Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391092
Status:
COMPLETED
Last Update Posted:
2015-08-28
First Post:
2006-10-20
Brief Title:
A Study of Avastin Bevacizumab in Combination With Herceptin TrastuzumabDocetaxel in Patients With HER2 Positive Metastatic Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With HerceptinDocetaxel and HerceptinDocetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-08
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 2 arm study will compare the efficacy and safety of Avastin plus Herceptindocetaxel versus Herceptindocetaxel alone in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease Patients will be randomized 11 to receive either Avastin 15mgkg iv q3weeks Herceptin 8mgkg iv loading dose and 6mgkg iv q3weeks maintenance docetaxel 100mgm2 iv q3weeks or Herceptin docetaxel alone The anticipated time on study treatment is until disease progression and the target sample size is 100-500 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