Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097344
Status:
TERMINATED
Last Update Posted:
2007-08-23
First Post:
2004-11-22
Brief Title:
The CAT Study Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
Sponsor:
Intarcia Therapeutics
Organization:
Intarcia Therapeutics
Study Overview
Official Title:
Phase 3 Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
Status:
TERMINATED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Identical study Biomed 777-CLP-029 did not meet superiority endpoint
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of an experimental drug atamestane plus an FDA-approved drug toremifene Fareston is more effective than another approved drug letrozole Femara in delaying the growth of breast cancer and whether the side effects of the combined hormonal therapy are different from the side effects of letrozole
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 rate of objective response as compared to single agent therapy with the approved aromatase inhibitor letrozole
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