2024
Endocrine-Sensitive Disease Rate in Postmenopausal Patients With Estrogen Receptor–Rich/ERBB2-Negative Breast Cancer Receiving Neoadjuvant Anastrozole, Fulvestrant, or Their Combination
X. C, Suman V, Sanati S, Vij K, Anurag M, Leitch A, Unzeitig G, Hoog J, Fernandez-Martinez A, Fan C, Gibbs R, Watson M, Dockter T, Hahn O, Guenther J, Caudle A, Crouch E, Tiersten A, Mita M, Razaq W, Hieken T, Wang Y, Rimawi M, Weiss A, Winer E, Hunt K, Perou C, Ellis M, Partridge A, Carey L. Endocrine-Sensitive Disease Rate in Postmenopausal Patients With Estrogen Receptor–Rich/ERBB2-Negative Breast Cancer Receiving Neoadjuvant Anastrozole, Fulvestrant, or Their Combination. JAMA Oncology 2024, 10: 362-371. PMID: 38236590, PMCID: PMC10797521, DOI: 10.1001/jamaoncol.2023.6038.Peer-Reviewed Original ResearchConceptsNeoadjuvant endocrine therapyBreast cancerWeek 4Neoadjuvant chemotherapyPostmenopausal womenPAM50 subtypesNonluminal tumorsClinical stage II to IIIRate of pathological complete responseClinical trialsHER2)-negative breast cancerPhase 3 randomized clinical trialLuminal B tumorsPathological complete responseLuminal A tumorsEarly-stage diseaseRandomized clinical trialsStage II to IIIAnastrozole armNeoadjuvant anastrozoleTumor Ki67Postmenopausal patientsB tumorsComplete responseA tumors
2022
The oral selective estrogen receptor degrader GDC-0810 (ARN-810) in postmenopausal women with hormone receptor-positive HER2-negative (HR + /HER2 −) advanced/metastatic breast cancer
Bardia A, Mayer I, Winer E, Linden H, Ma C, Parker B, Bellet M, Arteaga C, Cheeti S, Gates M, Chang C, Fredrickson J, Spoerke J, Moore H, Giltnane J, Friedman L, Chow Maneval E, Chan I, Jhaveri K. The oral selective estrogen receptor degrader GDC-0810 (ARN-810) in postmenopausal women with hormone receptor-positive HER2-negative (HR + /HER2 −) advanced/metastatic breast cancer. Breast Cancer Research And Treatment 2022, 197: 319-331. PMID: 36401732, PMCID: PMC9823088, DOI: 10.1007/s10549-022-06797-9.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerSelective estrogen receptor degraderDose escalationESR1 mutationsPostmenopausal womenBreast cancerEstrogen receptorCombination treatmentNon-complete response/non-progressive diseaseAdvanced/Metastatic Breast CancerOral selective estrogen receptor degraderPreliminary anti-tumor activityESR1 mutation statusPhase 2 dosePlasma ctDNA samplesCommon adverse eventsNon-progressive diseaseDose-limiting toxicityHormone-releasing hormoneSelective estrogen receptorAnti-tumor activityStable diseaseAdverse eventsPartial responseProgressive diseaseClinical Efficacy and Whole-Exome Sequencing of Liquid Biopsies in a Phase IB/II Study of Bazedoxifene and Palbociclib in Advanced Hormone Receptor-Positive Breast Cancer.
Tsuji J, Li T, Grinshpun A, Coorens T, Russo D, Anderson L, Rees R, Nardone A, Patterson C, Lennon NJ, Cibulskis C, Leshchiner I, Tayob N, Tolaney SM, Tung N, McDonnell DP, Krop IE, Winer EP, Stewart C, Getz G, Jeselsohn R. Clinical Efficacy and Whole-Exome Sequencing of Liquid Biopsies in a Phase IB/II Study of Bazedoxifene and Palbociclib in Advanced Hormone Receptor-Positive Breast Cancer. Clinical Cancer Research 2022, 28: 5066-5078. PMID: 36215125, PMCID: PMC9722539, DOI: 10.1158/1078-0432.ccr-22-2305.Peer-Reviewed Original ResearchConceptsProgression-free survivalPhase Ib/II studyCombination of palbociclibBreast cancerWhole-exome sequencingESR1 mutationsII studyClinical efficacySafety profileHormone receptor-positive/HER2-negative advanced breast cancerAdvanced hormone receptor-positive breast cancerHER2-negative advanced breast cancerHormone receptor-positive breast cancerThird-generation selective estrogen receptor modulatorMedian progression-free survivalEndocrine-resistant breast cancerReceptor-positive breast cancerShorter progression-free survivalSelective estrogen receptor modulatorsClinical benefit rateAcceptable safety profileAdvanced breast cancerEstrogen receptor modulatorsSelective ER degraderDNA whole-exome sequencingA Distinct Chromatin State Drives Therapeutic Resistance in Invasive Lobular Breast Cancer.
Nardone A, Qiu X, Spisak S, Nagy Z, Feiglin A, Feit A, Cohen Feit G, Xie Y, Font-Tello A, Guarducci C, Hermida-Prado F, Syamala S, Lim K, Munoz Gomez M, Pun M, Cornwell M, Liu W, Ors A, Mohammed H, Cejas P, Brock JB, Freedman ML, Winer EP, Fu X, Schiff R, Long HW, Metzger Filho O, Jeselsohn R. A Distinct Chromatin State Drives Therapeutic Resistance in Invasive Lobular Breast Cancer. Cancer Research 2022, 82: 3673-3686. PMID: 35950920, PMCID: PMC9588703, DOI: 10.1158/0008-5472.can-21-3186.Peer-Reviewed Original ResearchMeSH KeywordsBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, LobularChromatinDrug Resistance, NeoplasmFemaleHumansPrognosisReceptors, EstrogenTamoxifenConceptsInvasive lobular breast cancerInvasive ductal cancerLobular breast cancerTamoxifen resistanceBreast cancerInferior long-term outcomesTumor progressionLong-term outcomesBreast cancer subtypesPotential therapeutic avenuesDuctal cancerClinical findingsPoor outcomeReceptor axisClinical trialsDisease progressionPatient outcomesPreclinical modelsClinical investigationRelated commentaryTherapeutic avenuesCancer subtypesTherapeutic resistanceCancerClinical samplesOverall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, Conte P, Cameron DA, André F, Arteaga CL, Zarate JP, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. New England Journal Of Medicine 2022, 386: 942-950. PMID: 35263519, DOI: 10.1056/nejmoa2114663.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerSignificant overall survival benefitMedian overall survivalOverall survival benefitProgression-free survivalOverall survivalBreast cancerSurvival benefitHER2-negative advanced breast cancerKey secondary end pointProtocol-specified final analysisLonger progression-free survivalHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Negative advanced breast cancerStratified log-rank testFirst-line ribociclibSecondary end pointsFirst-line therapyNew safety signalsPhase 3 trialGrowth factor receptor 2Kaplan-Meier methodLog-rank testFactor receptor 2Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03).
Mayer EL, Fesl C, Hlauschek D, Garcia-Estevez L, Burstein HJ, Zdenkowski N, Wette V, Miller KD, Balic M, Mayer IA, Cameron D, Winer EP, Ponce Lorenzo JJ, Lake D, Pristauz-Telsnigg G, Haddad TC, Shepherd L, Iwata H, Goetz M, Cardoso F, Traina TA, Sabanathan D, Breitenstein U, Ackerl K, Metzger Filho O, Zehetner K, Solomon K, El-Abed S, Theall KP, Lu DR, Dueck A, Gnant M, DeMichele A. Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03). Journal Of Clinical Oncology 2022, 40: 449-458. PMID: 34995105, PMCID: PMC9851679, DOI: 10.1200/jco.21.01918.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleHumansNeoplasm StagingPiperazinesProtein Kinase InhibitorsPyridinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRisk FactorsTime FactorsConceptsInvasive disease-free survivalAdjuvant endocrine therapyHuman epidermal growth factor receptorEndocrine therapyEpidermal growth factor receptorPalbociclib exposureGrowth factor receptorBreast cancerHormone Receptor-Positive/Human Epidermal Growth Factor ReceptorAddition of palbociclibNovel adjuvant treatmentDisease-free survivalEarly breast cancerFactor receptorOral cancer therapyProtocol analysisPALLAS studyAdjuvant treatmentEarly discontinuationAdjuvant studiesDiscontinuation ratesDose modificationAnalysis populationCDK4/6 inhibitorsDrug persistence
2021
Molecular correlates of response to eribulin and pembrolizumab in hormone receptor-positive metastatic breast cancer
Keenan TE, Guerriero JL, Barroso-Sousa R, Li T, O’Meara T, Giobbie-Hurder A, Tayob N, Hu J, Severgnini M, Agudo J, Vaz-Luis I, Anderson L, Attaya V, Park J, Conway J, He MX, Reardon B, Shannon E, Wulf G, Spring LM, Jeselsohn R, Krop I, Lin NU, Partridge A, Winer EP, Mittendorf EA, Liu D, Van Allen EM, Tolaney SM. Molecular correlates of response to eribulin and pembrolizumab in hormone receptor-positive metastatic breast cancer. Nature Communications 2021, 12: 5563. PMID: 34548479, PMCID: PMC8455578, DOI: 10.1038/s41467-021-25769-z.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntigen PresentationAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenBreast NeoplasmsCytokinesDrug Resistance, NeoplasmEstrogensFemaleFuransGene Expression ProfilingGenetic HeterogeneityGenome, HumanGenomicsHumansImmune Checkpoint InhibitorsKetonesLymphocytes, Tumor-InfiltratingMaleMiddle AgedMutationNeoplasm MetastasisReceptors, EstrogenReceptors, ProgesteroneSignal TransductionSurvival RateTreatment OutcomeConceptsImmune checkpoint inhibitorsBreast cancerHormone receptor-positive metastatic breast cancerHormone receptor-positive breast cancerFinal overall survival resultsRandomized phase 2 trialReceptor-positive breast cancerMinimal therapeutic effectPhase 2 trialMetastatic breast cancerOverall survival resultsPre-treatment tumorsCheckpoint inhibitorsCytokine changesICI responseCombination therapyImmune infiltrationImmunoregulatory cytokinesSurvival resultsAntigen presentationTherapeutic effectTherapeutic validationCancerMolecular correlatesTumor heterogeneityGene expression signatures for tailoring adjuvant chemotherapy of luminal breast cancer: stronger evidence, greater trust
Piccart M, Kalinsky K, Gray R, Barlow W, Poncet C, Cardoso F, Winer E, Sparano J. Gene expression signatures for tailoring adjuvant chemotherapy of luminal breast cancer: stronger evidence, greater trust. Annals Of Oncology 2021, 32: 1077-1082. PMID: 34082017, DOI: 10.1016/j.annonc.2021.05.804.Peer-Reviewed Original ResearchTumor subtypes and survival in male breast cancer
Leone J, Freedman RA, Lin NU, Tolaney SM, Vallejo CT, Leone BA, Winer EP, Leone JP. Tumor subtypes and survival in male breast cancer. Breast Cancer Research And Treatment 2021, 188: 695-702. PMID: 33770314, DOI: 10.1007/s10549-021-06182-y.Peer-Reviewed Original ResearchConceptsBreast cancer-specific survivalOverall survivalTumor subtypesBreast cancerHormone receptorsWorse breast cancer-specific survivalMultivariate Cox proportional hazards analysisCox proportional hazards analysisPurposeMale breast cancerTumor subtype distributionCancer-specific survivalProportional hazards analysisInvasive breast cancerMale breast cancerAggressive tumor biologyCox hazard ratiosPopulation-based informationTN diseaseAdvanced diseaseHazard ratioHR-/HER2Inferior survivalMedian agePatient characteristicsPrognostic factorsPalbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study
Mayer EL, Dueck AC, Martin M, Rubovszky G, Burstein HJ, Bellet-Ezquerra M, Miller KD, Zdenkowski N, Winer EP, Pfeiler G, Goetz M, Ruiz-Borrego M, Anderson D, Nowecki Z, Loibl S, Moulder S, Ring A, Fitzal F, Traina T, Chan A, Rugo HS, Lemieux J, Henao F, Lyss A, Antolin Novoa S, Wolff AC, Vetter M, Egle D, Morris PG, Mamounas EP, Gil-Gil MJ, Prat A, Fohler H, Metzger Filho O, Schwarz M, DuFrane C, Fumagalli D, Theall KP, Lu DR, Bartlett CH, Koehler M, Fesl C, DeMichele A, Gnant M. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study. The Lancet Oncology 2021, 22: 212-222. PMID: 33460574, DOI: 10.1016/s1470-2045(20)30642-2.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalAdjuvant endocrine therapyDisease-free survivalInvasive disease-free survival eventsDisease-free survival eventsEndocrine therapySecond interim analysisBreast cancerInterim analysisAdverse eventsEastern Cooperative Oncology Group performance scoreSecond pre-planned interim analysisHER2-negative breast cancerEarly-stage breast cancerSurvival eventsIndependent data monitoring committeePre-planned interim analysisCommon grade 3Treatment-related deathsSerious adverse eventsProgression-free survivalEarly breast cancerMetastatic breast cancerInteractive response technologyGroup performance score
2020
A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor–Positive Breast Cancer
Krop I, Abramson V, Colleoni M, Traina T, Holmes F, Garcia-Estevez L, Hart L, Awada A, Zamagni C, Morris PG, Schwartzberg L, Chan S, Gucalp A, Biganzoli L, Steinberg J, Sica L, Trudeau M, Markova D, Tarazi J, Zhu Z, O'Brien T, Kelly C, Winer E, Yardley D. A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor–Positive Breast Cancer. Clinical Cancer Research 2020, 26: 6149-6157. PMID: 32988969, DOI: 10.1158/1078-0432.ccr-20-1693.Peer-Reviewed Original ResearchConceptsProgression-free survivalHormone receptor-positive breast cancerReceptor-positive breast cancerPhase II trialEndocrine therapyBreast cancerII trialAR mRNACohort 1Higher AR mRNA levelsLower ESR1 mRNA levelsET-naïve patientsGrade adverse eventsPrior endocrine therapyMetastatic breast cancerAndrogen receptor inhibitorMRNA levelsAR mRNA levelsESR1 mRNA levelsEnzalutamide armITT populationTreat populationAdvanced diseasePrimary endpointAdverse eventsAcquired FGFR and FGF Alterations Confer Resistance to Estrogen Receptor (ER) Targeted Therapy in ER+ Metastatic Breast Cancer
Mao P, Cohen O, Kowalski KJ, Kusiel JG, Buendia-Buendia JE, Cuoco MS, Exman P, Wander SA, Waks AG, Nayar U, Chung J, Freeman S, Rozenblatt-Rosen O, Miller VA, Piccioni F, Root DE, Regev A, Winer EP, Lin NU, Wagle N. Acquired FGFR and FGF Alterations Confer Resistance to Estrogen Receptor (ER) Targeted Therapy in ER+ Metastatic Breast Cancer. Clinical Cancer Research 2020, 26: 5974-5989. PMID: 32723837, DOI: 10.1158/1078-0432.ccr-19-3958.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBreast NeoplasmsCell Line, TumorDrug Resistance, NeoplasmExome SequencingFemaleFibroblast Growth Factor 3FulvestrantGene Expression Regulation, NeoplasticHumansMCF-7 CellsMiddle AgedMutationNeoplasm MetastasisPiperazinesProtein Kinase InhibitorsPyridinesReceptor, Fibroblast Growth Factor, Type 1Receptor, Fibroblast Growth Factor, Type 2Receptors, EstrogenXenograft Model Antitumor AssaysConceptsMetastatic breast cancerEstrogen receptorBreast cancerFGFR pathwaySelective estrogen receptor degraderCDK4/6 inhibitor palbociclibBreast cancer cellsMAPK pathwayWhole-exome sequencingResistant cell linesMAPK pathway inhibitorsFulvestrant resistanceInhibitor palbociclibDrug combinationsFGFR inhibitorsTherapyPathway inhibitorMEK inhibitorsConfer resistanceCancer cellsCancerInsulin receptorGenes/pathwaysBiopsyCell linesResponse to neoadjuvant chemotherapy and the 21-gene Breast Recurrence Score test in young women with estrogen receptor-positive early breast cancer
Sella T, Gelber SI, Poorvu PD, Kim HJ, Dominici L, Guzman-Arocho YD, Collins L, Ruddy KJ, Tamimi RM, Peppercorn JM, Schapira L, Borges VF, Come SE, Warner E, Snow C, Jakubowski DM, Russell CA, Winer EP, Rosenberg SM, Partridge AH. Response to neoadjuvant chemotherapy and the 21-gene Breast Recurrence Score test in young women with estrogen receptor-positive early breast cancer. Breast Cancer Research And Treatment 2020, 186: 157-165. PMID: 33150547, DOI: 10.1007/s10549-020-05989-5.Peer-Reviewed Original ResearchConceptsRecurrence Score resultsNeoadjuvant chemotherapyPathological complete responseBreast cancerBreast Cancer StudyYoung womenEstrogen receptor-positive early breast cancerReceptor-positive early breast cancerYoung Women's Breast Cancer StudyHER2-negative breast cancerScore resultsEarly breast cancerLogistic regression modelingAdjuvant chemotherapyNeoadjuvant therapyProspective cohortComplete responseMedian ageMultivariable analysisRecurrence scoreVs. 5Clinical careTumor specimensStage IPatientsEffect of Eribulin With or Without Pembrolizumab on Progression-Free Survival for Patients With Hormone Receptor–Positive, ERBB2-Negative Metastatic Breast Cancer
Tolaney SM, Barroso-Sousa R, Keenan T, Li T, Trippa L, Vaz-Luis I, Wulf G, Spring L, Sinclair NF, Andrews C, Pittenger J, Richardson ET, Dillon D, Lin NU, Overmoyer B, Partridge AH, Van Allen E, Mittendorf EA, Winer EP, Krop IE. Effect of Eribulin With or Without Pembrolizumab on Progression-Free Survival for Patients With Hormone Receptor–Positive, ERBB2-Negative Metastatic Breast Cancer. JAMA Oncology 2020, 6: 1598-1605. PMID: 32880602, PMCID: PMC7489368, DOI: 10.1001/jamaoncol.2020.3524.Peer-Reviewed Original ResearchConceptsProgression-free survivalObjective response rateTumor-infiltrating lymphocytesTumor mutational burdenPD-L1 statusOverall survivalHormonal therapyPrior linesPD-L1Clinical trialsMedian numberDay 1Cell death ligand 1 (PD-L1) inhibitorsERBB2-negative metastatic breast cancerMedian progression-free survivalDeath ligand 1 (PD-L1) inhibitorsEnd pointCause adverse eventsEfficacy of eribulinHormone receptor positiveMulticenter phase 2PD-L1 22C3Treatment-related deathsLines of chemotherapyPrimary end pointOncotype DX testing in node-positive breast cancer strongly impacts chemotherapy use at a comprehensive cancer center
Losk K, Freedman RA, Laws A, Kantor O, Mittendorf EA, Tan-Wasielewski Z, Trippa L, Lin NU, Winer EP, King TA. Oncotype DX testing in node-positive breast cancer strongly impacts chemotherapy use at a comprehensive cancer center. Breast Cancer Research And Treatment 2020, 185: 215-227. PMID: 32939592, DOI: 10.1007/s10549-020-05931-9.Peer-Reviewed Original ResearchMeSH KeywordsBreast NeoplasmsChemotherapy, AdjuvantFemaleGene Expression ProfilingHumansNeoplasm Recurrence, LocalReceptors, EstrogenRiskConceptsRecurrence-free survivalPN1 breast cancerRecurrence scoreChemotherapy useBreast cancerOverall survivalChemotherapy receiptPN1 patientsRS testingUse of RSNode-positive breast cancerOncotype DX recurrence scoreAdjuvant chemotherapy receiptLow genomic riskNode-positive diseaseAdjuvant treatment decisionsLow recurrence scoreShort-term outcomesMultivariate logistic regressionComprehensive cancer centerDX recurrence scoreOncotype DX testingChemotherapy omissionPT1-2N0Upfront surgeryClinical Significance of Circulating Tumor Cells in Hormone Receptor–positive Metastatic Breast Cancer Patients who Received Letrozole with or Without Bevacizumab
Magbanua MJM, Savenkov O, Asmus EJ, Ballman KV, Scott JH, Park JW, Dickler M, Partridge A, Carey LA, Winer EP, Rugo HS. Clinical Significance of Circulating Tumor Cells in Hormone Receptor–positive Metastatic Breast Cancer Patients who Received Letrozole with or Without Bevacizumab. Clinical Cancer Research 2020, 26: 4911-4920. PMID: 32586939, PMCID: PMC7501177, DOI: 10.1158/1078-0432.ccr-20-1329.Peer-Reviewed Original ResearchConceptsProgression-free survivalCTC-positive patientsHormone receptor-positive metastatic breast cancer patientsMetastatic breast cancer patientsAddition of bevacizumabBreast cancer patientsOverall survivalCancer patientsPredictive valueMean survival time analysisMedian progression-free survivalWorse progression-free survivalAssociation of CTCsCTC-negative patientsFirst-line settingRisk of progressionCox regression modelPotential predictive valueML of bloodAdditional time pointsCirculating Tumor CellsLetrozole armOS benefitPFS benefitMultivariable analysisPhase 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 changesA Phase II Study of Pembrolizumab in Combination With Palliative Radiotherapy for Hormone Receptor-positive Metastatic Breast Cancer
Barroso-Sousa R, Krop IE, Trippa L, Tan-Wasielewski Z, Li T, Osmani W, Andrews C, Dillon D, Richardson ET, Pastorello RG, Winer EP, Mittendorf EA, Bellon JR, Schoenfeld JD, Tolaney SM. A Phase II Study of Pembrolizumab in Combination With Palliative Radiotherapy for Hormone Receptor-positive Metastatic Breast Cancer. Clinical Breast Cancer 2020, 20: 238-245. PMID: 32113750, DOI: 10.1016/j.clbc.2020.01.012.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBiomarkers, TumorBreastBreast NeoplasmsCarcinoma, Ductal, BreastChemoradiotherapyDrug Administration ScheduleFemaleHumansInfusions, IntravenousMiddle AgedPalliative CareProgrammed Cell Death 1 ReceptorProgression-Free SurvivalReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneResponse Evaluation Criteria in Solid TumorsConceptsMetastatic breast cancerHormone receptor-positive metastatic breast cancerProgression-free survivalRadiation therapyObjective responseOverall survivalBreast cancerResponse rateMedian progression-free survivalCause adverse eventsGrade 3 eventsMedian prior linesMedian overall survivalObjective response ratePalliative radiation therapyPhase II studyTumor-infiltrating lymphocytesLymph node lesionsOverall response rateEpidermal growth factor receptorEligible patientsExploratory endpointsGrowth factor receptorPalliative radiotherapyPrimary endpoint
2019
Prognostic Impact of the 21-Gene Recurrence Score Assay Among Young Women With Node-Negative and Node-Positive ER-Positive/HER2-Negative Breast Cancer
Poorvu PD, Gelber SI, Rosenberg SM, Ruddy KJ, Tamimi RM, Collins LC, Peppercorn J, Schapira L, Borges VF, Come SE, Warner E, Jakubowski DM, Russell C, Winer EP, Partridge AH. Prognostic Impact of the 21-Gene Recurrence Score Assay Among Young Women With Node-Negative and Node-Positive ER-Positive/HER2-Negative Breast Cancer. Journal Of Clinical Oncology 2019, 38: 725-733. PMID: 31809240, PMCID: PMC7048163, DOI: 10.1200/jco.19.01959.Peer-Reviewed Original ResearchConceptsNode-positive breast cancerDistant recurrence-free survivalRecurrence scoreBreast cancerBreast Cancer StudyN0 diseaseN1 diseaseYoung womenYoung Women's Breast Cancer StudyPositive/HER2-negative breast cancerHER2-negative breast cancerHuman epidermal growth factor receptorEarly distant recurrenceEarly-stage estrogenN0 breast cancerRS risk groupsNode-positive diseaseMinority of patientsRecurrence-free survivalYears of ageEpidermal growth factor receptorGrowth factor receptorDistant recurrenceAxillary nodesEligible womenAtezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial
Schmid P, Rugo HS, Adams S, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Henschel V, Molinero L, Chui SY, Maiya V, Husain A, Winer EP, Loi S, Emens LA, Investigators I. Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncology 2019, 21: 44-59. PMID: 31786121, DOI: 10.1016/s1470-2045(19)30689-8.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorDouble-Blind MethodFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm InvasivenessNeoplasm MetastasisPaclitaxelPrognosisReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSurvival RateTriple Negative Breast NeoplasmsYoung AdultConceptsMetastatic triple-negative breast cancerInterim overall survival analysisTriple-negative breast cancerOverall survival analysisTreatment-related deathsMedian overall survivalNab-paclitaxelPhase 3 trialOverall survivalTreat populationBreast cancerSurvival analysisAtezolizumab groupPlacebo groupInterim analysisTreatment groupsEastern Cooperative Oncology Group performance statusDay 1Interactive voice-web response systemInvestigator-assessed progression-free survivalMeaningful overall survival benefitNew treatment-related deathsProgression-free survival resultsSolid Tumors version 1.1Tumor-infiltrating immune cells