VEGF Trap in Treating Patients With Metastatic Breast Cancer
Completed · Phase 2
Conditions studied: Metastatic Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
In brief
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
Key facts
- Study ID
- NCT00369655
- Run by
- National Cancer Institute (NCI)
- People needed
- 21
- Starts
- 2007-01-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2014-05-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed adenocarcinoma of the breast
- Clinical evidence of metastatic disease
- No more than 2 prior chemotherapy regimens for metastatic disease
- Prior neoadjuvant or adjuvant chemotherapy allowed*
- At least 1 prior regimen (in any setting) must have included a taxane and/or an anthracycline
- Measurable disease, defined as ≥ 1 lesion whose longest diameter can be accurately measured per RECIST criteria
- No nonmeasurable disease, defined as all other lesions, including small lesions(longest diameter < 20 mm) and truly nonmeasurable lesions, including the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Patients with HER2-positive tumors (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization [FISH]) must have received ≥ 1 prior trastuzumab (Herceptin®)-containing regimen in either the adjuvant or metastatic setting, unless there was a contraindication
- No known CNS metastases
- No evidence of leptomeningeal involvement
- Hormone receptor status not specified
- Male or female
- Menopausal status not specified
- ECOG performance status 0-1
- Life expectancy > 3 months
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
Where it is running
- North Central Cancer Treatment Group — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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