2022
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.
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 sequencingCirculating Tumor DNA and Late Recurrence in High-Risk Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer
Lipsyc-Sharf M, de Bruin EC, Santos K, McEwen R, Stetson D, Patel A, Kirkner GJ, Hughes ME, Tolaney SM, Partridge AH, Krop IE, Knape C, Feger U, Marsico G, Howarth K, Winer EP, Lin NU, Parsons HA. Circulating Tumor DNA and Late Recurrence in High-Risk Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer. Journal Of Clinical Oncology 2022, 40: 2408-2419. PMID: 35658506, PMCID: PMC9467679, DOI: 10.1200/jco.22.00908.Peer-Reviewed Original ResearchConceptsMinimal residual diseaseWhole-exome sequencingClinical recurrenceMetastatic recurrenceBreast cancerEarly-stage hormone receptor-positive breast cancerHormone receptor-positive breast cancerTumor tissueHigh-risk stage IIReceptor-positive breast cancerTumor DNAHuman epidermal growth factor receptorDistant metastatic recurrenceHormone receptor positiveMRD-positive patientsPlasma samplesTime of consentPrimary tumor tissuesSufficient tumor tissueEpidermal growth factor receptorAdjuvant settingGrowth factor receptorLocal recurrenceClinical outcomesDistant metastasisCirculating tumor DNA (ctDNA) and late recurrence in high-risk, hormone receptor–positive, HER2-negative breast cancer (CHiRP).
Lipsyc-Sharf M, De Bruin E, Santos K, McEwen R, Stetson D, Patel A, Kirkner G, Hughes M, Tolaney S, Krop I, Knape C, Feger U, Marsico G, Howarth K, Winer E, Lin N, Parsons H. Circulating tumor DNA (ctDNA) and late recurrence in high-risk, hormone receptor–positive, HER2-negative breast cancer (CHiRP). Journal Of Clinical Oncology 2022, 40: 103-103. DOI: 10.1200/jco.2022.40.16_suppl.103.Peer-Reviewed Original ResearchMinimal residual diseaseDistant metastatic recurrenceAdjuvant endocrine therapyWhole-exome sequencingEndocrine therapyMetastatic recurrenceClinical outcomesBreast cancerHormone receptor-positive breast cancerPlasma samplesTumor tissueHER2-negative breast cancerReceptor-positive breast cancerTumor DNACtDNA detectionRegular surveillance imagingStage 3 diseaseCurative intent chemotherapyTime of consentPrimary tumor tissuesCurrent practice standardsSufficient tumor tissueLiquid biopsy testsAdjuvant settingCtDNA dynamicsSystemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Guideline Update
Giordano SH, Franzoi MAB, Temin S, Anders CK, Chandarlapaty S, Crews JR, Kirshner JJ, Krop IE, Lin NU, Morikawa A, Patt DA, Perlmutter J, Ramakrishna N, Davidson NE. Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Guideline Update. Journal Of Clinical Oncology 2022, 40: 2612-2635. PMID: 35640077, DOI: 10.1200/jco.22.00519.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerBreast cancerSystemic therapyTrastuzumab deruxtecanGuideline recommendationsAdvanced human epidermal growth factor receptorHER2-positive advanced breast cancerProgesterone receptor-positive breast cancerClinical congestive heart failureEvidence-based guideline recommendationsStandard first-line therapyPositive advanced breast cancerLeft ventricular ejection fractionReceptor-positive breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorASCO Guideline UpdateThird-line settingSecond-line treatmentFirst-line therapyFirst-line treatmentTime of progressionAbsence of progressionCongestive heart failure
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 heterogeneity
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 events
2019
The Immune Microenvironment in Hormone Receptor–Positive Breast Cancer Before and After Preoperative Chemotherapy
Waks AG, Stover DG, Guerriero JL, Dillon D, Barry WT, Gjini E, Hartl C, Lo W, Savoie J, Brock J, Wesolowski R, Li Z, Damicis A, Philips AV, Wu Y, Yang F, Sullivan A, Danaher P, Brauer HA, Osmani W, Lipschitz M, Hoadley KA, Goldberg M, Perou CM, Rodig S, Winer EP, Krop IE, Mittendorf EA, Tolaney SM. The Immune Microenvironment in Hormone Receptor–Positive Breast Cancer Before and After Preoperative Chemotherapy. Clinical Cancer Research 2019, 25: 4644-4655. PMID: 31061067, PMCID: PMC6677598, DOI: 10.1158/1078-0432.ccr-19-0173.Peer-Reviewed Original ResearchConceptsStromal tumor-infiltrating lymphocytesImmune microenvironmentNeoadjuvant chemotherapyPD-L1Breast cancerHormone receptor-positive breast cancerBreast tumorsHormone receptor-positive/HER2-negative breast cancerHER2-negative breast cancerDistant metastasis-free survivalReceptor-positive breast cancerImmunotherapy-based approachesPAM50 intrinsic subtypesCheckpoint inhibitor therapyPD-L1 stainingTumor-infiltrating lymphocytesMetastasis-free survivalMacrophage-targeted therapiesRole of macrophagesPreoperative chemotherapyStandard chemotherapyInhibitor therapyResidual diseaseMyeloid signaturePoor response
2018
Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Clinical Practice Guideline Update
Giordano SH, Temin S, Chandarlapaty S, Crews JR, Esteva FJ, Kirshner JJ, Krop IE, Levinson J, Lin NU, Modi S, Patt DA, Perlmutter J, Ramakrishna N, Winer EP, Davidson NE. Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Clinical Practice Guideline Update. Journal Of Clinical Oncology 2018, 36: jco.2018.79.269. PMID: 29939838, DOI: 10.1200/jco.2018.79.2697.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerBreast cancerSystemic therapyTrastuzumab emtansineEstrogen receptor-positive/progesterone receptor-positive breast cancerAdvanced human epidermal growth factor receptorASCO Clinical Practice Guideline UpdateHER2-positive advanced breast cancerProgesterone receptor-positive breast cancerClinical congestive heart failureClinical Practice Guideline UpdateEvidence-based guideline recommendationsStandard first-line therapyPositive advanced breast cancerLeft ventricular ejection fractionReceptor-positive breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorThird-line settingSecond-line treatmentFirst-line therapyFirst-line treatmentProgression-free survivalTime of progression
2014
Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline
Giordano SH, Temin S, Kirshner JJ, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Gonzalez-Angulo AM, Krop I, Levinson J, Lin NU, Modi S, Patt DA, Perez EA, Perlmutter J, Ramakrishna N, Winer EP. Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline. Journal Of Clinical Oncology 2014, 32: 2078-2099. PMID: 24799465, PMCID: PMC6076031, DOI: 10.1200/jco.2013.54.0948.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAnastrozoleAntibodies, Monoclonal, HumanizedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials as TopicComorbidityDocetaxelDrug Administration ScheduleEvidence-Based MedicineFemaleHealth Status DisparitiesHealthcare DisparitiesHumansLapatinibLetrozoleMaytansineMolecular Targeted TherapyNitrilesQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSocieties, MedicalTaxoidsTrastuzumabTreatment OutcomeTriazolesUnited StatesConceptsAdvanced breast cancerHuman epidermal growth factor receptorSecond-line treatmentProgression-free survivalFirst-line treatmentBreast cancerPFS benefitT-DM1Epidermal growth factor receptorEndocrine therapyGrowth factor receptorSystemic therapyEstrogen receptor-positive/progesterone receptor-positive breast cancerAdvanced human epidermal growth factor receptorHER2-positive advanced breast cancerProgesterone receptor-positive breast cancerClinical Oncology Clinical Practice GuidelineClinical congestive heart failureStandard first-line therapyPositive advanced breast cancerLeft ventricular ejection fractionOncology Clinical Practice GuidelineReceptor-positive breast cancerThird-line settingFirst-line therapyA phase II study of preoperative capecitabine in women with operable hormone receptor positive breast cancer
Tolaney SM, Jeong J, Guo H, Brock J, Morganstern D, Come SE, Golshan M, Bellon J, Winer EP, Krop IE. A phase II study of preoperative capecitabine in women with operable hormone receptor positive breast cancer. Cancer Medicine 2014, 3: 293-299. PMID: 24464780, PMCID: PMC3987079, DOI: 10.1002/cam4.164.Peer-Reviewed Original ResearchConceptsHormone receptor-positive breast cancerReceptor-positive breast cancerPathological complete responsePositive breast cancerBreast cancerPreoperative capecitabineClinical responseHER2-negative operable breast cancerDihydropyrimidine dehydrogenaseOnly grade 3 toxicityOverall clinical response rateThymidine phosphorylaseGrade 3 responsePartial clinical responsePathological response assessmentsPreoperative chemotherapy regimensClinical response rateComplete clinical responseGrade 3 toxicityOperable breast cancerPhase II studyPalmar-plantar erythrodysesthesiaMetastatic breast cancerTime of surgeryMiller-Payne
2008
Short Preoperative Treatment With Erlotinib Inhibits Tumor Cell Proliferation in Hormone Receptor–Positive Breast Cancers
Guix M, de Matos Granja N, Meszoely I, Adkins TB, Wieman BM, Frierson KE, Sanchez V, Sanders ME, Grau AM, Mayer IA, Pestano G, Shyr Y, Muthuswamy S, Calvo B, Krontiras H, Krop IE, Kelley MC, Arteaga CL. Short Preoperative Treatment With Erlotinib Inhibits Tumor Cell Proliferation in Hormone Receptor–Positive Breast Cancers. Journal Of Clinical Oncology 2008, 26: 897-906. PMID: 18180460, DOI: 10.1200/jco.2007.13.5939.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAnimalsAntineoplastic AgentsBiomarkers, TumorBreast NeoplasmsCell ProliferationChemotherapy, AdjuvantErbB ReceptorsErlotinib HydrochlorideFemaleHumansImmunohistochemistryIn Situ Nick-End LabelingKi-67 AntigenMiceMice, NudeMiddle AgedNeoadjuvant TherapyNeoplasm StagingNeoplasms, Hormone-DependentProtein Kinase InhibitorsProtein-Tyrosine KinasesQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSignal TransductionTandem Mass SpectrometryTreatment OutcomeXenograft Model Antitumor AssaysConceptsTumor cell proliferationBreast cancerPreoperative treatmentCell proliferationHormone receptor-positive breast cancerP-S6P-AktEpidermal growth factor receptor (EGFR) tyrosine kinase inhibitor erlotinibHormone receptor-positive cancersReceptor-positive breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2ER-positive breast cancerP-EGFRTyrosine kinase inhibitor erlotinibTriple-negative breast cancerP-MAPKImmediate preoperative periodUntreated breast cancerGrowth factor receptor 2Day of surgeryInvasive breast cancerReceptor-positive cancersTriple-negative cancersKinase inhibitor erlotinib