Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448591
Status:
COMPLETED
Last Update Posted:
2015-05-25
First Post:
2007-03-16
Brief Title:
A Study of Avastin Bevacizumab Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-05
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:
This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane with or without additional chemotherapy as first-line treatment in patients with locally recurrent or metastatic breast cancer All patients will receive Avastin 10mgkg iv every 2 weeks or 15 mgkg iv every 3 weeks plus taxane-based chemotherapy If taxanes are contraindicated alternative chemotherapy other than anthracyclines or pegylated liposomal doxorubicin may be used The anticipated time on study treatment is until disease progression and the target sample size is 500 individuals
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