2022
CALGB 40603 (Alliance): Long-Term Outcomes and Genomic Correlates of Response and Survival After Neoadjuvant Chemotherapy With or Without Carboplatin and Bevacizumab in Triple-Negative Breast Cancer
Shepherd JH, Ballman K, Polley MC, Campbell JD, Fan C, Selitsky S, Fernandez-Martinez A, Parker JS, Hoadley KA, Hu Z, Li Y, Soloway MG, Spears PA, Singh B, Tolaney SM, Somlo G, Port ER, Ma C, Kuzma C, Mamounas E, Golshan M, Bellon JR, Collyar D, Hahn OM, Hudis CA, Winer EP, Partridge A, Hyslop T, Carey LA, Perou CM, Sikov WM. CALGB 40603 (Alliance): Long-Term Outcomes and Genomic Correlates of Response and Survival After Neoadjuvant Chemotherapy With or Without Carboplatin and Bevacizumab in Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2022, 40: 1323-1334. PMID: 35044810, PMCID: PMC9015203, DOI: 10.1200/jco.21.01506.Peer-Reviewed Original ResearchConceptsLong-term outcomesEvent-free survivalTriple-negative breast cancerResidual cancer burdenResidual diseaseImmune activationBreast cancerPathologic complete response rateRandomized phase II trialEnd pointSuperior long-term outcomesCox proportional hazards modelComplete response rateSecondary end pointsPhase II trialPretreatment tumor biopsiesKaplan-Meier methodOverall survival rateTumor-infiltrating lymphocytesLog-rank testPretreatment tumor samplesMinimal residual diseaseProportional hazards modelWeekly paclitaxelII trial
2021
ALEXANDRA/IMpassion030: A phase 3 study of standard adjuvant chemotherapy with or without atezolizumab in patients with early-stage triple-negative breast cancer.
Saji S, McArthur H, Ignatiadis M, Bailey A, El-Abed S, Brandao M, Metzger O, Lai C, Guillaume S, Fumagalli D, Agbor-tarh D, Seiller A, Xifro R, Honvault V, Viale G, DuFrane C, Barata T, Winer E, Gelber R, Piccart-Gebhart M. ALEXANDRA/IMpassion030: A phase 3 study of standard adjuvant chemotherapy with or without atezolizumab in patients with early-stage triple-negative breast cancer. Journal Of Clinical Oncology 2021, 39: tps597-tps597. DOI: 10.1200/jco.2021.39.15_suppl.tps597.Peer-Reviewed Original ResearchTriple-negative breast cancerInvasive disease-free survivalEarly-stage triple-negative breast cancerPD-L1Breast cancerAdjuvant chemotherapyStage triple-negative breast cancerMetastatic triple-negative breast cancerPD-L1 negative tumorsF. Hoffmann-La Roche LtdBreast International GroupOperable stage IIRandomized phase 3Same chemotherapy regimenStandard adjuvant chemotherapyCentral pathology reviewDisease-free survivalPD-L1 statusPhase 3 studyPhase 3 trialType of surgeryNegative breast cancerQuality of lifeAtezolizumab 1200Weekly paclitaxelPhase 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
2014
Gene expression signatures in pre- and post-therapy (Rx) specimens from CALGB 40601 (Alliance), a neoadjuvant phase III trial of weekly paclitaxel and trastuzumab with or without lapatinib for HER2-positive breast cancer (BrCa).
Carey L, Barry W, Pitcher B, Hoadley K, Cheang M, Anders C, Henry N, Tolaney S, Dang C, Krop I, Harris L, Berry D, Perou C, Winer E, Hudis C. Gene expression signatures in pre- and post-therapy (Rx) specimens from CALGB 40601 (Alliance), a neoadjuvant phase III trial of weekly paclitaxel and trastuzumab with or without lapatinib for HER2-positive breast cancer (BrCa). Journal Of Clinical Oncology 2014, 32: 506-506. DOI: 10.1200/jco.2014.32.15_suppl.506.Peer-Reviewed Original Research
2013
A Phase I dose-escalation study of the VEGFR inhibitor tivozanib hydrochloride with weekly paclitaxel in metastatic breast cancer
Mayer EL, Scheulen ME, Beckman J, Richly H, Duarte A, Cotreau MM, Strahs AL, Agarwal S, Steelman L, Winer EP, Dickler MN. A Phase I dose-escalation study of the VEGFR inhibitor tivozanib hydrochloride with weekly paclitaxel in metastatic breast cancer. Breast Cancer Research And Treatment 2013, 140: 331-339. PMID: 23868188, DOI: 10.1007/s10549-013-2632-9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsFemaleHumansMiddle AgedNeoplasm MetastasisPaclitaxelPhenylurea CompoundsProtein Kinase InhibitorsQuinolinesVascular Endothelial Growth Factor Receptor-1ConceptsMetastatic breast cancerTyrosine kinase inhibitorsWeekly paclitaxelPaclitaxel 90Breast cancerPhase I dose-escalation studyI dose-escalation studyVascular endothelial growth factor receptor 1Activity of tivozanibSafety/tolerabilityGrade 3/4 toxicitiesPeripheral sensory neuropathyPhase Ib studyDose-escalation studyResponse Evaluation CriteriaSelective tyrosine kinase inhibitorVEGFR-TKI treatmentSolid Tumors responseGrowth factor receptor 1Influence of paclitaxelFactor receptor 1Stable diseaseMBC patientsPartial responseProgressive diseaseClinical 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 responsePAM50 proliferation score as a predictor of weekly paclitaxel benefit in breast cancer
Martín M, Prat A, Rodríguez-Lescure Á, Caballero R, Ebbert MT, Munárriz B, Ruiz-Borrego M, Bastien RR, Crespo C, Davis C, Rodríguez CA, López-Vega JM, Furió V, García AM, Casas M, Ellis MJ, Berry DA, Pitcher BN, Harris L, Ruiz A, Winer E, Hudis C, Stijleman IJ, Tuck DP, Carrasco E, Perou CM, Bernard PS. PAM50 proliferation score as a predictor of weekly paclitaxel benefit in breast cancer. Breast Cancer Research And Treatment 2013, 138: 457-466. PMID: 23423445, PMCID: PMC3608881, DOI: 10.1007/s10549-013-2416-2.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCell ProliferationClinical Trials, Phase III as TopicCyclophosphamideEpirubicinFemaleFluorouracilHumansKaplan-Meier EstimateKi-67 AntigenMiddle AgedMulticenter Studies as TopicMultivariate AnalysisPaclitaxelProportional Hazards ModelsProspective StudiesRandomized Controlled Trials as TopicTreatment OutcomeConceptsGroup of patientsWeekly paclitaxelOverall survivalPAM50 subtypesProliferation scoreBreast cancerNode-positive operable breast cancerMultivariable Cox regression analysisLow proliferation statusAnthracycline-containing chemotherapyOperable breast cancerPhase III trialsSubset of patientsCox regression analysisClinical-pathological variablesFEC armMedian followAdjuvant therapySecondary endpointsIII trialsPathological variablesHistologic gradeClinical trialsAdjuvant FECKi-67
2012
CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC).
Rugo H, Barry W, Moreno-Aspitia A, Lyss A, Cirrincione C, Mayer E, Naughton M, Layman R, Carey L, Somer R, Perez E, Hudis C, Winer E. CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC). Journal Of Clinical Oncology 2012, 30: cra1002-cra1002. DOI: 10.1200/jco.2012.30.18_suppl.cra1002.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast cancerNab-paclitaxelPhase III trialsSensory neuropathyHazard ratioIII trialsInterim analysisGrade 2 sensory neuropathyMedian progression-free survivalAlbumin-bound formulationWeekly nanoparticle albuminPrimary end pointFirst-line therapyHormone receptor statusCause deathMeasurable diseaseWeek dosingWeekly paclitaxelHematologic toxicityFree survivalReceptor statusTaxane useExperimental armNanoparticle albuminCALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC).
Rugo H, Barry W, Moreno-Aspitia A, Lyss A, Cirrincione C, Mayer E, Naughton M, Layman R, Carey L, Somer R, Perez E, Hudis C, Winer E. CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC). Journal Of Clinical Oncology 2012, 30: cra1002-cra1002. DOI: 10.1200/jco.2012.30.15_suppl.cra1002.Peer-Reviewed Original Research
2011
P2-18-02: Cardiac Outcomes of Patients on Adjuvant Weekly Paclitaxel (T) and Trastuzumab (H) for Node Negative, HER2 Positive Breast Cancer (BCA).
Dang C, Tolaney S, Najita J, Gelman R, Yardley D, Marcom K, Albain K, Rugo H, Miller K, Ellis M, Shapira I, Wolff A, Carey L, Vahdat L, Burdette-Radoux S, Budd T, Krop I, Burstein H, Hudis C, Winer E. P2-18-02: Cardiac Outcomes of Patients on Adjuvant Weekly Paclitaxel (T) and Trastuzumab (H) for Node Negative, HER2 Positive Breast Cancer (BCA). Cancer Research 2011, 71: p2-18-02-p2-18-02. DOI: 10.1158/0008-5472.sabcs11-p2-18-02.Peer-Reviewed Original ResearchLeft ventricular ejection fractionCongestive heart failureHER2-positive breast cancerBenefit of chemotherapyPositive breast cancerBreast cancerHeart failureHigh-risk node-negative breast cancerIncidence of CHFSerial left ventricular ejection fractionSymptomatic congestive heart failureNode-negative breast cancerAdjuvant weekly paclitaxelAnthracycline-based treatmentNode-negative groupNode-negative populationVentricular systolic dysfunctionPhase II studyDisease-free survivalVentricular ejection fractionLVEF monitoringLVEF recoveryWeekly paclitaxelPrimary endpointProtocol therapyPaclitaxel efficacy and toxicity in older women with metastatic breast cancer: combined analysis of CALGB 9342 and 9840
Lichtman S, Hurria A, Cirrincione C, Seidman A, Winer E, Hudis C, Cohen H, Muss H, B F. Paclitaxel efficacy and toxicity in older women with metastatic breast cancer: combined analysis of CALGB 9342 and 9840. Annals Of Oncology 2011, 23: 632-638. PMID: 21693770, PMCID: PMC3331731, DOI: 10.1093/annonc/mdr297.Peer-Reviewed Original ResearchConceptsProgression-free survivalGood performance statusFirst-line therapyMetastatic breast cancerOverall survivalPerformance statusBreast cancerOlder womenLeukemia Group B StudySecond-line therapyImproved overall survivalDoses of paclitaxelEstrogen receptor-positive statusTolerability of paclitaxelToxic effectsBilirubin elevationPaclitaxel efficacyWeekly paclitaxelOlder patientsMetastatic sitesTumor responseSimilar efficacyPositive statusSpecific toxic effectsPatientsTroponin I and C-Reactive Protein Are Commonly Detected in Patients with Breast Cancer Treated with Dose-Dense Chemotherapy Incorporating Trastuzumab and Lapatinib
Morris PG, Chen C, Steingart R, Fleisher M, Lin N, Moy B, Come S, Sugarman S, Abbruzzi A, Lehman R, Patil S, Dickler M, McArthur HL, Winer E, Norton L, Hudis CA, Dang CT. Troponin I and C-Reactive Protein Are Commonly Detected in Patients with Breast Cancer Treated with Dose-Dense Chemotherapy Incorporating Trastuzumab and Lapatinib. Clinical Cancer Research 2011, 17: 3490-3499. PMID: 21372222, DOI: 10.1158/1078-0432.ccr-10-1359.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, PharmacologicalBiomarkers, TumorBreast NeoplasmsC-Reactive ProteinCarcinomaDose-Response Relationship, DrugFeasibility StudiesFemaleHumansLapatinibMiddle AgedQuinazolinesStroke VolumeTrastuzumabTroponin IConceptsLeft ventricular ejection fractionC-reactive proteinMedian left ventricular ejection fractionTroponin IDetectable C-reactive proteinDose-dense doxorubicinAnthracycline-based chemotherapyDose-dense chemotherapyVentricular ejection fractionProspective feasibility studyCardiac troponin IDetectable cTnIWeekly paclitaxelMonth 6CTnI levelsEjection fractionMonth 3Months 0Month 2Breast cancerEarly biomarkersPatientsChemotherapyEarly detectionTrastuzumab
2010
Randomized phase II trial of adding carboplatin and/or bevacizumab to neoadjuvant weekly paclitaxel and dose-dense AC in triple-negative breast cancer.
Sikov W, Perou C, Golshan M, Collyar D, Berry D, Hahn O, Singh B, Hudis C, Winer E. Randomized phase II trial of adding carboplatin and/or bevacizumab to neoadjuvant weekly paclitaxel and dose-dense AC in triple-negative breast cancer. Journal Of Clinical Oncology 2010, 28: tps110-tps110. DOI: 10.1200/jco.2010.28.15_suppl.tps110.Peer-Reviewed Original ResearchDose-Dense Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel With Trastuzumab and Lapatinib in HER2/neu–Overexpressed/Amplified Breast Cancer Is Not Feasible Because of Excessive Diarrhea
Dang C, Lin N, Moy B, Come S, Sugarman S, Morris P, Abbruzzi A, Chen C, Steingart R, Patil S, Norton L, Winer E, Hudis C. Dose-Dense Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel With Trastuzumab and Lapatinib in HER2/neu–Overexpressed/Amplified Breast Cancer Is Not Feasible Because of Excessive Diarrhea. Journal Of Clinical Oncology 2010, 28: 2982-2988. PMID: 20479410, PMCID: PMC3664034, DOI: 10.1200/jco.2009.26.5900.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclophosphamideDiarrheaDose-Response Relationship, DrugDoxorubicinFeasibility StudiesFemaleFilgrastimFollow-Up StudiesGene AmplificationGranulocyte Colony-Stimulating FactorHumansImmunoenzyme TechniquesIn Situ Hybridization, FluorescenceLapatinibMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPaclitaxelPilot ProjectsPolyethylene GlycolsQuinazolinesReceptor, ErbB-2Recombinant ProteinsSurvival RateTrastuzumabTreatment OutcomeConceptsDose-dense ACDose-dense doxorubicinGrade 3 diarrheaBreast cancerDose reductionDose delay/reductionHER2-positive breast cancerHuman epidermal growth factor receptorAsymptomatic LVEF declineCardiac event ratePrimary end pointCongestive heart failureMetastatic breast cancerVentricular ejection fractionDelays/reductionsEpidermal growth factor receptorExcessive diarrheaGrowth factor receptorLVEF declineWeekly paclitaxelEjection fractionHeart failureMedian agePatientsStage I
2009
Dose-Dense (dd) Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel (P) with Trastuzumab (T) and Lapatinib (L) in Early Breast Cancer (EBC); Troponin I and C-Reactive Protein as Biomarkers of Cardiotoxicity.
Morris P, Chen C, Lin N, Moy B, Come S, Abbruzzi A, Patil S, Winer E, Norton L, Hudis C, Dang C. Dose-Dense (dd) Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel (P) with Trastuzumab (T) and Lapatinib (L) in Early Breast Cancer (EBC); Troponin I and C-Reactive Protein as Biomarkers of Cardiotoxicity. Cancer Research 2009, 69: 3088-3088. DOI: 10.1158/0008-5472.sabcs-09-3088.Peer-Reviewed Original ResearchLeft ventricular ejection fractionCongestive heart failureC-reactive proteinEarly breast cancerBiomarkers of cardiotoxicityMinimal elevationEvidence of CHFElevated C-reactive proteinTroponin IDose-dense doxorubicinSensitive inflammatory markerAnti-HER2 agentsVentricular ejection fractionPre-planned analysisCardiac troponin IElevated TnIUncontrolled arrhythmiaWeekly paclitaxelInflammatory markersMUGA scanUnstable anginaEjection fractionHeart failureRecent MIProspective study5034 Troponin I and C-reactive protein as biomarkers for changes in left ventricular ejection fraction in patients with early stage breast cancer treated with dose-dense doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel with trastuzumab and lapatinib
Morris P, Chen C, Lin N, Moy B, Come S, Abbruzzi A, Winer E, Norton L, Hudis C, Dang C. 5034 Troponin I and C-reactive protein as biomarkers for changes in left ventricular ejection fraction in patients with early stage breast cancer treated with dose-dense doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel with trastuzumab and lapatinib. European Journal Of Cancer Supplements 2009, 7: 271. DOI: 10.1016/s1359-6349(09)70926-7.Peer-Reviewed Original ResearchDose-dense (DD) doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (P) with trastuzumab (T) and lapatinib (L) in HER2/neu-positive breast cancer is not feasible due to excessive diarrhea: updated results.
Dang C, Lin N, Moy B, Come S, Lake D, Theodoulou M, Troso-Sandoval T, Dickler M, Gorsky M, D'Andrea G, Modi S, Seidman A, Drullinsky P, Partridge A, Schapira L, Wulf G, Gilewski T, Atieh D, Mayer E, Isakoff S, Sugarman S, Fornier M, Traina T, Bromberg J, Currie V, Robson M, Burstein H, Overmoyer B, Ryan P, Kuter I, Younger J, Schumer S, Tung N, Zarwan C, Schnipper L, Chen C, Winer E, Norton L, Hudis C. Dose-dense (DD) doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (P) with trastuzumab (T) and lapatinib (L) in HER2/neu-positive breast cancer is not feasible due to excessive diarrhea: updated results. Cancer Research 2009, 69: 2108. DOI: 10.1158/0008-5472.sabcs-2108.Peer-Reviewed Original ResearchDd ACHER2- BCLVEF declineDose reductionHER2/neu-positive breast cancerCongestive heart failure ratesNeu-positive breast cancerAsymptomatic LVEF declineCardiac event rateDose-dense doxorubicinHeart failure ratesDose delaysExcessive diarrheaWeekly paclitaxelMedian ageCardiac safetyMonth 2Breast cancerEvent ratesCancer ResDiarrheaPilot studyLVEFLapatinibBaselinePaclitaxel in older women with breast cancer. Combined analysis of CALGB 9342 and 9840 with a focus on age.
Lichtman S, Hurria A, Cirrincione C, Seidman A, Winer E, Hudis C, Cohen H, Muss H. Paclitaxel in older women with breast cancer. Combined analysis of CALGB 9342 and 9840 with a focus on age. Cancer Research 2009, 69: 6112. DOI: 10.1158/0008-5472.sabcs-6112.Peer-Reviewed Original ResearchFirst-line therapyLines of therapyBreast cancerPatient ageOlder womenSide effectsLine therapyOlder adultsIncidence of gradeOnset of gradePrior chemotherapy regimenSecond-line patientsSingle-agent paclitaxelDoses of paclitaxelMetastatic breast cancerOnset of neurotoxicityRisk of fallsStandard prognostic variablesAge categoriesLikelihood of responseBetter performance scoresPerformance scoresBilirubin elevationPaclitaxel efficacyWeekly paclitaxel
2008
Preliminary safety results of dose-dense (dd) doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (P) with trastuzumab (T) and lapatinib (L) in HER2 overexpressed/amplified breast cancer (BCA)
Dang C, Lin N, Lake D, Dickler M, Modi S, Seidman A, Steingart R, Norton L, Winer E, Hudis C. Preliminary safety results of dose-dense (dd) doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (P) with trastuzumab (T) and lapatinib (L) in HER2 overexpressed/amplified breast cancer (BCA). Journal Of Clinical Oncology 2008, 26: 518-518. DOI: 10.1200/jco.2008.26.15_suppl.518.Peer-Reviewed Original ResearchRandomized 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