2024
Mortality Risks Over 20 Years in Men With Stage I to III Hormone Receptor–Positive Breast Cancer
Leone J, Hassett M, Freedman R, Tolaney S, Graham N, Tayob N, Vallejo C, Winer E, Lin N, Leone J. Mortality Risks Over 20 Years in Men With Stage I to III Hormone Receptor–Positive Breast Cancer. JAMA Oncology 2024, 10: 508-515. PMID: 38421673, PMCID: PMC10905378, DOI: 10.1001/jamaoncol.2023.7194.Peer-Reviewed Original ResearchBreast cancer-specific mortalityRisk of breast cancer-specific mortalityBreast cancer-specific mortality riskHR+ breast cancerBreast cancerStage I to III hormone receptor-positive breast cancerEnd Results ProgramPopulation-based dataHormone receptor-positive (HR+) breast cancerCancer-specific mortalityObservational cohort studyResults ProgramRisk of late mortalityHigher stages of diseaseHormone receptor-positive breast cancerReceptor-positive breast cancerMortality riskCohort studyRisk of distant recurrenceStage IIICumulative riskStage IIMultivariate regressionMedian follow-upGrade I tumors
2022
The feasibility of using an autologous GM-CSF-secreting breast cancer vaccine to induce immunity in patients with stage II–III and metastatic breast cancers
Anderson KS, Erick TK, Chen M, Daley H, Campbell M, Colson Y, Mihm M, Zakka LR, Hopper M, Barry W, Winer EP, Dranoff G, Overmoyer B. The feasibility of using an autologous GM-CSF-secreting breast cancer vaccine to induce immunity in patients with stage II–III and metastatic breast cancers. Breast Cancer Research And Treatment 2022, 194: 65-78. PMID: 35482127, PMCID: PMC9046531, DOI: 10.1007/s10549-022-06562-y.Peer-Reviewed Original ResearchConceptsBreast cancer vaccinesAutologous GM-CSFBreast cancerMetastatic diseaseGM-CSFStage IICancer vaccinesTumor cellsEvidence of diseaseStart of vaccinationInjection site reactionsMetastatic breast cancerUpper respiratory symptomsImmune cell infiltrationRole of vaccinationReplication-defective adenoviral vectorEvaluable patientsMethodsTumor cellsStable diseaseWeekly vaccinationsJoint painProgressive diseaseRespiratory symptomsFifth injectionTRIAL REGISTRATION
2021
The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention
Delahanty LM, Wadden TA, Goodwin PJ, Alfano CM, Thomson CA, Irwin ML, Neuhouser ML, Crane TE, Frank E, Spears PA, Gillis BP, Hershman DL, Paskett ED, Hopkins J, Bernstein V, Stearns V, White J, Hudis C, Winer EP, Carey L, Partridge AH, Ligibel JA. The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention. Obesity 2021, 30: 28-38. PMID: 34932888, PMCID: PMC9186690, DOI: 10.1002/oby.23287.Peer-Reviewed Original ResearchConceptsWeight loss interventionWeight loss trialLifestyle interventionHealth education materialsWeight lossLoss trialPhysical activityInvasive disease-free survivalDisease-free survivalBreast cancer patientsBreast cancer diagnosisCare of thousandsEducation materialsBaseline weightCancer outcomesCancer patientsHealth coachesCancer recurrenceBreast cancerCaloric restrictionStage IITrialsCancer diagnosisInterventionWomenA 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
A Prospective Phase I trial of Concurrent Cisplatin (CIS) and Radiation Therapy (RT) in Women with Stage II and III Triple-negative Breast Cancer (TNBC)
Bellon J, Chen Y, Rees R, Taghian A, Wong J, Punglia R, Shiloh R, Krishnan M, Andrews C, Isakoff S, Winer E, Tolaney S. A Prospective Phase I trial of Concurrent Cisplatin (CIS) and Radiation Therapy (RT) in Women with Stage II and III Triple-negative Breast Cancer (TNBC). International Journal Of Radiation Oncology • Biology • Physics 2019, 105: s43. DOI: 10.1016/j.ijrobp.2019.06.466.Peer-Reviewed Original Research
2016
Impact of neoadjuvant therapy on eligibility for and frequency of breast conservation in stage II–III HER2-positive breast cancer: surgical results of CALGB 40601 (Alliance)
Golshan M, Cirrincione CT, Sikov WM, Carey LA, Berry DA, Overmoyer B, Henry NL, Somlo G, Port E, Burstein HJ, Hudis C, Winer E, Ollila DW, for the Alliance for Clinical Trials in Oncology. Impact of neoadjuvant therapy on eligibility for and frequency of breast conservation in stage II–III HER2-positive breast cancer: surgical results of CALGB 40601 (Alliance). Breast Cancer Research And Treatment 2016, 160: 297-304. PMID: 27704226, PMCID: PMC5189982, DOI: 10.1007/s10549-016-4006-6.Peer-Reviewed Original ResearchConceptsNeoadjuvant systemic therapyBreast-conserving therapyBCT-eligible patientsPathologic complete responseSuccessful breast-conserving therapyHER2-positive breast cancerBCT eligibilityPCR rateBreast conservationSurgical assessmentBreast cancerStage IIHigh clinical response rateFinal surgical procedureClinical response rateSubset of patientsManagement of patientsPoor cosmetic outcomeSuccess rateCALGB 40601Converted patientsNeoadjuvant trialsNeoadjuvant therapyPrimary surgeryMulticentric disease
2015
Impact of Neoadjuvant Chemotherapy in Stage II–III Triple Negative Breast Cancer on Eligibility for Breast-conserving Surgery and Breast Conservation Rates
Golshan M, Cirrincione CT, Sikov WM, Berry DA, Jasinski S, Weisberg TF, Somlo G, Hudis C, Winer E, Ollila DW. Impact of Neoadjuvant Chemotherapy in Stage II–III Triple Negative Breast Cancer on Eligibility for Breast-conserving Surgery and Breast Conservation Rates. Annals Of Surgery 2015, 262: 434-439. PMID: 26222764, PMCID: PMC4710511, DOI: 10.1097/sla.0000000000001417.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinChemotherapy, AdjuvantDisease-Free SurvivalDoxorubicinFemaleHumansMastectomy, SegmentalMaximum Tolerated DoseMiddle AgedNeoadjuvant TherapyNeoplasm InvasivenessNeoplasm StagingPaclitaxelPatient SelectionPrognosisProspective StudiesSurvival AnalysisTreatment OutcomeTriple Negative Breast NeoplasmsYoung AdultConceptsNeoadjuvant systemic therapyBreast-conserving therapyTriple-negative breast cancerNegative breast cancerSuccessful breast-conserving therapyBCT candidatesBreast cancerStage IIAddition of carboplatinBCT-eligible patientsRandomized phase IIBreast conservation ratesTumor-free marginsBCT eligibilityNeoadjuvant paclitaxelNeoadjuvant chemotherapySystemic therapySurgical outcomesSurgical choiceTumor regressionPatient's discretionFactorial trialPatientsAbsolute increaseCancer
2014
Impact of the Addition of Carboplatin and/or Bevacizumab to Neoadjuvant Once-per-Week Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide on Pathologic Complete Response Rates in Stage II to III Triple-Negative Breast Cancer: CALGB 40603 (Alliance)
Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the Addition of Carboplatin and/or Bevacizumab to Neoadjuvant Once-per-Week Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide on Pathologic Complete Response Rates in Stage II to III Triple-Negative Breast Cancer: CALGB 40603 (Alliance). Journal Of Clinical Oncology 2014, 33: 13-21. PMID: 25092775, PMCID: PMC4268249, DOI: 10.1200/jco.2014.57.0572.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCyclophosphamideDose-Response Relationship, DrugDoxorubicinDrug Administration ScheduleFatigueFemaleHumansHypertensionMiddle AgedNeoadjuvant TherapyNeoplasm StagingNeutropeniaPaclitaxelRemission InductionThrombocytopeniaTreatment OutcomeTriple Negative Breast NeoplasmsConceptsTriple-negative breast cancerPathologic complete responseNeoadjuvant chemotherapyBreast/axillaStage IIBreast cancerPathologic complete response rateRandomized phase II trialAddition of carboplatinDose-dense doxorubicinRole of carboplatinComplete response ratePhase II trialStandard neoadjuvant chemotherapyThird of patientsAdjuvant trialsConcurrent carboplatinSkipped dosesWeek paclitaxelEarly discontinuationII trialPostoperative complicationsThromboembolic eventsDose modificationOverall survival
2013
Clinical and translational results of CALGB 40601: A neoadjuvant phase III trial of weekly paclitaxel and trastuzumab with or without lapatinib for HER2-positive breast cancer.
Carey L, Berry D, Ollila D, Harris L, Krop I, Weckstein D, Henry N, Anders C, Cirrincione C, Winer E, Perou C, Hudis C. Clinical and translational results of CALGB 40601: A neoadjuvant phase III trial of weekly paclitaxel and trastuzumab with or without lapatinib for HER2-positive breast cancer. Journal Of Clinical Oncology 2013, 31: 500-500. DOI: 10.1200/jco.2013.31.15_suppl.500.Peer-Reviewed Original ResearchHER2-positive breast cancerBreast pCR ratePathological complete responsePCR rateCALGB 40601Weekly paclitaxelResidual diseaseBreast cancerStage IIClinical stage IIDose-dense ACPhase III trialsProgression-free survivalHER2-targeted agentsBiomarkers of sensitivityGene copy number abnormalitiesTissue-based studiesEligible patientsNeoadjuvant settingNeoadjuvant studiesTH armPrimary endpointIII trialsMetastatic diseaseComplete response
2005
Prospective evaluation of concurrent paclitaxel and radiation therapy after adjuvant doxorubicin and cyclophosphamide chemotherapy for Stage II or III breast cancer
Burstein HJ, Bellon JR, Galper S, Lu HM, Kuter I, Taghian AG, Wong J, Gelman R, Bunnell CA, Parker LM, Garber JE, Winer EP, Harris JR, Powell SN. Prospective evaluation of concurrent paclitaxel and radiation therapy after adjuvant doxorubicin and cyclophosphamide chemotherapy for Stage II or III breast cancer. International Journal Of Radiation Oncology • Biology • Physics 2005, 64: 496-504. PMID: 16243442, DOI: 10.1016/j.ijrobp.2005.07.975.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDoxorubicinDrug Administration ScheduleFeasibility StudiesFemaleHumansPaclitaxelProspective StudiesRadiation PneumonitisRadiation-Sensitizing AgentsRadiotherapy DosageRadiotherapy, AdjuvantConceptsRadiation therapyBreast cancerAdjuvant doxorubicinConcurrent paclitaxelWeekly paclitaxelAC chemotherapyConcurrent radiationConcurrent treatmentGrade 2 radiation pneumonitisStage IIEarly-stage breast cancerAdjuvant AC chemotherapyDefinitive breast surgeryOperable stage IIWeekly paclitaxel treatmentConcurrent radiation therapyDose-limiting toxicityProtocol-based treatmentAdjuvant chemotherapyPaclitaxel scheduleSteroid therapyCyclophosphamide chemotherapyRadiation pneumonitisPulmonary injuryRadiation dermatitis
2003
Preoperative Therapy With Trastuzumab and Paclitaxel Followed by Sequential Adjuvant Doxorubicin/Cyclophosphamide for HER2 Overexpressing Stage II or III Breast Cancer: A Pilot Study
Burstein HJ, Harris LN, Gelman R, Lester SC, Nunes RA, Kaelin CM, Parker LM, Ellisen LW, Kuter I, Gadd MA, Christian RL, Kennedy PR, Borges VF, Bunnell CA, Younger J, Smith BL, Winer EP. Preoperative Therapy With Trastuzumab and Paclitaxel Followed by Sequential Adjuvant Doxorubicin/Cyclophosphamide for HER2 Overexpressing Stage II or III Breast Cancer: A Pilot Study. Journal Of Clinical Oncology 2003, 21: 46-53. PMID: 12506169, DOI: 10.1200/jco.2003.03.124.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptor 2Early-stage breast cancerPreoperative trastuzumabBreast cancerPreoperative therapyHER2 extracellular domainAdjuvant doxorubicinCyclophosphamide chemotherapyAdjuvant doxorubicin/cyclophosphamideStage IILeft ventricular ejection fractionEpidermal growth factor receptor 2Pilot studyDefinitive breast surgeryDoxorubicin/cyclophosphamideGrade 2 cardiotoxicityPathologic response rateAdvanced breast cancerComplete pathologic responseTrastuzumab-based treatmentGrowth factor receptor 2Ventricular ejection fractionStage breast cancerFactor receptor 2Sequential treatment program