Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262067
Status:
UNKNOWN
Last Update Posted:
2013-12-13
First Post:
2005-12-02
Brief Title:
A Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy in Untreated Metastatic Breast Cancer RIBBON 1
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
A Multicenter Phase III Randomized Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Untreated Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2013-11
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:
None
Brief Summary:
This is a Phase III multicenter randomized placebo-controlled trial designed to evaluate the efficacy and safety of bevacizumab in combination with chemotherapy compared with chemotherapy alone in subjects with previously untreated metastatic breast cancer
Detailed Description:
This study includes a blinded treatment phase an optional open-label post-progression phase and a survival follow-up phase During the blinded treatment phase patients receive chemotherapy and study drug bevacizumab or placebo every 3 weeks until disease progression treatment-limiting toxicity or death due to any cause The optional open-label post-progression phase consists of chemotherapy treatment per investigator discretion and optional treatment with open-label bevacizumab Patients who complete the study or who discontinue from treatment regardless of participation in the optional open-label post-progression phase will be followed for survival and subsequent anti-cancer therapies every 4 months until death withdrawal of consent loss to follow-up or study termination Patients who discontinue from treatment during the blinded treatment phase for reasons other than disease progression will have tumor assessments every 9 weeks until documented disease progression or death
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BO20094 | OTHER | Hoffmann-La Roche | None |