drugset / Trial / NCT00267553

Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer

NCT00267553 ↗

Phase 3 Terminated 200 enrolled Intarcia Therapeutics
RandomizedParallel-groupDouble-blindTreatment

Summary

Protocol 777-CLP-32 is the treatment and survival continuation protocol of Biomed 777-CLP-29, and will continue to compare combined hormonal therapy using the experimental aromatase inhibitor (AI) atamestane combined with the FDA-approved anti-estrogen toremifene (Fareston®), to the single agent FDA-approved aromatase inhibitor letrozole (Femara®) for the treatment of advanced breast cancer. The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of atamestane, plus toremifene (Fareston®), is more effective than letrozole (Femara®) in delaying the growth of breast cancer.

Timeline

Start
2005-11
Primary completion
—
Completion
2006-06

Outcome

Outcome not reported

Stopped: “This was a follow-on study to Biomed 777-CLP-029 which did not meet superiority endpoint”

Drugs

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

Indications