2024
Completion Rate and Positive Results Reporting Among Immunotherapy Trials in Breast Cancer, 2004-2023
Mariani M, Viale G, Galbardi B, Licata L, Bosi C, Dugo M, Notini G, Naldini M, Callari M, Criscitiello C, Pusztai L, Bianchini G. Completion Rate and Positive Results Reporting Among Immunotherapy Trials in Breast Cancer, 2004-2023. JAMA Network Open 2024, 7: e2423390. PMID: 39028669, PMCID: PMC11259908, DOI: 10.1001/jamanetworkopen.2024.23390.Peer-Reviewed Original ResearchConceptsCross-sectional studyPhase III trialsIII trialsBreast cancerImmunotherapy trialsLandscape of breast cancerPhase II studyPhase II trialPhase I trialSingle-center studySingle-center trialCancer immunotherapy trialsBreast cancer trialsPatient confidenceMain OutcomesFisher's exact testImmuno-oncology trialsTrial featuresProportion of trialsCompletion ratesAdjuvant settingPhase IIReport outcomesII trialPositive results
2021
Neoadjuvant durvalumab plus weekly nab-paclitaxel and dose-dense doxorubicin/cyclophosphamide in triple-negative breast cancer
Foldi J, Silber A, Reisenbichler E, Singh K, Fischbach N, Persico J, Adelson K, Katoch A, Horowitz N, Lannin D, Chagpar A, Park T, Marczyk M, Frederick C, Burrello T, Ibrahim E, Qing T, Bai Y, Blenman K, Rimm DL, Pusztai L. Neoadjuvant durvalumab plus weekly nab-paclitaxel and dose-dense doxorubicin/cyclophosphamide in triple-negative breast cancer. Npj Breast Cancer 2021, 7: 9. PMID: 33558513, PMCID: PMC7870853, DOI: 10.1038/s41523-021-00219-7.Peer-Reviewed Original ResearchStromal tumor-infiltrating lymphocytesWeekly nab-paclitaxelTriple-negative breast cancerPD-L1Nab-paclitaxelAdverse eventsBreast cancerGrade 3/4 treatment-related adverse eventsPhase I/II trialGrade 3/4 adverse eventsTreatment-related adverse eventsDoxorubicin/cyclophosphamidePhase II studyGuillain-Barre syndromeMononuclear inflammatory cellsPathologic complete responseTumor-infiltrating lymphocytesTumor cell stainingEvaluable patientsNeoadjuvant durvalumabSP263 antibodyII trialNeoadjuvant chemotherapyNeoadjuvant therapyPrimary endpoint
2020
Validation of an immunomodulatory gene signature algorithm to predict response to neoadjuvant immunochemotherapy in patients with primary triple-negative breast cancer.
Iwase T, Pusztai L, Blenman K, Li X, Seitz R, Nielsen T, Schweitzer B, Hout D, Bailey D, Zhang X, Shen Y, Ueno N. Validation of an immunomodulatory gene signature algorithm to predict response to neoadjuvant immunochemotherapy in patients with primary triple-negative breast cancer. Journal Of Clinical Oncology 2020, 38: 3117-3117. DOI: 10.1200/jco.2020.38.15_suppl.3117.Peer-Reviewed Original ResearchPrimary triple-negative breast cancerTriple-negative breast cancerPathological complete responsePD-L1 IHCIM subtypesPredictive valueNeoadjuvant immunochemotherapyBreast cancerPhase I/II trialPretreatment core-needle biopsiesAntigen-presenting immune cellsPossible predictive markerImmune cell populationsImmune cell processesCore needle biopsyNegative predictive valuePositive predictive valueStrong predictive valuePositive likelihood ratioNegative likelihood ratioImmunomodulatory subtypeNeoadjuvant immunotherapyII trialLikelihood ratioComplete response
2018
Single-arm, neoadjuvant, phase II trial of pertuzumab and trastuzumab administered concomitantly with weekly paclitaxel followed by 5-fluoruracil, epirubicin, and cyclophosphamide (FEC) for stage I–III HER2-positive breast cancer
Foldi J, Mougalian S, Silber A, Lannin D, Killelea B, Chagpar A, Horowitz N, Frederick C, Rispoli L, Burrello T, Abu-Khalaf M, Sabbath K, Sanft T, Brandt DS, Hofstatter EW, Hatzis C, DiGiovanna MP, Pusztai L. Single-arm, neoadjuvant, phase II trial of pertuzumab and trastuzumab administered concomitantly with weekly paclitaxel followed by 5-fluoruracil, epirubicin, and cyclophosphamide (FEC) for stage I–III HER2-positive breast cancer. Breast Cancer Research And Treatment 2018, 169: 333-340. PMID: 29396664, DOI: 10.1007/s10549-017-4653-2.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerPhase II trialII trialNeoadjuvant chemotherapyPCR rateHormone receptorsBreast cancerGrade 3/4 adverse eventsPathologic complete response rateCyclophosphamide neoadjuvant chemotherapyComplete response rateSymptomatic heart failureAsymptomatic decreaseNeoadjuvant settingWeekly paclitaxelAdverse eventsHeart failureTherapeutic plateauCardiac functionInterim analysisStage IResponse ratePurposeThe purposePatientsNegative cases
2017
Safety of MEDI4736 (anti-PD-L1 antibody) administered concomitant with weekly nab-paclitaxel and dose dense doxorubicin/cyclophosphamide (ddAC) as neoadjuvant chemotherapy for stage I-III triple negative breast cancer (TNBC): A Phase I/II trial.
Pusztai L, Silber A, Hofstatter E, Chung G, Horowitz N, Lannin D, Killelea B, Chagpar A, Szekely B, Frederick C, Rispoli L, DiGiovanna M. Safety of MEDI4736 (anti-PD-L1 antibody) administered concomitant with weekly nab-paclitaxel and dose dense doxorubicin/cyclophosphamide (ddAC) as neoadjuvant chemotherapy for stage I-III triple negative breast cancer (TNBC): A Phase I/II trial. Journal Of Clinical Oncology 2017, 35: 572-572. DOI: 10.1200/jco.2017.35.15_suppl.572.Peer-Reviewed Original ResearchImmune related adverse eventsTriple-negative breast cancerWeekly nab-paclitaxelWeeks of therapyNeoadjuvant chemotherapyDose levelsNab-paclitaxelPhase I/II trialPathologic complete response rateChest X-ray abnormalitiesDoxorubicin/cyclophosphamidePhase I toxicityComplete response rateImmune checkpoint inhibitorsPhase I portionRelated adverse eventsPhase II portionPhase I partX-ray abnormalitiesNegative breast cancerSequential taxaneAnthracycline chemotherapyCheckpoint inhibitorsII trialAdverse events
2013
Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Ixabepilone or Paclitaxel in Early Stage Breast Cancer and Evaluation of βIII‐Tubulin Expression as a Predictive Marker
Saura C, Tseng L, Chan S, Chacko RT, Campone M, Manikhas A, Nag SM, Leichman CG, Dasappa L, Fasching PA, de Mendoza F, Symmans WF, Liu D, Mukhopadhyay P, Horak C, Xing G, Pusztai L. Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Ixabepilone or Paclitaxel in Early Stage Breast Cancer and Evaluation of βIII‐Tubulin Expression as a Predictive Marker. The Oncologist 2013, 18: 787-794. PMID: 23853246, PMCID: PMC3720631, DOI: 10.1634/theoncologist.2013-0075.Peer-Reviewed Original ResearchConceptsEarly-stage breast cancerStage breast cancerPathologic complete responseΒIII-tubulin expressionBreast cancerTreatment armsWeekly paclitaxelPositive patientsPredictive markerNeoadjuvant doxorubicin/cyclophosphamideRandomized phase II trialΒIII-tubulinCommon nonhematologic toxicitiesDoxorubicin/cyclophosphamideInvasive breast adenocarcinomaPhase II trialCore needle biopsyCycles of ACHigh response rateSignificant differencesNeoadjuvant cyclophosphamideNonhematologic toxicityNeoadjuvant treatmentII trialNegative patientsBiomarker Analysis of Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Ixabepilone or Paclitaxel in Early-Stage Breast Cancer
Horak CE, Pusztai L, Xing G, Trifan OC, Saura C, Tseng LM, Chan S, Welcher R, Liu D. Biomarker Analysis of Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Ixabepilone or Paclitaxel in Early-Stage Breast Cancer. Clinical Cancer Research 2013, 19: 1587-1595. PMID: 23340299, DOI: 10.1158/1078-0432.ccr-12-1359.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsATP Binding Cassette Transporter, Subfamily BATP Binding Cassette Transporter, Subfamily B, Member 1Biomarkers, TumorBreast NeoplasmsCyclophosphamideDoxorubicinEpothilonesFemaleGene Expression ProfilingGene Expression Regulation, NeoplasticHumansMicrofilament ProteinsMicrotubule-Associated ProteinsNeoadjuvant TherapyNeoplasm ProteinsNuclear ProteinsPaclitaxelPrognosisTubulinConceptsMDR1 protein expressionNeoadjuvant doxorubicin/cyclophosphamideEarly-stage breast cancerDoxorubicin/cyclophosphamidePositive patientsProtein expressionTreatment armsBreast cancerPathologic complete response rateEfficacy of ixabepiloneInvasive breast adenocarcinomaComplete response ratePhase II trialCore needle biopsyRates of pCRΒIII-tubulin proteinNeoadjuvant settingII trialNegative patientsGene expressionPrimary cancerPredictive biomarkersPredictive markerRisk ratioNeedle biopsy
2010
Development of Candidate Genomic Markers to Select Breast Cancer Patients for Dasatinib Therapy
Moulder S, Yan K, Huang F, Hess KR, Liedtke C, Lin F, Hatzis C, Hortobagyi GN, Symmans WF, Pusztai L. Development of Candidate Genomic Markers to Select Breast Cancer Patients for Dasatinib Therapy. Molecular Cancer Therapeutics 2010, 9: 1120-1127. PMID: 20423993, DOI: 10.1158/1535-7163.mct-09-1117.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsBiomarkers, PharmacologicalBiomarkers, TumorBreast NeoplasmsCarcinomaCell Line, TumorDasatinibDrug Resistance, NeoplasmFemaleGene Expression ProfilingGene Expression Regulation, NeoplasticGenetic Association StudiesGenome, HumanHumansMatched-Pair AnalysisOligonucleotide Array Sequence AnalysisPatient SelectionPrognosisPyrimidinesThiazolesConceptsClinical trialsCell linesPhase I/II trialIndependent breast cancer cell linesEarly phase clinical trialsDasatinib-resistant cellsPrimary breast cancerBreast cancer patientsDasatinib-resistant cell linesDifferent patient subsetsBreast cancer cell linesGenomic predictorsCancer cell linesDasatinib therapyDifferent potential predictorsII trialPatient subsetsPatient selectionCancer patientsBreast cancerDasatinib sensitivityMammary epithelial cellsDasatinib responseActivity indexPatient samples
2007
Pharmacogenomic Predictor Discovery in Phase II Clinical Trials for Breast Cancer
Pusztai L, Anderson K, Hess KR. Pharmacogenomic Predictor Discovery in Phase II Clinical Trials for Breast Cancer. Clinical Cancer Research 2007, 13: 6080-6086. PMID: 17947471, DOI: 10.1158/1078-0432.ccr-07-0809.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials, Phase II as TopicGene Expression ProfilingGene Expression Regulation, NeoplasticHumansIn Situ Hybridization, FluorescenceOligonucleotide Array Sequence AnalysisPharmacogeneticsProbabilityRNA, MessengerTissue DistributionTrastuzumabConceptsPhase II studyPhase II trialII trialII studyBreast cancerTwo-stage phase II trialPhase II clinical trialPhase II trial designPredictors of responseMarker-positive patientsPhase II designUnselected patientsPatient populationClinical trialsTrastuzumab responseInsufficient responseTrial designResponse markersSame drugResponse rateMarker testingPotential predictorsMarker assessmentTrialsPatients