2011
Phase I/II Study of Trastuzumab in Combination With Everolimus (RAD001) in Patients With HER2-Overexpressing Metastatic Breast Cancer Who Progressed on Trastuzumab-Based Therapy
Morrow PK, Wulf GM, Ensor J, Booser DJ, Moore JA, Flores PR, Xiong Y, Zhang S, Krop IE, Winer EP, Kindelberger DW, Coviello J, Sahin AA, Nuñez R, Hortobagyi GN, Yu D, Esteva FJ. Phase I/II Study of Trastuzumab in Combination With Everolimus (RAD001) in Patients With HER2-Overexpressing Metastatic Breast Cancer Who Progressed on Trastuzumab-Based Therapy. Journal Of Clinical Oncology 2011, 29: 3126-3132. PMID: 21730275, PMCID: PMC3157979, DOI: 10.1200/jco.2010.32.2321.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsDisease-Free SurvivalEverolimusFemaleHumansImmunohistochemistryKaplan-Meier EstimateMiddle AgedNeoplasm MetastasisPTEN PhosphohydrolaseReceptor, ErbB-2Salvage TherapySirolimusTOR Serine-Threonine KinasesTrastuzumabConceptsHER2-overexpressing metastatic breast cancerMetastatic breast cancerProgression-free survivalCombination of everolimusTrastuzumab-based therapyPTEN lossBreast cancerPhase I/II studyMedian progression-free survivalDana-Farber Cancer InstituteTexas MD Anderson Cancer CenterMD Anderson Cancer CenterBeth Israel Deaconess Medical CenterClinical benefit ratePersistent stable diseaseAnderson Cancer CenterDownstream mammalian targetDaily everolimusNonhematologic toxicityStable diseaseII studyOverall survivalPartial responseHER2 overexpressingClinical benefit
2009
A phase II study of oral enzastaurin in patients with metastatic breast cancer previously treated with an anthracycline and a taxane containing regimen
Mina L, Krop I, Zon RT, Isakoff SJ, Schneider CJ, Yu M, Johnson C, Vaughn LG, Wang Y, Hristova-Kazmierski M, Shonukan OO, Sledge GW, Miller KD. A phase II study of oral enzastaurin in patients with metastatic breast cancer previously treated with an anthracycline and a taxane containing regimen. Investigational New Drugs 2009, 27: 565. PMID: 19214387, DOI: 10.1007/s10637-009-9220-1.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerPhase II studyPI3K/AktII studyBreast cancerGrade 3/4 hematologic toxicitiesMedian progression-free survivalGrade 3 nonhematologic toxicityHuman epidermal growth factor 2Epidermal growth factor 2Prior trastuzumab therapyCycles of therapySolid Tumors criteriaProgression-free survivalResponse Evaluation CriteriaBreast cancer pathogenesisSerine-threonine kinase inhibitorMBC progressionOral enzastaurinPrior anthracyclineEligible patientsHematologic toxicityMeasurable diseaseNonhematologic toxicityPrior regimens