2011
TBCRC009: A multicenter phase II study of cisplatin or carboplatin for metastatic triple-negative breast cancer and evaluation of p63/p73 as a biomarker of response.
Isakoff S, Goss P, Mayer E, Traina T, Carey L, Krag K, Rugo H, Liu M, Stearns V, Come S, Borger D, Quadrino C, Finkelstein D, Garber J, Ryan P, Winer E, Ellisen L. TBCRC009: A multicenter phase II study of cisplatin or carboplatin for metastatic triple-negative breast cancer and evaluation of p63/p73 as a biomarker of response. Journal Of Clinical Oncology 2011, 29: 1025-1025. DOI: 10.1200/jco.2011.29.15_suppl.1025.Peer-Reviewed Original Research
2009
Multicenter Phase II Study of Lapatinib in Patients with Brain Metastases from HER2-Positive Breast Cancer
Lin N, Diéras V, Paul D, Lossignol D, Christodoulou C, Stemmler H, Roché H, Liu M, Greil R, Ciruelos E, Loibl S, Gori S, Wardley A, Yardley D, Brufsky A, Blum J, Rubin S, Dharan B, Steplewski K, Zembryki D, Oliva C, Roychowdhury D, Paoletti P, Winer E. Multicenter Phase II Study of Lapatinib in Patients with Brain Metastases from HER2-Positive Breast Cancer. Clinical Cancer Research 2009, 15: 1452-1459. PMID: 19228746, DOI: 10.1158/1078-0432.ccr-08-1080.Peer-Reviewed Original ResearchConceptsBrain metastasesBreast cancerObjective responseVolumetric reductionCNS lesionsNeurologic signsCentral nervous system progressionMulticenter phase II studySmall phase 2 trialHER2-positive breast cancerCombination of lapatinibExtra-CNS diseaseProgressive brain metastasesPhase II studyPrimary end pointPhase 2 trialProgression-free survivalThird of patientsProgressive neurologic signsMajor clinical challengeCNS metastasesCranial radiationEligible patientsEvaluable patientsPrior trastuzumab
2003
Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm.
Burstein HJ, Harris LN, Marcom PK, Lambert-Falls R, Havlin K, Overmoyer B, Friedlander RJ, Gargiulo J, Strenger R, Vogel CL, Ryan PD, Ellis MJ, Nunes RA, Bunnell CA, Campos SM, Hallor M, Gelman R, Winer EP. Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm. Journal Of Clinical Oncology 2003, 21: 2889-95. PMID: 12885806, DOI: 10.1200/jco.2003.02.018.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlgorithmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsDisease ProgressionFemaleHeart DiseasesHumansInfusions, IntravenousMiddle AgedPredictive Value of TestsReceptor, ErbB-2ROC CurveSurvival AnalysisTrastuzumabTreatment OutcomeVinblastineVinorelbineConceptsLeft ventricular ejection fractionMetastatic breast cancerHER2-positive metastatic breast cancerBreast cancerHER2 extracellular domainResponse rateEjection fractionTumor markersNormal left ventricular ejection fractionMulticenter phase II studyMulticenter phase II trialPositive advanced breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Prior adjuvant chemotherapySafety of trastuzumabFirst-line chemotherapyPhase II studySymptomatic heart failureAdvanced breast cancerBaseline ejection fractionFirst-line therapyFirst-line treatmentPhase II trialTrastuzumab-based therapyMulticenter phase II study of oral bexarotene for patients with metastatic breast cancer.
Esteva FJ, Glaspy J, Baidas S, Laufman L, Hutchins L, Dickler M, Tripathy D, Cohen R, DeMichele A, Yocum RC, Osborne CK, Hayes DF, Hortobagyi GN, Winer E, Demetri GD. Multicenter phase II study of oral bexarotene for patients with metastatic breast cancer. Journal Of Clinical Oncology 2003, 21: 999-1006. PMID: 12637463, DOI: 10.1200/jco.2003.05.068.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBexaroteneBreast NeoplasmsDisease ProgressionDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleEstrogen Receptor ModulatorsFemaleHumansMiddle AgedReceptors, EstrogenReceptors, ProgesteroneSurvival AnalysisTamoxifenTetrahydronaphthalenesThyroid HormonesToremifeneTreatment OutcomeConceptsMetastatic breast cancerTamoxifen-resistant patientsPartial responseStable diseaseBreast cancerOral bexaroteneAdverse eventsCommon drug-related adverse eventsDrug-related serious adverse eventsDrug-related adverse eventsMulticenter phase II studyRefractory metastatic breast cancerRetinoid X receptor-selective retinoidEfficacy of bexarotenePhase II studySerious adverse eventsChemotherapy-refractory patientsGroup of patientsReceptor-selective retinoidsHormone-refractory patientsTreatment of patientsCases of pancreatitisDrug-related deathsPreclinical antitumor activityOral agents