2016
Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial
Krop IE, Mayer IA, Ganju V, Dickler M, Johnston S, Morales S, Yardley DA, Melichar B, Forero-Torres A, Lee SC, de Boer R, Petrakova K, Vallentin S, Perez EA, Piccart M, Ellis M, Winer E, Gendreau S, Derynck M, Lackner M, Levy G, Qiu J, He J, Schmid P. Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial. The Lancet Oncology 2016, 17: 811-821. PMID: 27155741, PMCID: PMC5524539, DOI: 10.1016/s1470-2045(16)00106-6.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBiomarkers, TumorBreast NeoplasmsDouble-Blind MethodDrug Resistance, NeoplasmEstradiolEstrogen Receptor AntagonistsFemaleFollow-Up StudiesFulvestrantHumansMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPrognosisReceptor, ErbB-2Receptors, EstrogenSalvage TherapySurvival RateConceptsProgression-free survivalSerious adverse eventsTreatment-related serious adverse eventsWorse adverse eventsPlacebo groupAdverse eventsNon-measurable diseaseAromatase inhibitor treatmentPIK3CA mutationsBreast cancerDay 1Grade 3Inhibitor treatmentDay 15Cycle 1Median progression-free survivalHER2-negative breast cancerEndocrine-resistant breast cancerPIK3CA-mutated tumorsPhase 2 studyPhase 2 trialMetastatic breast cancerWeeks of treatmentAromatase inhibitor resistanceF Hoffmann-La Roche
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
2005
Prognosis after local recurrence after conservative surgery and radiation for early-stage breast cancer
Galper S, Blood E, Gelman R, Abner A, Recht A, Kohli A, Wong JS, Smith D, Bellon J, Connolly J, Schnitt S, Winer E, Silver B, Harris JR. Prognosis after local recurrence after conservative surgery and radiation for early-stage breast cancer. International Journal Of Radiation Oncology • Biology • Physics 2005, 61: 348-357. PMID: 15667952, DOI: 10.1016/j.ijrobp.2004.06.011.Peer-Reviewed Original ResearchConceptsLocal recurrenceConservative surgeryBreast cancerDistant metastasisInitial diagnosisRadiation therapyEarly-stage invasive breast cancerDistant disease-free survivalEarly-stage breast cancerClinical stage IDisease-free survivalFinal study populationInvasive breast cancerLong-term prognosisProportional hazards modelNonbreast malignanciesActuarial freedomMedian followDistant failureSecond malignanciesIpsilateral breastLocal therapyRegional nodalMedian timeStudy population
2003
Clinical differences among the aromatase inhibitors.
Ligibel JA, Winer EP. Clinical differences among the aromatase inhibitors. Clinical Cancer Research 2003, 9: 473s-9s. PMID: 12538503.Peer-Reviewed Original ResearchConceptsAromatase inhibitorsAdjuvant settingLarge phase III trialsThird-generation aromatase inhibitorsFirst-line settingSecond-line therapyDisease-free survivalPhase III trialsMetastatic breast cancerMegesterol acetateATAC trialIII trialsMetastatic diseaseClinical differencesNonsteroidal agentsClinical significanceBreast cancerAromatase activityAnastrozoleLetrozoleStudy designTamoxifenTrialsExemestaneInhibitors