2020
Barriers to Clinical Trial Accrual: Perspectives of Community-Based Providers
Knelson LP, Cukras AR, Savoie J, Agarwal A, Guo H, Hu J, Fell G, Lederman R, Hughes ME, Winer EP, Lin NU, Tolaney SM. Barriers to Clinical Trial Accrual: Perspectives of Community-Based Providers. Clinical Breast Cancer 2020, 20: 395-401.e3. PMID: 32605813, DOI: 10.1016/j.clbc.2020.05.001.Peer-Reviewed Original ResearchConceptsTrial participationTrial referralClinical trialsBreast cancerNurse practitioners/physician assistantsPatient-related barriersReferral of patientsClinical Trial AccrualCancer enrollMetastatic trialsReferral patternsSurgical oncologistsTrial awarenessReferral practicesTrial investigatorsBreast oncologyTrial knowledgePatientsPhysician assistantsTrial optionsMedical education coursesPatient interestReferralProvider perspectivesLogistical barriers
2016
Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527
Freedman RA, Foster JC, Seisler DK, Lafky JM, Muss HB, Cohen HJ, Mandelblatt J, Winer EP, Hudis CA, Partridge AH, Carey LA, Cirrincione C, Moreno-Aspitia A, Kimmick G, Jatoi A, Hurria A. Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527. Journal Of Clinical Oncology 2016, 35: 421-431. PMID: 27992272, PMCID: PMC5455700, DOI: 10.1200/jco.2016.69.4182.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAgedBreast NeoplasmsChemotherapy, AdjuvantClinical Trials as TopicEligibility DeterminationFemaleHumansPatient SelectionConceptsOlder patientsMetastatic trialsAdjuvant trialsBreast cancerHormone receptor-negative tumorsBreast cancer treatment trialConclusion Older patientsSystemic therapy trialsReceptor-negative tumorsBreast cancer trialsCancer treatment trialsYears of ageAccrual challengesNeoadjuvant trialsAdjuvant studiesPatient ageTherapy cessationLymph nodesTherapeutic trialsTreatment cessationTumor sizeDisease characteristicsPatient populationTreatment trialsCancer trials
2015
Impact of Neoadjuvant Chemotherapy in Stage II–III Triple Negative Breast Cancer on Eligibility for Breast-conserving Surgery and Breast Conservation Rates
Golshan M, Cirrincione CT, Sikov WM, Berry DA, Jasinski S, Weisberg TF, Somlo G, Hudis C, Winer E, Ollila DW. Impact of Neoadjuvant Chemotherapy in Stage II–III Triple Negative Breast Cancer on Eligibility for Breast-conserving Surgery and Breast Conservation Rates. Annals Of Surgery 2015, 262: 434-439. PMID: 26222764, PMCID: PMC4710511, DOI: 10.1097/sla.0000000000001417.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinChemotherapy, AdjuvantDisease-Free SurvivalDoxorubicinFemaleHumansMastectomy, SegmentalMaximum Tolerated DoseMiddle AgedNeoadjuvant TherapyNeoplasm InvasivenessNeoplasm StagingPaclitaxelPatient SelectionPrognosisProspective StudiesSurvival AnalysisTreatment OutcomeTriple Negative Breast NeoplasmsYoung AdultConceptsNeoadjuvant systemic therapyBreast-conserving therapyTriple-negative breast cancerNegative breast cancerSuccessful breast-conserving therapyBCT candidatesBreast cancerStage IIAddition of carboplatinBCT-eligible patientsRandomized phase IIBreast conservation ratesTumor-free marginsBCT eligibilityNeoadjuvant paclitaxelNeoadjuvant chemotherapySystemic therapySurgical outcomesSurgical choiceTumor regressionPatient's discretionFactorial trialPatientsAbsolute increaseCancer
2010
International Guidelines for Management of Metastatic Breast Cancer: Can Metastatic Breast Cancer Be Cured?
Pagani O, Senkus E, Wood W, Colleoni M, Cufer T, Kyriakides S, Costa A, Winer EP, Cardoso F. International Guidelines for Management of Metastatic Breast Cancer: Can Metastatic Breast Cancer Be Cured? Journal Of The National Cancer Institute 2010, 102: 456-463. PMID: 20220104, PMCID: PMC3298957, DOI: 10.1093/jnci/djq029.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntineoplastic Combined Chemotherapy ProtocolsBone NeoplasmsBreast NeoplasmsCatheter AblationChemotherapy, AdjuvantClinical Trials as TopicCongresses as TopicConsensus Development Conferences as TopicDose-Response Relationship, DrugEarly Detection of CancerEuropeFemaleGene Expression ProfilingHumansImmunosuppressive AgentsInterdisciplinary CommunicationInternational CooperationLiver NeoplasmsLung NeoplasmsNeoplasm StagingNeoplastic Cells, CirculatingObserver VariationPatient Care TeamPatient SelectionPractice Guidelines as TopicRadiotherapy, AdjuvantSurvival RateConceptsMetastatic breast cancerOligometastatic diseaseBreast cancerMetastatic lesionsPrimary tumorEuropean Breast Cancer ConferenceFirst consensus recommendationsOptimal local treatmentRapid disease controlAvailable therapeutic optionsSubset of patientsLong-term outcomesLarge retrospective seriesDetectable metastatic lesionsAttractive therapeutic strategyChemotherapy optionsSurvival benefitSystemic therapyTreatment guidelinesRegional chemotherapyRetrospective seriesTask ForceLung metastasesTherapeutic optionsPatient population
2009
Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial
Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT, Ravdin P, Bugarini R, Baehner FL, Davidson NE, Sledge GW, Winer EP, Hudis C, Ingle JN, Perez EA, Pritchard KI, Shepherd L, Gralow JR, Yoshizawa C, Allred DC, Osborne CK, Hayes DF, America F. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. The Lancet Oncology 2009, 11: 55-65. PMID: 20005174, PMCID: PMC3058239, DOI: 10.1016/s1470-2045(09)70314-6.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials, Phase III as TopicCyclophosphamideDisease-Free SurvivalDoxorubicinFemaleFluorouracilGene Expression ProfilingGene Expression Regulation, NeoplasticGenetic TestingHumansKaplan-Meier EstimateLymphatic MetastasisMiddle AgedPatient SelectionPostmenopausePredictive Value of TestsProportional Hazards ModelsRandomized Controlled Trials as TopicReceptors, EstrogenRecurrenceRetrospective StudiesReverse Transcriptase Polymerase Chain ReactionRisk AssessmentTamoxifenTime FactorsTreatment OutcomeUnited StatesConceptsLow recurrence scorePositive breast cancerAnthracycline-based chemotherapyDisease-free survivalHigh recurrence scoreRecurrence scorePositive nodesBreast cancerPostmenopausal womenRetrospective analysisNode-positive breast cancerTamoxifen-alone groupTamoxifen-treated patientsPhase 3 trialNational Cancer InstituteEffect of recurrenceOverall survivalSpecific survivalSurvival benefitCox regressionHigh riskTreatment groupsCancer InstituteChemotherapyPredictive valueInternational Guidelines for Management of Metastatic Breast Cancer: Combination vs Sequential Single-Agent Chemotherapy
Cardoso F, Bedard PL, Winer EP, Pagani O, Senkus-Konefka E, Fallowfield LJ, Kyriakides S, Costa A, Cufer T, Albain KS, Force O. International Guidelines for Management of Metastatic Breast Cancer: Combination vs Sequential Single-Agent Chemotherapy. Journal Of The National Cancer Institute 2009, 101: 1174-1181. PMID: 19657108, PMCID: PMC2736293, DOI: 10.1093/jnci/djp235.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAnthracyclinesAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCapecitabineComorbidityCongresses as TopicCross-Over StudiesDeoxycytidineDrug Administration ScheduleEuropeEvidence-Based MedicineFemaleFluorouracilHumansInternational CooperationKarnofsky Performance StatusMenopausePatient SelectionPractice Guidelines as TopicQuality of LifeRandomized Controlled Trials as TopicSeverity of Illness IndexSocioeconomic FactorsTaxoidsVinblastineVinorelbineConceptsMetastatic breast cancerSequential single-agent chemotherapySingle-agent chemotherapyBreast cancerEarly-stage breast cancerEuropean Breast Cancer ConferenceSequential single agentsPatient-rated qualityRapid clinical progressionDisease-related factorsImpact of therapySequential monotherapyAdvanced diseaseSequential therapyVisceral metastasesCytotoxic chemotherapyTask ForceClinical progressionPredictive factorsTreatment optionsCancer ConferenceRapid symptomsSingle agentChemotherapyInternational guidelines
2008
Tangential Radiotherapy Without Axillary Surgery in Early-Stage Breast Cancer: Results of a Prospective Trial
Wong JS, Taghian AG, Bellon JR, Keshaviah A, Smith BL, Winer EP, Silver B, Harris JR. Tangential Radiotherapy Without Axillary Surgery in Early-Stage Breast Cancer: Results of a Prospective Trial. International Journal Of Radiation Oncology • Biology • Physics 2008, 72: 866-870. PMID: 18394815, DOI: 10.1016/j.ijrobp.2008.01.031.Peer-Reviewed Original ResearchConceptsNegative axillary nodesAxillary surgeryHormonal therapyBreast cancerAxillary nodesBreast radiotherapyLow regional recurrence ratesMedian pathologic tumor sizeHormone-responsive breast cancerMulti-institutional prospective studyEarly-stage breast cancerIpsilateral breast recurrencePathologic tumor sizeRegional nodal failureBreast-conserving surgeryInvasive breast cancerRegional nodal recurrenceWhole breast radiotherapyPositive breast cancerRegional recurrence rateLymphatic vessel invasionYears of ageAxillary treatmentBreast recurrenceMetastatic diseasePreoperative Therapy in Invasive Breast Cancer: Pathologic Assessment and Systemic Therapy Issues in Operable Disease
Gralow JR, Burstein HJ, Wood W, Hortobagyi GN, Gianni L, von Minckwitz G, Buzdar AU, Smith IE, Symmans WF, Singh B, Winer EP. Preoperative Therapy in Invasive Breast Cancer: Pathologic Assessment and Systemic Therapy Issues in Operable Disease. Journal Of Clinical Oncology 2008, 26: 814-819. PMID: 18258991, DOI: 10.1200/jco.2007.15.3510.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsAntineoplastic Agents, HormonalAromatase InhibitorsBreast NeoplasmsCongresses as TopicFemaleHumansMastectomy, SegmentalNational Cancer Institute (U.S.)Neoadjuvant TherapyNeoplasm, ResidualPatient Care TeamPatient SelectionPreoperative CareReceptor, ErbB-2Remission InductionUnited StatesConceptsOperable breast cancerPreoperative systemic therapyBreast conservation ratesSystemic therapyInvasive breast cancerBreast cancerTumor responsePreoperative therapyPathologic assessmentNational Cancer Institute StatePostoperative adjuvant systemic therapyInitial tumor responseAdjuvant systemic therapyPathologic complete responseSurrogate end pointsStandard of careMultimodality treatment programBreast cancer biologyAdjuvant settingOperable diseaseOverall survivalPreoperative chemotherapySystemic treatmentComplete responseLymph nodes
2005
Understanding the decisions of cancer clinical trial participants to enter research studies: Factors associated with informed consent, patient satisfaction, and decisional regret
Stryker JE, Wray RJ, Emmons KM, Winer E, Demetri G. Understanding the decisions of cancer clinical trial participants to enter research studies: Factors associated with informed consent, patient satisfaction, and decisional regret. Patient Education And Counseling 2005, 63: 104-109. PMID: 16242898, DOI: 10.1016/j.pec.2005.09.006.Peer-Reviewed Original ResearchAdultAnalysis of VarianceClinical Trials as TopicComprehensionDecision MakingFemaleHealth Knowledge, Attitudes, PracticeHealth Services Needs and DemandHumansInformed ConsentMaleMiddle AgedNeoplasmsPatient Education as TopicPatient ParticipationPatient SatisfactionPatient SelectionResearch SubjectsSurveys and QuestionnairesTeaching MaterialsTime FactorsUnited States
2003
Phase II, randomized, double-blind study of two dose levels of arzoxifene in patients with locally advanced or metastatic breast cancer.
Buzdar A, O’Shaughnessy J, Booser DJ, Pippen JE, Jones SE, Munster PN, Peterson P, Melemed AS, Winer E, Hudis C. Phase II, randomized, double-blind study of two dose levels of arzoxifene in patients with locally advanced or metastatic breast cancer. Journal Of Clinical Oncology 2003, 21: 1007-14. PMID: 12637464, DOI: 10.1200/jco.2003.06.108.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Agents, HormonalBiomarkers, TumorBreast NeoplasmsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug Resistance, NeoplasmEndometriumEstrogen Receptor ModulatorsFemaleHumansMiddle AgedPatient SelectionPiperidinesReceptors, EstrogenSurvival AnalysisTamoxifenThiophenesTreatment OutcomeConceptsMetastatic breast cancerClinical benefit rateBreast cancerTamoxifen refractoryTR patientsResponse rateDose levelsEnd pointSelective estrogen receptor modulatorsPhase II studyPrimary end pointSecondary end pointsTumor response rateDouble-blind studyEstrogen receptor statusMetastatic disease sitesEstrogen receptor modulatorsTreatment of TSSimilar TTPTamoxifen therapyII studyDaily doseLonger TTPReceptor statusDose-dependent toxicity
2000
Letter to the Editor
Patridge A, Winer E. Letter to the Editor. Clinical Breast Cancer 2000, 1: 164-165. PMID: 11899655, DOI: 10.1016/s1526-8209(11)70117-3.Peer-Reviewed Original Research