Phase II Study of the Antibody Drug Conjugate Trastuzumab-DM1 for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) –Positive Breast Cancer After Prior HER2-Directed Therapy
Burris HA, Rugo HS, Vukelja SJ, Vogel CL, Borson RA, Limentani S, Tan-Chiu E, Krop IE, Michaelson RA, Girish S, Amler L, Zheng M, Chu YW, Klencke B, O'Shaughnessy JA. Phase II Study of the Antibody Drug Conjugate Trastuzumab-DM1 for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) –Positive Breast Cancer After Prior HER2-Directed Therapy. Journal Of Clinical Oncology 2010, 29: 398-405. PMID: 21172893, DOI: 10.1200/jco.2010.29.5865.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsDisease-Free SurvivalFemaleHumansImmunotoxinsKaplan-Meier EstimateMaytansineMiddle AgedReceptor, ErbB-2RNA, MessengerTime FactorsTrastuzumabTreatment OutcomeUnited StatesConceptsHER2-positive metastatic breast cancerMetastatic breast cancerPhase II studyTrastuzumab-DM1II studyAdverse eventsResponse rateBreast cancerHER2 levelsMedian progression-free survival timeSingle-arm phase II studyRobust single-agent activityProgression-free survival timeHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorHER2-directed therapiesMaximum-tolerated doseMost adverse eventsObjective response ratePhase II doseGrowth factor receptor 2Single-agent activityHER2-positive tumorsReverse transcriptase-polymerase chain reaction