2023
A randomized phase II study of metronomic cyclophosphamide and methotrexate (CM) with or without bevacizumab in patients with advanced breast cancer
Mayer E, Tayob N, Ren S, Savoie J, Spigel D, Burris H, Ryan P, Harris L, Winer E, Burstein H. A randomized phase II study of metronomic cyclophosphamide and methotrexate (CM) with or without bevacizumab in patients with advanced breast cancer. Breast Cancer Research And Treatment 2023, 204: 123-132. PMID: 38019444, DOI: 10.1007/s10549-023-07167-9.Peer-Reviewed Original ResearchObjective response rateProgression-free survivalAdvanced breast cancerPhase II studyMetastatic breast cancerOverall survivalArm ABreast cancerArm BII studyMetronomic chemotherapyRandomized phase II studyGrade adverse eventsMetronomic oral cyclophosphamideOral metronomic chemotherapyMedian overall survivalStandard-dose chemotherapyFurther clinical evaluationMetronomic cyclophosphamideOral cyclophosphamideArm B.Primary endpointSecondary endpointsAdverse eventsDose chemotherapy
2019
Randomized phase II study of eribulin mesylate (E) with or without pembrolizumab (P) for hormone receptor-positive (HR+) metastatic breast cancer (MBC).
Tolaney S, Barroso-Sousa R, Keenan T, Trippa L, Hu J, Luis I, Wulf G, Spring L, Sinclair N, Andrews C, Pittenger J, Richardson E, Dillon D, Lin N, Overmoyer B, Partridge A, VanAllen E, Mittendorf E, Winer E, Krop I. Randomized phase II study of eribulin mesylate (E) with or without pembrolizumab (P) for hormone receptor-positive (HR+) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2019, 37: 1004-1004. DOI: 10.1200/jco.2019.37.15_suppl.1004.Peer-Reviewed Original ResearchProgression-free survivalObjective response rateNeutrophil-lymphocyte ratioTumor-infiltrating lymphocytesTumor mutation burdenOverall survivalPrior linesMedian progression-free survivalCheckpoint inhibitor monotherapyMedian prior linesKey secondary endpointLines of chemotherapyPD-L1 statusTime of progressionChemotherapy 1Eligible patientsHormonal therapyPrimary endpointProtocol therapySecondary endpointsInhibitor monotherapyArm BMedian ageArm ATherapy 2
2015
Genomic Analysis Reveals That Immune Function Genes Are Strongly Linked to Clinical Outcome in the North Central Cancer Treatment Group N9831 Adjuvant Trastuzumab Trial
Perez EA, Thompson EA, Ballman KV, Anderson SK, Asmann YW, Kalari KR, Eckel-Passow JE, Dueck AC, Tenner KS, Jen J, Fan JB, Geiger XJ, McCullough AE, Chen B, Jenkins RB, Sledge GW, Winer EP, Gralow JR, Reinholz MM. Genomic Analysis Reveals That Immune Function Genes Are Strongly Linked to Clinical Outcome in the North Central Cancer Treatment Group N9831 Adjuvant Trastuzumab Trial. Journal Of Clinical Oncology 2015, 33: 701-708. PMID: 25605861, PMCID: PMC4334774, DOI: 10.1200/jco.2014.57.6298.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalDNA, NeoplasmFemaleGene Expression Regulation, NeoplasticGenomicsHumansKaplan-Meier EstimateMiddle AgedMolecular Targeted TherapyProportional Hazards ModelsReceptor, ErbB-2TranscriptomeTrastuzumabConceptsRelapse-free survivalImmune function genesAdjuvant trastuzumab trialsArm BTrastuzumab trialsHazard ratioArm AHuman epidermal growth factor receptorClinicopathologic risk factorsProportional hazard ratiosEpidermal growth factor receptorGrowth factor receptorAdjuvant trastuzumabC patientsCombination chemotherapyClinical outcomesRisk factorsBreast cancerPatientsTrastuzumabPredictive signatureFunction genesChemotherapyGene enrichmentFactor receptor
2014
Circulating Tumor Cells and Response to Chemotherapy in Metastatic Breast Cancer: SWOG S0500
Smerage JB, Barlow WE, Hortobagyi GN, Winer EP, Leyland-Jones B, Srkalovic G, Tejwani S, Schott AF, O'Rourke MA, Lew DL, Doyle GV, Gralow JR, Livingston RB, Hayes DF. Circulating Tumor Cells and Response to Chemotherapy in Metastatic Breast Cancer: SWOG S0500. Journal Of Clinical Oncology 2014, 32: 3483-3489. PMID: 24888818, PMCID: PMC4209100, DOI: 10.1200/jco.2014.56.2561.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerFirst-line chemotherapyMedian overall survivalDays of therapyOverall survivalInitial therapyBreast cancerTumor cellsTrial of patientsMore effective treatmentsEvaluable patientsStandard chemotherapyPrimary outcomeArm APoor prognosisPrognostic significanceCytotoxic therapyAlternative chemotherapyEffective treatmentChemotherapyPatientsTherapyEarly switchingPersistent increaseMonths
2012
SU2C phase Ib study of pan-PI3K inhibitor BKM120 with letrozole in ER+/HER2- metastatic breast cancer (MBC).
Mayer I, Abramson V, Balko J, Isakoff S, Kuba M, Sanders M, Forero-Torres A, Yap J, Van Den Abbeele A, Li Y, Arteaga C, Winer E. SU2C phase Ib study of pan-PI3K inhibitor BKM120 with letrozole in ER+/HER2- metastatic breast cancer (MBC). Journal Of Clinical Oncology 2012, 30: 510-510. DOI: 10.1200/jco.2012.30.15_suppl.510.Peer-Reviewed Original ResearchMetastatic breast cancerPan-PI3K inhibitor BKM120FDG-PETArm API3K pathway alterationsPhase Ib studyPhase Ib trialPost-menopausal patientsPI3K pathway inhibitionPI3K mutationsPI3K inhibitorsIb trialStable diseaseVisceral metastasesUnacceptable toxicityMost patientsArm BMedian ageDisease progressionPharmacodynamic biomarkersBreast cancerTreatment responseTumor biopsiesAntiestrogen resistanceIb study
2011
Zoledronic acid preserves bone mineral density in premenopausal women who develop ovarian failure due to adjuvant chemotherapy: Final results from CALGB trial 79809
Shapiro C, Halabi S, Hars V, Archer L, Weckstein D, Kirshner J, Sikov W, Winer E, Burstein H, Hudis C, Isaacs C, Schilsky R, Paskett E. Zoledronic acid preserves bone mineral density in premenopausal women who develop ovarian failure due to adjuvant chemotherapy: Final results from CALGB trial 79809. European Journal Of Cancer 2011, 47: 683-689. PMID: 21324674, PMCID: PMC4211594, DOI: 10.1016/j.ejca.2010.11.024.Peer-Reviewed Original ResearchConceptsChemotherapy-induced ovarian failureBone mineral densityRapid bone lossFollicle-stimulating hormoneZoledronic acidBone lossAdjuvant chemotherapyPremenopausal womenLumbar spineOvarian failureMineral densityMonths of amenorrhoeaGrade 3 toxicityMedian percent changeArm AAmino bisphosphonateMIU/Control groupPercent changeChemotherapyPercentage changeMonthsWomenRandomizationYears