Viewing Study NCT00262067



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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