2021
A Phase 1 Dose-Escalation Trial of Radiation Therapy and Concurrent Cisplatin for Stage II and III Triple-Negative Breast Cancer
Bellon JR, Chen YH, Rees R, Taghian AG, Wong JS, Punglia RS, Shiloh RY, Warren LEG, Krishnan MS, Phillips J, Pretz J, Jimenez R, Macausland S, Pashtan I, Andrews C, Isakoff SJ, Winer EP, Tolaney SM. A Phase 1 Dose-Escalation Trial of Radiation Therapy and Concurrent Cisplatin for Stage II and III Triple-Negative Breast Cancer. International Journal Of Radiation Oncology • Biology • Physics 2021, 111: 45-52. PMID: 33713742, DOI: 10.1016/j.ijrobp.2021.03.002.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerBreast-conserving therapyDose-limiting toxicityBCT cohortRadiation therapyConcurrent cisplatinMastectomy cohortBreast cancerEarly-stage triple-negative breast cancerThree-year disease-free survivalPhase 1 dose-escalation trialStage IILocal-regional recurrence ratePhase 2 doseAdjuvant radiation therapyDisease-free survivalDose-escalation trialPhase 1b trialDose of cisplatinHER2-positive tumorsEligible patientsUrinary infectionAdditional patientsDose escalationRecurrence rate
2019
Local–regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial)
Bellon JR, Guo H, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Hudis CA, Krop I, Burstein HJ, Winer EP, Tolaney SM. Local–regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial). Breast Cancer Research And Treatment 2019, 176: 303-310. PMID: 31004299, DOI: 10.1007/s10549-019-05238-4.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerLocal-regional recurrenceDisease-free survivalEffective anti-HER2 therapyLRR-free survivalAnti-HER2 therapyBreast-conserving surgeryBreast cancerRadiation therapySystemic therapyHormone receptor-positive tumorsProspective multi-institutional studyHER2-negative diseaseHER2-positive diseaseNegative axillary nodesEffective systemic therapyProspective multicenter trialEarly-stage patientsKaplan-Meier methodReceptor-positive tumorsHER2-positive tumorsMulti-institutional studyFuture investigational effortsAdjuvant trastuzumabProtocol therapySeven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer
Tolaney SM, Guo H, Pernas S, Barry WT, Dillon DA, Ritterhouse L, Schneider BP, Shen F, Fuhrman K, Baltay M, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis MJ, Shapira I, Wolff AC, Carey LA, Overmoyer B, Partridge AH, Hudis CA, Krop IE, Burstein HJ, Winer EP. Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer. Journal Of Clinical Oncology 2019, 37: jco.19.00066. PMID: 30939096, PMCID: PMC7587424, DOI: 10.1200/jco.19.00066.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBreast NeoplasmsBreast Neoplasms, MaleChemotherapy, AdjuvantDisease-Free SurvivalFemaleFollow-Up StudiesGene Expression Regulation, NeoplasticGenetic Predisposition to DiseaseGenotypeHumansLymph NodesMaleMiddle AgedPaclitaxelPeripheral Nervous System DiseasesPoisson DistributionPolymorphism, Single NucleotideReceptor, ErbB-2RecurrenceRiskTrastuzumabTreatment OutcomeConceptsDisease-free survivalRecurrence-free intervalSmall HER2-positive tumorsAdjuvant paclitaxelHER2-positive tumorsLong-term outcomesTrastuzumab trialsBreast cancerOverall survivalSmall human epidermal growth factor receptor 2Breast cancer-specific survivalPaclitaxel-induced peripheral neuropathyExcellent long-term outcomesHuman epidermal growth factor receptor 2HER2-positive breast cancerEpidermal growth factor receptor 2Human epidermal growth factor receptorPAM50 intrinsic subtypesCancer-specific survivalPhase II studyPrimary end pointGrowth factor receptor 2Positive breast cancerTreatment of patientsSeven-year followThe immune profile of small HER2-positive breast cancers: a secondary analysis from the APT trial
Barroso-Sousa R, Barry WT, Guo H, Dillon D, Tan YB, Fuhrman K, Osmani W, Getz A, Baltay M, Dang C, Yardley D, Moy B, Marcom PK, Mittendorf EA, Krop IE, Winer EP, Tolaney SM. The immune profile of small HER2-positive breast cancers: a secondary analysis from the APT trial. Annals Of Oncology 2019, 30: 575-581. PMID: 30753274, PMCID: PMC8033534, DOI: 10.1093/annonc/mdz047.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenBiomarkers, TumorBreastBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMastectomyMiddle AgedPaclitaxelReceptor, ErbB-2TrastuzumabTumor BurdenTumor MicroenvironmentConceptsHER2-positive breast cancerSmall HER2-positive breast cancersImmune gene signaturesBreast cancerImmune profileAPT trialPD-L1Immune markersImmune microenvironmentSmall HER2-positive tumorsStromal PD-L1 expressionNode-negative breast cancerCell signatureGene signatureHuman epidermal growth factor receptorStromal PD-L1PD-L1 expressionHistological grade 2Luminal B tumorsB cell signaturesBreast cancer trialsHER2-positive tumorsImmune cell signaturesBasal-like tumorsHistological grade 1
2015
Racial differences in outcomes for patients with metastatic breast cancer by disease subtype
Vaz-Luis I, Lin NU, Keating NL, Barry WT, Lii H, Winer EP, Freedman RA. Racial differences in outcomes for patients with metastatic breast cancer by disease subtype. Breast Cancer Research And Treatment 2015, 151: 697-707. PMID: 26022349, DOI: 10.1007/s10549-015-3432-1.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerDe novo metastatic breast cancerNovo metastatic breast cancerBreast cancer-specific survivalCancer-specific survivalHER2-positive tumorsOverall survivalBreast cancerTreatment patternsBlack patientsRacial differencesDisease subgroupsMultivariate Cox proportional modelEnd Results-Medicare dataHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Impact of raceHER2-positive diseaseHR-negative diseaseHR-negative tumorsLonger median OSMedian overall survivalGrowth factor receptor 2Survival of womenCox proportional models
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
2012
A Phase II Study of Trastuzumab Emtansine in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab, Lapatinib, an Anthracycline, a Taxane, and Capecitabine
Krop IE, LoRusso P, Miller KD, Modi S, Yardley D, Rodriguez G, Guardino E, Lu M, Zheng M, Girish S, Amler L, Winer EP, Rugo HS. A Phase II Study of Trastuzumab Emtansine in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab, Lapatinib, an Anthracycline, a Taxane, and Capecitabine. Journal Of Clinical Oncology 2012, 30: 3234-3241. PMID: 22649126, DOI: 10.1200/jco.2011.40.5902.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAnthracyclinesAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsBridged-Ring CompoundsCapecitabineDeoxycytidineDisease-Free SurvivalFemaleFluorouracilHumansImmunotoxinsLapatinibMaleMaytansineMiddle AgedMolecular Targeted TherapyNeoplasm MetastasisQuinazolinesReceptor, ErbB-2TaxoidsTrastuzumabConceptsHER2-positive metastatic breast cancerHuman epidermal growth factor receptor 2Metastatic breast cancerProgression-free survivalOverall response rateMedian progression-free survivalPhase II studyT-DM1II studyTrastuzumab emtansineBreast cancerResponse rateSingle-arm phase II studyEpidermal growth factor receptor 2Human epidermal growth factor receptorClinical benefit rateHER2-directed therapiesMost adverse eventsGrowth factor receptor 2Single-agent activityHER2-positive tumorsMultiple chemotherapy agentsEffective new treatmentsFactor receptor 2Epidermal growth factor receptor
2009
Pathologic Features and Biomarker Expression among Young Women with Breast Cancer: Results from the Young Women's Breast Cancer Study.
Collins L, Collins L, Gelber S, Gelber S, Ruddy K, Ruddy K, Tamimi R, Tamimi R, Come S, Come S, Marotti J, Marotti J, Schapira L, Schapira L, Kereakoglow S, Brachtel E, Brachtel E, Winer E, Winer E, Partridge A, Partridge A. Pathologic Features and Biomarker Expression among Young Women with Breast Cancer: Results from the Young Women's Breast Cancer Study. Cancer Research 2009, 69: 6007-6007. DOI: 10.1158/0008-5472.sabcs-09-6007.Peer-Reviewed Original ResearchYoung Women's Breast Cancer StudyBreast Cancer StudyPoor prognostic featuresBasal-like carcinomasPathologic featuresBreast cancerYoung womenHER2 positivityPrognostic featuresTumor stageTumor necrosisER/PR negativityMulti-center prospective cohortInvasive breast cancerClinico-pathologic featuresHER2-positive tumorsCancer studiesHigh tumor gradeHigher tumor stageHigh-grade tumorsBasal-like phenotypeBiomarker expression patternsLogistic regression modelsPR negativityClinical characteristicsTopoisomerase IIα Amplification Does Not Predict Benefit From Dose-Intense Cyclophosphamide, Doxorubicin, and Fluorouracil Therapy in HER2-Amplified Early Breast Cancer: Results of CALGB 8541/150013
Harris LN, Broadwater G, Abu-Khalaf M, Cowan D, Thor AD, Budman D, Cirrincione CT, Berry DA, Winer EP, Hudis CA, Hayes DF, Friedman P, Ellis M, Dressler L. Topoisomerase IIα Amplification Does Not Predict Benefit From Dose-Intense Cyclophosphamide, Doxorubicin, and Fluorouracil Therapy in HER2-Amplified Early Breast Cancer: Results of CALGB 8541/150013. Journal Of Clinical Oncology 2009, 27: 3430-3436. PMID: 19470942, PMCID: PMC4979079, DOI: 10.1200/jco.2008.18.4085.Peer-Reviewed Original ResearchMeSH KeywordsAnthracyclinesAntibiotics, AntineoplasticAntigens, NeoplasmAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCyclophosphamideDNA Topoisomerases, Type IIDNA-Binding ProteinsDoxorubicinDrug InteractionsFluorouracilGene AmplificationHumansImmunohistochemistryReceptor, ErbB-2
2006
Molecular subtypes of breast cancer in relation to paclitaxel response and outcomes in women with metastatic disease: results from CALGB 9342
Harris LN, Broadwater G, Lin NU, Miron A, Schnitt SJ, Cowan D, Lara J, Bleiweiss I, Berry D, Ellis M, Hayes DF, Winer EP, Dressler L. Molecular subtypes of breast cancer in relation to paclitaxel response and outcomes in women with metastatic disease: results from CALGB 9342. Breast Cancer Research 2006, 8: r66. PMID: 17129383, PMCID: PMC1797029, DOI: 10.1186/bcr1622.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerTriple-negative tumorsOverall survivalBreast cancerP53 statusNegative tumorsHER2 statusHormone receptorsHormone receptor statusShorter median timeDoses of paclitaxelLonger overall survivalHER2-positive tumorsAfrican American patientsHormone receptor expressionPrimary tumor tissuesAdvanced diseaseMetastatic diseaseShorter OSReceptor statusMedian timeTreatment failureShorter survivalCaucasian patientsPathology reports