2020
PALLAS: A randomized phase III trial of adjuvant palbociclib with endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer
Mayer E, Gnant M, DeMichele A, Martin M, Burstein H, Prat A, Rubovszky G, Miller K, Pfeiler G, Winer E, Zdenkowski N, Anderson D, Nowecki Z, Loibl S, Fohler H, Metzger O, Fumagalli D, Theall K, Fesl C, Dueck A. PALLAS: A randomized phase III trial of adjuvant palbociclib with endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer. Annals Of Oncology 2020, 31: s1145. DOI: 10.1016/j.annonc.2020.08.2240.Peer-Reviewed Original Research
2019
Personalized Management of Chemotherapy‐Induced Peripheral Neuropathy Based on a Patient Reported Outcome: CALGB 40502 (Alliance)
Sharma MR, Mehrotra S, Gray E, Wu K, Barry WT, Hudis C, Winer EP, Lyss AP, Toppmeyer DL, Moreno‐Aspitia A, Lad TE, Velasco M, Overmoyer B, Rugo HS, Ratain MJ, Gobburu JV. Personalized Management of Chemotherapy‐Induced Peripheral Neuropathy Based on a Patient Reported Outcome: CALGB 40502 (Alliance). The Journal Of Clinical Pharmacology 2019, 60: 444-452. PMID: 31802506, PMCID: PMC7064382, DOI: 10.1002/jcph.1559.Peer-Reviewed Original ResearchMeSH KeywordsAlbuminsAlgorithmsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsComputer SimulationDrug Administration ScheduleDrug TaperingEpothilonesFemaleHumansModels, BiologicalPaclitaxelPatient Reported Outcome MeasuresPeripheral Nervous System DiseasesPrecision MedicineConceptsDose-adjustment algorithmPatient-reported outcome dataEarly time pointsNeuropathy scoreDose adjustmentNanoparticle albuminIndividual patientsTime pointsOutcome dataChemotherapy-induced peripheral neuropathyRandomized phase III trialFirst-line chemotherapyMetastatic breast cancerPhase III trialsPatient-reported outcomesA 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
2017
Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer (Alliance A011401): study design
Ligibel JA, Barry WT, Alfano C, Hershman DL, Irwin M, Neuhouser M, Thomson CA, Delahanty L, Frank E, Spears P, Paskett ED, Hopkins J, Bernstein V, Stearns V, White J, Hahn O, Hudis C, Winer EP, Wadden TA, Goodwin PJ. Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer (Alliance A011401): study design. Npj Breast Cancer 2017, 3: 37. PMID: 28948213, PMCID: PMC5608692, DOI: 10.1038/s41523-017-0040-8.Peer-Reviewed Original ResearchEarly breast cancerWeight loss interventionWeight loss programBreast cancer recurrenceBreast cancerBody weightWeight lossLoss interventionLoss programCancer recurrencePhysical activityHER-2 negative breast cancerInvasive disease-free survivalRandomized phase III trialDana-Farber Cancer InstitutePurposeful weight lossBaseline body weightCancer diagnosisDisease-free survivalExcess body weightPhase III trialsPoor prognostic factorIncidence of comorbiditiesBody mass indexWeight loss trialKinetic-Pharmacodynamic Model of Chemotherapy-Induced Peripheral Neuropathy in Patients with Metastatic Breast Cancer Treated with Paclitaxel, Nab-Paclitaxel, or Ixabepilone: CALGB 40502 (Alliance)
Mehrotra S, Sharma MR, Gray E, Wu K, Barry WT, Hudis C, Winer EP, Lyss AP, Toppmeyer DL, Moreno-Aspitia A, Lad TE, Valasco M, Overmoyer B, Rugo H, Ratain MJ, Gobburu JV. Kinetic-Pharmacodynamic Model of Chemotherapy-Induced Peripheral Neuropathy in Patients with Metastatic Breast Cancer Treated with Paclitaxel, Nab-Paclitaxel, or Ixabepilone: CALGB 40502 (Alliance). The AAPS Journal 2017, 19: 1411-1423. PMID: 28620884, PMCID: PMC5711539, DOI: 10.1208/s12248-017-0101-9.Peer-Reviewed Original ResearchConceptsChemotherapy-induced peripheral neuropathyProportion of patientsMetastatic breast cancerKinetic-pharmacodynamic modelIndirect response modelNab-paclitaxelDose modificationPeripheral neuropathyBreast cancerDrug effectsRandomized phase III trialLinear drug effectFirst-line chemotherapyPhase III trialsTime pointsDose-limiting toxicityLater time pointsEarly time pointsCALGB 40502Neurotoxicity ScaleIII trialsFunctional assessmentChemotherapeutic agentsPatientsCancer
2015
Molecular Heterogeneity and Response to Neoadjuvant Human Epidermal Growth Factor Receptor 2 Targeting in CALGB 40601, a Randomized Phase III Trial of Paclitaxel Plus Trastuzumab With or Without Lapatinib
Carey LA, Berry DA, Cirrincione CT, Barry WT, Pitcher BN, Harris LN, Ollila DW, Krop IE, Henry NL, Weckstein DJ, Anders CK, Singh B, Hoadley KA, Iglesia M, Cheang MC, Perou CM, Winer EP, Hudis CA. Molecular Heterogeneity and Response to Neoadjuvant Human Epidermal Growth Factor Receptor 2 Targeting in CALGB 40601, a Randomized Phase III Trial of Paclitaxel Plus Trastuzumab With or Without Lapatinib. Journal Of Clinical Oncology 2015, 34: 542-549. PMID: 26527775, PMCID: PMC4980567, DOI: 10.1200/jco.2015.62.1268.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarcinomaEstrogen Receptor alphaFemaleGene ExpressionHumansImmunoglobulin GLapatinibMiddle AgedNeoadjuvant TherapyNeoplasm, ResidualPaclitaxelQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRNA, MessengerTrastuzumabTreatment OutcomeTumor MicroenvironmentTumor Suppressor Protein p53Young AdultConceptsPathologic complete response rateCALGB 40601Dual therapyIntrinsic subtypesHormone receptor-negative diseaseRandomized phase III trialHuman epidermal growth factor receptor 2End pointHER2-positive breast cancerEpidermal growth factor receptor 2Correlative end pointsDual HER2 blockadeHER2-positive diseaseComplete response ratePrimary end pointPhase III trialsProgression-free survivalReceptor-negative diseaseAddition of lapatinibGrowth factor receptor 2Immune cell signaturesFactor receptor 2Gene expression-based assaysMolecular featuresDual HER2Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance)
Rugo HS, Barry WT, Moreno-Aspitia A, Lyss AP, Cirrincione C, Leung E, Mayer EL, Naughton M, Toppmeyer D, Carey LA, Perez EA, Hudis C, Winer EP. Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance). Journal Of Clinical Oncology 2015, 33: 2361-2369. PMID: 26056183, PMCID: PMC4500830, DOI: 10.1200/jco.2014.59.5298.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsDrug Administration ScheduleEpothilonesFemaleHumansMiddle AgedNanoparticlesNeoplasm MetastasisNeoplasm Recurrence, LocalPaclitaxelTreatment OutcomeConceptsAdvanced breast cancerProgression-free survivalNab-paclitaxelBreast cancerInterim analysisMedian progression-free survivalRandomized phase III trialEarly dose reductionSecond interim analysisFirst-line therapyPhase III trialsMetastatic breast cancerFirst interim analysisEligible patientsLine chemotherapyNonhematologic toxicityPalliative chemotherapyHazard ratioIII trialsOverall survivalPeripheral neuropathyTreatment failureExperimental armLocally RecurrentArm C
2009
Quality of Life of Early Stage Breast Cancer Patients 65 Years Old or Older Randomized to Standard Chemotherapy or Capecitabine: A Cancer and Leukemia Group B Study (CALGB 49907).
Kornblith A, Archer L, Lan L, Kimmick G, Partridge A, Casey R, Bennett S, Hudis C, Winer E, Cohen H, Muss H. Quality of Life of Early Stage Breast Cancer Patients 65 Years Old or Older Randomized to Standard Chemotherapy or Capecitabine: A Cancer and Leukemia Group B Study (CALGB 49907). Cancer Research 2009, 69: 5035-5035. DOI: 10.1158/0008-5472.sabcs-09-5035.Peer-Reviewed Original ResearchEnd of treatmentSimilar clinical outcomesStandard chemotherapyClinical outcomesCapecitabine patientsQoL resultsTreatment recommendationsLess toxicityLeukemia Group B StudyRandomized phase III trialBetter overall QoLPatients 65 yearsStandard chemotherapy armOlder cancer patientsPhase III trialsWorse clinical outcomesSystemic side effectsBetter body imageQuality of lifeCapecitabine armChemotherapy armLess constipationWorse diarrheaCapecitabine treatmentMetastatic setting
2008
Randomized Phase III Trial of Weekly Compared With Every-3-Weeks Paclitaxel for Metastatic Breast Cancer, With Trastuzumab for all HER-2 Overexpressors and Random Assignment to Trastuzumab or Not in HER-2 Nonoverexpressors: Final Results of Cancer and Leukemia Group B Protocol 9840
Seidman AD, Berry D, Cirrincione C, Harris L, Muss H, Marcom PK, Gipson G, Burstein H, Lake D, Shapiro CL, Ungaro P, Norton L, Winer E, Hudis C. Randomized Phase III Trial of Weekly Compared With Every-3-Weeks Paclitaxel for Metastatic Breast Cancer, With Trastuzumab for all HER-2 Overexpressors and Random Assignment to Trastuzumab or Not in HER-2 Nonoverexpressors: Final Results of Cancer and Leukemia Group B Protocol 9840. Journal Of Clinical Oncology 2008, 26: 1642-1649. PMID: 18375893, DOI: 10.1200/jco.2007.11.6699.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerWeekly paclitaxelResponse rateBreast cancerHER-2-positive patientsRandomized phase III trialHuman epidermal growth factor receptor 2End pointEpidermal growth factor receptor 2Grade 3 neuropathyPrimary end pointSecondary end pointsGrowth factor receptor 2Phase II trialPhase III trialsTreatment-limiting toxicityFactor receptor 2Paclitaxel scheduleII trialIII trialsOverall survivalPaclitaxel therapyPositive patientsWeekly dosingReceptor 2
1999
Safety and efficacy of using a single agent or a phase II agent before instituting standard combination chemotherapy in previously untreated metastatic breast cancer patients: report of a randomized study--Cancer and Leukemia Group B 8642.
Costanza M, Weiss R, Henderson I, Norton L, Berry D, Cirrincione C, Winer E, Wood W, Frei III E, McIntyre O, Schilsky R. Safety and efficacy of using a single agent or a phase II agent before instituting standard combination chemotherapy in previously untreated metastatic breast cancer patients: report of a randomized study--Cancer and Leukemia Group B 8642. Journal Of Clinical Oncology 1999, 17: 1397-406. PMID: 10334524, DOI: 10.1200/jco.1999.17.5.1397.Peer-Reviewed Original ResearchMeSH KeywordsAdenineAdultAgedAminoglycosidesAnalysis of VarianceAnti-Bacterial AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarboplatinCyclophosphamideDoxorubicinFemaleFluorouracilFollow-Up StudiesHumansImidesIsoquinolinesMelphalanMiddle AgedNaphthalimidesNeoplasm StagingOrganophosphonatesProspective StudiesSurvival AnalysisTrimetrexateConceptsPhase II agentMetastatic breast cancer patientsStandard combination chemotherapyMetastatic breast cancerBreast cancer patientsSingle agentResponse rateCombination chemotherapyCancer patientsBreast cancerUntreated metastatic breast cancer patientsMeasurable metastatic breast cancerRandomized phase III trialPhase III trialsDuration of responseSingle-agent drugsTreatment of patientsCumulative response rateSuggestion of benefitLow response rateImmediate chemotherapyIII trialsMetastatic diseaseVisceral diseaseRandomized studyRandomized phase III trial comparing the new potent and selective third-generation aromatase inhibitor vorozole with megestrol acetate in postmenopausal advanced breast cancer patients. North American Vorozole Study Group.
Goss PE, Winer EP, Tannock IF, Schwartz on behalf of the North American Vorozole Study Grou L. Randomized phase III trial comparing the new potent and selective third-generation aromatase inhibitor vorozole with megestrol acetate in postmenopausal advanced breast cancer patients. North American Vorozole Study Group. Journal Of Clinical Oncology 1999, 17: 52-63. PMID: 10458218, DOI: 10.1200/jco.1999.17.1.52.Peer-Reviewed Original ResearchConceptsPostmenopausal advanced breast cancer patientsAdvanced breast cancer patientsPhase III trialsBreast cancer patientsMegestrol acetateIII trialsCancer patientsTreatment groupsRandomized phase III trialUpper respiratory tract infectionSecond-line therapyAdvanced breast cancerDiscontinuation of treatmentRespiratory tract infectionsAromatase inhibitor vorozoleQuality of lifeMore dyspneaPostmenopausal womenAdverse eventsHot flushesMedian durationObjective responsePartial responseTamoxifen treatmentTract infections