A Phase 3 interventional study of Atamestane and toremifene in Breast Neoplasms and Neoplasms, Hormone-Dependent, sponsored by Intarcia Therapeutics. Terminated at 35 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-09-10.
Sponsored by Intarcia Therapeutics · Phase 3, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 200 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Intarcia Therapeutics is the lead sponsor of 21 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
In conjunction with the data from Biomed 777-CLP-29, obtain safety, survival and time to treatment failure (TTF) data for both arms in this continuation study.
This study is terminated, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.
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Intarcia Therapeutics