2024
Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial-Efficacy and Biomarker Discovery.
Albain K, Yau C, Petricoin E, Wolf D, Lang J, Chien A, Haddad T, Forero-Torres A, Wallace A, Kaplan H, Pusztai L, Euhus D, Nanda R, Elias A, Clark A, Godellas C, Boughey J, Isaacs C, Tripathy D, Lu J, Yung R, Gallagher R, Wulfkuhle J, Brown-Swigart L, Krings G, Chen Y, Potter D, Stringer-Reasor E, Blair S, Asare S, Wilson A, Hirst G, Singhrao R, Buxton M, Clennell J, Sanil A, Berry S, Asare A, Matthews J, DeMichele A, Hylton N, Melisko M, Perlmutter J, Rugo H, Symmans W, Van't Veer L, Yee D, Berry D, Esserman L. Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial-Efficacy and Biomarker Discovery. Clinical Cancer Research 2024, 30: 729-740. PMID: 38109213, PMCID: PMC10956403, DOI: 10.1158/1078-0432.ccr-22-2256.Peer-Reviewed Original ResearchPathological complete responseI-SPY2Breast cancerStage II/III breast cancerPhase II neoadjuvant trialTie2 receptorEarly-stage breast cancerT-cell gene signatureHormone receptorsDoxorubicin/cyclophosphamideHER2-negative diseaseHER2-positive diseaseStandard neoadjuvant therapyEvent-free survivalPhase III trialsPaclitaxel-based chemotherapyBreast cancer trialsPathway-specific biomarkersCell gene signatureNeoadjuvant trialsWeekly paclitaxelNeoadjuvant therapyPrimary endpointIII trialsPCR rate
2013
Developing Safety Criteria for Introducing New Agents into Neoadjuvant Trials
DeMichele A, Berry DA, Zujewski J, Hunsberger S, Rubinstein L, Tomaszewski JE, Kelloff G, Perlmutter J, Buxton M, Lyandres J, Albain KS, Benz C, Chien AJ, Haluska P, Leyland-Jones B, Liu MC, Munster P, Olopade O, Park JW, Parker BA, Pusztai L, Tripathy D, Rugo H, Yee D, Esserman L. Developing Safety Criteria for Introducing New Agents into Neoadjuvant Trials. Clinical Cancer Research 2013, 19: 2817-2823. PMID: 23470967, PMCID: PMC4096560, DOI: 10.1158/1078-0432.ccr-12-2620.Peer-Reviewed Original ResearchConceptsNeoadjuvant trialsNeoadjuvant settingStandard therapyInvestigational agentsDrug developmentPhase II neoadjuvant trialI-SPY2 trialSafe drug developmentShort-term endpointsNeoadjuvant studiesCurable patientsPathologic responsePoor prognosisNovel therapiesBreast cancerNovel agentsSafety dataStudy populationDisease processEfficacious drugsNew agentsDrug AdministrationPatient exposurePatient safetyStudy design