Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083993
Status:
TERMINATED
Last Update Posted:
2011-11-08
First Post:
2004-06-04
Brief Title:
Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Phase 3 Randomized Placebo-Controlled Double-Blind Study of Oral CCI-779 Administered in Combination With Letrozole vs Letrozole Alone as First Line Hormonal Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this clinical research study postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus CCI-779 and letrozole or a placebo and letrozole in first-line hormonal treatment The primary endpoint of this study is to determine overall progression free survival
Individual subjects will participate in the active treatment phase of the study until disease progression or withdrawal of consent provided that test article is being tolerated All subjects will be asked to participate in the long-term follow-up phase of the study which includes follow-up every 3 months until disease progression for subjects who withdraw for reasons other than documented progressive disease or until any new cancer treatment is received and for survival The estimated duration of study participation is 34 months
Individual subjects will participate in the active treatment phase of the study until disease progression or withdrawal of consent provided that test article is being tolerated All subjects will be asked to participate in the long-term follow-up phase of the study which includes follow-up every 3 months until disease progression for subjects who withdraw for reasons other than documented progressive disease or until any new cancer treatment is received and for survival The estimated duration of study participation is 34 months
Detailed Description:
None
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