2015
Chemotherapy-related amenorrhea after adjuvant paclitaxel–trastuzumab (APT trial)
Ruddy KJ, Guo H, Barry W, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis MJ, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Hudis C, Krop IE, Burstein HJ, Winer EP, Partridge AH, Tolaney SM. Chemotherapy-related amenorrhea after adjuvant paclitaxel–trastuzumab (APT trial). Breast Cancer Research And Treatment 2015, 151: 589-596. PMID: 25981899, PMCID: PMC5057177, DOI: 10.1007/s10549-015-3426-z.Peer-Reviewed Original ResearchConceptsChemotherapy-related amenorrheaChemotherapy initiationMenopausal symptomsBreast cancerAdjuvant breast cancer therapyEarly-stage breast cancerNode-negative HER2Weeks of paclitaxelStage breast cancerLast menstrual periodBreast cancer therapyAdjuvant paclitaxelAmenorrhea ratesAPT trialEligible patientsEvaluable populationPremenopausal womenAdjuvant studiesTrastuzumab monotherapyMedian timeMenstrual periodCancer regimensAmenorrheaTrastuzumabMonths
2013
Pertuzumab: Optimizing HER2 Blockade
Metzger-Filho O, Winer EP, Krop I. Pertuzumab: Optimizing HER2 Blockade. Clinical Cancer Research 2013, 19: 5552-5556. PMID: 23942091, DOI: 10.1158/1078-0432.ccr-13-0518.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicFemaleHumansReceptor, ErbB-2Receptor, ErbB-3ConceptsBreast cancerAdvanced HER2-positive breast cancerHER2-positive breast cancerRecombinant humanized monoclonal antibodyAddition of pertuzumabTrastuzumab/pertuzumabPhase III studyProgression-free survivalFirst-line treatmentMetastatic breast cancerRisk of mortalityHumanized monoclonal antibodyHeterodimerization of HER2EGF receptorMechanism of actionHER2 blockadeIII studyClinical dataHER familyHER2-HER3 heterodimersPertuzumabDrug AdministrationMonoclonal antibodiesU.S. FoodHER2-HER3
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 ResearchMeSH KeywordsAntibiotics, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicDaunorubicinDoxorubicinHumansLiposomesConceptsLiposomal 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
2003
Do Patients Participating in Clinical Trials Want to Know Study Results?
Partridge AH, Burstein HJ, Gelman RS, Marcom PK, Winer EP. Do Patients Participating in Clinical Trials Want to Know Study Results? Journal Of The National Cancer Institute 2003, 95: 491-492. PMID: 12644548, DOI: 10.1093/jnci/95.6.491.Peer-Reviewed Original Research
2001
New Combinations with Herceptin® in Metastatic Breast Cancer
Winer E, Burstein H. New Combinations with Herceptin® in Metastatic Breast Cancer. Oncology 2001, 61: 50-57. PMID: 11694788, DOI: 10.1159/000055402.Peer-Reviewed Original ResearchMeSH KeywordsAnastrozoleAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicCyclophosphamideDeoxycytidineDoxorubicinDrug InteractionsDrug SynergismEpirubicinFemaleFluorouracilGemcitabineHeart DiseasesHematologic DiseasesHumansMethotrexateNeoplasm MetastasisNitrilesOrganoplatinum CompoundsPaclitaxelTamoxifenThiotepaTrastuzumabTreatment OutcomeTriazolesVinblastineVinorelbineConceptsMetastatic breast cancerBreast cancerHormonal agentsSide effectsHER2-positive metastatic breast cancerPivotal phase III trialsHER2-positive breast cancerSingle-agent vinorelbineCombination of trastuzumabPhase II trialPhase III trialsMajor side effectsPossible side effectsHormonal therapyII trialIII trialsCombination regimensPreclinical dataClinical trialsMost womenBetter outcomesTrastuzumabCancerTrialsLiposomal formulation
1995
Oral vinorelbine (Navelbine) in the treatment of advanced breast cancer.
Winer EP, Chu L, Spicer DV. Oral vinorelbine (Navelbine) in the treatment of advanced breast cancer. Seminars In Oncology 1995, 22: 72-8; discussion 78-9. PMID: 7740337.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAgedAged, 80 and overAntineoplastic AgentsBreast NeoplasmsClinical Trials, Phase II as TopicFemaleHumansVinblastineVinorelbineConceptsAdvanced breast cancerOral vinorelbineBreast cancerIntravenous administrationResponse rateMulticenter phase II trialAdvanced breast cancer patientsPhase II trialHigh first-pass effectBreast cancer patientsFirst-pass effectPharmacokinetics of vinorelbineII trialCancer patientsClinical investigationVinorelbineHigh clearance rateSoft gelatin capsulesClearance ratePatientsCancerPharmacokinetic studyLow bioavailabilityAdministrationGelatin capsules