2020
A Phase II Study of Pembrolizumab in Combination With Palliative Radiotherapy for Hormone Receptor-positive Metastatic Breast Cancer
Barroso-Sousa R, Krop IE, Trippa L, Tan-Wasielewski Z, Li T, Osmani W, Andrews C, Dillon D, Richardson ET, Pastorello RG, Winer EP, Mittendorf EA, Bellon JR, Schoenfeld JD, Tolaney SM. A Phase II Study of Pembrolizumab in Combination With Palliative Radiotherapy for Hormone Receptor-positive Metastatic Breast Cancer. Clinical Breast Cancer 2020, 20: 238-245. PMID: 32113750, DOI: 10.1016/j.clbc.2020.01.012.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBiomarkers, TumorBreastBreast NeoplasmsCarcinoma, Ductal, BreastChemoradiotherapyDrug Administration ScheduleFemaleHumansInfusions, IntravenousMiddle AgedPalliative CareProgrammed Cell Death 1 ReceptorProgression-Free SurvivalReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneResponse Evaluation Criteria in Solid TumorsConceptsMetastatic breast cancerHormone receptor-positive metastatic breast cancerProgression-free survivalRadiation therapyObjective responseOverall survivalBreast cancerResponse rateMedian progression-free survivalCause adverse eventsGrade 3 eventsMedian prior linesMedian overall survivalObjective response ratePalliative radiation therapyPhase II studyTumor-infiltrating lymphocytesLymph node lesionsOverall response rateEpidermal growth factor receptorEligible patientsExploratory endpointsGrowth factor receptorPalliative radiotherapyPrimary endpoint
2015
Adjuvant Paclitaxel and Trastuzumab for Node-Negative, HER2-Positive Breast Cancer
Tolaney SM, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Guo H, Hudis CA, Krop IE, Burstein HJ, Winer EP. Adjuvant Paclitaxel and Trastuzumab for Node-Negative, HER2-Positive Breast Cancer. New England Journal Of Medicine 2015, 372: 134-141. PMID: 25564897, PMCID: PMC4313867, DOI: 10.1056/nejmoa1406281.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleFollow-Up StudiesHumansInfusions, IntravenousMastectomy, SegmentalMiddle AgedNeoplasm Recurrence, LocalPaclitaxelRadiotherapyReceptor, ErbB-2Survival RateTrastuzumabConceptsHER2-positive breast cancerBreast cancerAdjuvant paclitaxelEjection fractionInvasive diseaseStage I HER2-positive breast cancerHuman epidermal growth factor receptor type 2Epidermal growth factor receptor type 2Symptomatic congestive heart failureHER2-negative breast cancerLeft ventricular ejection fractionDistant metastatic breast cancerFactor receptor type 2Discontinuation of trastuzumabGrade 3 neuropathySingle standard treatmentPrimary end pointCongestive heart failureMetastatic breast cancerVentricular ejection fractionPositive breast cancerInvestigator-initiated studyReceptor type 2Disease-specific eventsMedian follow
2011
A Phase II Study of Sagopilone (ZK 219477; ZK-EPO) in Patients With Breast Cancer and Brain Metastases
Freedman RA, Bullitt E, Sun L, Gelman R, Harris G, Ligibel JA, Krop IE, Partridge AH, Eisenberg E, Winer EP, Lin NU. A Phase II Study of Sagopilone (ZK 219477; ZK-EPO) in Patients With Breast Cancer and Brain Metastases. Clinical Breast Cancer 2011, 11: 376-383. PMID: 21697017, PMCID: PMC3773692, DOI: 10.1016/j.clbc.2011.03.024.Peer-Reviewed Original ResearchConceptsMedian progression-free survivalProgression-free survivalObjective response ratePhase II studyBrain metastasesChallenging clinical problemBreast cancerCentral nervous systemII studyOverall survivalMagnetic resonance angiographyClinical problemCentral nervous system (CNS) objective response rateResponse rateCNS objective response rateCommon grade 3 toxicitiesProgressive metastatic breast cancerBreast cancer brain metastasesProgressive CNS diseaseGrade 3 toxicityRecurrent brain metastasesWhole brain radiotherapyCancer brain metastasesMetastatic breast cancerHigh-resolution magnetic resonance angiographyZoledronic 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
2003
Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm.
Burstein HJ, Harris LN, Marcom PK, Lambert-Falls R, Havlin K, Overmoyer B, Friedlander RJ, Gargiulo J, Strenger R, Vogel CL, Ryan PD, Ellis MJ, Nunes RA, Bunnell CA, Campos SM, Hallor M, Gelman R, Winer EP. Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm. Journal Of Clinical Oncology 2003, 21: 2889-95. PMID: 12885806, DOI: 10.1200/jco.2003.02.018.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlgorithmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsDisease ProgressionFemaleHeart DiseasesHumansInfusions, IntravenousMiddle AgedPredictive Value of TestsReceptor, ErbB-2ROC CurveSurvival AnalysisTrastuzumabTreatment OutcomeVinblastineVinorelbineConceptsLeft ventricular ejection fractionMetastatic breast cancerHER2-positive metastatic breast cancerBreast cancerHER2 extracellular domainResponse rateEjection fractionTumor markersNormal left ventricular ejection fractionMulticenter phase II studyMulticenter phase II trialPositive advanced breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Prior adjuvant chemotherapySafety of trastuzumabFirst-line chemotherapyPhase II studySymptomatic heart failureAdvanced breast cancerBaseline ejection fractionFirst-line therapyFirst-line treatmentPhase II trialTrastuzumab-based therapy
1999
Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years of age or older
Vogel C, O’Rourke M, Winer E, Hochster H, Chang A, Adamkiewicz B, White R, McGuirt C. Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years of age or older. Annals Of Oncology 1999, 10: 397-402. PMID: 10370781, DOI: 10.1023/a:1008364222793.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAgingAntineoplastic Agents, PhytogenicBreast NeoplasmsDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesHumansInfusions, IntravenousMiddle AgedProspective StudiesSeverity of Illness IndexTreatment OutcomeVinblastineVinorelbineConceptsAdvanced breast cancerDose-limiting toxicityBreast cancerSide effectsNonhematologic toxicityElderly patientsMeasurable advanced breast cancerMajor dose-limiting toxicityActivity of vinorelbineMedian dose intensityFirst-line chemotherapyObjective response rateFirst-line therapyPhase II trialSubjective side effectsInjection site reactionsWomen 60 yearsGastrointestinal side effectsGeneralized painIntravenous vinorelbinePrior chemotherapyAbdominal painChest painII trialCytotoxic chemotherapy
1996
Continuous infusion 5-fluorouracil as first-line therapy for metastatic breast cancer.
Chu L, Sutton LM, Peterson BL, Havlin KA, Winer EP. Continuous infusion 5-fluorouracil as first-line therapy for metastatic breast cancer. The Journal Of Infusional Chemotherapy 1996, 6: 211-6. PMID: 9229318.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerSymptom Distress ScaleFunctional Living Index-CancerFirst-line settingFirst-line therapyBreast cancerContinuous infusionDisease progressionPrevious phase II studyRefractory metastatic breast cancerAdequate bone marrowContinuous infusion fluorouracilGrade 3 mucositisECOG performance statusMedian overall survivalObjective response ratePhase II studyContinuous intravenous infusionQuality of lifeEvaluable diseaseFLIC scoresInfusion fluorouracilMeasurable diseasePrior chemotherapyIndex cancer
1994
Pharmacokinetic, bioavailability, and feasibility study of oral vinorelbine in patients with solid tumors.
Rowinsky EK, Noe DA, Trump DL, Winer EP, Lucas VS, Wargin WA, Hohneker JA, Lubejko B, Sartorius SE, Ettinger DS. Pharmacokinetic, bioavailability, and feasibility study of oral vinorelbine in patients with solid tumors. Journal Of Clinical Oncology 1994, 12: 1754-63. PMID: 8083697, DOI: 10.1200/jco.1994.12.9.1754.Peer-Reviewed Original ResearchConceptsMaximum-tolerated doseOral administrationOral formulationOral vinorelbineGrade 3Large first-pass effectLower starting doseSemisynthetic vinca alkaloidChronic oral administrationHepatic blood flowPhase II evaluationPharmacokinetic studyDivided-dose scheduleMaximum plasma concentrationFirst-pass effectSteady-state volumeGelatin capsulesPlasma drug dispositionPharmacologic exposuresPrincipal toxicityStarting doseDose escalationOral dosesOral doseCancer patients
1992
High-Dose Oral Tamoxifen, a Potential Multidrug-Resistance-Reversal Agent: Phase I Trial in Combination With Vinblastine
Trump DL, Smith DC, Ellis PG, Rogers MP, Schold SC, Winer EP, Panella TJ, Jordan VC, Fine RL. High-Dose Oral Tamoxifen, a Potential Multidrug-Resistance-Reversal Agent: Phase I Trial in Combination With Vinblastine. Journal Of The National Cancer Institute 1992, 84: 1811-1816. PMID: 1359155, DOI: 10.1093/jnci/84.23.1811.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAntineoplastic Combined Chemotherapy ProtocolsATP Binding Cassette Transporter, Subfamily B, Member 1Drug Administration ScheduleDrug ResistanceFemaleHumansInfusions, IntravenousMaleMembrane GlycoproteinsMiddle AgedNeoplasm ProteinsNeoplasmsTamoxifenVinblastineConceptsLoading doseN-desmethyltamoxifenOral tamoxifenContinuous infusionPlasma concentrationsHigh-dose oral tamoxifenDose-limiting toxic effectPhase I clinical trialAdvanced epithelial tumorsHigh-dose tamoxifenTriphenylethylene antiestrogen tamoxifenPhase II trialDose-limiting toxicityPhase I trialDoses of tamoxifenStart of treatmentP-glycoprotein functionToxicity of vinblastineAnti-neoplastic agentsToxic effectsMetabolite N-desmethyltamoxifenIntracellular concentrationAsymptomatic prolongationStarting doseII trial