2011
P1-06-23: Changes in Gene Expression after One Dose of Trastuzumab (T) in HER2+ Breast Cancer Cell Lines Predict Novel Pathways of Response in HER2 Positive Early Stage Breast Cancer.
Sprecher E, Lezon-Geyda K, Sarkar S, Bossuyt V, Narayaan M, Kumar A, Krop I, Winer E, Tuck D, Kleinstein S, Harris L. P1-06-23: Changes in Gene Expression after One Dose of Trastuzumab (T) in HER2+ Breast Cancer Cell Lines Predict Novel Pathways of Response in HER2 Positive Early Stage Breast Cancer. Cancer Research 2011, 71: p1-06-23-p1-06-23. DOI: 10.1158/0008-5472.sabcs11-p1-06-23.Peer-Reviewed Original ResearchPathologic complete responseBreast cancer patientsBreast cancer cell linesSensitive cell linesCancer cell linesCancer patientsSingle doseBreast cancerHER2-positive early-stage breast cancerPositive early-stage breast cancerCell linesBreast tumorsEarly breast cancer patientsEarly-stage breast cancerDose of trastuzumabEarly-stage HER2Early breast cancerResistant breast tumorsStage breast cancerTumor core biopsiesPathway analysisMechanism of actionResistant HER2RECIST criteriaClinical response
2009
Tolerability and efficacy of 500 mg fulvestrant in postmenopausal women with estrogen receptor (ER)+ advanced breast cancer
Come S, Parker L, Wulf G, Kuter I, Ryan P, Tkaczuk K, Borges V, Kasper H, Gelman R, Winer E. Tolerability and efficacy of 500 mg fulvestrant in postmenopausal women with estrogen receptor (ER)+ advanced breast cancer. Journal Of Clinical Oncology 2009, 27: 1050-1050. DOI: 10.1200/jco.2009.27.15_suppl.1050.Peer-Reviewed Original ResearchClinical benefit rateStable diseasePartial responseComplete responseEstrogen receptorEndocrine therapyMedian timeBreast cancerEvaluable metastatic breast cancerFirst-line metastatic settingInjection site discomfortAdjuvant endocrine therapyAdjuvant endocrine treatmentPhase II studyTreatment-related toxicityMetastatic breast cancerAdvanced diseaseEndocrine treatmentMetastatic settingPostmenopausal patientsPrimary endpointRECIST criteriaVisceral metastasesII studyPostmenopausal womenUniformly 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 ratePhase II trial of lapatinib for brain metastases in patients with HER2+ breast cancer
Lin N, Carey L, Liu M, Younger J, Come S, Bullitt E, Van Den Abbeele A, Li X, Hochberg F, Winer E. Phase II trial of lapatinib for brain metastases in patients with HER2+ breast cancer. Journal Of Clinical Oncology 2006, 24: 503-503. DOI: 10.1200/jco.2006.24.18_suppl.503.Peer-Reviewed Original ResearchBrain metastasesBreast cancerObjective responsePrimary endpointCNS lesionsCNS diseaseCentral nervous system metastasesVolumetric declinesCentral radiology reviewProgressive brain metastasesNervous system metastasesPhase II trialEfficacy of lapatinibMetastatic breast cancerFDG-PET scansMean age 52Analysis of QOLCommon AEsEligible patientsMeasurable diseasePo bidII trialPrior radiationRECIST criteriaSecondary endpoints