2023
Immunological and clinicopathological features predict HER2-positive breast cancer prognosis in the neoadjuvant NeoALTTO and CALGB 40601 randomized trials
Rediti M, Fernandez-Martinez A, Venet D, Rothé F, Hoadley K, Parker J, Singh B, Campbell J, Ballman K, Hillman D, Winer E, El-Abed S, Piccart M, Di Cosimo S, Symmans W, Krop I, Salgado R, Loi S, Pusztai L, Perou C, Carey L, Sotiriou C. Immunological and clinicopathological features predict HER2-positive breast cancer prognosis in the neoadjuvant NeoALTTO and CALGB 40601 randomized trials. Nature Communications 2023, 14: 7053. PMID: 37923752, PMCID: PMC10624889, DOI: 10.1038/s41467-023-42635-2.Peer-Reviewed Original ResearchConceptsEvent-free survivalHER2-positive breast cancerPathological complete responseCALGB 40601Breast cancerBreast pathological complete responseStromal tumor-infiltrating lymphocytesHormone receptor statusPhase III trialsClinical nodal statusIndependent prognostic factorTumor-infiltrating lymphocytesIdentification of patientsBreast cancer prognosisT cell receptorNeoadjuvant paclitaxelNeoadjuvant therapyIII trialsNodal statusComplete responsePrognostic factorsPrognostic scoreReceptor statusClinicopathological featuresResidual disease
2020
Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance), a Neoadjuvant Phase III Trial of Paclitaxel-Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer.
Fernandez-Martinez A, Krop IE, Hillman DW, Polley MY, Parker JS, Huebner L, Hoadley KA, Shepherd J, Tolaney S, Henry NL, Dang C, Harris L, Berry D, Hahn O, Hudis C, Winer E, Partridge A, Perou CM, Carey LA. Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance), a Neoadjuvant Phase III Trial of Paclitaxel-Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer. Journal Of Clinical Oncology 2020, 38: 4184-4193. PMID: 33095682, PMCID: PMC7723687, DOI: 10.1200/jco.20.01276.Peer-Reviewed Original ResearchConceptsPathologic complete responseRelapse-free survivalHuman epidermal growth factor receptor 2HER2-positive breast cancerBetter relapse-free survivalOverall survivalCALGB 40601Breast cancerImmune signaturesGene expression signaturesDe-escalation treatment strategiesPrediction of pCREnd pointEpidermal growth factor receptor 2Shorter relapse-free survivalPrimary end pointResidual disease groupSecondary end pointsUntreated stage IIGood prognostic factorGrowth factor receptor 2Phase III trialsExpression signaturesFactor receptor 2OS benefit
2018
SPS-3 A prognostic model integrating clinical data and gene signatures in phase III neoadjuvant trial CALGB 40601 (Alliance)
Tanioka M, Parker J, Henry L, Tolaney S, Dang C, Krop I, Harris L, Hillman D, Polley M, Berry D, Winer E, Carey L, Perou C. SPS-3 A prognostic model integrating clinical data and gene signatures in phase III neoadjuvant trial CALGB 40601 (Alliance). Annals Of Oncology 2018, 29: vii50. DOI: 10.1093/annonc/mdy373.Peer-Reviewed Original Research
2017
Axillary Management of Stage II/III Breast Cancer in Patients Treated with Neoadjuvant Systemic Therapy: Results of CALGB 40601 (HER2-Positive) and CALGB 40603 (Triple-Negative)
Ollila DW, Cirrincione CT, Berry DA, Carey LA, Sikov WM, Hudis CA, Winer EP, Golshan M. Axillary Management of Stage II/III Breast Cancer in Patients Treated with Neoadjuvant Systemic Therapy: Results of CALGB 40601 (HER2-Positive) and CALGB 40603 (Triple-Negative). Journal Of The American College Of Surgeons 2017, 224: 688-694. PMID: 28089784, PMCID: PMC5616181, DOI: 10.1016/j.jamcollsurg.2016.12.036.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAxillaBiopsyBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, LobularFemaleHumansLymph Node ExcisionLymph NodesLymphatic MetastasisMastectomyMiddle AgedNeoadjuvant TherapyNeoplasm StagingPractice Patterns, Physicians'Receptor, ErbB-2Sentinel Lymph Node BiopsyTriple Negative Breast NeoplasmsUnited StatesConceptsAxillary lymph node dissectionNeoadjuvant systemic therapyNode-positive patientsSentinel node biopsyStage II/III breast cancerResidual axillary diseaseNode biopsyAxillary diseaseSystemic therapyBreast cancerAxillary node evaluationAxillary surgical proceduresPathologic nodal statusLymph node dissectionNode-positive diseaseCore needle biopsyFine-needle aspirationAxillary evaluationAxillary managementCALGB 40601N0 diseaseAxillary procedureNode dissectionRadiologic stagingNodal status
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
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 HER2
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
Impact of neoadjuvant chemotherapy plus HER2-targeting on breast conservation rates: Surgical results from CALGB 40601 (Alliance).
Ollila D, Berry D, Cirrincione C, Carey L, Amos K, Henry N, Winer E, Hudis C, Golshan M. Impact of neoadjuvant chemotherapy plus HER2-targeting on breast conservation rates: Surgical results from CALGB 40601 (Alliance). Journal Of Clinical Oncology 2013, 31: 501-501. DOI: 10.1200/jco.2013.31.15_suppl.501.Peer-Reviewed Original ResearchNeoadjuvant therapyBCT candidatesCALGB 40601Neoadjuvant chemotherapySystemic therapySurgical resultsBreast surgeonsBreast cancerTumor-free surgical marginsBreast cancer ptsNeoadjuvant systemic therapyOperable breast cancerBreast conservation ratesPhase III trialsAnti-HER2 treatmentModern systemic therapyBreast cancer operationsBCT eligibilityCancer ptsEligible patientsNeoadjuvant trialsTherapy ratesIII trialsSurgical marginsCancer operationsClinical 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