Open Label Treatment and Survival Continuation 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 survival time for subjects with advanced breast cancer.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
In conjunction with the data from Biomed 777-CLP-29, compare the time to progression (TTP) in the atamestane plus toremifene arm to the TTP in the letrozole plus placebo arm
Peter Langecker, MD, PhD
United States: Food and Drug Administration
|Fountain Valley, California 92708|
|Columbia, Missouri 65203|
|Austin, Texas 78705|
|Seattle, Washington 98195|
|Flint, Michigan 48532|
|McLean, Virginia 22101|