2022
The feasibility of using an autologous GM-CSF-secreting breast cancer vaccine to induce immunity in patients with stage II–III and metastatic breast cancers
Anderson KS, Erick TK, Chen M, Daley H, Campbell M, Colson Y, Mihm M, Zakka LR, Hopper M, Barry W, Winer EP, Dranoff G, Overmoyer B. The feasibility of using an autologous GM-CSF-secreting breast cancer vaccine to induce immunity in patients with stage II–III and metastatic breast cancers. Breast Cancer Research And Treatment 2022, 194: 65-78. PMID: 35482127, PMCID: PMC9046531, DOI: 10.1007/s10549-022-06562-y.Peer-Reviewed Original ResearchMeSH KeywordsBreast NeoplasmsCancer VaccinesFeasibility StudiesFemaleGenetic VectorsGranulocyte-Macrophage Colony-Stimulating FactorHumansConceptsBreast cancer vaccinesAutologous GM-CSFBreast cancerMetastatic diseaseGM-CSFStage IICancer vaccinesTumor cellsEvidence of diseaseStart of vaccinationInjection site reactionsMetastatic breast cancerUpper respiratory symptomsImmune cell infiltrationRole of vaccinationReplication-defective adenoviral vectorEvaluable patientsMethodsTumor cellsStable diseaseWeekly vaccinationsJoint painProgressive diseaseRespiratory symptomsFifth injectionTRIAL REGISTRATION
2019
A phase II feasibility study of palbociclib in combination with adjuvant endocrine therapy for hormone receptor-positive invasive breast carcinoma
Mayer EL, DeMichele A, Rugo HS, Miller K, Waks AG, Come SE, Mulvey T, Jeselsohn R, Overmoyer B, Guo H, Barry WT, Bartlett C, Koehler M, Winer EP, Burstein HJ. A phase II feasibility study of palbociclib in combination with adjuvant endocrine therapy for hormone receptor-positive invasive breast carcinoma. Annals Of Oncology 2019, 30: 1514-1520. PMID: 31250880, DOI: 10.1093/annonc/mdz198.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalEstradiolFeasibility StudiesFemaleFulvestrantHumansMiddle AgedNeoplasm InvasivenessNeoplasm StagingPiperazinesProtein Kinase InhibitorsPyridinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneConceptsEarly breast cancerEndocrine therapyAdjuvant palbociclibBreast cancerHormone receptor-positive/HER2-negative metastatic breast cancerHER2-negative metastatic breast cancerPhase II feasibility studyProlong progression-free survivalRandomized phase III trialAdjuvant endocrine therapyPrimary end pointStage III diseasePhase II trialPhase III trialsProgression-free survivalMetastatic breast cancerYears of therapyStart of treatmentInvasive breast carcinomaEligible patientsFebrile neutropeniaPrior chemotherapyWeeks on/1II trialCumulative incidence
2014
Extended Therapy With Letrozole and Ovarian Suppression in Premenopausal Patients With Breast Cancer After Tamoxifen
Ruddy KJ, DeSantis SD, Barry W, Guo H, Block CC, Borges V, Winer EP, Partridge AH. Extended Therapy With Letrozole and Ovarian Suppression in Premenopausal Patients With Breast Cancer After Tamoxifen. Clinical Breast Cancer 2014, 14: 413-416. PMID: 24970714, DOI: 10.1016/j.clbc.2014.04.007.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsChemotherapy, AdjuvantFeasibility StudiesFemaleFollow-Up StudiesGonadotropin-Releasing HormoneHumansLetrozoleMiddle AgedNeoplasm GradingNeoplasm StagingNitrilesOvariectomyPremenopausePrognosisSurvival RateTamoxifenTriazolesConceptsPremenopausal womenAdjuvant tamoxifenEndocrine therapyExtended therapyAromatase inhibitorsBreast cancerStandard adjuvant endocrine therapyGonadotropin-releasing hormone agonistSingle-arm clinical trialPhase II single-arm clinical trialsEarly study closureYears of tamoxifenAdjuvant endocrine therapySubstantial side effectsProtocol-directed therapyCommon toxicitiesLengthier coursesPremenopausal patientsOvarian suppressionPoor accrualPostmenopausal patientsVaginal drynessHormone agonistStudy closureBone loss
2011
Troponin I and C-Reactive Protein Are Commonly Detected in Patients with Breast Cancer Treated with Dose-Dense Chemotherapy Incorporating Trastuzumab and Lapatinib
Morris PG, Chen C, Steingart R, Fleisher M, Lin N, Moy B, Come S, Sugarman S, Abbruzzi A, Lehman R, Patil S, Dickler M, McArthur HL, Winer E, Norton L, Hudis CA, Dang CT. Troponin I and C-Reactive Protein Are Commonly Detected in Patients with Breast Cancer Treated with Dose-Dense Chemotherapy Incorporating Trastuzumab and Lapatinib. Clinical Cancer Research 2011, 17: 3490-3499. PMID: 21372222, DOI: 10.1158/1078-0432.ccr-10-1359.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, PharmacologicalBiomarkers, TumorBreast NeoplasmsCarcinomaC-Reactive ProteinDose-Response Relationship, DrugFeasibility StudiesFemaleHumansLapatinibMiddle AgedQuinazolinesStroke VolumeTrastuzumabTroponin IConceptsLeft ventricular ejection fractionC-reactive proteinMedian left ventricular ejection fractionTroponin IDetectable C-reactive proteinDose-dense doxorubicinAnthracycline-based chemotherapyDose-dense chemotherapyVentricular ejection fractionProspective feasibility studyCardiac troponin IDetectable cTnIWeekly paclitaxelMonth 6CTnI levelsEjection fractionMonth 3Months 0Month 2Breast cancerEarly biomarkersPatientsChemotherapyEarly detectionTrastuzumab
2010
Dose-Dense Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel With Trastuzumab and Lapatinib in HER2/neu–Overexpressed/Amplified Breast Cancer Is Not Feasible Because of Excessive Diarrhea
Dang C, Lin N, Moy B, Come S, Sugarman S, Morris P, Abbruzzi A, Chen C, Steingart R, Patil S, Norton L, Winer E, Hudis C. Dose-Dense Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel With Trastuzumab and Lapatinib in HER2/neu–Overexpressed/Amplified Breast Cancer Is Not Feasible Because of Excessive Diarrhea. Journal Of Clinical Oncology 2010, 28: 2982-2988. PMID: 20479410, PMCID: PMC3664034, DOI: 10.1200/jco.2009.26.5900.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclophosphamideDiarrheaDose-Response Relationship, DrugDoxorubicinFeasibility StudiesFemaleFilgrastimFollow-Up StudiesGene AmplificationGranulocyte Colony-Stimulating FactorHumansImmunoenzyme TechniquesIn Situ Hybridization, FluorescenceLapatinibMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPaclitaxelPilot ProjectsPolyethylene GlycolsQuinazolinesReceptor, ErbB-2Recombinant ProteinsSurvival RateTrastuzumabTreatment OutcomeConceptsDose-dense ACDose-dense doxorubicinGrade 3 diarrheaBreast cancerDose reductionDose delay/reductionHER2-positive breast cancerHuman epidermal growth factor receptorAsymptomatic LVEF declineCardiac event ratePrimary end pointCongestive heart failureMetastatic breast cancerVentricular ejection fractionDelays/reductionsEpidermal growth factor receptorExcessive diarrheaGrowth factor receptorLVEF declineWeekly paclitaxelEjection fractionHeart failureMedian agePatientsStage I
2007
Blood Vessel Morphologic Changes Depicted with MR Angiography during Treatment of Brain Metastases: A Feasibility Study1
Bullitt E, Lin NU, Smith JK, Zeng D, Winer EP, Carey LA, Lin W, Ewend MG. Blood Vessel Morphologic Changes Depicted with MR Angiography during Treatment of Brain Metastases: A Feasibility Study1. Radiology 2007, 245: 824-30. PMID: 17954616, PMCID: PMC2615672, DOI: 10.1148/radiol.2453061889.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBrain NeoplasmsBreast NeoplasmsFeasibility StudiesFemaleHumansMagnetic Resonance AngiographyMaleMiddle AgedProspective StudiesConceptsBrain metastasesVessel tortuosityTumor treatment responseMR angiographyBreast cancerTreatment responseMorphologic changesBrain MR angiographyTreatment failure 1Vascular morphologic changesInstitutional review board approvalHealthy control subjectsReview board approvalMagnetic resonance angiographyHIPAA-compliant studyLapatinib therapyNineteen patientsClinical courseControl subjectsAbnormal vesselsTumor volumeFailure 1Board approvalPatientsResonance angiography
2005
Prospective evaluation of concurrent paclitaxel and radiation therapy after adjuvant doxorubicin and cyclophosphamide chemotherapy for Stage II or III breast cancer
Burstein HJ, Bellon JR, Galper S, Lu HM, Kuter I, Taghian AG, Wong J, Gelman R, Bunnell CA, Parker LM, Garber JE, Winer EP, Harris JR, Powell SN. Prospective evaluation of concurrent paclitaxel and radiation therapy after adjuvant doxorubicin and cyclophosphamide chemotherapy for Stage II or III breast cancer. International Journal Of Radiation Oncology • Biology • Physics 2005, 64: 496-504. PMID: 16243442, DOI: 10.1016/j.ijrobp.2005.07.975.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDoxorubicinDrug Administration ScheduleFeasibility StudiesFemaleHumansPaclitaxelProspective StudiesRadiation PneumonitisRadiation-Sensitizing AgentsRadiotherapy DosageRadiotherapy, AdjuvantConceptsRadiation therapyBreast cancerAdjuvant doxorubicinConcurrent paclitaxelWeekly paclitaxelAC chemotherapyConcurrent radiationConcurrent treatmentGrade 2 radiation pneumonitisStage IIEarly-stage breast cancerAdjuvant AC chemotherapyDefinitive breast surgeryOperable stage IIWeekly paclitaxel treatmentConcurrent radiation therapyDose-limiting toxicityProtocol-based treatmentAdjuvant chemotherapyPaclitaxel scheduleSteroid therapyCyclophosphamide chemotherapyRadiation pneumonitisPulmonary injuryRadiation dermatitis
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