Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028990
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2002-01-04
Brief Title:
Paclitaxel With or Without Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Randomized Phase III Tial Of Paclitaxel Versus Paclitaxel Plus Bevacizumab rhuMAb VEGF As First-Line Therapy For Locally Recurrent or Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
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:
RATIONALE Drugs used in chemotherapy such as paclitaxel work in different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as bevacizumab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or deliver cancer-killing substances to them It is not yet known whether paclitaxel works better with or without bevacizumab in treating breast cancer
PURPOSE This randomized phase III trial is to see if paclitaxel works better with or without bevacizumab in treating patients who have locally recurrent or metastatic breast cancer
PURPOSE This randomized phase III trial is to see if paclitaxel works better with or without bevacizumab in treating patients who have locally recurrent or metastatic breast cancer
Detailed Description:
OBJECTIVES
Compare the time to treatment failure in patients with locally recurrent or metastatic breast cancer treated with paclitaxel with or without bevacizumab
Compare the objective response rate duration of response overall survival and time to progression in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to disease-free interval no more than 24 months vs more than 24 months number of metastatic sites less than 3 vs 3 or more treatment with prior adjuvant chemotherapy yes vs no and estrogen receptor status positive vs negative vs unknown Patients are randomized to one of two treatment arms
Arm I Patients receive paclitaxel IV over 1 hour on days 1 8 and 15 followed by bevacizumab IV over 30-90 minutes on days 1 and 15
Arm II Patients receive paclitaxel as in arm I In both arms courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and on day 1 of weeks 17 and 33
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 316-650 patients 158-325 per treatment arm will be accrued for this study within 31 months
Compare the time to treatment failure in patients with locally recurrent or metastatic breast cancer treated with paclitaxel with or without bevacizumab
Compare the objective response rate duration of response overall survival and time to progression in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to disease-free interval no more than 24 months vs more than 24 months number of metastatic sites less than 3 vs 3 or more treatment with prior adjuvant chemotherapy yes vs no and estrogen receptor status positive vs negative vs unknown Patients are randomized to one of two treatment arms
Arm I Patients receive paclitaxel IV over 1 hour on days 1 8 and 15 followed by bevacizumab IV over 30-90 minutes on days 1 and 15
Arm II Patients receive paclitaxel as in arm I In both arms courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and on day 1 of weeks 17 and 33
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 316-650 patients 158-325 per treatment arm will be accrued for this study within 31 months
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 |
|---|---|---|---|
| NSABP-E2100 | None | None | None |
| E2100 | None | None | None |
| NCCTG-E2100 | None | None | None |
| CAN-NCIC-MAC3 | None | None | None |