Chemotherapy and Bevacizumab in Treating Women With Invasive Breast Cancer
Recruitment status was Recruiting
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This clinical trial is studying how well giving chemotherapy together with bevacizumab works in treating women with invasive breast cancer.
Drug: doxorubicin hydrochloride
Procedure: adjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dose-Dense Adjuvant Chemotherapy Plus Bevacizumab in Lymph Node Positive Breast Cancer: A Pilot Study|
- Incidence of treatment failure [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Adverse events [ Designated as safety issue: Yes ]
- Disease-free survival at 2 and 5 years [ Designated as safety issue: No ]
- Correlation of circulating tumor cell and circulating endothelial progenitor cell assay results with clinical outcomes [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
- Determine the feasibility and toxicity of dose-dense adjuvant chemotherapy and bevacizumab followed by single-agent bevacizumab in women with lymph-node positive, invasive breast cancer.
- Estimate the 2-year and 5-year disease-free survival of patients treated with this regimen.
- Describe the detection rate of circulating tumor cells and circulating endothelial cells before initiating adjuvant treatment in these patients.
OUTLINE: This is an open-label, pilot study.
- Dose-dense chemotherapy (courses 1-8): Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 2 weeks for 4 courses. Patients then receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 2 weeks for 4 courses.
- Bevacizumab (courses 1-20): Beginning with course 1 of chemotherapy, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 8 courses. Patients then receive bevacizumab alone every 3 weeks for 12 courses.
Patients also receive filgrastim (G-CSF) daily on days 3-10 OR pegfilgrastim once on day 2 of each chemotherapy course.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
|United States, California|
|Santa Monica, California, United States, 90404|
|Contact: Linnea Chap, MD 310-633-8400|
|Study Chair:||Linnea Chap, MD||Premiere Oncology|