A Randomized Phase II Trial of Docetaxel With or Without Bevacizumab as First-Line Therapy for HER2-Negative Metastatic Breast Cancer
OBJECTIVES:
Primary
- Compare the antitumor activity of docetaxel with vs without bevacizumab, in terms of
time to disease progression, in women with HER2-negative stage IV breast cancer.
Secondary
- Compare response rates, duration of response, and overall survival of patients treated
with these regimens.
- Compare the safety and toxicity of these regimens in these patients.
OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are
stratified according to prior adjuvant and/or neoadjuvant chemotherapy (none vs prior
chemotherapy without a taxane vs prior chemotherapy with a taxane). Patients are randomized
to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days
in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes
on day 1. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity. Patients who experience unacceptable toxicity due to docetaxel
may continue on bevacizumab alone until disease progression or bevacizumab-related
unacceptable toxicity.
After completion of study treatment, patients are followed within 30 days and then every 12
weeks thereafter.
PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this
study within 3 months.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Antitumor activity
Time to disease progression
No
Sara Hurvitz, MD
Principal Investigator
Jonsson Comprehensive Cancer Center
United States: Federal Government
CDR0000442877
NCT00217672
May 2005
Name | Location |
---|---|
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |