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
2019
37O Subgroup analysis of IMpassion130: Atezolizumab + nab-paclitaxel (nab-P) in patients (pts) with advanced triple-negative breast cancer (TNBC) in Asian countries
Iwata H, Im S, Sohn J, Jung K, Im Y, Lee K, Inoue K, Tamura K, Wong A, Emens L, Barrios C, Adams S, Schneeweiss A, Diéras V, Winer E, Chui S, Henschel V, Rugo H, Loi S, Schmid P. 37O Subgroup analysis of IMpassion130: Atezolizumab + nab-paclitaxel (nab-P) in patients (pts) with advanced triple-negative breast cancer (TNBC) in Asian countries. Annals Of Oncology 2019, 30: ix13-ix14. DOI: 10.1093/annonc/mdz418.Peer-Reviewed Original ResearchTriple-negative breast cancerAdvanced triple-negative breast cancerGenentech/RochePD-L1 expressionPD-L1Bristol-Myers SquibbF. Hoffmann-La RocheDaiichi SankyoBoehringer IngelheimHoffmann-La RocheSeattle GeneticsRoche/GenentechTumor-infiltrating immune cellsBreast Cancer Research FoundationECOG PS 0Key secondary endpointPD-L1 positivityNew safety signalsPD-L1 testingCo-primary endpointsEli LillyCancer Research FoundationNational Cancer InstituteMedical writing assistanceMedical Research CouncilIMpassion130: updated overall survival (OS) from a global, randomized, double-blind, placebo-controlled, Phase III study of atezolizumab (atezo) + nab- paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC).
Schmid P, Adams S, Rugo H, Schneeweiss A, Barrios C, Iwata H, Dieras V, Henschel V, Molinero L, Chui S, Husain A, Winer E, Loi S, Emens L. IMpassion130: updated overall survival (OS) from a global, randomized, double-blind, placebo-controlled, Phase III study of atezolizumab (atezo) + nab- paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC). Journal Of Clinical Oncology 2019, 37: 1003-1003. DOI: 10.1200/jco.2019.37.15_suppl.1003.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerOverall survivalPD-L1OS analysisTriple-negative breast cancerECOG PS 0Median overall survivalPrimary PFS analysisPD-L1 testingPhase III studyCo-primary endpointsEligible ptsOS benefitData cutoffIII studyNab-paclitaxelPS 0AtezoBreast cancerPFS analysisPlaceboNP armTumor tissueSafety updateOS data
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