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
2010
Ethics of Mandatory Research Biopsy for Correlative End Points Within Clinical Trials in Oncology
Peppercorn J, Shapira I, Collyar D, Deshields T, Lin N, Krop I, Grunwald H, Friedman P, Partridge AH, Schilsky RL, Bertagnolli MM. Ethics of Mandatory Research Biopsy for Correlative End Points Within Clinical Trials in Oncology. Journal Of Clinical Oncology 2010, 28: 2635-2640. PMID: 20406927, PMCID: PMC5596502, DOI: 10.1200/jco.2009.27.2443.Peer-Reviewed Original ResearchConceptsResearch biopsiesResearch participantsVoluntary informed consentCorrelative end pointsEthical concernsRisk of harmScientific questionsEthics CommitteeClinical trialsInformed consentInformed adultsScientific issuesEnd pointConsentClinical investigatorsCancer clinical trialsQuestionsEthicsPredictive biomarkersBiopsyIssuesCancer tissuesConductNovel interventionsBiologic basis