-Positive Breast Cancer
Tolaney SM, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Guo H, Hudis CA, Krop IE, Burstein HJ, Winer EP. Adjuvant Paclitaxel and Trastuzumab for Node-Negative, HER2-Positive Breast Cancer. New England Journal Of Medicine 2015, 372: 134-141. PMID: 25564897, PMCID: PMC4313867, DOI: 10.1056/nejmoa1406281.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleFollow-Up StudiesHumansInfusions, IntravenousMastectomy, SegmentalMiddle AgedNeoplasm Recurrence, LocalPaclitaxelRadiotherapyReceptor, ErbB-2Survival RateTrastuzumabConceptsHER2-positive breast cancerBreast cancerAdjuvant paclitaxelEjection fractionInvasive diseaseStage I HER2-positive breast cancerHuman epidermal growth factor receptor type 2Epidermal growth factor receptor type 2Symptomatic congestive heart failureHER2-negative breast cancerLeft ventricular ejection fractionDistant metastatic breast cancerFactor receptor type 2Discontinuation of trastuzumabGrade 3 neuropathySingle standard treatmentPrimary end pointCongestive heart failureMetastatic breast cancerVentricular ejection fractionPositive breast cancerInvestigator-initiated studyReceptor type 2Disease-specific eventsMedian follow
2014
Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline
Giordano SH, Temin S, Kirshner JJ, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Gonzalez-Angulo AM, Krop I, Levinson J, Lin NU, Modi S, Patt DA, Perez EA, Perlmutter J, Ramakrishna N, Winer EP. Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline. Journal Of Clinical Oncology 2014, 32: 2078-2099. PMID: 24799465, PMCID: PMC6076031, DOI: 10.1200/jco.2013.54.0948.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAnastrozoleAntibodies, Monoclonal, HumanizedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials as TopicComorbidityDocetaxelDrug Administration ScheduleEvidence-Based MedicineFemaleHealth Status DisparitiesHealthcare DisparitiesHumansLapatinibLetrozoleMaytansineMolecular Targeted TherapyNitrilesQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSocieties, MedicalTaxoidsTrastuzumabTreatment OutcomeTriazolesUnited StatesConceptsAdvanced breast cancerHuman epidermal growth factor receptorSecond-line treatmentProgression-free survivalFirst-line treatmentBreast cancerPFS benefitT-DM1Epidermal growth factor receptorEndocrine therapyGrowth factor receptorSystemic therapyEstrogen receptor-positive/progesterone receptor-positive breast cancerAdvanced human epidermal growth factor receptorHER2-positive advanced breast cancerProgesterone receptor-positive breast cancerClinical Oncology Clinical Practice GuidelineClinical congestive heart failureStandard first-line therapyPositive advanced breast cancerLeft ventricular ejection fractionOncology Clinical Practice GuidelineReceptor-positive breast cancerThird-line settingFirst-line therapy
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