Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027885
Status:
COMPLETED
Last Update Posted:
2013-06-17
First Post:
2001-12-07
Brief Title:
Phase II Bevacizumab Tax In Advanced Breast Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Randomized Phase II Study of Bevacizumab in Combination With Docetaxel in Locally Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 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 Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells
PURPOSE This randomized phase II trial is to see if docetaxel with or without bevacizumab followed by surgery radiation therapy and combination chemotherapy works better in treating patients who have stage III or stage IV breast cancer
PURPOSE This randomized phase II trial is to see if docetaxel with or without bevacizumab followed by surgery radiation therapy and combination chemotherapy works better in treating patients who have stage III or stage IV breast cancer
Detailed Description:
OBJECTIVES
Determine the effect of bevacizumab and docetaxel on reduction of microvessel density and induction of apoptosis of endothelial and tumor cells in patients with locally advanced breast cancer
Determine the safety profile of this regimen in these patients
Compare the effect of docetaxel and bevacizumab in terms of objective response stabilization of disease and progression-free survival in these patients
OUTLINE This is a randomized study Patients are stratified according to disease stage Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8
Arm II Patients receive docetaxel as in arm I Treatment in both arms repeats every 8 weeks for 2 courses in the absence of disease progression or unacceptable toxicity
After the second course patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery Three to six weeks after surgery patients undergo radiotherapy 5 days a week for 7 weeks
Approximately 4 weeks after the completion of radiotherapy patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV over 30-60 minutes on day 1 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients with estrogen andor progesterone receptor-positive disease also receive oral tamoxifen daily for 5 years beginning after the completion of chemotherapy Post-menopausal patients may receive oral anastrozole once daily for 5 years instead of tamoxifen
Patients are followed at 3 6 and 12 months every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients 30 per treatment arm will be accrued for this study
Determine the effect of bevacizumab and docetaxel on reduction of microvessel density and induction of apoptosis of endothelial and tumor cells in patients with locally advanced breast cancer
Determine the safety profile of this regimen in these patients
Compare the effect of docetaxel and bevacizumab in terms of objective response stabilization of disease and progression-free survival in these patients
OUTLINE This is a randomized study Patients are stratified according to disease stage Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8
Arm II Patients receive docetaxel as in arm I Treatment in both arms repeats every 8 weeks for 2 courses in the absence of disease progression or unacceptable toxicity
After the second course patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery Three to six weeks after surgery patients undergo radiotherapy 5 days a week for 7 weeks
Approximately 4 weeks after the completion of radiotherapy patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV over 30-60 minutes on day 1 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients with estrogen andor progesterone receptor-positive disease also receive oral tamoxifen daily for 5 years beginning after the completion of chemotherapy Post-menopausal patients may receive oral anastrozole once daily for 5 years instead of tamoxifen
Patients are followed at 3 6 and 12 months every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients 30 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| NCI-2722 | OTHER | CTEPNCI | httpsreporternihgovquickSearchP30CA043703 |
| U01CA062502 | NIH | None | None |
| P30CA043703 | NIH | None | None |
| CWRU-3100 | OTHER | None | None |