2014
Comparison of Doxorubicin and Cyclophosphamide Versus Single-Agent Paclitaxel As Adjuvant Therapy for Breast Cancer in Women With 0 to 3 Positive Axillary Nodes: CALGB 40101 (Alliance)
Shulman LN, Berry DA, Cirrincione CT, Becker HP, Perez EA, O'Regan R, Martino S, Shapiro CL, Schneider CJ, Kimmick G, Burstein HJ, Norton L, Muss H, Hudis CA, Winer EP. Comparison of Doxorubicin and Cyclophosphamide Versus Single-Agent Paclitaxel As Adjuvant Therapy for Breast Cancer in Women With 0 to 3 Positive Axillary Nodes: CALGB 40101 (Alliance). Journal Of Clinical Oncology 2014, 32: 2311-2317. PMID: 24934787, PMCID: PMC4105484, DOI: 10.1200/jco.2013.53.7142.Peer-Reviewed Original ResearchConceptsRelapse-free survivalSingle-agent paclitaxelOverall survivalHazard ratioBreast cancerTreatment-related deathsCycles of therapyOperable breast cancerPositive axillary nodesPrimary end pointDuration of therapyOptimal adjuvant chemotherapyComparison of doxorubicinAdjuvant chemotherapyCALGB 40101Median followAdjuvant therapyHematologic toxicityPositive nodesAxillary nodesPatient deathBalance efficacyPatientsEnd pointTherapy
2013
Comparison of doxorubicin and cyclophosphamide (AC) versus single-agent paclitaxel (T) as adjuvant therapy for breast cancer in women with 0-3 positive axillary nodes: CALGB 40101.
Shulman L, Berry D, Cirrincione C, Becker H, Perez E, O'Regan R, Martino S, Shapiro C, Atkins J, Schneider C, Kimmick G, Burstein H, Norton L, Muss H, Hudis C, Winer E. Comparison of doxorubicin and cyclophosphamide (AC) versus single-agent paclitaxel (T) as adjuvant therapy for breast cancer in women with 0-3 positive axillary nodes: CALGB 40101. Journal Of Clinical Oncology 2013, 31: 1007-1007. DOI: 10.1200/jco.2013.31.15_suppl.1007.Peer-Reviewed Original ResearchRelapse-free survivalHazard ratioOverall survivalBreast cancerEarly-stage breast cancerCycles of therapyNon-hematologic toxicitiesOperable breast cancerPositive axillary nodesSingle-agent paclitaxelTreatment-related deathsOptimal adjuvant chemotherapyStage breast cancerConfidence intervalsComparison of doxorubicinAdjuvant chemotherapyCALGB 40101Hematologic toxicityAdjuvant therapyPositive nodesPrimary endpointAxillary nodesVs. 4Conclusion of equivalenceGrade 3
2009
A phase II study of ixabepilone plus trastuzumab for metastatic HER2-positive breast cancer.
Tolaney S, Najita J, Chen W, Savoie J, Fornier M, Krop I, Winer E, Bunnell C. A phase II study of ixabepilone plus trastuzumab for metastatic HER2-positive breast cancer. Cancer Research 2009, 69: 3137. DOI: 10.1158/0008-5472.sabcs-3137.Peer-Reviewed Original ResearchMetastatic HER2-positive breast cancerHER2-positive breast cancerCombination of ixabepiloneBreast cancerPartial responseCohort 1Response rateMetastatic diseaseCohort 2Clinical benefit rateHigher cardiac toxicityRefractory breast cancerSubsequent-line therapyTrastuzumab-containing regimensCycles of therapyPhase II studyTreatment-related toxicityCohort of patientsEncouraging response ratesMetastatic breast cancerSame treatment regimenOverall response ratePrior chemotherapyStable diseaseElevated transaminases
2007
A pilot study of adjuvant bevacizumab after neoadjuvant chemotherapy for high-risk breast cancer
Mayer E, Miller K, Rugo H, Peppercorn J, Carey L, Ryabin N, Winer E, Burstein H. A pilot study of adjuvant bevacizumab after neoadjuvant chemotherapy for high-risk breast cancer. Journal Of Clinical Oncology 2007, 25: 561-561. DOI: 10.1200/jco.2007.25.18_suppl.561.Peer-Reviewed Original ResearchNeoadjuvant chemotherapyBreast cancerAdjuvant bevacizumabAntiangiogenic therapyAnthracycline-containing neoadjuvant chemotherapyHigh-risk breast cancerAdjuvant antiangiogenic therapyResidual invasive carcinomaSingle-agent bevacizumabCycles of therapyTreatment-related toxicityChemotherapy-resistant diseasePhase II trialResidual breast cancerRisk of recurrenceNovel antiangiogenic therapiesEligible patientsMild arthralgiaAgent bevacizumabBevacizumab monotherapyII trialPrimary endpointMedian ageOngoing trialsOral chemotherapy
2006
Combination therapy with gefitinib and capecitabine in metastatic breast cancer (MBC): A phase I trial
Mayer E, Harris L, Partridge A, Gelman R, Schumer S, Comanaru R, Long M, Sampson E, Burstein H, Winer E. Combination therapy with gefitinib and capecitabine in metastatic breast cancer (MBC): A phase I trial. Journal Of Clinical Oncology 2006, 24: 10564-10564. DOI: 10.1200/jco.2006.24.18_suppl.10564.Peer-Reviewed Original ResearchMetastatic breast cancerMicroelectronic monitoring systemOral regimenValidation cohortDose reductionHand/foot syndromeSubstantial anti-tumor activityEGFR tyrosine kinase inhibitor gefitinibPhase IDose-escalation cohortsGrade 3 diarrheaGrade 4 toxicityCycles of therapyGrade 3 toxicityGrade 3/4 toxicitiesPhase I trialTyrosine kinase inhibitor gefitinibPost-therapy valuesMean numberCycle 1Lack of progressionAnti-tumor activityKinase inhibitor gefitinibEvaluable ptsUnresolved toxicity
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