2021
Prospective Study Testing a Simplified Paclitaxel Premedication Regimen in Patients with Early Breast Cancer
Barroso-Sousa R, Vaz-Luis I, Di Meglio A, Hu J, Li T, Rees R, Sinclair N, Milisits L, Leone JP, Constantine M, Faggen M, Briccetti F, Block C, Partridge A, Burstein H, Waks AG, Tayob N, Trippa L, Tolaney SM, Hassett MJ, Winer EP, Lin NU. Prospective Study Testing a Simplified Paclitaxel Premedication Regimen in Patients with Early Breast Cancer. The Oncologist 2021, 26: 927-933. PMID: 34472667, PMCID: PMC8571744, DOI: 10.1002/onco.13960.Peer-Reviewed Original ResearchConceptsGrade hypersensitivity reactionsHypersensitivity reactionsPaclitaxel cyclesCycle 3Breast cancerCycle 1Grade 2 hypersensitivity reactionGrade 3 hypersensitivity reactionDose-dense doxorubicinDose-dense paclitaxelGrade 3 eventsUse of corticosteroidsEarly breast cancerSingle-arm studyAdministration of antihistaminesHistamine H2 blockersCycle 2Corticosteroid premedicationDd ACDexamethasone premedicationPaclitaxel regimenPremedication protocolDexamethasone usePaclitaxel doseProtocol therapy
2020
A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials
Amiri-Kordestani L, Xie D, Tolaney SM, Bloomquist E, Tang S, Ibrahim A, Goldberg KB, Theoret MR, Pazdur R, Sridhara R, Winer EP, Beaver JA. A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials. Annals Of Oncology 2020, 31: 1704-1708. PMID: 32866625, DOI: 10.1016/j.annonc.2020.08.2106.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalEarly breast cancerHER2-positive early breast cancerTH armOverall survivalAdjuvant paclitaxelTrastuzumab trialsReceptor statusLow-risk early breast cancerHuman epidermal growth factor receptor 2Positive early breast cancerPropensity scoreEpidermal growth factor receptor 2De-escalate therapyDisease-free survivalGrowth factor receptor 2Progesterone receptor statusSingle-arm studyEstrogen receptor statusSingle-arm trialPatient-level dataFactor receptor 2Drug Administration analysisCovariates of ageHistorical clinical trialsAvoiding Peg-Filgrastim Prophylaxis During the Paclitaxel Portion of the Dose-Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen: A Prospective Study
Vaz-Luis I, Barroso-Sousa R, Di Meglio A, Hu J, Rees R, Sinclair N, Milisits L, Leone JP, Constantine M, Faggen M, Briccetti F, Block C, O'Neil K, Partridge A, Burstein H, Waks AG, Trippa L, Tolaney SM, Hassett M, Winer EP, Lin NU. Avoiding Peg-Filgrastim Prophylaxis During the Paclitaxel Portion of the Dose-Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen: A Prospective Study. Journal Of Clinical Oncology 2020, 38: 2390-2397. PMID: 32330102, PMCID: PMC7367545, DOI: 10.1200/jco.19.02484.Peer-Reviewed Original ResearchConceptsDose-dense paclitaxelPeg-filgrastimFebrile neutropeniaDay 1Adjuvant breast cancer chemotherapyCycle 1 day 1Patient experienced febrile neutropeniaCycles of paclitaxelDose-dense doxorubicinExperienced febrile neutropeniaPrimary end pointSingle-arm studyBreast cancer chemotherapyYears of ageDose delaysDoxorubicin-cyclophosphamidePaclitaxel cyclesPaclitaxel regimenPatients 18Investigator's discretionMedian ageTreatment delayProspective studyPrespecified algorithmBreast cancerPhase II Single-Arm Study of Preoperative Letrozole for Estrogen Receptor-Positive Postmenopausal Ductal Carcinoma In Situ: CALGB 40903 (Alliance).
Hwang ES, Hyslop T, Hendrix LH, Duong S, Bedrosian I, Price E, Caudle A, Hieken T, Guenther J, Hudis CA, Winer E, Lyss AP, Dickson-Witmer D, Hoefer R, Ollila DW, Hardman T, Marks J, Chen YY, Krings G, Esserman L, Hylton N. Phase II Single-Arm Study of Preoperative Letrozole for Estrogen Receptor-Positive Postmenopausal Ductal Carcinoma In Situ: CALGB 40903 (Alliance). Journal Of Clinical Oncology 2020, 38: 1284-1292. PMID: 32125937, PMCID: PMC7164489, DOI: 10.1200/jco.19.00510.Peer-Reviewed Original ResearchConceptsER-positive DCISMagnetic resonance imagingPreoperative letrozoleEndocrine therapyDuctal carcinomaInvasive cancerH-scorePhase II single-arm studyExtended endocrine therapyMonths of letrozolePrimary endocrine therapyPrimary nonoperative treatmentPrimary end pointBreast magnetic resonance imagingCooperative group trialsSingle-arm studyER H-scoreShort-term coursePositive DCISNonoperative treatmentPostmenopausal patientsPostmenopausal womenFuture trialsStudy protocolBiomarker changes
2019
A phase II study of pembrolizumab in combination with palliative radiotherapy (RT) for hormone receptor-positive (HR+) metastatic breast cancer (MBC).
Barroso-Sousa R, Krop I, Trippa L, Tan-Wasielewski Z, Li T, Osmani W, Andrews C, Dillon D, Richardson E, Winer E, Mittendorf E, Schoenfeld J, Tolaney S. A phase II study of pembrolizumab in combination with palliative radiotherapy (RT) for hormone receptor-positive (HR+) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2019, 37: 1047-1047. DOI: 10.1200/jco.2019.37.15_suppl.1047.Peer-Reviewed Original ResearchMetastatic breast cancerNeutrophil/lymphocyte ratioObjective response rateProgression-free survivalTumor-infiltrating lymphocytesPalliative radiotherapyAdverse eventsHormone receptor-positive metastatic breast cancerPhase II single-arm studyMedian progression-free survivalCause adverse eventsDistant tumor responsesECOG PS 1Prior cytotoxic therapyImmune checkpoint inhibitorsPD-L1 expressionPD-L1 statusPhase II studySingle-arm studyTotal RT doseUnexpected adverse eventsECOG PSEligible ptsRECIST v1.1Measurable lesionsAvoiding peg-filgrastim (Peg-F) prophylaxis during the paclitaxel (T) portion of the dose-dense (DD) doxorubicin-cyclophosphamide (AC)-T regimen: A prospective study.
Barroso-Sousa R, Luis I, Di Meglio A, Hu J, Rees R, Sinclair N, Milisits L, Leone J, Constantine M, Faggen M, Briccetti F, Block C, Partridge A, Burstein H, Waks A, Trippa L, Tolaney S, Hassett M, Winer E, Lin N. Avoiding peg-filgrastim (Peg-F) prophylaxis during the paclitaxel (T) portion of the dose-dense (DD) doxorubicin-cyclophosphamide (AC)-T regimen: A prospective study. Journal Of Clinical Oncology 2019, 37: 517-517. DOI: 10.1200/jco.2019.37.15_suppl.517.Peer-Reviewed Original ResearchAbsolute neutrophil countFebrile neutropeniaDd ACGrowth factorAdjuvant breast cancer chemotherapyCycle 1 day 1Dose-dense doxorubicinSingle-arm studyBreast cancer chemotherapyPre-specified algorithmT regimenHematologic toxicityProtocol therapySecondary endpointsPrimary endpointDose modificationInvestigator's discretionMedian ageNeutrophil countProspective studyTreatment delayDose reductionCommon reasonRegimenDay 1
2015
A phase 2 single-arm study to assess clinical activity, efficacy and safety of enzalutamide (ENZA) with trastuzumab in HER2+ AR+ metastatic or locally advanced breast cancer.
Trudeau M, Winer E, Steinberg J, Liosatos M, Poondru S, Dydo M, Peterson A, Gradishar W. A phase 2 single-arm study to assess clinical activity, efficacy and safety of enzalutamide (ENZA) with trastuzumab in HER2+ AR+ metastatic or locally advanced breast cancer. Journal Of Clinical Oncology 2015, 33: tps640-tps640. DOI: 10.1200/jco.2015.33.15_suppl.tps640.Peer-Reviewed Original Research
2012
A phase II study of afatinib (BIBW 2992), an irreversible ErbB family blocker, in patients with HER2-positive metastatic breast cancer progressing after trastuzumab
Lin NU, Winer EP, Wheatley D, Carey LA, Houston S, Mendelson D, Munster P, Frakes L, Kelly S, Garcia AA, Cleator S, Uttenreuther-Fischer M, Jones H, Wind S, Vinisko R, Hickish T. A phase II study of afatinib (BIBW 2992), an irreversible ErbB family blocker, in patients with HER2-positive metastatic breast cancer progressing after trastuzumab. Breast Cancer Research And Treatment 2012, 133: 1057-1065. PMID: 22418700, PMCID: PMC3387495, DOI: 10.1007/s10549-012-2003-y.Peer-Reviewed Original ResearchConceptsHER2-positive metastatic breast cancerErbB family blockerMetastatic breast cancerBreast cancer patientsAdverse eventsCancer patientsBreast cancerEastern Cooperative Oncology Group performance statusHER2-positive breast cancer patientsIrreversible ErbB family blockerMedian progression-free survivalTreatment-related adverse eventsPositive breast cancer patientsHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Common Terminology CriteriaMedian overall survivalObjective response ratePhase II studyProgression-free survivalGrowth factor receptor 2Single-arm studyPrior chemotherapy linesPromising clinical activityFactor receptor 2
2007
Association 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
2005
Efficacy of Pegfilgrastim and Darbepoetin Alfa As Hematopoietic Support for Dose-Dense Every-2-Week Adjuvant Breast Cancer Chemotherapy
Burstein HJ, Parker LM, Keshaviah A, Doherty J, Partridge AH, Schapira L, Ryan PD, Younger J, Harris LN, Moy B, Come SE, Schumer ST, Bunnell CA, Haldoupis M, Gelman R, Winer EP. Efficacy of Pegfilgrastim and Darbepoetin Alfa As Hematopoietic Support for Dose-Dense Every-2-Week Adjuvant Breast Cancer Chemotherapy. Journal Of Clinical Oncology 2005, 23: 8340-8347. PMID: 16293865, DOI: 10.1200/jco.2005.02.8621.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAlgorithmsAnemiaAntineoplastic Combined Chemotherapy ProtocolsBostonBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDarbepoetin alfaDoxorubicinErythrocyte TransfusionErythropoietinFemaleFilgrastimGranulocyte Colony-Stimulating FactorHumansMiddle AgedNeutropeniaPaclitaxelPolyethylene GlycolsRecombinant ProteinsTreatment OutcomeConceptsDose-dense ACPercentage of patientsRBC transfusionFebrile neutropeniaDarbepoetin alfaAdjuvant chemotherapyAdjuvant breast cancer chemotherapyDarbepoetin alfa therapyDoxorubicin/cyclophosphamidePrimary end pointSingle-arm studyBreast cancer chemotherapyEfficacy of pegfilgrastimHematopoietic growth factorsAlfa therapyDose-densePaclitaxel cyclesHematologic toxicityArm studyBreast cancerModest leukocytosisHematopoietic supportPatientsStage ITransfusion