Docetaxel With Bevacizumab as First-Line Therapy in Treating Women With Stage IV Breast Cancer
Recruitment status was Active, not recruiting
RATIONALE: Drugs used in chemotherapy, such as docetaxel, 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 stopping blood flow to the tumor. It is not yet known whether giving docetaxel together with bevacizumab is more effective than docetaxel alone in treating breast cancer.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with bevacizumab works compared to docetaxel alone as first-line therapy in treating women with stage IV breast cancer.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial of Docetaxel With or Without Bevacizumab as First-Line Therapy for HER2-Negative Metastatic Breast Cancer|
- Antitumor activity [ Time Frame: Time to disease progression ] [ Designated as safety issue: No ]
- Comparison of response rates, duration of response, and overall survival [ Time Frame: Time of death ] [ Designated as safety issue: No ]
- Comparison of safety and toxicity [ Time Frame: When adverse events occur ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2005|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
Bevacizumab: 15 mg/kg IV every 3 weeks. Subjects continue on study until disease progression, unacceptable toxicity, or withdrawal of patient consent.
15 mg/kg IV every 3 weeks. Subjects continue on study until disease progression, unacceptable toxicity, or withdrawal of patient consent.
Other Name: AvastinDrug: docetaxel
75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
Other Name: Taxotere
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217672
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Sara Hurvitz, MD||Jonsson Comprehensive Cancer Center|