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
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
2008
Cardiac Safety Analysis of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With or Without Trastuzumab in the North Central Cancer Treatment Group N9831 Adjuvant Breast Cancer Trial
Perez EA, Suman VJ, Davidson NE, Sledge GW, Kaufman PA, Hudis CA, Martino S, Gralow JR, Dakhil SR, Ingle JN, Winer EP, Gelmon KA, Gersh BJ, Jaffe AS, Rodeheffer RJ. Cardiac Safety Analysis of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With or Without Trastuzumab in the North Central Cancer Treatment Group N9831 Adjuvant Breast Cancer Trial. Journal Of Clinical Oncology 2008, 26: 1231-1238. PMID: 18250349, PMCID: PMC4048960, DOI: 10.1200/jco.2007.13.5467.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclophosphamideDose-Response Relationship, DrugDoxorubicinFemaleFluorouracilHeartHeart FailureHumansPrognosisReceptor, ErbB-2Risk FactorsSurvival RateTamoxifenTrastuzumabVentricular Dysfunction, LeftConceptsLeft ventricular ejection fractionAdjuvant breast cancer trialsBreast cancer trialsCardiac eventsLVEF decreaseCumulative incidenceArm BCancer trialsHER2-positive operable breast cancerPotential cardiac risk factorsOlder ageTrastuzumab-containing armsCardiac risk factorsOperable breast cancerVentricular ejection fractionAntihypertensive medicationsTrastuzumab discontinuationWeekly paclitaxelCardiac medicationsEjection fractionAntihypertensive agentsCardiac dysfunctionCardiac safetyCardiac functionControl arm