Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119262
Status:
COMPLETED
Last Update Posted:
2014-05-15
First Post:
2005-07-12
Brief Title:
Bevacizumab and Combination Chemotherapy in Patients With Lymph Node Positive Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Feasibility Trial Incorporating Bevacizumab Into Dose Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Patients With Lymph Node Positive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-12
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 phase II trial is studying how well giving bevacizumab together with combination chemotherapy works in treating patients who have undergone surgery for breast cancer that has spread to the lymph nodes Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Drugs used in chemotherapy work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving bevacizumab together with more than one chemotherapy drug combination chemotherapy may be a better way to block tumor growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the incidence of clinically apparent cardiac dysfunction in patients with lymph node positive breast cancer treated with bevacizumab and dose dense doxorubicincyclophosphamide followed by paclitaxel ddAC T
SECONDARY OBJECTIVES
I To evaluate changes in LVEF during treatment II To evaluate non-cardiac toxicity
OUTLINE This is a non-randomized multicenter study Patients are sequentially assigned to 1 of 2 treatment arms
Arm A Patients receive doxorubicin IV cyclophosphamide IV over 20-30 minutes and bevacizumab IV over 30-90 minutes on day 1 Patients also receive filgrastim G-CSF subcutaneously SQ on days 2-11 or pegfilgrastim SC on day 2 Treatment repeats every 14 days for 4 courses Patients then receive paclitaxel IV over 3 hours and bevacizumab IV over 30-90 minutes on day 1 Patients also receive G-CSF or pegfilgrastim as above Treatment with paclitaxel bevacizumab and G-CSF or pegfilgrastim repeats every 14 days for 4 courses Patients then receive bevacizumab alone every 14 days for up to 18 courses
Arm B Patients receive doxorubicin cyclophosphamide and G-CSF or pegfilgrastim as in group I Patients then receive paclitaxel bevacizumab and G-CSF or pegfilgrastim as in group I Patients then receive bevacizumab alone every 14 days for up to 22 courses
Treatment in both groups continues in the absence of disease recurrence or unacceptable toxicity
Patients who require radiotherapy post-lumpectomy or who plan radiotherapy at the discretion of the investigator post-mastectomy undergo radiotherapy beginning within 6 weeks after the completion of chemotherapy
Premenopausal patients with estrogen receptor ER andor progesterone receptor PR positive disease receive oral tamoxifen once daily for 5 years beginning at the time of radiotherapy or within 6 weeks after the completion of chemotherapy Postmenopausal patients with ER andor PR positive disease receive an aromatase inhibitor eg anastrozole letrozole or exemestane or tamoxifen followed by an aromatase inhibitor once daily for up to 10 years
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for up to 3 years from study entry
ACCRUAL A total of 226 patients 104 on arm A and 122 on arm B were accrued for this study
I To determine the incidence of clinically apparent cardiac dysfunction in patients with lymph node positive breast cancer treated with bevacizumab and dose dense doxorubicincyclophosphamide followed by paclitaxel ddAC T
SECONDARY OBJECTIVES
I To evaluate changes in LVEF during treatment II To evaluate non-cardiac toxicity
OUTLINE This is a non-randomized multicenter study Patients are sequentially assigned to 1 of 2 treatment arms
Arm A Patients receive doxorubicin IV cyclophosphamide IV over 20-30 minutes and bevacizumab IV over 30-90 minutes on day 1 Patients also receive filgrastim G-CSF subcutaneously SQ on days 2-11 or pegfilgrastim SC on day 2 Treatment repeats every 14 days for 4 courses Patients then receive paclitaxel IV over 3 hours and bevacizumab IV over 30-90 minutes on day 1 Patients also receive G-CSF or pegfilgrastim as above Treatment with paclitaxel bevacizumab and G-CSF or pegfilgrastim repeats every 14 days for 4 courses Patients then receive bevacizumab alone every 14 days for up to 18 courses
Arm B Patients receive doxorubicin cyclophosphamide and G-CSF or pegfilgrastim as in group I Patients then receive paclitaxel bevacizumab and G-CSF or pegfilgrastim as in group I Patients then receive bevacizumab alone every 14 days for up to 22 courses
Treatment in both groups continues in the absence of disease recurrence or unacceptable toxicity
Patients who require radiotherapy post-lumpectomy or who plan radiotherapy at the discretion of the investigator post-mastectomy undergo radiotherapy beginning within 6 weeks after the completion of chemotherapy
Premenopausal patients with estrogen receptor ER andor progesterone receptor PR positive disease receive oral tamoxifen once daily for 5 years beginning at the time of radiotherapy or within 6 weeks after the completion of chemotherapy Postmenopausal patients with ER andor PR positive disease receive an aromatase inhibitor eg anastrozole letrozole or exemestane or tamoxifen followed by an aromatase inhibitor once daily for up to 10 years
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for up to 3 years from study entry
ACCRUAL A total of 226 patients 104 on arm A and 122 on arm B were 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 |
|---|---|---|---|
| E2104 | OTHER | CTEP | httpsreporternihgovquickSearchU10CA021115 |
| NCI-2012-02977 | REGISTRY | None | None |
| U10CA021115 | NIH | None | None |
| E2104 | OTHER | None | None |