Erlotinib and Bevacizumab in Treating Women With Stage IV Breast Cancer
Recruitment status was Active, not recruiting
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes needed for their growth. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining erlotinib with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is to see if combining erlotinib with bevacizumab works in treating women who have stage IV breast cancer.
Drug: erlotinib hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of OSI-774 In Combination With Bevacizumab In Patients With Stage IV Breast Cancer|
|Study Start Date:||December 2002|
- Determine the efficacy of erlotinib and bevacizumab, in terms of objective response rate, in women with previously treated stage IV breast cancer.
- Determine the toxicity of this regimen in these patients.
- Determine the time to disease progression and duration of response of patients treated with this regimen.
- Determine the proportion of patients achieving stabilization of disease for at least 6 months after treatment with this regimen.
- Correlate the molecular profile of the primary breast tumor with response in patients treated with this regimen.
- Correlate an analysis of circulating endothelial cells with serum markers of angiogenesis and response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily and bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-18.5 months.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Maura N. Dickler, MD||Memorial Sloan-Kettering Cancer Center|