2020
A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials
Amiri-Kordestani L, Xie D, Tolaney SM, Bloomquist E, Tang S, Ibrahim A, Goldberg KB, Theoret MR, Pazdur R, Sridhara R, Winer EP, Beaver JA. A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials. Annals Of Oncology 2020, 31: 1704-1708. PMID: 32866625, DOI: 10.1016/j.annonc.2020.08.2106.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalEarly breast cancerHER2-positive early breast cancerTH armOverall survivalAdjuvant paclitaxelTrastuzumab trialsReceptor statusLow-risk early breast cancerHuman epidermal growth factor receptor 2Positive early breast cancerPropensity scoreEpidermal growth factor receptor 2De-escalate therapyDisease-free survivalGrowth factor receptor 2Progesterone receptor statusSingle-arm studyEstrogen receptor statusSingle-arm trialPatient-level dataFactor receptor 2Drug Administration analysisCovariates of ageHistorical clinical trials
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
2009
Uniformly positive (>80%) HER2 expression maximizes sensitivity and specificity for prediction of response to trastuzumab in CALGB 9840.
Rimm D, Broadwater G, Friedman P, Berry D, Seidman A, Hudis C, Winer E, Harris L, Thor A. Uniformly positive (>80%) HER2 expression maximizes sensitivity and specificity for prediction of response to trastuzumab in CALGB 9840. Cancer Research 2009, 69: 6046. DOI: 10.1158/0008-5472.sabcs-6046.Peer-Reviewed Original ResearchPrediction of responseHER2 expressionCooperative group clinical trialsPositive HER2 expressionGroup clinical trialReceiver operator characteristic curveOperator characteristic curveSubset of casesArea of expressionHeterogeneity of expressionHER2 stainingTH armNeoadjuvant settingStable diseaseProgressive diseaseRECIST criteriaPartial responseClinical outcomesCAP guidelinesPatient selectionPercentage of tissueT therapyClinical trialsHER2 testsLarge cohort