2018
A phase I study of palbociclib (PALBO) plus everolimus (EVE) and exemestane (EXE) in hormone-receptor positive (HR+)/HER2- metastatic breast cancer (MBC) after progression on a CDK4/6 inhibitor (CDK4/6i): safety, tolerability and pharmacokinetic (PK) analysis.
Barroso-Sousa R, Guo H, Barry W, Ferreira A, Rees R, Winer E, Wagle N, Tolaney S. A phase I study of palbociclib (PALBO) plus everolimus (EVE) and exemestane (EXE) in hormone-receptor positive (HR+)/HER2- metastatic breast cancer (MBC) after progression on a CDK4/6 inhibitor (CDK4/6i): safety, tolerability and pharmacokinetic (PK) analysis. Journal Of Clinical Oncology 2018, 36: 1068-1068. DOI: 10.1200/jco.2018.36.15_suppl.1068.Peer-Reviewed Original Research
2017
18F-Fluoroestradiol PET/CT Measurement of Estrogen Receptor Suppression during a Phase I Trial of the Novel Estrogen Receptor-Targeted Therapeutic GDC-0810: Using an Imaging Biomarker to Guide Drug Dosage in Subsequent Trials
Wang Y, Ayres KL, Goldman DA, Dickler MN, Bardia A, Mayer IA, Winer E, Fredrickson J, Arteaga CL, Baselga J, Manning HC, Mahmood U, Ulaner GA. 18F-Fluoroestradiol PET/CT Measurement of Estrogen Receptor Suppression during a Phase I Trial of the Novel Estrogen Receptor-Targeted Therapeutic GDC-0810: Using an Imaging Biomarker to Guide Drug Dosage in Subsequent Trials. Clinical Cancer Research 2017, 23: 3053-3060. PMID: 28011460, PMCID: PMC5474190, DOI: 10.1158/1078-0432.ccr-16-2197.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBiomarkers, PharmacologicalBreast NeoplasmsCinnamatesDose-Response Relationship, DrugEstradiolEstrogen Receptor alphaFemaleFulvestrantHumansIndazolesMiddle AgedMolecular ImagingMolecular Targeted TherapyPositron Emission Tomography Computed TomographyReceptors, EstrogenTamoxifenConceptsFES-PET/CTPET/CTClinical trialsER-positive metastatic breast cancerPhase IPhase I clinical trialEstrogen receptor occupancyPhase II trialMetastatic breast cancerSubsequent clinical trialsClin Cancer ResER downregulationFulvestrant therapyAntagonist/Escalation trialII trialTarget lesionsBreast cancerER occupancyUseful biomarkerPatientsReceptor occupancyDay 3Uptake valueDrug dosage
2014
Phase I study of oral BKM120 and oral olaparib for high-grade serous ovarian cancer (HGSC) or triple-negative breast cancer (TNBC).
Matulonis U, Wulf G, Birrer M, Westin S, Quy P, Bell-McGuinn K, Lasonde B, Whalen C, Aghajanian C, Solit D, Mills G, Cantley L, Winer E. Phase I study of oral BKM120 and oral olaparib for high-grade serous ovarian cancer (HGSC) or triple-negative breast cancer (TNBC). Journal Of Clinical Oncology 2014, 32: 2510-2510. DOI: 10.1200/jco.2014.32.15_suppl.2510.Peer-Reviewed Original Research
2010
Phase I study of lapatinib (L) in combination with whole-brain radiation therapy (WBRT) in patients (pts) with brain metastases from HER2-positive breast cancer.
Lin N, Ramakrishna N, Younger W, Storniolo A, Come S, Gelman R, Eisenberg E, Winer E. Phase I study of lapatinib (L) in combination with whole-brain radiation therapy (WBRT) in patients (pts) with brain metastases from HER2-positive breast cancer. Journal Of Clinical Oncology 2010, 28: 1154-1154. DOI: 10.1200/jco.2010.28.15_suppl.1154.Peer-Reviewed Original Research
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
2006
Combination therapy with gefitinib and capecitabine in metastatic breast cancer (MBC): A phase I trial
Mayer E, Harris L, Partridge A, Gelman R, Schumer S, Comanaru R, Long M, Sampson E, Burstein H, Winer E. Combination therapy with gefitinib and capecitabine in metastatic breast cancer (MBC): A phase I trial. Journal Of Clinical Oncology 2006, 24: 10564-10564. DOI: 10.1200/jco.2006.24.18_suppl.10564.Peer-Reviewed Original ResearchMetastatic breast cancerMicroelectronic monitoring systemOral regimenValidation cohortDose reductionHand/foot syndromeSubstantial anti-tumor activityEGFR tyrosine kinase inhibitor gefitinibPhase IDose-escalation cohortsGrade 3 diarrheaGrade 4 toxicityCycles of therapyGrade 3 toxicityGrade 3/4 toxicitiesPhase I trialTyrosine kinase inhibitor gefitinibPost-therapy valuesMean numberCycle 1Lack of progressionAnti-tumor activityKinase inhibitor gefitinibEvaluable ptsUnresolved toxicity
2004
Efficacy and safety of liposomal anthracyclines in Phase I/II clinical trials
Alberts DS, Muggia FM, Carmichael J, Winer EP, Jahanzeb M, Venook AP, Skubitz KM, Rivera E, Sparano JA, Dibella NJ, Stewart SJ, Kavanagh JJ, Gabizon AA. Efficacy and safety of liposomal anthracyclines in Phase I/II clinical trials. Seminars In Oncology 2004, 31: 53-90. PMID: 15717738, DOI: 10.1053/j.seminoncol.2004.08.010.Peer-Reviewed Original ResearchConceptsLiposomal anthracyclinesClinical trialsConventional anthracyclinesLiposomal doxorubicinTumor typesPhase I/II clinical trialsSingle-agent therapyRange of dosesAnthracycline therapyLiposomal daunorubicinAnthracycline treatmentPharmacologic advantageContinuous infusionPatient populationHematologic tumorsClinical dataPreclinical studiesPharmacokinetic profileAnthracyclinesDrug concentrationsCytotoxic agentsTumor cellsPhase ITrialsFurther studies