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document
Randomized , double-blind , multicenter trial comparing two doses of arzoxifene ( LY353381 ) in hormone-sensitive advanced or metastatic breast cancer patients . BACKGROUND This randomized , double-blind , phase II study assessed two doses of the selective estrogen receptor modulator arzoxifene in women with advanced breast cancer . The primary end point was to choose the best of two doses of arzoxifene based on the response rate or the clinical benefit rate ( CBR ) . Pharmacokinetics and toxicities were also assessed . PATIENTS AND METHODS Ninety-two patients with advanced breast cancer received arzoxifene 20 or 50 mg/day . Tumor response was assessed using World Health Organization criteria . Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria ( NCI-CTC ) system . Pharmacokinetic data were analyzed using the NONMEM software program ( GloboMax , Hanover , MD , USA ) . RESULTS Response rates in the 20 mg arm were numerically higher than the 50-mg arm according to the investigator ( 40.5 % versus 36.4 % ) and the independent review panel ( 42.9 % versus 27.3 % ) . CBR was higher in the 20 mg arm according to the investigator ( 64.3 % versus 61.4 % ) and the independent review panel ( 59.5 % versus 47.7 % ) . Arzoxifene was well tolerated . There were no study drug-related deaths . Mean observed steady-state plasma concentrations of arzoxifene were 3.62 and 7.48 ng/ml for the 20 and 50 mg doses , respectively . CONCLUSIONS There were no significant differences in efficacy or safety between 20 and 50 mg of arzoxifene . Accordingly , arzoxifene 20 mg/day was selected for further study in patients with breast cancer .
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Intervention_Pharmacological
arzoxifene ( LY353381 )
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Intervention_Pharmacological
selective estrogen receptor modulator arzoxifene
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Intervention_Pharmacological
arzoxifene
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Intervention_Pharmacological
arzoxifene 20 or 50 mg/day
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Intervention_Physical
World Health Organization criteria
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Intervention_Educational
Toxicities were graded according to the
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Intervention_Physical
National Cancer Institute Common Toxicity Criteria ( NCI-CTC ) system
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Intervention_Pharmacological
Arzoxifene
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Intervention_Pharmacological
arzoxifene
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Intervention_Pharmacological
arzoxifene
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Intervention_Pharmacological
arzoxifene
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Outcome_Physical
response rate or the clinical benefit rate ( CBR )
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Outcome_Other
Pharmacokinetics
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Outcome_Other
toxicities
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Outcome_Physical
Tumor response
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Outcome_Adverse-effects
Toxicities
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Outcome_Other
Pharmacokinetic data
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Outcome_Physical
Response rates
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Outcome_Other
CBR
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Outcome_Mortality
drug-related deaths .
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Outcome_Physical
steady-state plasma concentrations
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Outcome_Other
efficacy
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Outcome_Other
safety
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Participant_Condition
hormone-sensitive advanced or metastatic breast cancer patients
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Participant_Sex
women
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Participant_Condition
with advanced breast cancer
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Participant_Sample-size
Ninety-two