{
"info": {
"nct_id": "NCT00476827",
"official_title": "A Phase II Safety and Tolerability Study of Avastin When Added to Single-agent Chemotherapy to Treat Patient With Breast Cancer Metastatic to Brain",
"inclusion_criteria": "* Female, 18+, with evaluable metastatic breast cancer and stable brain metastases\n* Must have received definitive radiotherapy\n* No evidence, or history of, central nervous system hemorrhage\n* Adequate organ and hematological function\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Active infection, non-healing wound, or history of any bleeding diathesis or coagulopathy\n* Uncontrolled hypertension, congestive heart failure, peripheral vascular disease",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Female, 18+, with evaluable metastatic breast cancer and stable brain metastases",
"criterions": [
{
"exact_snippets": "Female",
"criterion": "gender",
"requirements": [
{
"requirement_type": "value",
"expected_value": "female"
}
]
},
{
"exact_snippets": "18+",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "evaluable metastatic breast cancer",
"criterion": "metastatic breast cancer",
"requirements": [
{
"requirement_type": "evaluable",
"expected_value": true
}
]
},
{
"exact_snippets": "stable brain metastases",
"criterion": "brain metastases",
"requirements": [
{
"requirement_type": "stability",
"expected_value": "stable"
}
]
}
]
},
{
"line": "* Must have received definitive radiotherapy",
"criterions": [
{
"exact_snippets": "Must have received definitive radiotherapy",
"criterion": "definitive radiotherapy",
"requirements": [
{
"requirement_type": "receipt",
"expected_value": true
}
]
}
]
},
{
"line": "* No evidence, or history of, central nervous system hemorrhage",
"criterions": [
{
"exact_snippets": "No evidence, or history of, central nervous system hemorrhage",
"criterion": "central nervous system hemorrhage",
"requirements": [
{
"requirement_type": "evidence",
"expected_value": false
},
{
"requirement_type": "history",
"expected_value": false
}
]
}
]
},
{
"line": "* Adequate organ and hematological function",
"criterions": [
{
"exact_snippets": "Adequate organ ... function",
"criterion": "organ function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "Adequate ... hematological function",
"criterion": "hematological function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Active infection, non-healing wound, or history of any bleeding diathesis or coagulopathy",
"criterions": [
{
"exact_snippets": "Active infection",
"criterion": "infection",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "non-healing wound",
"criterion": "wound healing",
"requirements": [
{
"requirement_type": "status",
"expected_value": "non-healing"
}
]
},
{
"exact_snippets": "history of any bleeding diathesis",
"criterion": "bleeding diathesis",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "history of any ... coagulopathy",
"criterion": "coagulopathy",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Uncontrolled hypertension, congestive heart failure, peripheral vascular disease",
"criterions": [
{
"exact_snippets": "Uncontrolled hypertension",
"criterion": "hypertension",
"requirements": [
{
"requirement_type": "control",
"expected_value": false
}
]
},
{
"exact_snippets": "congestive heart failure",
"criterion": "congestive heart failure",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "peripheral vascular disease",
"criterion": "peripheral vascular disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}