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

• Status: Terminated
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intarcia Therapeutics
• Treatments: Atamestane; Estrogens; Letrozole; Toremifene

Criteria

Inclusion Criteria:

• To be eligible to receive continued treatment, subjects must remain eligible to receive study drug at the time of their last Biomed 777-CLP-29 visit

• To continue on survival follow-up, subjects must be in survival follow-up in study Biomed 777-CLP-29

• Written informed consent obtained for subjects who continue study drug treatment

Exclusion Criteria:

• Subjects who have withdrawn consent to participate in Biomed 777-CLP-29 for any reason

• Subjects for whom the investigator considers study participation is no longer in the best interest of those subjects.