Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333775
Status:
COMPLETED
Last Update Posted:
2016-01-27
First Post:
2006-06-05
Brief Title:
A Study of Bevacizumab Avastin in Women With HER2 Negative Metastatic Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomised Double Blind Placebo Controlled Multicentre Study to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Docetaxel in Comparison With Docetaxel Plus Placebo as First Line Treatment for Patients With HER2 Negative Metastatic and Locally Recurrent Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-12
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 study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel versus docetaxel plus placebo in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease The anticipated time on treatment is 1-2 years and the target sample size is 500 individuals
Detailed Description:
Five participants randomized to the docetaxel 100 mgm2 plus placebo group actually received docetaxel 100 mgm2 plus bevacizumab 75 mgkg and are included in the docetaxel 100 mgm2 plus bevacizumab 75 mgkg group for the adverse event results Sixteen participants randomized to the docetaxel 100 mgm2 plus placebo group actually received docetaxel 100 mgm2 plus bevacizumab 150 mgkg and are included in the docetaxel 100 mgm2 plus bevacizumab 150 mgkg group for the adverse event results
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 |
|---|---|---|---|
| 2005-003862-40 | EUDRACT_NUMBER | None | None |