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
PD09-05: SU2C Phase Ib Study of pan-PI3K Inhibitor BKM120 Plus Aromatase Inhibitor Letrozole in ER+/HER2− Metastatic Breast Cancer (MBC).
Mayer I, Balko J, Kuba M, Sanders M, Yap J, Li Y, Winer E, Arteaga C. PD09-05: SU2C Phase Ib Study of pan-PI3K Inhibitor BKM120 Plus Aromatase Inhibitor Letrozole in ER+/HER2− Metastatic Breast Cancer (MBC). Cancer Research 2011, 71: pd09-05-pd09-05. DOI: 10.1158/0008-5472.sabcs11-pd09-05.Peer-Reviewed Original ResearchPan-PI3K inhibitor BKM120Metastatic breast cancerFDG-PET imagingAromatase inhibitorsBreast cancerSafe side effect profilePhase Ib clinical trialAlternative administration schedulesDiagnostic tumor biopsiesGrade 3 transaminitisMost common toxicitiesPI3K-targeted therapiesSafety/tolerabilityPhase Ib studyMetastatic bone diseaseSide effect profileMonths of initiationPost-menopausal patientsWeeks of treatmentPI3K pathway inhibitionMost breast cancersAromatase inhibitor letrozoleProgression of diseasePI3K/AktCommon toxicities
2001
Phase II Evaluation Of Thalidomide In Patients With Metastatic Breast Cancer
Baidas S, Winer E, Fleming G, Harris L, Pluda J, Crawford J, Yamauchi H, Isaacs C, Hanfelt J, Tefft M, Flockhart D, Johnson, Hawkins M, Lippman M, Hayes D. Phase II Evaluation Of Thalidomide In Patients With Metastatic Breast Cancer. Journal Of The Peripheral Nervous System 2001, 6: 65-66. DOI: 10.1046/j.1529-8027.2001.01008-20.x.Peer-Reviewed Original ResearchMetastatic breast cancerWeeks of treatmentProgressive diseaseBreast cancerDose levelsProgressive metastatic breast cancerGrowth factor serum levelsSingle-agent thalidomideFactor serum levelsPhase II evaluationLack of efficacyDifferent patient populationsLow dose levelsAngiogenic growth factorsStable diseaseDry mouthAdverse eventsSkin rashComplete responseSerum levelsPatient populationWeek 16II evaluationGrade 3Patients
2000
Phase II evaluation of thalidomide in patients with metastatic breast cancer.
Baidas S, Winer E, Fleming G, Harris L, Pluda J, Crawford J, Yamauchi H, Isaacs C, Hanfelt J, Tefft M, Flockhart D, Johnson M, Hawkins M, Lippman M, Hayes D. Phase II evaluation of thalidomide in patients with metastatic breast cancer. Journal Of Clinical Oncology 2000, 18: 2710-7. PMID: 10894870, DOI: 10.1200/jco.2000.18.14.2710.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAngiogenesis InhibitorsBreast NeoplasmsDrug Administration ScheduleEndothelial Growth FactorsFemaleFibroblast Growth Factor 2Growth SubstancesHumansLymphokinesMatrix MetalloproteinasesMiddle AgedNeoplasm MetastasisProspective StudiesThalidomideTumor Necrosis Factor-alphaVascular Endothelial Growth Factor AVascular Endothelial Growth FactorsConceptsMetastatic breast cancerWeeks of treatmentProgressive diseaseBreast cancerDose levelsProgressive metastatic breast cancerGrowth factor serum levelsSingle-agent thalidomideFactor serum levelsPhase II evaluationLack of efficacyDifferent patient populationsLow dose levelsAngiogenic growth factorsStable diseaseDry mouthAdverse eventsSkin rashComplete responseSerum levelsPatient populationWeek 16II evaluationGrade 3Patients