Ignite Creation Date:
2024-05-05 @ 11:08 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01266213
Status:
UNKNOWN
Last Update Posted:
2017-05-01
First Post:
2010-12-19
Brief Title:
Fulvestrant FGoserelin G vs Anastrozole AG vs G for Premenopausal Women
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Randomized Phase II Study OF Goserelin G Plus Fulvestrant F vs G Plus Anastrozole Avs G Alone for HR Tamoxifen Pretreated Premenopausal Woman
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
FLAG
Brief Summary:
Fulvestrant is an ER antagonist with no agonist effects which binds blocks and degrades the ER Fulvestrant is comparable to third-generation aromatase inhibitors in terms of efficacy and tolerability for patients who have progressed on prior tamoxifen therapy and past studies have found all three-third-generation AIs to be at least as good as tamoxifen in first-line metastatic therapy in postmenopausal women Fulvestrant has been studied little in premenopausal women despite of its attractive mechanism of actions The clinical effectiveness of fulvestrant as a treatment for advanced breast cancer has previously been demonstrated at the standard dose AD 250 mgmo in several phase III clinical trials in postmenopausal women However there is evidence to suggest that doses of fulvestrant higher than 250 mg may have greater pharmacodynamic activity against the ER pathway Moreover dose-dependent clinical activity has been observed for fulvestrant The activity of a fulvestrant high-dose HD 500 mgmo regimen has been investigated in two recent studies A pilot Japanese study showed fulvestrant HD to have clinical activity in the treatment of advanced or recurrent breast cancer to be well tolerated and to result in plasma levels approximately double those seen with fulvestrant low-dose Subsequently a neoadjuvant study comparing fulvestrant low-dose and high-dose reported that significantly greater Ki67 and ER downregulation was achieved with the high-dose compared with the low-dose regimen and that both doses were well tolerated A recent randomized trial also showed superior outcome of high-dose fulvestrant than AI
Based on this rationale we introduced high-dose fulvestrant with LHRH agonist as a randomized trial comparing with AI plus LHRH agonist and LHRH alone in premenopausal metastatic breast cancer patients who failed to tamoxifen treatment
Based on this rationale we introduced high-dose fulvestrant with LHRH agonist as a randomized trial comparing with AI plus LHRH agonist and LHRH alone in premenopausal metastatic breast cancer patients who failed to tamoxifen treatment
Detailed Description:
This randomized phase II trial is studying fulvestrant with goserelin for ovarian suppression by goserelin to see how well it works compared to anastrozole with goserelin and goserelin alone in recurrent or metastatic ER-positive 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