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
2018
4th ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4) † † These guidelines were developed by the European School of Oncology (ESO) and the European Society for Medical Oncology (ESMO).
Cardoso F, Senkus E, Costa A, Papadopoulos E, Aapro M, André F, Harbeck N, Lopez B, Barrios CH, Bergh J, Biganzoli L, Boers-Doets CB, Cardoso MJ, Carey LA, Cortés J, Curigliano G, Diéras V, Saghir N, Eniu A, Fallowfield L, Francis PA, Gelmon K, Johnston SRD, Kaufman B, Koppikar S, Krop IE, Mayer M, Nakigudde G, Offersen BV, Ohno S, Pagani O, Paluch-Shimon S, Penault-Llorca F, Prat A, Rugo HS, Sledge GW, Spence D, Thomssen C, Vorobiof DA, Xu B, Norton L, Winer EP. 4th ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4) † † These guidelines were developed by the European School of Oncology (ESO) and the European Society for Medical Oncology (ESMO). Annals Of Oncology 2018, 29: 1634-1657. PMID: 30032243, PMCID: PMC7360146, DOI: 10.1093/annonc/mdy192.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkers, TumorBiopsy, Large-Core NeedleBreastBreast NeoplasmsChemoradiotherapy, AdjuvantClinical Trials as TopicConsensus Development Conferences as TopicEuropeEvidence-Based MedicineFemaleHumansIntegrative MedicineMastectomyMedical OncologyNeoadjuvant TherapyNeoplasm StagingSocieties, MedicalTreatment Outcome
2017
Using ePrognosis to estimate 2-year all-cause mortality in older women with breast cancer: Cancer and Leukemia Group B (CALGB) 49907 and 369901 (Alliance A151503)
Kimmick GG, Major B, Clapp J, Sloan J, Pitcher B, Ballman K, Barginear M, Freedman RA, Artz A, Klepin HD, Lafky JM, Hopkins J, Winer E, Hudis C, Muss H, Cohen H, Jatoi A, Hurria A, Mandelblatt J. Using ePrognosis to estimate 2-year all-cause mortality in older women with breast cancer: Cancer and Leukemia Group B (CALGB) 49907 and 369901 (Alliance A151503). Breast Cancer Research And Treatment 2017, 163: 391-398. PMID: 28283904, PMCID: PMC5508575, DOI: 10.1007/s10549-017-4188-6.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overBreast NeoplasmsClinical Trials as TopicFemaleHumansKaplan-Meier EstimateLeukemiaPrognosisQuality of LifeConceptsMortality rateBreast cancerNon-cancer mortality risksOlder breast cancer patientsStage I-IIA diseaseTwo-year mortality rateAdjuvant therapy decisionsResultsPatients' mean ageCooperative group studiesKaplan-Meier methodOverall survival estimatesBreast cancer patientsAvailable clinical informationCommunity-dwelling eldersObserved mortality rateBreast Cancer StudyAdjuvant therapyCause mortalityMost patientsOlder patientsBetter prognosisWorse prognosisPoor prognosisTrial populationMean age
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 trialsPerils of the Pathologic Complete Response
Rose BS, Winer EP, Mamon HJ. Perils of the Pathologic Complete Response. Journal Of Clinical Oncology 2016, 34: 3959-3962. PMID: 27551115, DOI: 10.1200/jco.2016.68.1718.Peer-Reviewed Original Research
2014
Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline
Giordano SH, Temin S, Kirshner JJ, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Gonzalez-Angulo AM, Krop I, Levinson J, Lin NU, Modi S, Patt DA, Perez EA, Perlmutter J, Ramakrishna N, Winer EP. Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline. Journal Of Clinical Oncology 2014, 32: 2078-2099. PMID: 24799465, PMCID: PMC6076031, DOI: 10.1200/jco.2013.54.0948.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAnastrozoleAntibodies, Monoclonal, HumanizedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials as TopicComorbidityDocetaxelDrug Administration ScheduleEvidence-Based MedicineFemaleHealth Status DisparitiesHealthcare DisparitiesHumansLapatinibLetrozoleMaytansineMolecular Targeted TherapyNitrilesQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSocieties, MedicalTaxoidsTrastuzumabTreatment OutcomeTriazolesUnited StatesConceptsAdvanced breast cancerHuman epidermal growth factor receptorSecond-line treatmentProgression-free survivalFirst-line treatmentBreast cancerPFS benefitT-DM1Epidermal growth factor receptorEndocrine therapyGrowth factor receptorSystemic therapyEstrogen receptor-positive/progesterone receptor-positive breast cancerAdvanced human epidermal growth factor receptorHER2-positive advanced breast cancerProgesterone receptor-positive breast cancerClinical Oncology Clinical Practice GuidelineClinical congestive heart failureStandard first-line therapyPositive advanced breast cancerLeft ventricular ejection fractionOncology Clinical Practice GuidelineReceptor-positive breast cancerThird-line settingFirst-line therapyTrastuzumab Emtansine: A Novel Antibody–Drug Conjugate for HER2-Positive Breast Cancer
Krop I, Winer EP. Trastuzumab Emtansine: A Novel Antibody–Drug Conjugate for HER2-Positive Breast Cancer. Clinical Cancer Research 2014, 20: 15-20. PMID: 24135146, DOI: 10.1158/1078-0432.ccr-13-0541.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerT-DM1Breast cancerAntibody-drug conjugatesAntibody-dependent cell-mediated cytotoxicityRecent phase III trialsHER2-positive breast cancerNovel antibody-drug conjugateCapecitabine/lapatinibFirst-line settingHepatic transaminase elevationsCombination of trastuzumabPhase II studyProgression-free survivalPhase III trialsInhibition of HER2Cell-mediated cytotoxicityFavorable toxicity profileHER2-positive tumor cellsMonoclonal antibody trastuzumabTransaminase elevationII studyIII trialsOverall survivalAdverse events
2013
Q&A: Eric Winer on Neoadjuvant Clinical Trials
Winer E. Q&A: Eric Winer on Neoadjuvant Clinical Trials. Cancer Discovery 2013, 3: 832-832. PMID: 23928759, DOI: 10.1158/2159-8290.cd-nd2013-017.Peer-Reviewed Original Research
2011
The ethical use of mandatory research biopsies
Olson EM, Lin NU, Krop IE, Winer EP. The ethical use of mandatory research biopsies. Nature Reviews Clinical Oncology 2011, 8: 620-625. PMID: 21808265, PMCID: PMC3632075, DOI: 10.1038/nrclinonc.2011.114.Peer-Reviewed Original Research
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
Sharing Study Results With Trial Participants: Time for Action
Partridge AH, Winer EP. Sharing Study Results With Trial Participants: Time for Action. Journal Of Clinical Oncology 2009, 27: 838-839. PMID: 19164202, DOI: 10.1200/jco.2008.20.0865.Peer-Reviewed Original Research
2008
Endocrine and targeted manipulation of breast cancer: Summary statement for the Sixth Cambridge Conference
Come SE, Buzdar AU, Ingle JN, Johnston SRD, Brodie AM, Coombes RC, Miller WR, Pritchard KI, Winer EP, Zujewski JA, Goss PE. Endocrine and targeted manipulation of breast cancer: Summary statement for the Sixth Cambridge Conference. Cancer 2008, 112: 673-678. PMID: 18072254, DOI: 10.1002/cncr.23194.Peer-Reviewed Original ResearchConceptsEarly breast cancerBreast cancerEndocrine therapyEndocrine agentsPreclinical modelsBreast cancer prevention effortsCancer prevention effortsEndocrine treatmentOngoing trialsTumor responseKey trialsMultidisciplinary meetingValuable followPatient carePatient treatmentTherapyCancerPrevention effortsReview of dataPatientsTreatmentRecent dataConference proceedingsTrialsEndocrineSummary of aromatase inhibitor clinical trials in postmenopausal women with early breast cancer
Buzdar AU, Coombes RC, Goss PE, Winer EP. Summary of aromatase inhibitor clinical trials in postmenopausal women with early breast cancer. Cancer 2008, 112: 700-709. PMID: 18072256, DOI: 10.1002/cncr.23193.Peer-Reviewed Original ResearchConceptsAromatase inhibitorsEndocrine therapyAdjuvant therapyPostmenopausal womenClinical trialsBreast cancerEstrogen receptor-positive breast cancerEfficacy of AIsReceptor-positive breast cancerInitial adjuvant therapyEarly breast cancerEnd-organ effectsGold standard treatmentYears of treatmentAI therapyThrombolic eventsNight sweatsSkeletal eventsVaginal bleedingEndometrial cancerHot flashesBone resorptionEfficacy dataDisease outcomeOptimal duration
2007
Local Therapy and Survival in Breast Cancer
Punglia RS, Morrow M, Winer EP, Harris JR. Local Therapy and Survival in Breast Cancer. New England Journal Of Medicine 2007, 356: 2399-2405. PMID: 17554121, DOI: 10.1056/nejmra065241.Peer-Reviewed Original ResearchDo cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations
Wray RJ, Stryker JE, Winer E, Demetri G, Emmons KM. Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations. Journal Of Cancer Education 2007, 22: 21. PMID: 17570804, DOI: 10.1007/bf03174370.Peer-Reviewed Original ResearchAssociation between pharmaceutical involvement and outcomes in breast cancer clinical trials
Peppercorn J, Blood E, Winer E, Partridge A. Association between pharmaceutical involvement and outcomes in breast cancer clinical trials. Cancer 2007, 109: 1239-1246. PMID: 17326054, DOI: 10.1002/cncr.22528.Peer-Reviewed Original ResearchConceptsBreast cancer clinical trialsCancer clinical trialsPharmaceutical involvementClinical researchClinical trialsPharmaceutical industry involvementBreast cancer clinical researchSingle-arm studyDisease-specific outcomesClinical breast cancer researchCancer clinical researchBreast cancer researchEnglish-language medical journalsPharmaceutical industry fundingProvision of drugsMetastatic diseaseMedical therapyEligible studiesBreast cancerClinical studiesTrial designStudy designUnpublished studiesHealth fundingPharmaceutical industry support
2006
Cancer and Leukemia Group B Breast Committee: Decades of Progress and Plans for the Future
Hudis CA, Winer EP. Cancer and Leukemia Group B Breast Committee: Decades of Progress and Plans for the Future. Clinical Cancer Research 2006, 12: 3576s-3580s. PMID: 16740788, DOI: 10.1158/1078-0432.ccr-06-9016.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsBreast NeoplasmsClinical Trials as TopicFemaleHistory, 20th CenturyHumansLeukemiaMedical OncologyNeoplasmsSocieties, MedicalProceedings of the Fifth International Conference on Recent Advances and Future Directions in Endocrine Therapy for Breast Cancer: Conference Summary Statement
Come SE, Buzdar AU, Ingle JN, Arteaga CL, Brown M, Dowsett M, Hilsenbeck SG, Kumar R, Johnston SR, Lee AV, Paik S, Pritchard KI, Winer EP, Hart C. Proceedings of the Fifth International Conference on Recent Advances and Future Directions in Endocrine Therapy for Breast Cancer: Conference Summary Statement. Clinical Cancer Research 2006, 12: 997s-1000s. PMID: 16467115, DOI: 10.1158/1078-0432.ccr-05-2268.Peer-Reviewed Original Research
2005
Aromatase inhibitors as adjuvant therapy for postmenopausal women: a therapeutic advance but many unresolved questions
Ligibel JA, Winer EP. Aromatase inhibitors as adjuvant therapy for postmenopausal women: a therapeutic advance but many unresolved questions. Breast Cancer Research 2005, 7: 255. PMID: 16457700, PMCID: PMC1410766, DOI: 10.1186/bcr1347.Peer-Reviewed Original ResearchMeSH KeywordsAgedAromatase InhibitorsBreast NeoplasmsChemotherapy, AdjuvantClinical Trials as TopicFemaleHumansMiddle AgedPostmenopauseTreatment OutcomeConceptsAromatase inhibitorsPostmenopausal womenEarly-stage breast cancerCourse of tamoxifenAdjuvant hormonal therapyStage breast cancerAdjuvant settingAdjuvant therapyHormonal therapyUpfront therapyOngoing trialsMajor trialsTherapeutic advancesBreast cancerTherapyInhibitorsTrialsWomenTamoxifenYearsCancerUnderstanding 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