2022
Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT
Francis P, Fleming G, Láng I, Ciruelos E, Bonnefoi H, Bellet M, Bernardo A, Climent M, Martino S, Bermejo B, Burstein H, Davidson N, Geyer C, Walley B, Ingle J, Coleman R, Müller B, Le Du F, Loibl S, Winer E, Ruepp B, Loi S, Colleoni M, Coates A, Gelber R, Goldhirsch A, Regan M, Group F. Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT. Journal Of Clinical Oncology 2022, 41: 1370-1375. PMID: 36493334, PMCID: PMC10419521, DOI: 10.1200/jco.22.01065.Peer-Reviewed Original ResearchConceptsOvarian function suppressionDisease-free survivalAdjuvant endocrine therapyPrimary end pointOverall survivalAdjuvant tamoxifenEndocrine therapyEnd pointBreast cancerHuman epidermal growth factor receptor-2-negative tumoursTamoxifen plus ovarian function suppressionHormone receptor-positive breast cancerReceptor-positive breast cancerClinical trial updateOvarian Function TrialPremenopausal breast cancerHigher baseline riskPrior chemotherapyPremenopausal womenTrial updateClinical trialsBaseline riskMultiple end pointsTamoxifenExemestane
2021
Clinical Efficacy and Molecular Response Correlates of the WEE1 Inhibitor Adavosertib Combined with Cisplatin in Patients with Metastatic Triple-Negative Breast Cancer
Keenan TE, Li T, Vallius T, Guerriero JL, Tayob N, Kochupurakkal B, Davis J, Pastorello R, Tahara RK, Anderson L, Conway J, He MX, Shannon E, Godin RE, Sorger PK, D'Andrea A, Overmoyer B, Winer EP, Mittendorf EA, Van Allen EM, Shapiro GI, Tolaney SM. Clinical Efficacy and Molecular Response Correlates of the WEE1 Inhibitor Adavosertib Combined with Cisplatin in Patients with Metastatic Triple-Negative Breast Cancer. Clinical Cancer Research 2021, 27: 983-991. PMID: 33257427, PMCID: PMC7887044, DOI: 10.1158/1078-0432.ccr-20-3089.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerObjective response rateTriple-negative breast cancerWEE1 inhibitor adavosertibPrior linesClinical benefitBreast cancerMedian progression-free survivalTreatment-related grade 3One-sided type I errorImmune-infiltrated tumorsPhase II studyProgression-free survivalT cell infiltrationImmune gene expressionPrior chemotherapyStable diseaseProtocol therapyII studyPartial responseAdverse eventsMedian ageClinical efficacyGrade 3Tumor biopsies
2019
A phase II feasibility study of palbociclib in combination with adjuvant endocrine therapy for hormone receptor-positive invasive breast carcinoma
Mayer EL, DeMichele A, Rugo HS, Miller K, Waks AG, Come SE, Mulvey T, Jeselsohn R, Overmoyer B, Guo H, Barry WT, Bartlett C, Koehler M, Winer EP, Burstein HJ. A phase II feasibility study of palbociclib in combination with adjuvant endocrine therapy for hormone receptor-positive invasive breast carcinoma. Annals Of Oncology 2019, 30: 1514-1520. PMID: 31250880, DOI: 10.1093/annonc/mdz198.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalEstradiolFeasibility StudiesFemaleFulvestrantHumansMiddle AgedNeoplasm InvasivenessNeoplasm StagingPiperazinesProtein Kinase InhibitorsPyridinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneConceptsEarly breast cancerEndocrine therapyAdjuvant palbociclibBreast cancerHormone receptor-positive/HER2-negative metastatic breast cancerHER2-negative metastatic breast cancerPhase II feasibility studyProlong progression-free survivalRandomized phase III trialAdjuvant endocrine therapyPrimary end pointStage III diseasePhase II trialPhase III trialsProgression-free survivalMetastatic breast cancerYears of therapyStart of treatmentInvasive breast carcinomaEligible patientsFebrile neutropeniaPrior chemotherapyWeeks on/1II trialCumulative incidence
2018
Association of Cell-Free DNA Tumor Fraction and Somatic Copy Number Alterations With Survival in Metastatic Triple-Negative Breast Cancer
Stover DG, Parsons HA, Ha G, Freeman SS, Barry WT, Guo H, Choudhury AD, Gydush G, Reed SC, Rhoades J, Rotem D, Hughes ME, Dillon DA, Partridge AH, Wagle N, Krop IE, Getz G, Golub TR, Love JC, Winer EP, Tolaney SM, Lin NU, Adalsteinsson VA. Association of Cell-Free DNA Tumor Fraction and Somatic Copy Number Alterations With Survival in Metastatic Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2018, 36: jco.2017.76.003. PMID: 29298117, PMCID: PMC5815405, DOI: 10.1200/jco.2017.76.0033.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerPrimary triple-negative breast cancerTumor fractionSomatic copy number alterationsCell-free DNABreast cancerSingle tertiary care institutionCopy number alterationsRetrospective cohort studySpecific somatic copy number alterationsTertiary care institutionNovel therapeutic approachesNumber alterationsCfDNA tumor fractionMetastatic survivalPrior chemotherapyTNBC cohortMetastatic settingCohort studyOverall survivalCancer Genome AtlasClinicopathologic factorsWorse survivalPrimary tumor
2017
Phase 2 study of pembrolizumab (pembro) monotherapy for previously treated metastatic triple-negative breast cancer (mTNBC): KEYNOTE-086 cohort A.
Adams S, Schmid P, Rugo H, Winer E, Loirat D, Awada A, Cescon D, Iwata H, Campone M, Nanda R, Hui R, Curigliano G, Toppmeyer D, O'Shaughnessy J, Loi S, Paluch-Shimon S, Card D, Zhao J, Karantza V, Cortes J. Phase 2 study of pembrolizumab (pembro) monotherapy for previously treated metastatic triple-negative breast cancer (mTNBC): KEYNOTE-086 cohort A. Journal Of Clinical Oncology 2017, 35: 1008-1008. DOI: 10.1200/jco.2017.35.15_suppl.1008.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerTreatment-related AEsPD-L1 expressionPD-L1Manageable safetyTriple-negative breast cancerECOG PS 0Subset of ptsDisease control ratePhase 2 studyPoor prognostic factorEfficacy/safetyBest overall responseCohort A.Evaluable ptsKEYNOTE-012Median DoRMedian PFSPrior chemotherapyData cutoffPembrolizumab monotherapyDurable responsesMetastatic diseasePrior linesPS 0
2014
Adjuvant Ovarian Suppression in Premenopausal Breast Cancer
Francis PA, Regan MM, Fleming GF, Láng I, Ciruelos E, Bellet M, Bonnefoi HR, Climent MA, Da Prada GA, Burstein HJ, Martino S, Davidson NE, Geyer CE, Walley BA, Coleman R, Kerbrat P, Buchholz S, Ingle JN, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Colleoni M, Viale G, Coates AS, Goldhirsch A, Gelber RD. Adjuvant Ovarian Suppression in Premenopausal Breast Cancer. New England Journal Of Medicine 2014, 372: 436-446. PMID: 25495490, PMCID: PMC4341825, DOI: 10.1056/nejmoa1412379.Peer-Reviewed Original ResearchConceptsTamoxifen plus ovarian suppressionOvarian suppressionRate of freedomBreast cancerTamoxifen groupPremenopausal womenPrimary analysisDisease-free survival ratesPositive early breast cancerAdjuvant ovarian suppressionNonreceipt of chemotherapyYears of tamoxifenDisease-free survivalPremenopausal breast cancerEarly breast cancerOvarian estrogen productionOverall study populationSuppression groupGreater treatment effectUse of exemestaneAdjuvant chemotherapyPrior chemotherapyMost recurrencesPrognostic factorsPrior receiptPhase III Study of Iniparib Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin in Patients With Metastatic Triple-Negative Breast Cancer
O'Shaughnessy J, Schwartzberg L, Danso MA, Miller KD, Rugo HS, Neubauer M, Robert N, Hellerstedt B, Saleh M, Richards P, Specht JM, Yardley DA, Carlson RW, Finn RS, Charpentier E, Garcia-Ribas I, Winer EP. Phase III Study of Iniparib Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin in Patients With Metastatic Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2014, 32: 3840-3847. PMID: 25349301, DOI: 10.1200/jco.2014.55.2984.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBenzamidesCarboplatinDeoxycytidineDisease ProgressionDisease-Free SurvivalFemaleGemcitabineHumansKaplan-Meier EstimateMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingProportional Hazards ModelsRisk FactorsTime FactorsTreatment OutcomeTriple Negative Breast NeoplasmsUnited StatesConceptsMetastatic triple-negative breast cancerProgression-free survivalTriple-negative breast cancerCoprimary end pointsOverall survivalBreast cancerRandomized phase II trialEnd pointStage IV/Clinical benefit ratePhase II trialPhase III studyPhase III trialsStandard of careWarrants further evaluationLack of treatmentCarboplatin areaITT populationPrevious chemotherapyPrior chemotherapyII trialIII studyIII trialsSurvival benefitSafety profile
2013
A phase II study of ixabepilone and trastuzumab for metastatic HER2-positive breast cancer
Tolaney SM, Najita J, Sperinde J, Huang W, Chen WY, Savoie J, Fornier M, Winer EP, Bunnell C, Krop IE. A phase II study of ixabepilone and trastuzumab for metastatic HER2-positive breast cancer. Annals Of Oncology 2013, 24: 1841-1847. PMID: 23559151, PMCID: PMC3690910, DOI: 10.1093/annonc/mdt121.Peer-Reviewed Original ResearchConceptsMetastatic HER2-positive breast cancerHER2-positive breast cancerCombination of ixabepilonePhase II studyBreast cancerII studyMetastatic diseaseCohort 2Cohort 1Treatment-related toxic effectsClinical benefit rateSubsequent-line therapyTrastuzumab-containing regimensMetastatic breast cancerPrior chemotherapyLine therapyBenefit rateOverall RRDay 1PatientsTrastuzumabIxabepiloneCancerTumor biomarkersCohort
2009
A phase II study of ixabepilone plus trastuzumab for metastatic HER2-positive breast cancer.
Tolaney S, Najita J, Chen W, Savoie J, Fornier M, Krop I, Winer E, Bunnell C. A phase II study of ixabepilone plus trastuzumab for metastatic HER2-positive breast cancer. Cancer Research 2009, 69: 3137. DOI: 10.1158/0008-5472.sabcs-3137.Peer-Reviewed Original ResearchMetastatic HER2-positive breast cancerHER2-positive breast cancerCombination of ixabepiloneBreast cancerPartial responseCohort 1Response rateMetastatic diseaseCohort 2Clinical benefit rateHigher cardiac toxicityRefractory breast cancerSubsequent-line therapyTrastuzumab-containing regimensCycles of therapyPhase II studyTreatment-related toxicityCohort of patientsEncouraging response ratesMetastatic breast cancerSame treatment regimenOverall response ratePrior chemotherapyStable diseaseElevated transaminasesA phase I study of an autologous GM-CSF-secreting breast cancer vaccine.
Anderson K, Hodi F, Sasada T, Canning C, Hassett M, Mayer E, Hannagan K, Wong J, Colson Y, Shoji B, Najita J, Sibani S, LaBaer J, Winer E, Dranoff G. A phase I study of an autologous GM-CSF-secreting breast cancer vaccine. Cancer Research 2009, 69: 4124. DOI: 10.1158/0008-5472.sabcs-4124.Peer-Reviewed Original ResearchBreast cancer vaccinesGM-CSFAutologous GM-CSFCancer vaccinesLung cancerSkin biopsiesImmune responseECOG performance status 0Antigen-specific immune responsesLocal injection site reactionsPerformance status 0Anti-tumor immunityInjection site reactionsMetastatic breast cancerMalignant pleural effusionReplication-defective adenoviral vectorMultiple tumor modelsGM-CSF secretionBreast cancer cellsTumor cell yieldGranulocyte-macrophage colonyAutologous vaccinationMeasurable diseasePrior chemotherapyStable disease
2007
Trastuzumab plus vinorelbine or taxane chemotherapy for HER2‐overexpressing metastatic breast cancer: The trastuzumab and vinorelbine or taxane study
Burstein HJ, Keshaviah A, Baron AD, Hart RD, Lambert‐Falls R, Marcom PK, Gelman R, Winer EP. Trastuzumab plus vinorelbine or taxane chemotherapy for HER2‐overexpressing metastatic breast cancer: The trastuzumab and vinorelbine or taxane study. Cancer 2007, 110: 965-972. PMID: 17614302, DOI: 10.1002/cncr.22885.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlopeciaAnemiaAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsConstipationDisease ProgressionDrug Administration ScheduleFatigueFemaleHumansKaplan-Meier EstimateMiddle AgedNauseaNeoplasm MetastasisPaclitaxelProspective StudiesReceptor, ErbB-2TrastuzumabTreatment OutcomeVinblastineVinorelbineConceptsMetastatic breast cancerBreast cancerTrastuzumab armEpisodes of cardiotoxicityFirst-line therapyDermatologic toxicitiesEvaluable patientsPrior chemotherapyVinorelbine therapyAdvanced diseaseChemotherapy regimenEligible patientsGastrointestinal toxicityPoor accrualTaxane chemotherapyTaxane therapyMore anemiaMedian timeTrastuzumab treatmentFluid retentionDisease progressionChemotherapy agentsTreatment decisionsVinorelbineSide effectsPhase II study of CT-2103 as first- or second-line chemotherapy in patients with metastatic breast cancer: unexpected incidence of hypersensitivity reactions
Lin NU, Parker LM, Come SE, Burstein HJ, Haldoupis M, Ryabin N, Gelman R, Winer EP, Shulman LN. Phase II study of CT-2103 as first- or second-line chemotherapy in patients with metastatic breast cancer: unexpected incidence of hypersensitivity reactions. Investigational New Drugs 2007, 25: 369-375. PMID: 17345004, DOI: 10.1007/s10637-007-9034-y.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerHypersensitivity reactionsEfficacy of CTBreast cancerPrior linesPatient populationGrade 3HER2-negative metastatic breast cancerSmall studyHER2-negative breast cancerTrue drug allergyPhase II studySecond-line chemotherapyPercent of womenNovel conjugatesAdjuvant settingConjugated paclitaxelEighteen womenIntravenous CTMetastatic treatmentPrior chemotherapyRoutine premedicationDrug allergyII studyObjective response
2006
Rebeccamycin analog for refractory breast cancer: A randomized phase II trial of dosing schedules
Burstein HJ, Overmoyer B, Gelman R, Silverman P, Savoie J, Clarke K, Dumadag L, Younger J, Ivy P, Winer EP. Rebeccamycin analog for refractory breast cancer: A randomized phase II trial of dosing schedules. Investigational New Drugs 2006, 25: 161-164. PMID: 16969707, DOI: 10.1007/s10637-006-9007-6.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerDifferent treatment schedulesBreast cancerTreatment scheduleAdjuvant chemotherapyArm 2Arm 1Response rateAnthracycline-based adjuvant chemotherapyRefractory advanced breast cancerRandomized phase II trialPrior chemotherapy regimensRefractory breast cancerModest clinical activityPhase II trialPrimary study endpointMetastatic breast cancerCentral venous accessAnemia 5Eligible patientsMeasurable diseaseNausea/Prior chemotherapyStable diseaseChemotherapy regimensMenopausal-type symptoms in young breast cancer survivors
Leining M, Gelber S, Rosenberg R, Przypyszny M, Winer E, Partridge A. Menopausal-type symptoms in young breast cancer survivors. Annals Of Oncology 2006, 17: 1777-1782. PMID: 16971671, DOI: 10.1093/annonc/mdl299.Peer-Reviewed Original ResearchConceptsYoung breast cancer survivorsBreast cancer survivorsOvarian suppressionCancer survivorsBreast cancerBreast Cancer Prevention Trial Symptom ChecklistBothersome menopausal symptomsAge 40 yearsTreatment decision makingLong-term qualityTime of surveyPrior chemotherapyPostmenopausal statusBothersome symptomsSymptom scoresHot flashesMenopausal symptomsAromatase inhibitorsInternet-based surveyBaseline anxietySymptom ChecklistSymptomsYoung womenSurvivorsWomenTrastuzumab and vinorelbine or taxane chemotherapy for HER2+ metastatic breast cancer: The TRAVIOTA study
Burstein H, Keshaviah A, Baron A, Hart R, Lambert-Falls R, Marcom P, Gelman R, Winer E. Trastuzumab and vinorelbine or taxane chemotherapy for HER2+ metastatic breast cancer: The TRAVIOTA study. Journal Of Clinical Oncology 2006, 24: 650-650. DOI: 10.1200/jco.2006.24.18_suppl.650.Peer-Reviewed Original ResearchMetastatic breast cancerAdvanced breast cancerBreast cancerTaxane chemotherapyResponse rateMore frequent grade 3Stage IV breast cancerComparable clinical activityFrequent grade 3Protocol-based therapySide effect profileHigh response rateDose delaysEligible patientsMeasurable diseasePrior chemotherapyVinorelbine therapyWeekly taxanesWeekly vinorelbineChemotherapy regimenPrimary endpointTaxane therapyHematological toxicityEffect profileClinical trialsQuality of life (QOL) companion to CALGB 9840: A phase III study of paclitaxel (P) via weekly 1 hour (hr) versus standard 3 hour infusion every 3 weeks with trastuzumab in the treatment of patients with/without HER-2/neu-overexpressing metastatic breast cancer
Naughton M, Gu L, Wang X, Seidman A, Winer E, Kornblith A. Quality of life (QOL) companion to CALGB 9840: A phase III study of paclitaxel (P) via weekly 1 hour (hr) versus standard 3 hour infusion every 3 weeks with trastuzumab in the treatment of patients with/without HER-2/neu-overexpressing metastatic breast cancer. Journal Of Clinical Oncology 2006, 24: 674-674. DOI: 10.1200/jco.2006.24.18_suppl.674.Peer-Reviewed Original ResearchNegative patientsQOL differencesGreater efficacyMain trial resultsPrior radiation therapyMetastatic breast cancerPhase III studyTreatment of patientsMain outcome measuresEORTC-C30Prior chemotherapyBreast symptomsIII studyPerformance statusPatient ageHour infusionTreatment armsBreast moduleGlobal QoLCancer symptomsBreast cancerClinical dataQoL dataOutcome measuresRadiation therapy
2001
Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer.
Burstein H, Kuter I, Campos S, Gelman R, Tribou L, Parker L, Manola J, Younger J, Matulonis U, Bunnell C, Partridge A, Richardson P, Clarke K, Shulman L, Winer E. Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer. Journal Of Clinical Oncology 2001, 19: 2722-30. PMID: 11352965, DOI: 10.1200/jco.2001.19.10.2722.Peer-Reviewed Original ResearchConceptsGrade 2 cardiac toxicityAdvanced breast cancerBreast cancerResponse rateCardiac toxicityHER2-overexpressing metastatic breast cancerOnly grade 4 toxicityHER2-positive breast cancerCumulative doxorubicin doseGrade 4 toxicityStudy of trastuzumabSymptomatic heart failureThird-line therapyFirst-line therapyType of chemotherapyMetastatic breast cancerPercent of womenHigh response rateConcurrent trastuzumabPrior chemotherapyWeekly vinorelbineMetastatic diseasePositive patientsHeart failureDoxorubicin dose
2000
Docetaxel administered on a weekly basis for metastatic breast cancer.
Burstein H, Manola J, Younger J, Parker L, Bunnell C, Scheib R, Matulonis U, Garber J, Clarke K, Shulman L, Winer E. Docetaxel administered on a weekly basis for metastatic breast cancer. Journal Of Clinical Oncology 2000, 18: 1212-9. PMID: 10715290, DOI: 10.1200/jco.2000.18.6.1212.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerWeekly docetaxelBreast cancerPrior chemotherapyCumulative docetaxel doseGrade 4 toxicityGrade 3 toxicityPercent of patientsWeeks of therapySide effect profileSubgroup of patientsSimilar response ratesAdjuvant chemotherapyDocetaxel doseStable diseasePartial responseComplete responseTreat analysisTreatment breaksEffect profileFluid retentionPatient preferencesDisease progressionRepetitive dosingDose reduction
1999
Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years of age or older
Vogel C, O’Rourke M, Winer E, Hochster H, Chang A, Adamkiewicz B, White R, McGuirt C. Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years of age or older. Annals Of Oncology 1999, 10: 397-402. PMID: 10370781, DOI: 10.1023/a:1008364222793.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAgingAntineoplastic Agents, PhytogenicBreast NeoplasmsDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesHumansInfusions, IntravenousMiddle AgedProspective StudiesSeverity of Illness IndexTreatment OutcomeVinblastineVinorelbineConceptsAdvanced breast cancerDose-limiting toxicityBreast cancerSide effectsNonhematologic toxicityElderly patientsMeasurable advanced breast cancerMajor dose-limiting toxicityActivity of vinorelbineMedian dose intensityFirst-line chemotherapyObjective response rateFirst-line therapyPhase II trialSubjective side effectsInjection site reactionsWomen 60 yearsGastrointestinal side effectsGeneralized painIntravenous vinorelbinePrior chemotherapyAbdominal painChest painII trialCytotoxic chemotherapy
1996
Continuous infusion 5-fluorouracil as first-line therapy for metastatic breast cancer.
Chu L, Sutton LM, Peterson BL, Havlin KA, Winer EP. Continuous infusion 5-fluorouracil as first-line therapy for metastatic breast cancer. The Journal Of Infusional Chemotherapy 1996, 6: 211-6. PMID: 9229318.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerSymptom Distress ScaleFunctional Living Index-CancerFirst-line settingFirst-line therapyBreast cancerContinuous infusionDisease progressionPrevious phase II studyRefractory metastatic breast cancerAdequate bone marrowContinuous infusion fluorouracilGrade 3 mucositisECOG performance statusMedian overall survivalObjective response ratePhase II studyContinuous intravenous infusionQuality of lifeEvaluable diseaseFLIC scoresInfusion fluorouracilMeasurable diseasePrior chemotherapyIndex cancer