This phase II trial is studying how well VEGF Trap works in treating patients with metastatic breast cancer. VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor
PRIMARY OBJECTIVES: I. Assess the antitumor activity of VEGF Trap, in terms of tumor response rate, in patients with metastatic breast cancer who have received =\< 2 prior chemotherapy regimens for metastatic disease, including a taxane and/or anthracycline. II. Assess the 6-month progression-free survival rate in patients treated with VEGF Trap. SECONDARY OBJECTIVES: I. Describe the adverse event profile (grade using the NCI CTCAE version 3.0) of VEGF Trap in these patients. II. Describe the progression-free survival times in patients treated with VEGF Trap. III. Describe the overall survival of patients treated with VEGF Trap. IV. Describe the duration of response in patients treated with VEGF Trap. OUTLINE: This is a multicenter study. Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3-6 months for up to 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
North Central Cancer Treatment Group
Rochester, Minnesota, United States
Proportion of Patients With Confirmed Tumor Response
Confirmed tumor response was defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria on 2 consecutive evaluations at least 8 weeks apart.
Time frame: Up to 5 years
Proportion of Patients Receiving Vascular Endothelial Growth Factor (VEGF) Trap With 6-month Progression-free Survival
The 6-month progression free survival rate was defined as the proportion of efficacy-evaluable patients on study treatment and progression-free 6 months from registration. Patients who died without documentation of progression will be considered to have progressed on the date of their death.
Time frame: 6 months
Progression Free Survival
Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who died without documentation of progression being considered to have progressed on the date of their death.
Time frame: Time from registration to disease progression or death (up to 5 years)
Overall Survival
Overall survival time was defined as the number of months from registration to the date of death or last follow-up
Time frame: Time from registration to death or last follow up (up to 5 years)
Median Duration of Response
Duration of response was defined as for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a complete response or partial response to the date progression is documented.
Time frame: Up to 5 years
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Number of Participant With Previous Treatment of Anti-HER2 With Cardiac Events
Time frame: Up to 5 years