2020
Primary analysis of KAITLIN: A phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC).
Harbeck N, Im S, Barrios C, Bonnefoi H, Gralow J, Toi M, Ellis P, Gianni L, Swain S, Im Y, De Laurentiis M, Nowecki Z, Shah J, Boulet T, Liu H, Macharia H, Trask P, Song C, Winer E, Krop I. Primary analysis of KAITLIN: A phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC). Journal Of Clinical Oncology 2020, 38: 500-500. DOI: 10.1200/jco.2020.38.15_suppl.500.Peer-Reviewed Original ResearchHER2-positive early breast cancerInvasive disease-free survivalEarly breast cancerPatient-reported outcomesCo-primary endpointsStandard of careT-DM1ITT populationOverall survivalAnthracycline-based chemotherapyOpen-label studyDisease-free survivalPhase III studyWeeks of surgeryHigh-risk populationChemotherapy-associated toxicityAdjuvant taxanesConcurrent trastuzumabEndocrine therapySecondary endpointsAdjuvant radiotherapyAdjuvant therapyIII studyNodal statusMore patients
2013
A phase II study of bevacizumab in combination with vinorelbine and trastuzumab in HER2-positive metastatic breast cancer
Lin NU, Seah DS, Gelman R, Desantis S, Mayer EL, Isakoff S, DiPiro P, Krop IE, Come SE, Weckstein D, Winer EP, Burstein HJ. A phase II study of bevacizumab in combination with vinorelbine and trastuzumab in HER2-positive metastatic breast cancer. Breast Cancer Research And Treatment 2013, 139: 403-410. PMID: 23645007, DOI: 10.1007/s10549-013-2551-9.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerGrade 3/4 non-hematologic toxicitiesHER2-positive metastatic breast cancerNon-hematologic toxicitiesTreatment-related toxicityBreast cancerCommon treatment-related toxicitiesFirst-line patientsProtocol-based therapySecond-line cohortSecond-line patientsSecond-line settingPhase II studyProportion of patientsCombination of vinorelbineCo-primary endpointsEligible patientsFebrile neutropeniaMedian PFSII studyMedian durationObjective responsePrior linesUnacceptable toxicityMedian age
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