2022
The Phase II MutHER Study of Neratinib Alone and in Combination with Fulvestrant in HER2-Mutated, Non-amplified Metastatic Breast CancerNeratinib and Fulvestrant in HER2-Mutated Breast Cancer
X. C, Luo J, Freedman RA, Pluard TJ, Nangia JR, Lu J, Valdez-Albini F, Cobleigh M, Jones JM, Lin NU, Winer EP, Marcom PK, Thomas S, Anderson J, Haas B, Bucheit L, Bryce R, Lalani AS, Carey LA, Goetz MP, Gao F, Kimmick G, Pegram MD, Ellis MJ, Bose R. The Phase II MutHER Study of Neratinib Alone and in Combination with Fulvestrant in HER2-Mutated, Non-amplified Metastatic Breast CancerNeratinib and Fulvestrant in HER2-Mutated Breast Cancer. Clinical Cancer Research 2022, 28: 1258-1267. PMID: 35046057, DOI: 10.1158/1078-0432.ccr-21-3418.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerBreast cancerER cohortEstrogen receptor-positive breast cancerReceptor-positive breast cancerClinical benefit rateDual HER2 blockadePhase II trialEfficacy of neratinibHER2 blockadeNeratinib monotherapyStable diseaseII trialHER2 mutationsLobular histologyPartial responseEndocrine resistanceBenefit ratePatientsFurther evaluationCancerFulvestrantHER2NeratinibProgression
2016
TransCONFIRM: Identification of a Genetic Signature of Response to Fulvestrant in Advanced Hormone Receptor–Positive Breast Cancer
Jeselsohn R, Barry WT, Migliaccio I, Biagioni C, Zhao J, De Tribolet-Hardy J, Guarducci C, Bonechi M, Laing N, Winer EP, Brown M, Di Leo A, Malorni L. TransCONFIRM: Identification of a Genetic Signature of Response to Fulvestrant in Advanced Hormone Receptor–Positive Breast Cancer. Clinical Cancer Research 2016, 22: 5755-5764. PMID: 27185372, PMCID: PMC5124409, DOI: 10.1158/1078-0432.ccr-16-0148.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalBreast NeoplasmsDisease-Free SurvivalDouble-Blind MethodEpidermal Growth FactorEstradiolFemaleFulvestrantGene Expression ProfilingHepatocyte Nuclear Factor 3-alphaHumansMiddle AgedPostmenopauseReceptors, EstrogenSignal TransductionTranscription Factor AP-2TranscriptomeConceptsProgression-free survivalBreast cancerPredictive biomarkersCONFIRM studyMetastatic estrogen receptor-positive breast cancerEstrogen receptor-positive breast cancerReceptor-positive breast cancerGene signatureBiologic pathwaysAdvanced breast cancerMetastatic breast cancerMultivariate Cox modelPotential new therapeutic targetEstrogen receptor antagonistNew therapeutic targetsNegative predictive valuePrimary tumor samplesNovel gene signatureMetastatic ERPrimary ERReceptor antagonistFulvestrant treatmentDecreased responseCox modelER levelsAdjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update on Ovarian Suppression
Burstein HJ, Lacchetti C, Anderson H, Buchholz TA, Davidson NE, Gelmon KE, Giordano SH, Hudis CA, Solky AJ, Stearns V, Winer EP, Griggs JJ. Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update on Ovarian Suppression. Journal Of Clinical Oncology 2016, 34: 1689-1701. PMID: 26884586, DOI: 10.1200/jco.2015.65.9573.Peer-Reviewed Original ResearchConceptsReceptor-positive breast cancerAdjuvant endocrine therapyOvarian suppressionStandard adjuvant therapyEndocrine therapyBreast cancerAdjuvant chemotherapyAdjuvant therapyAromatase inhibitorsClinical Oncology Clinical Practice Guideline UpdateHormone receptor-positive breast cancerEstrogen receptor-positive breast cancerClinical Practice Guideline UpdateStage I breast cancerDisease-free survivalHigh-risk patientsLow-risk patientsI breast cancerSubset of patientsOverall clinical benefitRandomized clinical trialsNode-negative cancersQuality of lifeDistant recurrencePremenopausal women
2008
Pharmacogenomic Variation of CYP2D6 and the Choice of Optimal Adjuvant Endocrine Therapy for Postmenopausal Breast Cancer: A Modeling Analysis
Punglia RS, Burstein HJ, Winer EP, Weeks JC. Pharmacogenomic Variation of CYP2D6 and the Choice of Optimal Adjuvant Endocrine Therapy for Postmenopausal Breast Cancer: A Modeling Analysis. Journal Of The National Cancer Institute 2008, 100: 642-648. PMID: 18445827, PMCID: PMC2864146, DOI: 10.1093/jnci/djn100.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Agents, HormonalAromatase InhibitorsBreast NeoplasmsChemotherapy, AdjuvantCytochrome P-450 CYP2D6Decision Support TechniquesDisease-Free SurvivalEstrogen Receptor ModulatorsFemaleGenotypeHumansMarkov ChainsMiddle AgedMutationNeoplasms, Hormone-DependentOdds RatioPostmenopauseReceptors, EstrogenSelective Estrogen Receptor ModulatorsTamoxifenConceptsDisease-free survivalWt/wt patientsAromatase inhibitorsBreast cancerCYP2D6 genotypeEndocrine therapyWT patientsNorth Central Cancer Treatment Group trialsEstrogen receptor-positive breast cancerBreast International Group (BIG) 1Optimal adjuvant endocrine therapyReceptor-positive breast cancerDisease-free survival outcomesAromatase inhibitor monotherapyAdjuvant endocrine therapyAdjuvant endocrine treatmentPostmenopausal breast cancerActive tamoxifen metabolitesBreast cancer patientsCytochrome P450 2D6Adjuvant tamoxifenEndocrine treatmentPostmenopausal womenHazard ratioInhibitor monotherapyOptimizing Endocrine Therapy for Estrogen Receptor–Positive Breast Cancer: Treating the Right Patients for the Right Length of Time
Lin NU, Winer EP. Optimizing Endocrine Therapy for Estrogen Receptor–Positive Breast Cancer: Treating the Right Patients for the Right Length of Time. Journal Of Clinical Oncology 2008, 26: 1919-1921. PMID: 18332468, DOI: 10.1200/jco.2007.14.7744.Peer-Reviewed Original ResearchConceptsEstrogen receptor-positive breast cancerReceptor-positive breast cancerEndocrine therapyBreast cancerRight patientRight lengthPatientsTherapyCancerSummary 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
Could treatment with tamoxifen be superior to aromatase inhibitors in early-stage breast cancer after pharmacogenomic testing? A modeling analysis
Punglia R, Winer E, Weeks J, Burstein H. Could treatment with tamoxifen be superior to aromatase inhibitors in early-stage breast cancer after pharmacogenomic testing? A modeling analysis. Journal Of Clinical Oncology 2007, 25: 502-502. DOI: 10.1200/jco.2007.25.18_suppl.502.Peer-Reviewed Original ResearchDisease-free survivalOptimal treatment strategyAromatase inhibitorsHazard ratioUnselected womenTreatment strategiesBreast cancerEstrogen receptor-positive breast cancerWt/wt patientsReceptor-positive breast cancerEarly-stage breast cancerAnnual recurrence riskAdjuvant endocrine treatmentEfficacy of tamoxifenPercent of patientsActive tamoxifen metabolitesWT cohortsEndocrine treatmentBIG 1Initial treatmentTamoxifen metabolitesCancer recurrenceUnselected groupMutation carriersPharmacogenomic testing