2019
Pre- and Postoperative Neratinib for HER2-Positive Breast Cancer Brain Metastases: Translational Breast Cancer Research Consortium 022
Freedman RA, Gelman RS, Agar NYR, Santagata S, Randall EC, Lopez B, Connolly RM, Dunn IF, Van Poznak CH, Anders CK, Melisko ME, Silvestri K, Cotter CM, Componeschi KP, Marte JM, Moy B, Blackwell KL, Puhalla SL, Ibrahim N, Moynihan TJ, Nangia J, Tung N, Burns R, Rimawi MF, Krop IE, Wolff AC, Winer EP, Lin NU, Consortium T. Pre- and Postoperative Neratinib for HER2-Positive Breast Cancer Brain Metastases: Translational Breast Cancer Research Consortium 022. Clinical Breast Cancer 2019, 20: 145-151.e2. PMID: 31558424, PMCID: PMC7035200, DOI: 10.1016/j.clbc.2019.07.011.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAntineoplastic Combined Chemotherapy ProtocolsBrainBrain NeoplasmsBreastBreast NeoplasmsChemotherapy, AdjuvantCraniotomyDrug Administration ScheduleFemaleHumansMiddle AgedNeoadjuvant TherapyPilot ProjectsQuinolinesReceptor, ErbB-2Tissue DistributionTreatment OutcomeConceptsCentral nervous system penetrationCerebrospinal fluidBrain metastasesStudy treatmentDisease progressionHER2-positive breast cancer brain metastasesHER2-positive metastatic breast cancerHER2-positive brain metastasesBreast cancer brain metastasesGrade 3 diarrheaCancer brain metastasesMetastatic breast cancerCentral nervous systemResected tumor tissueBlood-based analysesNeratinib monotherapyPostoperative cyclesParenchymal tumorsStudy protocolBreast cancerTumor histopathologyPatientsNervous systemSmall cohortSurgical tissues
2014
A phase II study of preoperative capecitabine in women with operable hormone receptor positive breast cancer
Tolaney SM, Jeong J, Guo H, Brock J, Morganstern D, Come SE, Golshan M, Bellon J, Winer EP, Krop IE. A phase II study of preoperative capecitabine in women with operable hormone receptor positive breast cancer. Cancer Medicine 2014, 3: 293-299. PMID: 24464780, PMCID: PMC3987079, DOI: 10.1002/cam4.164.Peer-Reviewed Original ResearchConceptsHormone receptor-positive breast cancerReceptor-positive breast cancerPathological complete responsePositive breast cancerBreast cancerPreoperative capecitabineClinical responseHER2-negative operable breast cancerDihydropyrimidine dehydrogenaseOnly grade 3 toxicityOverall clinical response rateThymidine phosphorylaseGrade 3 responsePartial clinical responsePathological response assessmentsPreoperative chemotherapy regimensClinical response rateComplete clinical responseGrade 3 toxicityOperable breast cancerPhase II studyPalmar-plantar erythrodysesthesiaMetastatic breast cancerTime of surgeryMiller-Payne
2013
A Phase 1 trial of the poly(ADP-ribose) polymerase inhibitor olaparib (AZD2281) in combination with the anti-angiogenic cediranib (AZD2171) in recurrent epithelial ovarian or triple-negative breast cancer
Liu JF, Tolaney SM, Birrer M, Fleming GF, Buss MK, Dahlberg SE, Lee H, Whalen C, Tyburski K, Winer E, Ivy P, Matulonis UA. A Phase 1 trial of the poly(ADP-ribose) polymerase inhibitor olaparib (AZD2281) in combination with the anti-angiogenic cediranib (AZD2171) in recurrent epithelial ovarian or triple-negative breast cancer. European Journal Of Cancer 2013, 49: 2972-2978. PMID: 23810467, PMCID: PMC3956307, DOI: 10.1016/j.ejca.2013.05.020.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapsulesCarcinoma, Ovarian EpithelialDiarrheaDose-Response Relationship, DrugDrug Administration ScheduleFatigueFemaleHumansMiddle AgedNauseaNeoplasm Recurrence, LocalNeoplasms, Glandular and EpithelialOvarian NeoplasmsPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneReceptors, Vascular Endothelial Growth FactorTabletsTreatment OutcomeConceptsTriple-negative breast cancerOvarian cancer patientsOverall response rateCombination of cediranibCancer patientsBreast cancerDose levelsMetastatic triple-negative breast cancerEvaluable breast cancer patientsPARP inhibitorsClinical benefit rateGrade 3 fatigueGrade 3 hypertensionPhase 2 dosingVascular endothelial growth factor receptorResponse Evaluation CriteriaSolid Tumors 1.1Endothelial growth factor receptorPhase 1 trialBreast cancer patientsDose-escalation designHighest dose levelPolymerase inhibitor olaparibCA125 criteriaGrowth factor receptor
2010
Adherence and Persistence With Oral Adjuvant Chemotherapy in Older Women With Early-Stage Breast Cancer in CALGB 49907: Adherence Companion Study 60104
Partridge AH, Archer L, Kornblith AB, Gralow J, Grenier D, Perez E, Wolff AC, Wang X, Kastrissios H, Berry D, Hudis C, Winer E, Muss H. Adherence and Persistence With Oral Adjuvant Chemotherapy in Older Women With Early-Stage Breast Cancer in CALGB 49907: Adherence Companion Study 60104. Journal Of Clinical Oncology 2010, 28: 2418-2422. PMID: 20368559, PMCID: PMC2881723, DOI: 10.1200/jco.2009.26.4671.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAge FactorsAgedAged, 80 and overAntimetabolites, AntineoplasticBreast NeoplasmsCanadaCapecitabineChemotherapy, AdjuvantDeoxycytidineDrug Administration ScheduleDrug MonitoringFemaleFluorouracilHumansKaplan-Meier EstimateLinear ModelsLogistic ModelsMastectomyMedication AdherenceMicro-Electrical-Mechanical SystemsNeoplasm StagingRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeUnited StatesConceptsEarly-stage breast cancerBreast cancerCALGB 49907Oral chemotherapyClinical trialsOlder womenPatients age 65 yearsOral adjuvant chemotherapyPill bottle openingsNode-negative diseaseHormone receptor statusRelapse-free survivalRandomized clinical trialsAge 65 yearsMulticenter clinical trialNumber of dosesPercent of participantsLogistic regression modelsAdjuvant chemotherapyProtocol therapyOral therapyStandard chemotherapyMedian ageReceptor statusPatient adherence
2009
Tolerability of and adherence to combination oral therapy with gefitinib and capecitabine in metastatic breast cancer
Mayer EL, Partridge AH, Harris LN, Gelman RS, Schumer ST, Burstein HJ, Winer EP. Tolerability of and adherence to combination oral therapy with gefitinib and capecitabine in metastatic breast cancer. Breast Cancer Research And Treatment 2009, 117: 615-623. PMID: 19294501, PMCID: PMC4578795, DOI: 10.1007/s10549-009-0366-5.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerStable diseaseValidation cohortBreast cancerSequential cohortsPhase ICombination oral therapyOral antineoplastic therapyDays on/7Primary endpointSecondary endpointsOral therapyPartial responseAntineoplastic therapySerious toxicityDose reductionDrug dosesM2/dayCohortSignificant toxicityPatientsTherapyMTDCycle 1Capecitabine
2003
Use of the Peroxisome Proliferator-Activated Receptor (PPAR) γ Ligand Troglitazone as Treatment for Refractory Breast Cancer: A Phase II Study
Burstein HJ, Demetri GD, Mueller E, Sarraf P, Spiegelman BM, Winer EP. Use of the Peroxisome Proliferator-Activated Receptor (PPAR) γ Ligand Troglitazone as Treatment for Refractory Breast Cancer: A Phase II Study. Breast Cancer Research And Treatment 2003, 79: 391-397. PMID: 12846423, DOI: 10.1023/a:1024038127156.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerSerum tumor markersBreast cancerTumor markersTumor differentiationDisease progressionAdvanced breast cancer refractoryElevated serum tumor markersRefractory metastatic breast cancerPeroxisome proliferator-activated receptor γBreast cancer refractoryRefractory breast cancerPhase II studyPercentage of patientsProliferator-activated receptor γDifferent patient populationsCancer refractoryChemotherapy regimenII studyObjective responseSystemic therapyPO QDHormonal regimensHepatic toxicityPatient population
2002
Adherence to Therapy With Oral Antineoplastic Agents
Partridge AH, Avorn J, Wang PS, Winer EP. Adherence to Therapy With Oral Antineoplastic Agents. Journal Of The National Cancer Institute 2002, 94: 652-661. PMID: 11983753, DOI: 10.1093/jnci/94.9.652.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdolescentAntineoplastic AgentsChildClinical Trials as TopicDrug UtilizationHumansNeoplasmsPatient ComplianceConceptsOral antineoplastic agentsAntineoplastic agentsOral antineoplastic therapyOral anticancer agentsAssessment of adherenceStudy of adherencePrediction of adherenceImplementation of interventionsChemotherapy recommendationsOral medicationsPrescribed regimensClinical outcomesPatient adherencePediatric populationAdherence ratesPoor adherenceAntineoplastic therapyAdherence issuesClinical trialsCancer preventionPhysician's officeAdherence behaviorAvailable evidenceAdherenceCertain populations
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 ResearchMeSH KeywordsAdministration, OralAdultAgedAntineoplastic AgentsArea Under CurveBreast NeoplasmsFemaleHumansMiddle AgedTreatment OutcomeTretinoinConceptsMetastatic 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
1995
Oral vinorelbine (Navelbine) in the treatment of advanced breast cancer.
Winer EP, Chu L, Spicer DV. Oral vinorelbine (Navelbine) in the treatment of advanced breast cancer. Seminars In Oncology 1995, 22: 72-8; discussion 78-9. PMID: 7740337.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAgedAged, 80 and overAntineoplastic AgentsBreast NeoplasmsClinical Trials, Phase II as TopicFemaleHumansVinblastineVinorelbineConceptsAdvanced breast cancerOral vinorelbineBreast cancerIntravenous administrationResponse rateMulticenter phase II trialAdvanced breast cancer patientsPhase II trialHigh first-pass effectBreast cancer patientsFirst-pass effectPharmacokinetics of vinorelbineII trialCancer patientsClinical investigationVinorelbineHigh clearance rateSoft gelatin capsulesClearance ratePatientsCancerPharmacokinetic studyLow bioavailabilityAdministrationGelatin capsules
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