Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atamestane | Small molecule | — | — |
| Subject | Letrozole | Other / unclassified | — | — |
| Subject | Toremifene | Small molecule | — | — |