2021
Chemotherapy-related amenorrhea (CRA) after adjuvant ado-trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT Trial)
Ruddy KJ, Zheng Y, Tayob N, Hu J, Dang CT, Yardley DA, Isakoff SJ, Valero VV, Faggen MG, Mulvey TM, Bose R, Sella T, Weckstein DJ, Wolff AC, Reeder-Hayes KE, Rugo HS, Ramaswamy B, Zuckerman DS, Hart LL, Gadi VK, Constantine M, Cheng KL, Briccetti FM, Schneider BP, Merrill Garrett A, Kelly Marcom P, Albain KS, DeFusco PA, Tung NM, Ardman BM, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu MC, Rosenberg S, DeMeo MK, Burstein HJ, Winer EP, Krop IE, Partridge AH, Tolaney SM. Chemotherapy-related amenorrhea (CRA) after adjuvant ado-trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT Trial). Breast Cancer Research And Treatment 2021, 189: 103-110. PMID: 34120223, DOI: 10.1007/s10549-021-06267-8.Peer-Reviewed Original ResearchConceptsChemotherapy-related amenorrheaEarly-stage breast cancerRisk of infertilityAdo-trastuzumab emtansineT-DM1Gonadotropin-releasing hormone agonistAdjuvant T-DM1T-DM1 3.6Amenorrhea ratesPermanent menopauseStandard HER2Chemotherapy regimensPrimary endpointProtocol therapyMedian ageOvarian toxicityPremature menopauseHormone agonistBreast cancerMenstrual dataMonthsAmenorrheaEmtansineMenopauseTrastuzumabPhase I study of JAK1/2 inhibitor ruxolitinib with weekly paclitaxel for the treatment of HER2-negative metastatic breast cancer
Lynce F, Williams JT, Regan MM, Bunnell CA, Freedman RA, Tolaney SM, Chen WY, Mayer EL, Partridge AH, Winer EP, Overmoyer B. Phase I study of JAK1/2 inhibitor ruxolitinib with weekly paclitaxel for the treatment of HER2-negative metastatic breast cancer. Cancer Chemotherapy And Pharmacology 2021, 87: 673-679. PMID: 33585999, DOI: 10.1007/s00280-021-04245-x.Peer-Reviewed Original ResearchConceptsHER2-negative metastatic breast cancerMetastatic breast cancerBreast cancerWeekly paclitaxelAdvanced diseaseHormone receptor-positive diseaseTriple-negative breast cancerGrade 4/5 toxicitiesMost frequent toxicitiesPhase 2 doseWeekly paclitaxel 80Receptor-positive diseaseDose-escalation designJAK1/2 inhibitor ruxolitinibCombination of ruxolitinibBreast cancer cellsOral ruxolitinibPaclitaxel 80PurposePreclinical studiesChemotherapy regimensFrequent toxicitiesProtocol therapyMethodsEligible patientsThirteen patientsVisceral disease
2020
TBCRC 048: Phase II Study of Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination-Related Genes.
Tung NM, Robson ME, Ventz S, Santa-Maria CA, Nanda R, Marcom PK, Shah PD, Ballinger TJ, Yang ES, Vinayak S, Melisko M, Brufsky A, DeMeo M, Jenkins C, Domchek S, D'Andrea A, Lin NU, Hughes ME, Carey LA, Wagle N, Wulf GM, Krop IE, Wolff AC, Winer EP, Garber JE. TBCRC 048: Phase II Study of Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination-Related Genes. Journal Of Clinical Oncology 2020, 38: 4274-4282. PMID: 33119476, DOI: 10.1200/jco.20.02151.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerObjective response rateProgression-free survivalPoly (ADP-ribose) polymerase (PARP) inhibitorsPhase II studyBreast cancerMutation carriersII studyMedian progression-free survivalNegative metastatic breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Clinical benefit rateHER2-negative diseasePlatinum-refractory diseaseGrowth factor receptor 2Population of patientsFactor receptor 2Homologous recombination-related genesConfirmed responsesEligible patientsMeasurable diseaseSecondary endpointsChemotherapy regimensPrimary endpoint
2015
Variation in type of adjuvant chemotherapy received among patients with stage I breast cancer: A multi‐institutional study
Vaz-Luis I, Hughes ME, Cronin AM, Rugo HS, Edge SB, Moy B, Theriault RL, Hassett MJ, Winer EP, Lin NU. Variation in type of adjuvant chemotherapy received among patients with stage I breast cancer: A multi‐institutional study. Cancer 2015, 121: 1937-1948. PMID: 25757412, PMCID: PMC4457605, DOI: 10.1002/cncr.29310.Peer-Reviewed Original ResearchConceptsStage I breast cancerI breast cancerHuman epidermal growth factor receptor 2Breast cancerAdjuvant chemotherapyIntensive regimensNational Comprehensive Cancer Network centersEpidermal growth factor receptor 2Choice of regimenHER2-negative diseaseHER2-positive diseaseCombination of docetaxelPercentage of patientsProspective cohort studyType of chemotherapyGrowth factor receptor 2Time of diagnosisAmerican Joint CommitteeMultivariable logistic regressionFactor receptor 2Multi-institutional studyCommon regimensChemotherapy regimensIntensive chemotherapyCohort study
2012
Combination antiangiogenic therapy in advanced breast cancer: a phase 1 trial of vandetanib, a VEGFR inhibitor, and metronomic chemotherapy, with correlative platelet proteomics
Mayer EL, Isakoff SJ, Klement G, Downing SR, Chen WY, Hannagan K, Gelman R, Winer EP, Burstein HJ. Combination antiangiogenic therapy in advanced breast cancer: a phase 1 trial of vandetanib, a VEGFR inhibitor, and metronomic chemotherapy, with correlative platelet proteomics. Breast Cancer Research And Treatment 2012, 136: 169-178. PMID: 23001754, PMCID: PMC5472381, DOI: 10.1007/s10549-012-2256-5.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, MetronomicAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, PharmacologicalBlood PlateletsBreast NeoplasmsCombined Modality TherapyCyclophosphamideDrug-Related Side Effects and Adverse ReactionsFemaleGene Expression Regulation, NeoplasticHumansMethotrexateMiddle AgedNeoplasm StagingNeovascularization, PathologicPiperidinesPlatelet Factor 4ProteomicsQuinazolinesVascular Endothelial Growth Factor AVascular Endothelial Growth Factor Receptor-1ConceptsMetastatic breast cancerBreast cancerMetronomic chemotherapyAntiangiogenic therapyCombination antiangiogenic therapyDose-escalation cohortsPrior chemotherapy regimensResponse-evaluable patientsAdvanced breast cancerModest clinical activityDose-limiting toxicityPhase 1 studyPhase 1 trialVascular endothelial growth factorPlatelet factor 4Platelet-associated proteinsEndothelial growth factorEligible patientsLFT abnormalitiesMetronomic cyclophosphamideStable diseaseChemotherapy regimensPrimary endpointSecondary endpointsPartial responseSix Cycles of Doxorubicin and Cyclophosphamide or Paclitaxel Are Not Superior to Four Cycles As Adjuvant Chemotherapy for Breast Cancer in Women With Zero to Three Positive Axillary Nodes: Cancer and Leukemia Group B 40101
Shulman LN, Cirrincione CT, Berry DA, Becker HP, Perez EA, O'Regan R, Martino S, Atkins JN, Mayer E, Schneider CJ, Kimmick G, Norton L, Muss H, Winer EP, Hudis C. Six Cycles of Doxorubicin and Cyclophosphamide or Paclitaxel Are Not Superior to Four Cycles As Adjuvant Chemotherapy for Breast Cancer in Women With Zero to Three Positive Axillary Nodes: Cancer and Leukemia Group B 40101. Journal Of Clinical Oncology 2012, 30: 4071-4076. PMID: 22826271, PMCID: PMC3494835, DOI: 10.1200/jco.2011.40.6405.Peer-Reviewed Original ResearchConceptsRelapse-free survivalHuman epidermal growth factor receptor 2Primary breast cancerPositive nodesBreast cancerHazard ratioAdjuvant chemotherapyChemotherapy regimenEstrogen receptor/progesterone receptorPrimary efficacy end pointEpidermal growth factor receptor 2Dose-dense fashionDoxorubicin/cyclophosphamideAdjusted hazard ratioCycles of doxorubicinEfficacy end pointOperable breast cancerPositive axillary nodesER/PgRGrowth factor receptor 2Factor receptor 2Chemotherapy regimensAxillary nodesMenopausal statusClinical outcomes
2010
Physical and Psychological Outcomes Among Women in a Telephone-Based Exercise Intervention During Adjuvant Therapy for Early Stage Breast Cancer
Ligibel JA, Partridge A, Giobbie-Hurder A, Campbell N, Shockro L, Salinardi T, Winer EP. Physical and Psychological Outcomes Among Women in a Telephone-Based Exercise Intervention During Adjuvant Therapy for Early Stage Breast Cancer. Journal Of Women's Health 2010, 19: 1553-1559. PMID: 20629579, DOI: 10.1089/jwh.2009.1760.Peer-Reviewed Original ResearchConceptsEarly-stage breast cancerStage breast cancerExercise interventionBreast cancerWeight gainAdjuvant therapyHome-based exercise interventionModerate-intensity aerobic exercise interventionSingle-arm pilot studyIntensive chemotherapy regimensAerobic exercise interventionBreast cancer patientsActivity/weekBreast cancer recurrenceBreast cancer diagnosisAdjuvant chemotherapyChemotherapy regimensPostoperative complicationsSedentary womenWeek 12Cancer outcomesPoor QoLCancer patientsCardiorespiratory fitnessWeekly exercise
2007
Toxicity of Older and Younger Patients Treated With Adjuvant Chemotherapy for Node-Positive Breast Cancer: The Cancer and Leukemia Group B Experience
Muss HB, Berry DA, Cirrincione C, Budman DR, Henderson IC, Citron ML, Norton L, Winer EP, Hudis CA. Toxicity of Older and Younger Patients Treated With Adjuvant Chemotherapy for Node-Positive Breast Cancer: The Cancer and Leukemia Group B Experience. Journal Of Clinical Oncology 2007, 25: 3699-3704. PMID: 17704418, DOI: 10.1200/jco.2007.10.9710.Peer-Reviewed Original ResearchConceptsAdjuvant chemotherapy regimensTreatment-related deathsYounger patientsAdjuvant chemotherapyHematologic toxicityNonhematologic toxicityChemotherapy regimensOlder patientsGrade 3Acute myeloid leukemia/myelodysplastic syndromeNational Cancer Institute grade 3Grade 4 hematologic toxicityLeukemia Group B experienceLeukemia/myelodysplastic syndromeNode-positive breast cancerComparison of cyclophosphamideNode-positive patientsPercent of patientsHealthy older patientsStrict eligibility criteriaRisk of toxicityCALGB 9741Patients 65Elderly patientsOverall survival
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 regimens
2004
Failure of Higher-Dose Paclitaxel to Improve Outcome in Patients With Metastatic Breast Cancer: Cancer and Leukemia Group B Trial 9342
Winer EP, Berry DA, Woolf S, Duggan D, Kornblith A, Harris LN, Michaelson RA, Kirshner JA, Fleming GF, Perry MC, Graham ML, Sharp SA, Keresztes R, Henderson IC, Hudis C, Muss H, Norton L. Failure of Higher-Dose Paclitaxel to Improve Outcome in Patients With Metastatic Breast Cancer: Cancer and Leukemia Group B Trial 9342. Journal Of Clinical Oncology 2004, 22: 2061-2068. PMID: 15169793, DOI: 10.1200/jco.2004.08.048.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerBreast cancerQuality of lifeOptimal doseResponse rateSignificant dose-response relationshipHigh-dose armPrior chemotherapy regimensHigh-dose therapySymptom assessment questionnaireCycles of treatmentSelf-administered qualitySignificant differencesDose-response relationshipChemotherapy regimensDose therapyHematologic toxicityDose armAssessment QuestionnaireHigh dosesMultivariate analysisSignificant associationInfusionCancerRegimens