2024
Phase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor–Positive, Early-Stage Breast Cancer
Chavez-MacGregor M, Miao J, Pusztai L, Goetz M, Rastogi P, Ganz P, Mamounas E, Paik S, Bandos H, Razaq W, O'Dea A, Kaklamani V, Silber A, Flaum L, Andreopoulou E, Wendt A, Carney J, Sharma P, Gralow J, Lew D, Barlow W, Hortobagyi G. Phase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor–Positive, Early-Stage Breast Cancer. Journal Of Clinical Oncology 2024, 42: 3012-3021. PMID: 38833643, PMCID: PMC11565489, DOI: 10.1200/jco.23.02344.Peer-Reviewed Original ResearchInvasive disease-free survivalHormone receptor-positiveEndocrine therapyOverall survivalBreast cancerHazard ratioReceptor-positiveHigh riskSubset analysisHormone receptor-positive metastatic breast cancerRisk groupsHormone receptor-positive BCEarly-stage breast cancerStratified log-rank testProgression-free survivalEfficacy of everolimusDisease-free survivalMetastatic breast cancerPlacebo-controlled trialSecondary end pointsLog-rank testHighest grade 3Treatment completion ratesPhase IIIEverolimus armEfficacy of subsequent treatments after disease progression on CDK4/6 inhibitors therapy in patients with hormone receptor-positive metastatic breast cancer: A Kaplan-Meier derived individual-patient data meta-analysis.
Ravani L, Calomeni P, Vilbert M, Madeira T, Wang M, Deng D, Testa L, Clifton K, Wander S, Lustberg M. Efficacy of subsequent treatments after disease progression on CDK4/6 inhibitors therapy in patients with hormone receptor-positive metastatic breast cancer: A Kaplan-Meier derived individual-patient data meta-analysis. Journal Of Clinical Oncology 2024, 42: 1065-1065. DOI: 10.1200/jco.2024.42.16_suppl.1065.Peer-Reviewed Original ResearchProgression-free survivalRandomized Controlled TrialsEndocrine therapyOverall survivalET monotherapyDisease progressionHormone receptor-positive/human epidermal growth factor receptor 2-negativeAssociated with longer progression-free survivalHormone receptor-positive metastatic breast cancerPooled analysisPooling of randomized controlled trialsCohort studyCyclin-dependent kinase 4/6 inhibitorsLonger progression-free survivalProgression-free survival benefitCDK4/6 inhibitor therapyIndividual-patient data meta-analysisMetastatic breast cancerPhase III trialsMeta-analysisStandard-of-careObservational cohort studyPotential clinical benefitIndividual patient dataPatient data
2023
A Phase I Study of Ruxolitinib in Combination with Abemaciclib for Patients with Primary or Post-Polycythemia Vera/Essential Thrombocythemia Myelofibrosis
Bewersdorf J, Derkach A, Masarova L, Pemmaraju N, Stein E, Mauro M, Rampal R, Bose P. A Phase I Study of Ruxolitinib in Combination with Abemaciclib for Patients with Primary or Post-Polycythemia Vera/Essential Thrombocythemia Myelofibrosis. Blood 2023, 142: 6440. DOI: 10.1182/blood-2023-174322.Peer-Reviewed Original ResearchDuration of responseMaximum tolerated doseDose of ruxolitinibCDK4/6 inhibitorsStable doseTolerated doseHormone receptor-positive metastatic breast cancerRisk of progression to acute myeloid leukemiaSymptom scoresPhase I dose-escalation trialProgression to acute myeloid leukemiaTreatment of hormone receptor-positive metastatic breast cancerAbsolute neutrophil count <Cancer CenterCombination of CDK4/6 inhibitorsUS FDAMemorial Sloan Kettering Cancer CenterGrade 1 diarrheaMedian overall survivalPre-study doseDose-limiting toxicityMD Anderson Cancer CenterBone marrow fibrosisNeutrophil count <Platelet count <Comparing the prognostic and predictive utility of serum thymidine kinase 1 and CA 15-3 in patients with hormone receptor positive metastatic breast cancer starting first-line endocrine therapy in SWOG S0226.
Cobain E, Barlow W, Paoletti C, Bergqvist M, Williams A, Ritzen H, Mehta R, Gralow J, Hortobagyi G, Albain K, Pusztai L, Sharma P, Godwin A, Thompson A, Hayes D, Rae J. Comparing the prognostic and predictive utility of serum thymidine kinase 1 and CA 15-3 in patients with hormone receptor positive metastatic breast cancer starting first-line endocrine therapy in SWOG S0226. Journal Of Clinical Oncology 2023, 41: 1076-1076. DOI: 10.1200/jco.2023.41.16_suppl.1076.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast cancerThymidine kinase 1 activityHormone receptor-positive metastatic breast cancerPositive metastatic breast cancerOverall survivalEndocrine therapyCA 15Breast cancerCA15-3Predictors of PFSFirst-line endocrine therapySubsequent progression-free survivalWorse progression-free survivalSerum thymidine kinase 1Systemic endocrine therapyMultivariable Cox modelCox regression analysisWorse overall survivalHypothesis-generating dataCycles of treatmentTamoxifen useSystemic therapySerum levelsMultivariable analysis
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 heterogeneityEvaluating Serum Thymidine Kinase 1 in Hormone Receptor Positive Metastatic Breast Cancer Patients Receiving First Line Endocrine Therapy in the SWOG S0226 Trial
Paoletti C, Barlow WE, Cobain EF, Bergqvist M, Mehta RS, Gralow JR, Hortobagyi GN, Albain KS, Pusztai L, Sharma P, Godwin AK, Thompson AM, Hayes DF, Rae JM. Evaluating Serum Thymidine Kinase 1 in Hormone Receptor Positive Metastatic Breast Cancer Patients Receiving First Line Endocrine Therapy in the SWOG S0226 Trial. Clinical Cancer Research 2021, 27: clincanres.1562.2021. PMID: 34521624, PMCID: PMC8595696, DOI: 10.1158/1078-0432.ccr-21-1562.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClinical Trials as TopicFemaleHumansKaplan-Meier EstimateMiddle AgedPrognosisReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRetrospective StudiesThymidine KinaseTreatment OutcomeConceptsProgression-free survivalMetastatic breast cancerFirst-line endocrine therapyOverall survivalEndocrine therapyHormone receptor-positive metastatic breast cancer patientsHormone receptor-positive metastatic breast cancerPositive metastatic breast cancer patientsSubsequent progression-free survivalMetastatic breast cancer patientsWorse progression-free survivalCombination endocrine therapySerum thymidine kinase 1Trial of anastrozoleThymidine kinase 1 activityBreast cancer patientsLog-rank testLine endocrine therapyDu/LAdjuvant tamoxifenPrognostic effectCox regressionPoor prognosisWorse prognosisKaplan-Meier
2020
The Genomic Landscape of Intrinsic and Acquired Resistance to Cyclin-Dependent Kinase 4/6 Inhibitors in Patients with Hormone Receptor–Positive Metastatic Breast Cancer
Wander SA, Cohen O, Gong X, Johnson GN, Buendia-Buendia JE, Lloyd MR, Kim D, Luo F, Mao P, Helvie K, Kowalski KJ, Nayar U, Waks AG, Parsons SH, Martinez R, Litchfield LM, Ye XS, Yu C, Jansen VM, Stille JR, Smith PS, Oakley GJ, Chu QS, Batist G, Hughes ME, Kremer JD, Garraway LA, Winer EP, Tolaney SM, Lin NU, Buchanan SG, Wagle N. The Genomic Landscape of Intrinsic and Acquired Resistance to Cyclin-Dependent Kinase 4/6 Inhibitors in Patients with Hormone Receptor–Positive Metastatic Breast Cancer. Cancer Discovery 2020, 10: 1174-1193. PMID: 32404308, PMCID: PMC8815415, DOI: 10.1158/2159-8290.cd-19-1390.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsBiopsyBreast NeoplasmsCell Cycle ProteinsCell Line, TumorCheckpoint Kinase 1Drug Resistance, NeoplasmExome SequencingFemaleGenomicsHumansProtein Kinase InhibitorsProto-Oncogene Proteins c-aktProto-Oncogene Proteins p21(ras)Receptors, SteroidRetinoblastoma Binding ProteinsUbiquitin-Protein LigasesConceptsCyclin-dependent kinase 4/6 inhibitorsMetastatic breast cancerBreast cancerResistant tumorsHormone receptor-positive metastatic breast cancerHormone receptor-positive breast cancerReceptor-positive breast cancerEstrogen receptor expressionCandidate resistance mechanismsWhole-exome sequencingPrecision-based approachesCDK4/6i resistanceMechanisms of resistanceReceptor expressionTherapeutic strategiesCDK4/6iTherapeutic opportunitiesPatient samplesTumorsIssue featurePatientsCancerAcquired ResistanceCancer cellsAlterationsA 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
Evaluating the addition of bevacizumab to endocrine therapy as first-line treatment for hormone receptor–positive metastatic breast cancer: a pooled analysis from the LEA (GEICAM/2006-11_GBG51) and CALGB 40503 (Alliance) trials
Martín M, Loibl S, Hyslop T, De la Haba-Rodríguez J, Aktas B, Cirrincione CT, Mehta K, Barry WT, Morales S, Carey LA, Garcia-Saenz JA, Partridge A, Martinez-Jañez N, Hahn O, Winer E, Guerrero-Zotano A, Hudis C, Casas M, Rodriguez-Martin C, Furlanetto J, Carrasco E, Dickler MN, Group G, GBG, Oncology A. Evaluating the addition of bevacizumab to endocrine therapy as first-line treatment for hormone receptor–positive metastatic breast cancer: a pooled analysis from the LEA (GEICAM/2006-11_GBG51) and CALGB 40503 (Alliance) trials. European Journal Of Cancer 2019, 117: 91-98. PMID: 31276981, PMCID: PMC6718694, DOI: 10.1016/j.ejca.2019.06.002.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBone NeoplasmsBreast NeoplasmsEvaluation Studies as TopicFemaleFollow-Up StudiesFulvestrantHumansLetrozoleMiddle AgedNeoplasm Recurrence, LocalPrognosisReceptors, EstrogenReceptors, ProgesteroneSoft Tissue NeoplasmsSurvival RateTamoxifenConceptsProgression-free survivalClinical benefit rateObjective response rateEndocrine therapyMetastatic breast cancerOverall survivalGrade IIIBreast cancerHormone receptor-positive metastatic breast cancerMedian progression-free survivalAddition of BevSignificant additional toxicityStandard endocrine therapyDe novo diseaseAddition of bevacizumabFirst-line treatmentPredictors of efficacyNovo diseaseRecurrent diseaseLiver eventsEndocrine sensitivityBenefit rateAdditional toxicityPatientsResponse rateA phase II study of pembrolizumab in combination with palliative radiotherapy (RT) for hormone receptor-positive (HR+) metastatic breast cancer (MBC).
Barroso-Sousa R, Krop I, Trippa L, Tan-Wasielewski Z, Li T, Osmani W, Andrews C, Dillon D, Richardson E, Winer E, Mittendorf E, Schoenfeld J, Tolaney S. A phase II study of pembrolizumab in combination with palliative radiotherapy (RT) for hormone receptor-positive (HR+) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2019, 37: 1047-1047. DOI: 10.1200/jco.2019.37.15_suppl.1047.Peer-Reviewed Original ResearchMetastatic breast cancerNeutrophil/lymphocyte ratioObjective response rateProgression-free survivalTumor-infiltrating lymphocytesPalliative radiotherapyAdverse eventsHormone receptor-positive metastatic breast cancerPhase II single-arm studyMedian progression-free survivalCause adverse eventsDistant tumor responsesECOG PS 1Prior cytotoxic therapyImmune checkpoint inhibitorsPD-L1 expressionPD-L1 statusPhase II studySingle-arm studyTotal RT doseUnexpected adverse eventsECOG PSEligible ptsRECIST v1.1Measurable lesions
2018
Whole exome sequencing (WES) in hormone-receptor positive (HR+) metastatic breast cancer (MBC) to identify mediators of resistance to cyclin-dependent kinase 4/6 inhibitors (CDK4/6i).
Wander S, Cohen O, Johnson G, Kim D, Luo F, Mao P, Nayar U, Helvie K, Marini L, Freeman S, Getz G, Garraway L, Winer E, Lin N, Wagle N. Whole exome sequencing (WES) in hormone-receptor positive (HR+) metastatic breast cancer (MBC) to identify mediators of resistance to cyclin-dependent kinase 4/6 inhibitors (CDK4/6i). Journal Of Clinical Oncology 2018, 36: 12016-12016. DOI: 10.1200/jco.2018.36.15_suppl.12016.Peer-Reviewed Original ResearchMetastatic breast cancerWhole-exome sequencingHormone receptor-positive metastatic breast cancerCyclin-dependent kinase 4/6 inhibitorsPositive metastatic breast cancerMediators of resistanceBreast cancerExome sequencingCancer
2016
Randomized phase II trial of fulvestrant alone or in combination with bortezomib in hormone receptor-positive metastatic breast cancer resistant to aromatase inhibitors: a New York Cancer Consortium trial
Adelson K, Ramaswamy B, Sparano JA, Christos PJ, Wright JJ, Raptis G, Han G, Villalona-Calero M, Ma CX, Hershman D, Baar J, Klein P, Cigler T, Budd GT, Novik Y, Tan AR, Tannenbaum S, Goel A, Levine E, Shapiro CL, Andreopoulou E, Naughton M, Kalinsky K, Waxman S, Germain D. Randomized phase II trial of fulvestrant alone or in combination with bortezomib in hormone receptor-positive metastatic breast cancer resistant to aromatase inhibitors: a New York Cancer Consortium trial. Npj Breast Cancer 2016, 2: 16037. PMID: 28721390, PMCID: PMC5515340, DOI: 10.1038/npjbcancer.2016.37.Peer-Reviewed Original ResearchProgression-free survivalSelective estrogen receptor downregulatorsMetastatic breast cancerER-positive metastatic breast cancerMedian progression-free survivalArm ABreast cancerArm BHormone receptor-positive metastatic breast cancerRandomized phase II trialPhase II trialEstrogen receptor downregulatorsProteasome inhibitor bortezomibPFS ratesII trialConsortium TrialHazard ratioPostmenopausal womenPreclinical modelsInhibitor bortezomibBortezomibCancerProteasome inhibitorsAdditional evaluationTrialsPhase III Trial Evaluating Letrozole As First-Line Endocrine Therapy With or Without Bevacizumab for the Treatment of Postmenopausal Women With Hormone Receptor–Positive Advanced-Stage Breast Cancer: CALGB 40503 (Alliance)
Dickler MN, Barry WT, Cirrincione CT, Ellis MJ, Moynahan ME, Innocenti F, Hurria A, Rugo HS, Lake DE, Hahn O, Schneider BP, Tripathy D, Carey LA, Winer EP, Hudis CA. Phase III Trial Evaluating Letrozole As First-Line Endocrine Therapy With or Without Bevacizumab for the Treatment of Postmenopausal Women With Hormone Receptor–Positive Advanced-Stage Breast Cancer: CALGB 40503 (Alliance). Journal Of Clinical Oncology 2016, 34: 2602-2609. PMID: 27138575, PMCID: PMC5012690, DOI: 10.1200/jco.2015.66.1595.Peer-Reviewed Original ResearchConceptsProlong progression-free survivalHormone receptor-positive metastatic breast cancerMetastatic breast cancerAddition of bevacizumabMedian PFSMeasurable diseaseOverall survivalGrade 3Breast cancerAnti-vascular endothelial growth factor therapyBevacizumab prolongs progression-free survivalDe novo metastatic breast cancerEndothelial growth factor therapyNovo metastatic breast cancerRole of bevacizumabTrial of letrozoleMedian overall survivalTreatment-related toxicityDisease-free intervalPhase III trialsProgression-free survivalGrowth factor therapyStage breast cancerHazard of progressionLine endocrine therapy
2014
Endocrine Therapy With or Without Inhibition of Epidermal Growth Factor Receptor and Human Epidermal Growth Factor Receptor 2: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant With or Without Lapatinib for Postmenopausal Women With Hormone Receptor–Positive Advanced Breast Cancer—CALGB 40302 (Alliance)
Burstein HJ, Cirrincione CT, Barry WT, Chew HK, Tolaney SM, Lake DE, Ma C, Blackwell KL, Winer EP, Hudis CA. Endocrine Therapy With or Without Inhibition of Epidermal Growth Factor Receptor and Human Epidermal Growth Factor Receptor 2: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant With or Without Lapatinib for Postmenopausal Women With Hormone Receptor–Positive Advanced Breast Cancer—CALGB 40302 (Alliance). Journal Of Clinical Oncology 2014, 32: 3959-3966. PMID: 25348000, PMCID: PMC4251959, DOI: 10.1200/jco.2014.56.7941.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalDouble-Blind MethodEstradiolFemaleFulvestrantHormonesHumansLapatinibMiddle AgedPostmenopauseProportional Hazards ModelsQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneTreatment OutcomeConceptsMedian progression-free survivalProgression-free survivalOverall survivalBreast cancerHormone receptor-positive advanced breast cancerHormone receptor-positive metastatic breast cancerAdvanced ER-positive breast cancerHuman epidermal growth factor receptor 2 (HER2) statusLonger median progression-free survivalEpidermal growth factor receptor 2 statusProgesterone receptor-positive tumorsHuman epidermal growth factor receptor 2ER-positive breast cancerEpidermal growth factor receptor 2Advanced breast cancerPhase III trialsGrowth factor receptor 2Metastatic breast cancerReceptor-positive tumorsHER2-positive tumorsAromatase inhibitor treatmentFactor receptor 2Epidermal growth factor receptorDifferential treatment effectsGrowth factor receptor
2011
Gefitinib or Placebo in Combination with Tamoxifen in Patients with Hormone Receptor–Positive Metastatic Breast Cancer: A Randomized Phase II Study
Osborne CK, Neven P, Dirix LY, Mackey JR, Robert J, Underhill C, Schiff R, Gutierrez C, Migliaccio I, Anagnostou VK, Rimm DL, Magill P, Sellers M. Gefitinib or Placebo in Combination with Tamoxifen in Patients with Hormone Receptor–Positive Metastatic Breast Cancer: A Randomized Phase II Study. Clinical Cancer Research 2011, 17: 1147-1159. PMID: 21220480, PMCID: PMC3074404, DOI: 10.1158/1078-0432.ccr-10-1869.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsDrug-Related Side Effects and Adverse ReactionsErbB ReceptorsFemaleGefitinibHumansMiddle AgedNeoplasms, Hormone-DependentPlacebosQuinazolinesReceptor, ErbB-2Receptors, EstrogenSignal TransductionTamoxifenTreatment OutcomeConceptsAdjuvant aromatase inhibitorsMetastatic breast cancerBreast cancerHormone receptor-positive metastatic breast cancerPositive metastatic breast cancerRandomized phase II studyRandomized phase II trialClinical benefit ratePhase II studyPhase II trialProgression-free survivalStratum 1Epidermal growth factor receptor inhibitor gefitinibFurther investigationAdjuvant tamoxifenImproved PFSPFS HRAI therapyII studyII trialMetastatic diseaseAppropriate patientsPredictive biomarkersPrimary tumorTamoxifen resistance
This site is protected by hCaptcha and its Privacy Policy and Terms of Service apply