Dose-Dense Adjuvant Chemotherapy Plus Bevacizumab in Lymph Node Positive Breast Cancer: A Pilot Study
- 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
- 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.
Masking: Open Label, Primary Purpose: Treatment
Incidence of treatment failure
Linnea Chap, MD
|Premiere Oncology||Santa Monica, California 90404|