VEGF Trap in Treating Patients With Metastatic Breast Cancer
Summary
RATIONALE: VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well VEGF Trap works in treating patients with metastatic breast cancer.
Description
OBJECTIVES:
Primary
- 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.
- Assess the 6-month progression-free survival rate in patients treated with VEGF Trap.
Secondary
- Describe the adverse event profile (grade using the NCI CTCAE version 3.0) of VEGF Trap in these patients.
- Describe the progression-free survival times in patients treated with VEGF Trap.
- Describe the overall survival of patients treated with VEGF Trap.
- 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.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Study Design
Masking: Open Label, Primary Purpose: Treatment
Conditions
Breast Cancer
Intervention
aflibercept
Location
Mayo Clinic Scottsdale
Scottsdale
Arizona
United States
85259-5499
Status
Active, not recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00369655
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Inflammatory Breast Neoplasms
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
Carcinoma, Lobular
A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)
Mucin-1
Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.
Breast Neoplasms
Tumors or cancer of the human BREAST.
Brca1 Protein
The phosphoprotein encoded by the BRCA1 gene (GENE, BRCA1). In normal cells the BRCA1 protein is localized in the nucleus, whereas in the majority of breast cancer cell lines and in malignant pleural effusions from breast cancer patients, it is localized mainly in the cytoplasm. (Science 1995;270(5237):713,789-91)
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