Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044291
Status:
COMPLETED
Last Update Posted:
2015-07-31
First Post:
2002-08-23
Brief Title:
Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
Sponsor:
Intarcia Therapeutics
Organization:
Intarcia Therapeutics
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 the first line combination hormonal therapy 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 in postmenopausal patients with locally advanced or metastatic breast cancer and whether the side effects of the combination are different from the side effects of letrozole
Detailed Description:
Breast cancer cells are often very dependent on estrogens to continue to grow Atamestane blocks the formation of estrogens and androgenic precursors in the body 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 maximal suppression of estrogen stimulation of breast cancer cells This study is designed to determine whether combination therapy will lengthen the time to disease progression and the rate of objective response compared to single agent aromatase inhibitor therapy with 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