2017
Phase 2 study of pembrolizumab (pembro) monotherapy for previously treated metastatic triple-negative breast cancer (mTNBC): KEYNOTE-086 cohort A.
Adams S, Schmid P, Rugo H, Winer E, Loirat D, Awada A, Cescon D, Iwata H, Campone M, Nanda R, Hui R, Curigliano G, Toppmeyer D, O'Shaughnessy J, Loi S, Paluch-Shimon S, Card D, Zhao J, Karantza V, Cortes J. Phase 2 study of pembrolizumab (pembro) monotherapy for previously treated metastatic triple-negative breast cancer (mTNBC): KEYNOTE-086 cohort A. Journal Of Clinical Oncology 2017, 35: 1008-1008. DOI: 10.1200/jco.2017.35.15_suppl.1008.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerTreatment-related AEsPD-L1 expressionPD-L1Manageable safetyTriple-negative breast cancerECOG PS 0Subset of ptsDisease control ratePhase 2 studyPoor prognostic factorEfficacy/safetyBest overall responseCohort A.Evaluable ptsKEYNOTE-012Median DoRMedian PFSPrior chemotherapyData cutoffPembrolizumab monotherapyDurable responsesMetastatic diseasePrior linesPS 0
2012
Phase I, open-label study of olaparib plus cisplatin in patients with advanced solid tumors.
Balmaña J, Tung N, Isakoff S, Graña B, Ryan P, Rafi R, Tracy M, Winer E, Baselga J, Garber J. Phase I, open-label study of olaparib plus cisplatin in patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: 1009-1009. DOI: 10.1200/jco.2012.30.15_suppl.1009.Peer-Reviewed Original ResearchAdvanced solid tumorsHematologic AEsEvaluable ptsMonotherapy phaseDose reductionSolid tumorsAntitumor activityOpen-label studyDose-limiting toxicityCisplatin-related toxicityDose-finding studyDrug-related deathsOral PARP inhibitorLong respondersOlaparib capsulesNeoadjuvant settingPrior regimensStable diseaseDurable responsesObjective responsePeritoneal cancerTherapy cyclesMedian numberBreast cancerTreatment cyclesActivity of cabozantinib (XL184) in metastatic breast cancer (MBC): Results from a phase II randomized discontinuation trial (RDT).
Winer E, Tolaney S, Nechushtan H, Berger R, Kurzrock R, Ron I, Schoffski P, Awada A, Yasenchak C, Burris H, Ramies D, Rafferty T, Shen X. Activity of cabozantinib (XL184) in metastatic breast cancer (MBC): Results from a phase II randomized discontinuation trial (RDT). Journal Of Clinical Oncology 2012, 30: 535-535. DOI: 10.1200/jco.2012.30.15_suppl.535.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast cancerBone scanTumor regressionWk 12Common grade 3/4 AEsMedian progression-free survivalPost-baseline tumour assessmentActivity of cabozantinibGrade 5 AEsMedian age 56Median prior linesObjective response rateObjective tumor regressionStudy days 1Breast cancer developmentDysregulation of METBone painEligible patientsEvaluable ptsMeasurable diseasePrior anthracyclineSerum NTxImproved painPrimary endpoint
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