2022
The oral selective estrogen receptor degrader GDC-0810 (ARN-810) in postmenopausal women with hormone receptor-positive HER2-negative (HR + /HER2 −) advanced/metastatic breast cancer
Bardia A, Mayer I, Winer E, Linden H, Ma C, Parker B, Bellet M, Arteaga C, Cheeti S, Gates M, Chang C, Fredrickson J, Spoerke J, Moore H, Giltnane J, Friedman L, Chow Maneval E, Chan I, Jhaveri K. The oral selective estrogen receptor degrader GDC-0810 (ARN-810) in postmenopausal women with hormone receptor-positive HER2-negative (HR + /HER2 −) advanced/metastatic breast cancer. Breast Cancer Research And Treatment 2022, 197: 319-331. PMID: 36401732, PMCID: PMC9823088, DOI: 10.1007/s10549-022-06797-9.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerSelective estrogen receptor degraderDose escalationESR1 mutationsPostmenopausal womenBreast cancerEstrogen receptorCombination treatmentNon-complete response/non-progressive diseaseAdvanced/Metastatic Breast CancerOral selective estrogen receptor degraderPreliminary anti-tumor activityESR1 mutation statusPhase 2 dosePlasma ctDNA samplesCommon adverse eventsNon-progressive diseaseDose-limiting toxicityHormone-releasing hormoneSelective estrogen receptorAnti-tumor activityStable diseaseAdverse eventsPartial responseProgressive diseaseThe feasibility of using an autologous GM-CSF-secreting breast cancer vaccine to induce immunity in patients with stage II–III and metastatic breast cancers
Anderson KS, Erick TK, Chen M, Daley H, Campbell M, Colson Y, Mihm M, Zakka LR, Hopper M, Barry W, Winer EP, Dranoff G, Overmoyer B. The feasibility of using an autologous GM-CSF-secreting breast cancer vaccine to induce immunity in patients with stage II–III and metastatic breast cancers. Breast Cancer Research And Treatment 2022, 194: 65-78. PMID: 35482127, PMCID: PMC9046531, DOI: 10.1007/s10549-022-06562-y.Peer-Reviewed Original ResearchConceptsBreast cancer vaccinesAutologous GM-CSFBreast cancerMetastatic diseaseGM-CSFStage IICancer vaccinesTumor cellsEvidence of diseaseStart of vaccinationInjection site reactionsMetastatic breast cancerUpper respiratory symptomsImmune cell infiltrationRole of vaccinationReplication-defective adenoviral vectorEvaluable patientsMethodsTumor cellsStable diseaseWeekly vaccinationsJoint painProgressive diseaseRespiratory symptomsFifth injectionTRIAL REGISTRATION
2013
A Phase I dose-escalation study of the VEGFR inhibitor tivozanib hydrochloride with weekly paclitaxel in metastatic breast cancer
Mayer EL, Scheulen ME, Beckman J, Richly H, Duarte A, Cotreau MM, Strahs AL, Agarwal S, Steelman L, Winer EP, Dickler MN. A Phase I dose-escalation study of the VEGFR inhibitor tivozanib hydrochloride with weekly paclitaxel in metastatic breast cancer. Breast Cancer Research And Treatment 2013, 140: 331-339. PMID: 23868188, DOI: 10.1007/s10549-013-2632-9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsFemaleHumansMiddle AgedNeoplasm MetastasisPaclitaxelPhenylurea CompoundsProtein Kinase InhibitorsQuinolinesVascular Endothelial Growth Factor Receptor-1ConceptsMetastatic breast cancerTyrosine kinase inhibitorsWeekly paclitaxelPaclitaxel 90Breast cancerPhase I dose-escalation studyI dose-escalation studyVascular endothelial growth factor receptor 1Activity of tivozanibSafety/tolerabilityGrade 3/4 toxicitiesPeripheral sensory neuropathyPhase Ib studyDose-escalation studyResponse Evaluation CriteriaSelective tyrosine kinase inhibitorVEGFR-TKI treatmentSolid Tumors responseGrowth factor receptor 1Influence of paclitaxelFactor receptor 1Stable diseaseMBC patientsPartial responseProgressive disease
2009
Neoadjuvant cisplatin and bevacizumab in triple negative breast cancer (TNBC): Safety and efficacy
Ryan P, Tung N, Isakoff S, Golshan M, Richardson A, Corben A, Smith B, Gelman R, Winer E, Garber J. Neoadjuvant cisplatin and bevacizumab in triple negative breast cancer (TNBC): Safety and efficacy. Journal Of Clinical Oncology 2009, 27: 551-551. DOI: 10.1200/jco.2009.27.15_suppl.551.Peer-Reviewed Original ResearchTriple-negative breast cancerClinical partial responseClinical complete responseNeoadjuvant cisplatinNeoadjuvant therapyPulmonary embolismBreast cancerStable diseaseProgressive diseasePathological responseHearing lossWeeks x 4 cyclesTreatment of TNBCSingle-arm phase II trialArm phase II trialCycles of bevacizumabEfficacy of bevacizumabGrade 4 toxicityComplete pathological responseAddition of bevacizumabPhase II trialMetastatic breast cancerEfficacy of chemotherapyNegative breast cancerTissue-based assaysUniformly positive (>80%) HER2 expression maximizes sensitivity and specificity for prediction of response to trastuzumab in CALGB 9840.
Rimm D, Broadwater G, Friedman P, Berry D, Seidman A, Hudis C, Winer E, Harris L, Thor A. Uniformly positive (>80%) HER2 expression maximizes sensitivity and specificity for prediction of response to trastuzumab in CALGB 9840. Cancer Research 2009, 69: 6046. DOI: 10.1158/0008-5472.sabcs-6046.Peer-Reviewed Original ResearchPrediction of responseHER2 expressionCooperative group clinical trialsPositive HER2 expressionGroup clinical trialReceiver operator characteristic curveOperator characteristic curveSubset of casesArea of expressionHeterogeneity of expressionHER2 stainingTH armNeoadjuvant settingStable diseaseProgressive diseaseRECIST criteriaPartial responseClinical outcomesCAP guidelinesPatient selectionPercentage of tissueT therapyClinical trialsHER2 testsLarge cohort
2006
Superiority of bi-dimensional measurements compared to RECIST in measuring response of metastatic brain tumors
Kilpatrick M, Linn N, Smith J, Winer E, Bullitt E, Carey L, Ewend M. Superiority of bi-dimensional measurements compared to RECIST in measuring response of metastatic brain tumors. Journal Of Clinical Oncology 2006, 24: 1542-1542. DOI: 10.1200/jco.2006.24.18_suppl.1542.Peer-Reviewed Original ResearchMetastatic brain tumorsProgressive diseaseRECIST criteriaBrain tumorsDana-Farber/Harvard Cancer CenterProspective phase II studyMetastatic breast cancer lesionsPhase II studyBreast cancer lesionsVolume measurementsStable diseaseBrain metastasesII studyPartial responseClinical benefitTumor sizeCancer CenterTumor responseMetastatic natureTumor volumeRECISTBi-dimensional measurementsBidimensional criteriaCancer lesionsResponse rate
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
1997
Pharmacokinetics and clinical impact of all-trans retinoic acid in metastatic breast cancer: a phase II trial
Sutton L, Warmuth M, Petros W, Winer E. Pharmacokinetics and clinical impact of all-trans retinoic acid in metastatic breast cancer: a phase II trial. Cancer Chemotherapy And Pharmacology 1997, 40: 335-341. PMID: 9225952, DOI: 10.1007/s002800050666.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerBreast cancerTrans retinoic acidSystemic exposureMonths durationClinical pharmacologyPharmacokinetic analysisInitial systemic exposureM2 three timesCycles of therapyPhase II studyPhase II trialRetinoic acidStable diseaseII trialTumor cytoreductionUnacceptable toxicityFirst doseII studyPartial responsePatient withdrawalProgressive diseaseTreatment regimenInitial doseSingle institution