2013
TBCRC 018: Phase II study of iniparib plus chemotherapy to treat triple-negative breast cancer (TNBC) central nervous system (CNS) metastases (mets).
Anders C, Deal A, Abramson V, Liu M, Storniolo A, Carpenter J, Puhalla S, Nanda R, Melhem-Bertrandt A, Lin N, Marcom P, Van Poznak C, Stearns V, Melisko M, Smith J, Karginova O, Winer E, Perou C, Wolff A, Carey L. TBCRC 018: Phase II study of iniparib plus chemotherapy to treat triple-negative breast cancer (TNBC) central nervous system (CNS) metastases (mets). Journal Of Clinical Oncology 2013, 31: 515-515. DOI: 10.1200/jco.2013.31.15_suppl.515.Peer-Reviewed Original ResearchQuality of lifeBlood-brain barrierResponse rateCommon grade 3/4 adverse eventsCentral nervous system metastasesGrade 3/4 adverse eventsClinical benefit rateNervous system metastasesPhase II studyTumor response rateKaplan-Meier methodWhole brain RTHalf of womenBetter response rateSmall molecule anti-cancer agentTopoisomerase I inhibitorAdvanced TNBCCorrelative endpointsEligible ptsGermline BRCA1/2Measurable lesionsMedian TTPRadiation-naïveAnti-cancer agentsPrimary endpoint
2003
Phase II, randomized, double-blind study of two dose levels of arzoxifene in patients with locally advanced or metastatic breast cancer.
Buzdar A, O’Shaughnessy J, Booser DJ, Pippen JE, Jones SE, Munster PN, Peterson P, Melemed AS, Winer E, Hudis C. Phase II, randomized, double-blind study of two dose levels of arzoxifene in patients with locally advanced or metastatic breast cancer. Journal Of Clinical Oncology 2003, 21: 1007-14. PMID: 12637464, DOI: 10.1200/jco.2003.06.108.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Agents, HormonalBiomarkers, TumorBreast NeoplasmsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug Resistance, NeoplasmEndometriumEstrogen Receptor ModulatorsFemaleHumansMiddle AgedPatient SelectionPiperidinesReceptors, EstrogenSurvival AnalysisTamoxifenThiophenesTreatment OutcomeConceptsMetastatic breast cancerClinical benefit rateBreast cancerTamoxifen refractoryTR patientsResponse rateDose levelsEnd pointSelective estrogen receptor modulatorsPhase II studyPrimary end pointSecondary end pointsTumor response rateDouble-blind studyEstrogen receptor statusMetastatic disease sitesEstrogen receptor modulatorsTreatment of TSSimilar TTPTamoxifen therapyII studyDaily doseLonger TTPReceptor statusDose-dependent toxicity
1995
Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer.
Jones S, Winer E, Vogel C, Laufman L, Hutchins L, O'Rourke M, Lembersky B, Budman D, Bigley J, Hohneker J. Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer. Journal Of Clinical Oncology 1995, 13: 2567-74. PMID: 7595708, DOI: 10.1200/jco.1995.13.10.2567.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibiotics, AntineoplasticAntineoplastic AgentsBreast NeoplasmsDisease ProgressionDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHematologic DiseasesHumansInjections, IntravenousMelphalanMiddle AgedProportional Hazards ModelsProspective StudiesQuality of LifeSurvival RateVinblastineVinorelbineConceptsQuality of lifeAdvanced breast cancerCancer-related symptomsTreatment failureBreast cancerALK patientsSurvival rateStabilization of diseaseEfficacy end pointTumor response ratePopulation of patientsMedian survival rateCommon toxicitiesProspective multicenterObjective responseSeptic deathSurvival benefitRandomized comparisonPatient populationPatientsIntergroup differencesTreatment centersResponse rateEnd pointVinorelbine tartrate