2016
HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician’s choice plus trastuzumab in patients with previously treated, anthracycline-naïve, HER2-positive, locally advanced/metastatic breast cancer
Miller K, Cortes J, Hurvitz SA, Krop IE, Tripathy D, Verma S, Riahi K, Reynolds JG, Wickham TJ, Molnar I, Yardley DA. HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician’s choice plus trastuzumab in patients with previously treated, anthracycline-naïve, HER2-positive, locally advanced/metastatic breast cancer. BMC Cancer 2016, 16: 352. PMID: 27259714, PMCID: PMC4893300, DOI: 10.1186/s12885-016-2385-z.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerProgression-free survivalPhase 2 trialMetastatic breast cancerBreast cancerDisease progressionOverall survivalMM-302Physician's choiceInvestigator-assessed progression-free survivalMetastatic HER2-positive breast cancerRandomized phase 2 trialEpidermal growth factor receptor 2Anthracycline-naïve patientsBackgroundHuman epidermal growth factor receptor 2Objective response rateGrowth factor receptor 2Positive breast cancerAdo-trastuzumab emtansineKey inclusion criteriaFactor receptor 2Quality of lifeOS ratesRECIST v1.1Refractory HER2
2012
Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane.
Pegram M, Blackwell K, Miles D, Bianchi G, Krop I, Welslau M, Baselga J, Oh D, Dieras V, Guardino E, Olsen S, Fang L, Lu M, Verma S. Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane. Journal Of Clinical Oncology 2012, 30: 98-98. DOI: 10.1200/jco.2012.30.27_suppl.98.Peer-Reviewed Original ResearchMetastatic breast cancerT-DM1End pointProgressive diseaseAdverse eventsCytotoxic agent DM1Primary end pointUnexpected safety signalsPalmar-plantar erythrodysesthesiaPhase III studyFinal PFS analysisRefractory HER2Prior therapyBaseline demographicsIII studyMedian durationRandomized studyPlantar erythrodysesthesiaUnmanageable toxicityDisease characteristicsAdvanced BCTrastuzumab emtansineNovel therapiesSafety signalsBreast cancerPrimary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane.
Blackwell K, Miles D, Gianni L, Krop I, Welslau M, Baselga J, Pegram M, Oh D, Dieras V, Olsen S, Fang L, Lu M, Guardino E, Verma S. Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane. Journal Of Clinical Oncology 2012, 30: lba1-lba1. DOI: 10.1200/jco.2012.30.18_suppl.lba1.Peer-Reviewed Original ResearchMetastatic breast cancerT-DM1End pointProgressive diseaseAdverse eventsCytotoxic agent DM1Primary end pointUnexpected safety signalsPalmar-plantar erythrodysesthesiaPhase III studyFinal PFS analysisRefractory HER2Prior therapyBaseline demographicsIII studyMedian durationRandomized studyPlantar erythrodysesthesiaUnmanageable toxicityDisease characteristicsAdvanced BCTrastuzumab emtansineNovel therapiesSafety signalsBreast cancer