Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267553
Status:
TERMINATED
Last Update Posted:
2007-09-10
First Post:
2005-12-20
Brief Title:
Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer
Sponsor:
Intarcia Therapeutics
Organization:
Intarcia Therapeutics
Study Overview
Official Title:
Open Label Treatment and Survival Continuation Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
Status:
TERMINATED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This was a follow-on study to Biomed 777-CLP-029 which did not meet superiority endpoint
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None