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

Stopped early · Phase 3

Conditions studied: Breast Neoplasms, Neoplasms, Hormone-Dependent

In brief

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.

Key facts

Study ID

NCT00267553

Run by

Intarcia Therapeutics

People needed

200

Starts

2005-11-01

Expected to finish

2006-06-01

Last updated by the study team

2007-09-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Subjects who have withdrawn consent to participate in Biomed 777-CLP-29 for any reason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

Where it is running

• Study site — Greenbrae, California, United States
• Study site — Saint Joseph, Michigan, United States
• Study site — Kansas City, Missouri, United States
• Study site — Houston, Texas, United States
• Study site — Norfolk, Virginia, United States
• Study site — Lacey, Washington, United States
• Study site — Ottawa, Ontario, Canada
• Study site — Thunder Bay, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Arkhangelsk, Russia
• Study site — Kazan', Russia
• Study site — Krasnodar, Russia
• Study site — Leningrad Region, Russia
• Study site — Lipetsk, Russia
• Study site — Moscow, Russia
• Study site — Murmansk, Russia
• Study site — Nizhny Novgorod, Russia
• Study site — Novosibirsk, Russia
• Study site — Obninsk, Russia
• Study site — Ryazan, Russia
• Study site — Saint Petersburg, Russia
• Study site — Samara, Russia
• Study site — Stavropol, Russia
• Study site — Tomsk, Russia
• Study site — Veliky Novgorod, Russia

Full record on ClinicalTrials.gov

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