Phase 3 Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
Aromatase is an enzyme expressed in tissues such as muscle and fat in postmenopausal women.
These non-ovarian tissues become the dominant sources of estrogen in postmenopausal women.
Breast cancer cells are often very dependent on estrogens to continue to grow. Atamestane
blocks the formation of estrogens from androgenic precursors in the body via the aromatase
enzyme. Toremifene blocks circulating and intracellular estrogens from stimulating estrogen
receptors in breast cancer cells. The goal of therapy with atamestane, an aromatase
inhibitor, in combination with the estrogen receptor antagonist, toremifene, is to achieve
complete suppression of estrogen stimulation of breast cancer cells. This study is designed
to determine whether combined hormonal therapy will lengthen the time to disease progression
and the rate of objective response, as compared to single agent therapy with the approved
aromatase inhibitor letrozole.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Time to progression
Edith Perez, MD
Study Chair
Professor of Medicine, Mayo Clinic, Jacksonville, Florida
United States: Food and Drug Administration
Biomed 777-CLP-30
NCT00097344
December 2004
August 2006
Name | Location |
---|---|
Research Site | Alabaster, Alabama |
Research Site | Mesa, Arizona |
Research Site | Bentonville, Arkansas |
Research Site | Anaheim, California |
Research Site | Danbury, Connecticut |
Research Site | Boca Raton, Florida |
Research Site | Albany, Georgia |
Research Site | Bloomington, Indiana |
Research Site | Hays, Kansas |
Research Site | Ashland, Kentucky |
Research Site | Baton Rouge, Louisiana |
Research Site | Baltimore, Maryland |
Research Site | Battle Kreek, Michigan |
Research Site | Alexandria, Minnesota |
Research Site | Branson, Missouri |
Research Site | Billings, Montana |
Research Site | Las Vegas, Nevada |
Research Site | Belleville, New Jersey |
Research Site | Albany, New York |
Research Site | Akron, Ohio |
Research Site | Allentown, Pennsylvania |
Research Site | Charleston, South Carolina |
Research Site | Chattanooga, Tennessee |
Research Site | Abilene, Texas |
Research Site | Ivins, Utah |
Research Site | Abington, Virginia |
Research Site | Auburn, Washington |
Research Site | Appleton, Wisconsin |