2019
A Prospective Phase I trial of Concurrent Cisplatin (CIS) and Radiation Therapy (RT) in Women with Stage II and III Triple-negative Breast Cancer (TNBC)
Bellon J, Chen Y, Rees R, Taghian A, Wong J, Punglia R, Shiloh R, Krishnan M, Andrews C, Isakoff S, Winer E, Tolaney S. A Prospective Phase I trial of Concurrent Cisplatin (CIS) and Radiation Therapy (RT) in Women with Stage II and III Triple-negative Breast Cancer (TNBC). International Journal Of Radiation Oncology • Biology • Physics 2019, 105: s43. DOI: 10.1016/j.ijrobp.2019.06.466.Peer-Reviewed Original ResearchCorrection: 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. Correction: 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 2019, 25: 1435-1435. PMID: 30770494, DOI: 10.1158/1078-0432.ccr-18-4266.Peer-Reviewed Original Research
2017
Phase I dose escalation study of the PI3kinase pathway inhibitor BKM120 and the oral poly (ADP ribose) polymerase (PARP) inhibitor olaparib for the treatment of high-grade serous ovarian and breast cancer
Matulonis U, Wulf G, Barry W, Birrer M, Westin S, Farooq S, Bell-McGuinn K, Obermayer E, Whalen C, Spagnoletti T, Luo W, Liu H, Hok R, Aghajanian C, Solit D, Mills G, Taylor B, Won H, Berger M, Palakurthi S, Liu J, Cantley L, Winer E. Phase I dose escalation study of the PI3kinase pathway inhibitor BKM120 and the oral poly (ADP ribose) polymerase (PARP) inhibitor olaparib for the treatment of high-grade serous ovarian and breast cancer. Annals Of Oncology 2017, 28: 512-518. PMID: 27993796, PMCID: PMC5834157, DOI: 10.1093/annonc/mdw672.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAminopyridinesBRCA1 ProteinBRCA2 ProteinBreast NeoplasmsDose-Response Relationship, DrugFemaleGerm-Line MutationHumansMiddle AgedMorpholinesNeoplasm GradingNeoplasm Recurrence, LocalOvarian NeoplasmsPhosphoinositide-3 Kinase InhibitorsPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsPoly(ADP-ribose) PolymerasesConceptsGermline BRCA mutationsOvarian cancerStudy treatmentPARP inhibitorsRandomized phase II studyDose-expansion cohortsPhase II studyPhase I trialDose-escalation designWild-type patientsBiomarkers of responsePARP inhibitor combinationsCombination of BKM120Polymerase inhibitor olaparibPoly (ADP-ribose) polymerase (PARP) inhibitor olaparibPI3K inhibitorsAdditional DLTsOlaparib 300Preclinical synergyRecurrent breastEscalation studyII studyI trialClinical benefitBRCA mutations
2014
Phase I trial of olaparib in combination with cisplatin for the treatment of patients with advanced breast, ovarian and other solid tumors
Balmaña J, Tung N, Isakoff S, Graña B, Ryan P, Saura C, Lowe E, Frewer P, Winer E, Baselga J, Garber J. Phase I trial of olaparib in combination with cisplatin for the treatment of patients with advanced breast, ovarian and other solid tumors. Annals Of Oncology 2014, 25: 1656-1663. PMID: 24827126, DOI: 10.1093/annonc/mdu187.Peer-Reviewed Original ResearchConceptsAdvanced solid tumorsSolid tumorsBRCA1/2 mutationsDay 1Overall objective response rateBID days 1Grade 3 neutropeniaObjective response ratePhase I trialTreatment of patientsGermline BRCA1/2 mutationsColony-stimulating factorWarrants further investigationAdvanced breastHematologic supportMeasurable diseaseOral olaparibAdverse eventsI trialTreatment cohortsLipase elevationCisplatin dosesFrequent gradePreliminary efficacyStandard treatment
2011
A phase I trial of the PARP inhibitor olaparib (AZD2281) in combination with the antiangiogenic cediranib (AZD2171) in recurrent ovarian or triple-negative breast cancer.
Liu J, Fleming G, Tolaney S, Birrer M, Penson R, Berlin S, Whalen C, Tyburski K, Matijevich K, Kasparian E, Roche M, Lee H, Winer E, Ivy S, Matulonis U. A phase I trial of the PARP inhibitor olaparib (AZD2281) in combination with the antiangiogenic cediranib (AZD2171) in recurrent ovarian or triple-negative breast cancer. Journal Of Clinical Oncology 2011, 29: 5028-5028. DOI: 10.1200/jco.2011.29.15_suppl.5028.Peer-Reviewed Original Research
2009
Phase I Study of Nonpegylated Liposomal Doxorubicin plus Trastuzumab in Patients with HER2-Positive Breast Cancer
Theodoulou M, Batist G, Campos S, Winer E, Welles L, Hudis C. Phase I Study of Nonpegylated Liposomal Doxorubicin plus Trastuzumab in Patients with HER2-Positive Breast Cancer. Clinical Breast Cancer 2009, 9: 101-107. PMID: 19433391, DOI: 10.3816/cbc.2009.n.019.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerCardiac toxicityBreast cancerLiposomal doxorubicinTreatment cyclesCardiac safetyLeft ventricular ejection fraction reductionHER2/neu 2Median progression-free survivalVentricular ejection fraction reductionHER2-positive breast cancerClinical cardiac assessmentCumulative anthracycline dosesEjection fraction reductionNonpegylated Liposomal DoxorubicinGrade 3/4 neutropeniaObjective tumor responseHER2-positive patientsProgression-free survivalPhase I trialClinical cardiac toxicityAnthracycline dosesCytotoxic regimensFebrile neutropeniaTrastuzumab regimen
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
1992
High-Dose Oral Tamoxifen, a Potential Multidrug-Resistance-Reversal Agent: Phase I Trial in Combination With Vinblastine
Trump DL, Smith DC, Ellis PG, Rogers MP, Schold SC, Winer EP, Panella TJ, Jordan VC, Fine RL. High-Dose Oral Tamoxifen, a Potential Multidrug-Resistance-Reversal Agent: Phase I Trial in Combination With Vinblastine. Journal Of The National Cancer Institute 1992, 84: 1811-1816. PMID: 1359155, DOI: 10.1093/jnci/84.23.1811.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAntineoplastic Combined Chemotherapy ProtocolsATP Binding Cassette Transporter, Subfamily B, Member 1Drug Administration ScheduleDrug ResistanceFemaleHumansInfusions, IntravenousMaleMembrane GlycoproteinsMiddle AgedNeoplasm ProteinsNeoplasmsTamoxifenVinblastineConceptsLoading doseN-desmethyltamoxifenOral tamoxifenContinuous infusionPlasma concentrationsHigh-dose oral tamoxifenDose-limiting toxic effectPhase I clinical trialAdvanced epithelial tumorsHigh-dose tamoxifenTriphenylethylene antiestrogen tamoxifenPhase II trialDose-limiting toxicityPhase I trialDoses of tamoxifenStart of treatmentP-glycoprotein functionToxicity of vinblastineAnti-neoplastic agentsToxic effectsMetabolite N-desmethyltamoxifenIntracellular concentrationAsymptomatic prolongationStarting doseII trialModulation of O6-alkylguanine-DNA alkyltransferase-mediated carmustine resistance using streptozotocin: a phase I trial.
Panella TJ, Smith DC, Schold SC, Rogers MP, Winer EP, Fine RL, Crawford J, Herndon JE, Trump DL. Modulation of O6-alkylguanine-DNA alkyltransferase-mediated carmustine resistance using streptozotocin: a phase I trial. Cancer Research 1992, 52: 2456-9. PMID: 1533174.Peer-Reviewed Original ResearchConceptsFmol/M2/dayDose-limiting toxicityPhase I trialDose of BCNUSerum alkaline phosphataseBCNU doseSTZ doseStarting dosePartial responseSerum creatinineThird doseDose escalationI trialMild elevationDay 3BCNU resistanceNitrosourea resistanceSTZBCNU cytotoxicityBCNUDoseAdditional studiesO6-alkylguanine-DNA alkyltransferaseAlkaline phosphatase