drugset / Trial / NCT00044291

Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

NCT00044291

Phase 3 Completed 865 enrolled Intarcia Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether the first line combination hormonal therapy of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying the growth of breast cancer in postmenopausal patients with locally advanced or metastatic breast cancer, and whether the side effects of the combination are different from the side effects of letrozole.

Timeline

Start
2002-06
Primary completion
2006-01
Completion
2006-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Atamestane Small molecule
Comparator Letrozole Other / unclassified
Subject Toremifene Small molecule

Indications