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