2021
Physical Activity, Weight, and Outcomes in Patients Receiving Chemotherapy for Metastatic Breast Cancer (C40502/Alliance)
Ligibel JA, Huebner L, Rugo HS, Burstein HJ, Toppmeyer DL, Anders CK, Ma C, Barry WT, Suman V, Carey LA, Partridge AH, Hudis CA, Winer EP. Physical Activity, Weight, and Outcomes in Patients Receiving Chemotherapy for Metastatic Breast Cancer (C40502/Alliance). JNCI Cancer Spectrum 2021, 5: pkab025-. PMID: 33981951, PMCID: PMC8103727, DOI: 10.1093/jncics/pkab025.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBody HeightBody Mass IndexBody WeightBreast NeoplasmsEpothilonesExerciseFemaleHumansMiddle AgedObesityPaclitaxelProgression-Free SurvivalProportional Hazards ModelsTreatment OutcomeYoung AdultConceptsProgression-free survivalMetastatic breast cancerBody mass indexOverall survivalPhysical activityBreast cancerMass indexMET hoursFirst-line taxane-based chemotherapyHormone receptor-positive cancersBaseline body mass indexFirst-line chemotherapyTaxane-based chemotherapyReceptor-positive cancersRecreational physical activityRates of obesityMetastatic diseaseCox modelingMedian ageOverall mortalityRandomized trialsTask hoursMetabolic equivalentsPatientsCancer
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 outcomes
2017
Kinetic-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
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)
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
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
2011
A Phase II Study of Sagopilone (ZK 219477; ZK-EPO) in Patients With Breast Cancer and Brain Metastases
Freedman RA, Bullitt E, Sun L, Gelman R, Harris G, Ligibel JA, Krop IE, Partridge AH, Eisenberg E, Winer EP, Lin NU. A Phase II Study of Sagopilone (ZK 219477; ZK-EPO) in Patients With Breast Cancer and Brain Metastases. Clinical Breast Cancer 2011, 11: 376-383. PMID: 21697017, PMCID: PMC3773692, DOI: 10.1016/j.clbc.2011.03.024.Peer-Reviewed Original ResearchConceptsMedian progression-free survivalProgression-free survivalObjective response ratePhase II studyBrain metastasesChallenging clinical problemBreast cancerCentral nervous systemII studyOverall survivalMagnetic resonance angiographyClinical problemCentral nervous system (CNS) objective response rateResponse rateCNS objective response rateCommon grade 3 toxicitiesProgressive metastatic breast cancerBreast cancer brain metastasesProgressive CNS diseaseGrade 3 toxicityRecurrent brain metastasesWhole brain radiotherapyCancer brain metastasesMetastatic breast cancerHigh-resolution magnetic resonance angiography