2024
Entinostat, nivolumab and ipilimumab for women with advanced HER2-negative breast cancer: a phase Ib trial
Roussos Torres E, Ho W, Danilova L, Tandurella J, Leatherman J, Rafie C, Wang C, Brufsky A, LoRusso P, Chung V, Yuan Y, Downs M, O’Connor A, Shin S, Hernandez A, Engle E, Piekarz R, Streicher H, Talebi Z, Rudek M, Zhu Q, Anders R, Cimino-Mathews A, Fertig E, Jaffee E, Stearns V, Connolly R. Entinostat, nivolumab and ipilimumab for women with advanced HER2-negative breast cancer: a phase Ib trial. Nature Cancer 2024, 5: 866-879. PMID: 38355777, PMCID: PMC11552660, DOI: 10.1038/s43018-024-00729-w.Peer-Reviewed Original ResearchHormone receptor-positive breast cancerReceptor-positive breast cancerTriple-negative breast cancerClinical benefit rateProgression-free survivalBreast cancerBenefit rateAdvanced HER2-negative breast cancerAdvanced triple-negative breast cancerHER2-negative breast cancerResponse rateNivolumab + ipilimumabPD-L1 statusDose-limiting toxicityPhase Ib trialTumor mutational burdenPhase II trialDose escalationExpansion cohortPD-L1II trialMutational burdenPrimary endpointSecondary endpointsMyeloid cells
2023
Phase Ib study of HSP90 inhibitor, onalespib (AT13387), in combination with paclitaxel in patients with advanced triple-negative breast cancer
Williams N, Quiroga D, Johnson C, Brufsky A, Chambers M, Bhattacharya S, Patterson M, Sardesai S, Stover D, Lustberg M, Noonan A, Cherian M, Bystry D, Hill K, Chen M, Phelps M, Grever M, Stephens J, Ramaswamy B, Carson W, Wesolowski R. Phase Ib study of HSP90 inhibitor, onalespib (AT13387), in combination with paclitaxel in patients with advanced triple-negative breast cancer. Therapeutic Advances In Medical Oncology 2023, 15: 17588359231217976. PMID: 38152697, PMCID: PMC10752118, DOI: 10.1177/17588359231217976.Peer-Reviewed Original ResearchAdvanced triple-negative breast cancerTriple-negative breast cancerProgression-free survivalDuration of responseOverall response ratePrior taxane therapyAdverse eventsTaxane therapyCombination therapyBreast cancerMedian DORMedian progression-free survivalNon-hematologic adverse eventsPhase Ib studyPhase Ib trialPhase II doseAcceptable toxicity profileDose-limiting toxicityDrug interaction profileIb trialIntravenous paclitaxelPaclitaxel efficacyExpansion cohortCombination regimenMetastatic disease
2021
Ultrasound augments on-demand breast tumor radiosensitization and apoptosis through a tri-responsive combinatorial delivery theranostic platform
Bhardwaj P, Goda JS, Pai V, Chaudhari P, Mohanty B, Pai T, Vishwakarma K, Thorat R, Wadasadawala T, Banerjee R. Ultrasound augments on-demand breast tumor radiosensitization and apoptosis through a tri-responsive combinatorial delivery theranostic platform. Nanoscale 2021, 13: 17077-17092. PMID: 34622906, DOI: 10.1039/d1nr04211d.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerBreast cancerAdvanced triple-negative breast cancerPathological response rateCombination of paclitaxelTumor microvessel densityNOD-SCID micePET-CT imagingDose-dependent systemic toxicityCell proliferation markersChemoradiotherapeutic efficacyClinical radiosensitizerNeoadjuvant chemotherapyNeoadjuvant chemoradiotherapyTNBC xenograftsAggressive tumorsCombinatorial regimenConcomitant useMouse survivalMicrovessel densityPathological responseClinical utilitySpatio-temporal deliveryResponse rateSolid tumorsPD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel–Treated Advanced Triple-Negative Breast Cancer
Rugo HS, Loi S, Adams S, Schmid P, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Winer EP, Kockx MM, Peeters D, Chui SY, Lin JC, Nguyen-Duc A, Viale G, Molinero L, Emens LA. PD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel–Treated Advanced Triple-Negative Breast Cancer. Journal Of The National Cancer Institute 2021, 113: 1733-1743. PMID: 34097070, PMCID: PMC8634452, DOI: 10.1093/jnci/djab108.Peer-Reviewed Original ResearchConceptsNab-paclitaxelPD-L1Metastatic triple-negative breast cancer patientsAdvanced triple-negative breast cancerAnalytical concordanceTriple-negative breast cancer patientsTriple-negative breast cancerDouble-positive casesCombined positive scorePD-L1 statusPD-L1 assaysBreast cancer patientsSingle positive caseMore patientsSP263 assaysClinical outcomesClinical benefitCancer patientsClinical activityBreast cancerSP142SP263PatientsPhase IIIPositive scoreAtezolizumab and nab-Paclitaxel in Advanced Triple-Negative Breast Cancer: Biomarker Evaluation of the IMpassion130 Study
Emens LA, Molinero L, Loi S, Rugo HS, Schneeweiss A, Diéras V, Iwata H, Barrios CH, Nechaeva M, Nguyen-Duc A, Chui SY, Husain A, Winer EP, Adams S, Schmid P. Atezolizumab and nab-Paclitaxel in Advanced Triple-Negative Breast Cancer: Biomarker Evaluation of the IMpassion130 Study. Journal Of The National Cancer Institute 2021, 113: 1005-1016. PMID: 33523233, PMCID: PMC8328980, DOI: 10.1093/jnci/djab004.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerMetastatic triple-negative breast cancerProgression-free survivalPD-L1Tumor immune microenvironmentBreast cancerIntratumoral CD8Nab-paclitaxelClinical benefitImmune microenvironmentImmune cellsBRCA1/2 mutationsAdvanced triple-negative breast cancerStromal tumor-infiltrating lymphocytesNab-paclitaxel 100Immune checkpoint inhibitorsOverall survival benefitTumor-infiltrating lymphocytesMetastatic tumor tissueBRCA1/2 mutation statusCheckpoint inhibitorsOverall survivalSurvival benefitImmune biomarkersClinical activity
2020
Prospective multi-institutional evaluation of pathologist assessment of PD-L1 assays for patient selection in triple negative breast cancer
Reisenbichler ES, Han G, Bellizzi A, Bossuyt V, Brock J, Cole K, Fadare O, Hameed O, Hanley K, Harrison BT, Kuba MG, Ly A, Miller D, Podoll M, Roden AC, Singh K, Sanders MA, Wei S, Wen H, Pelekanou V, Yaghoobi V, Ahmed F, Pusztai L, Rimm DL. Prospective multi-institutional evaluation of pathologist assessment of PD-L1 assays for patient selection in triple negative breast cancer. Modern Pathology 2020, 33: 1746-1752. PMID: 32300181, PMCID: PMC8366569, DOI: 10.1038/s41379-020-0544-x.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerNegative breast cancerOverall percent agreementPD-L1Intraclass correlation coefficientBreast cancerAdvanced triple-negative breast cancerPD-L1 positive casesImmune cell stainingMultiple pathologistsPD-L1 scoringMulti-institutional evaluationLung cancer studiesAtezolizumab therapySP142 assaySP263 assaysPatient selectionSP263SP142US FoodDrug AdministrationPathologist's assessmentPositive casesReal-world settingPercent agreementThe path to a better biomarker: application of a risk management framework for the implementation of PD‐L1 and TILs as immuno‐oncology biomarkers in breast cancer clinical trials and daily practice
Gonzalez‐Ericsson P, Stovgaard ES, Sua LF, Reisenbichler E, Kos Z, Carter JM, Michiels S, Le Quesne J, Nielsen TO, Lænkholm A, Fox SB, Adam J, Bartlett JM, Rimm DL, Quinn C, Peeters D, Dieci MV, Vincent‐Salomon A, Cree I, Hida AI, Balko JM, Haynes HR, Frahm I, Acosta‐Haab G, Balancin M, Bellolio E, Yang W, Kirtani P, Sugie T, Ehinger A, Castaneda CA, Kok M, McArthur H, Siziopikou K, Badve S, Fineberg S, Gown A, Viale G, Schnitt SJ, Pruneri G, Penault‐Llorca F, Hewitt S, Thompson EA, Allison KH, Symmans WF, Bellizzi AM, Brogi E, Moore DA, Larsimont D, Dillon DA, Lazar A, Lien H, Goetz MP, Broeckx G, Bairi K, Harbeck N, Cimino‐Mathews A, Sotiriou C, Adams S, Liu S, Loibl S, Chen I, Lakhani SR, Juco JW, Denkert C, Blackley EF, Demaria S, Leon‐Ferre R, Gluz O, Zardavas D, Emancipator K, Ely S, Loi S, Salgado R, Sanders M, Group I. The path to a better biomarker: application of a risk management framework for the implementation of PD‐L1 and TILs as immuno‐oncology biomarkers in breast cancer clinical trials and daily practice. The Journal Of Pathology 2020, 250: 667-684. PMID: 32129476, DOI: 10.1002/path.5406.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerTumor-infiltrating lymphocytesPD-L1Breast cancerPatient selectionInter-reader reproducibilityEarly-stage triple-negative breast cancerPD-1/PD-L1 inhibitorsStage triple-negative breast cancerAdvanced triple-negative breast cancerPD-1/PD-L1High tumor-infiltrating lymphocytesImmune checkpoint inhibitor therapyAddition of atezolizumabPD-L1 assessmentSuboptimal patient selectionCheckpoint inhibitor therapyOptimal patient selectionPD-L1 expressionPD-L1 inhibitorsDaily practiceStandard of careImmuno-therapeutic approachesNegative breast cancerEosin-stained slides
2019
37O Subgroup analysis of IMpassion130: Atezolizumab + nab-paclitaxel (nab-P) in patients (pts) with advanced triple-negative breast cancer (TNBC) in Asian countries
Iwata H, Im S, Sohn J, Jung K, Im Y, Lee K, Inoue K, Tamura K, Wong A, Emens L, Barrios C, Adams S, Schneeweiss A, Diéras V, Winer E, Chui S, Henschel V, Rugo H, Loi S, Schmid P. 37O Subgroup analysis of IMpassion130: Atezolizumab + nab-paclitaxel (nab-P) in patients (pts) with advanced triple-negative breast cancer (TNBC) in Asian countries. Annals Of Oncology 2019, 30: ix13-ix14. DOI: 10.1093/annonc/mdz418.Peer-Reviewed Original ResearchTriple-negative breast cancerAdvanced triple-negative breast cancerGenentech/RochePD-L1 expressionPD-L1Bristol-Myers SquibbF. Hoffmann-La RocheDaiichi SankyoBoehringer IngelheimHoffmann-La RocheSeattle GeneticsRoche/GenentechTumor-infiltrating immune cellsBreast Cancer Research FoundationECOG PS 0Key secondary endpointPD-L1 positivityNew safety signalsPD-L1 testingCo-primary endpointsEli LillyCancer Research FoundationNational Cancer InstituteMedical writing assistanceMedical Research Council
2018
Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer
Schmid P, Adams S, Rugo HS, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Hegg R, Im SA, Shaw Wright G, Henschel V, Molinero L, Chui SY, Funke R, Husain A, Winer EP, Loi S, Emens LA. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. New England Journal Of Medicine 2018, 379: 2108-2121. PMID: 30345906, DOI: 10.1056/nejmoa1809615.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerProgression-free survivalMedian progression-free survivalMedian overall survivalNab-paclitaxelBreast cancerOverall survivalPD-L1Adverse eventsTreat analysisPositive tumorsAdvanced triple-negative breast cancerDeath ligand 1 (PD-L1) expressionAdjuvant taxane therapyPrimary end pointLigand 1 expressionPhase 3 trialNew adverse effectsTreat populationTaxane therapyLiver metastasesAggressive diseasePoor outcomeSafety profileEnzalutamide for the Treatment of Androgen Receptor–Expressing Triple-Negative Breast Cancer
Traina TA, Miller K, Yardley DA, Eakle J, Schwartzberg LS, O'Shaughnessy J, Gradishar W, Schmid P, Winer E, Kelly C, Nanda R, Gucalp A, Awada A, Garcia-Estevez L, Trudeau ME, Steinberg J, Uppal H, Tudor IC, Peterson A, Cortes J. Enzalutamide for the Treatment of Androgen Receptor–Expressing Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2018, 36: jco.2016.71.349. PMID: 29373071, PMCID: PMC5858523, DOI: 10.1200/jco.2016.71.3495.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerClinical benefit rateAR-positive triple-negative breast cancerProgression-free survivalAndrogen receptorNuclear androgen receptorEvaluable subgroupITT populationBreast cancerEnd pointAdverse eventsAdvanced triple-negative breast cancerMedian progression-free survivalTreatment-related grade 3Safety of enzalutamideHigher adverse eventsMedian overall survivalPhase II studyPrimary end pointSecondary end pointsSubset of patientsII studyOverall survivalPostbaseline assessmentSafety profile
2016
Pembrolizumab in Patients With Advanced Triple-Negative Breast Cancer: Phase Ib KEYNOTE-012 Study
Nanda R, Chow LQ, Dees EC, Berger R, Gupta S, Geva R, Pusztai L, Pathiraja K, Aktan G, Cheng JD, Karantza V, Buisseret L. Pembrolizumab in Patients With Advanced Triple-Negative Breast Cancer: Phase Ib KEYNOTE-012 Study. Journal Of Clinical Oncology 2016, 34: 2460-2467. PMID: 27138582, PMCID: PMC6816000, DOI: 10.1200/jco.2015.64.8931.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerAdvanced triple-negative breast cancerPD-L1Antitumor activityBreast cancerCell death protein 1 (PD-1) inhibitorsSingle-agent phase II studyAdvanced PD-L1Single-agent pembrolizumabStudy of immunotherapyTreatment-related deathsImmune checkpoint inhibitionPhase Ib studyPhase Ib trialPhase II studyAcceptable safety profilePD-L1 expressionOverall response rateProtein 1 inhibitorCommon toxicitiesIb trialKEYNOTE-012TNBC cohortII studyMedian duration
2015
Phase I dose-finding study of the gamma secretase inhibitor PF-03084014 (PF-4014) in combination with docetaxel in patients (pts) with advanced triple-negative breast cancer (TNBC).
Curigliano G, Aftimos P, Dees E, LoRusso P, Pegram M, Awada A, Huang B, Cesari R, Jiang Y, Shaik M, Kern K, Locatelli M. Phase I dose-finding study of the gamma secretase inhibitor PF-03084014 (PF-4014) in combination with docetaxel in patients (pts) with advanced triple-negative breast cancer (TNBC). Journal Of Clinical Oncology 2015, 33: 1068-1068. DOI: 10.1200/jco.2015.33.15_suppl.1068.Peer-Reviewed Original ResearchTriple-negative breast cancerAdvanced triple-negative breast cancerPhase I dose-finding studyDose-finding studyPF-03084014Breast cancerPatientsDocetaxelCancer
2014
TBCRC 018: phase II study of iniparib in combination with irinotecan to treat progressive triple negative breast cancer brain metastases
Anders C, Deal AM, Abramson V, Liu MC, Storniolo AM, Carpenter JT, Puhalla S, Nanda R, Melhem-Bertrandt A, Lin NU, Kelly Marcom P, Van Poznak C, Stearns V, Melisko M, Smith JK, Karginova O, Parker J, Berg J, Winer EP, Peterman A, Prat A, Perou CM, Wolff AC, Carey LA. TBCRC 018: phase II study of iniparib in combination with irinotecan to treat progressive triple negative breast cancer brain metastases. Breast Cancer Research And Treatment 2014, 146: 557-566. PMID: 25001612, PMCID: PMC4112043, DOI: 10.1007/s10549-014-3039-y.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBenzamidesBrain NeoplasmsCamptothecinDrug-Related Side Effects and Adverse ReactionsFemaleHumansIrinotecanMiddle AgedNeoplasm StagingReceptor, ErbB-2Survival AnalysisTriple Negative Breast NeoplasmsVascular Endothelial Growth Factor AConceptsTriple-negative breast cancerClinical benefit rateBrain metastasesOverall survivalResponse rateTriple negative breast cancer brain metastasisCommon grade 3/4 adverse eventsAdvanced triple-negative breast cancerGrade 3/4 adverse eventsIntracranial clinical benefit rateBreast cancer brain metastasesGrade 3/4 diarrheaIntracranial response ratesProgressive brain metastasesMedian overall survivalPhase II studyPrimary end pointCancer brain metastasesHalf of patientsHealth-related qualityBRCA germline mutationsTreatment-refractory diseaseBlood-brain barrierNegative breast cancerGermline BRCA1/2 status
2010
Poly(ADP-Ribose) Polymerase Inhibition: “Targeted” Therapy for Triple-Negative Breast Cancer
Anders CK, Winer EP, Ford JM, Dent R, Silver DP, Sledge GW, Carey LA. Poly(ADP-Ribose) Polymerase Inhibition: “Targeted” Therapy for Triple-Negative Breast Cancer. Clinical Cancer Research 2010, 16: 4702-4710. PMID: 20858840, PMCID: PMC2948607, DOI: 10.1158/1078-0432.ccr-10-0939.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerBreast cancerPARP inhibitorsClinical trialsAdvanced triple-negative breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2PARP inhibitionAdvanced breast cancerGrowth factor receptor 2Clinico-pathologic featuresPositive breast cancerNovel therapeutic classFactor receptor 2Mechanism of actionPreclinical rationalePreclinical modelsNovel agentsReceptor 2CancerTherapeutic classesPolymerase inhibitorsPolymerase inhibitionDNA repairInhibitors
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