Metronomic Chemotherapy in Combination With Bevacizumab for Advanced Breast Cancer
- Compare the overall response rate in women with metastatic breast cancer treated with
metronomic low-dose cyclophosphamide and methotrexate with or without bevacizumab.
- Compare the progression-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Correlate markers of angiogenesis, including vascular endothelial growth factor and
circulating endothelial cells, at baseline and during treatment, with response in
patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive low-dose oral cyclophosphamide once daily on days 1-28,
low-dose oral methotrexate twice daily on days 1, 2, 8, 9, 15, 16, 22 and 23, and
bevacizumab IV over 30-90 minutes on days 1 and 15.
- Arm II: Patients receive cyclophosphamide and methotrexate as in arm I. In both arms,
courses repeat every 28 days in the absence of disease progression or unacceptable
Patients in arm II who have progressive disease have the option of discontinuing treatment
or crossing over to arm I.
PROJECTED ACCRUAL: A total of 36-66 patients (18-33 per treatment arm) will be accrued for
this study within 7-12 months.
Allocation: Randomized, Primary Purpose: Treatment
Clinical response rate (complete and partial) as measured by RECIST criteria
Harold J. Burstein, MD, PhD
Dana-Farber Cancer Institute
United States: Federal Government
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|