{
    "info": {
        "nct_id": "NCT00394082",
        "official_title": "A Phase II Trial of Weekly Administration of ABI-007 In Combination With Bevacizumab in Women With Metastatic Breast Cancer",
        "inclusion_criteria": "* Pathologically confirmed adenocarcinoma of the breast.\n* Stage IV disease.\n* Measurable disease (defined as the presence of at least one lesion that can be accurately measured in at least one dimension with longest diameter greater or = 1.0 cm with spiral computed tomography (CT) scan).\n* Patients must not be a candidate for Herceptin therapy (i.e., patients with HER-2 positive disease (gene amplification by fluorescence in situ hybridization (FISH) or 3 + overexpression by ICH) and patients with unknown HER-2 status are ineligible unless the treating physicians has determined that Herceptin-based therapy would be inappropriate or not indicated).\n* For subjects with prior anthracycline exposure, normal cardiac function including a baseline left ventricle ejection fraction >50% or above institution's lower limit of normal and a normal electrocardiogram (ECG) (as assessed by the investigator).\n* At least 2 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease within the radiation portal.\n* International Normalized Ratio (INR) < 1.5 and activated partial thromboplastin time within normal limits (APTT WNL).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Female > 18 years of age.\n* Patients have the following blood counts at Baseline: absolute neutrophil count (ANC) greater or equal to 1.5 x 10^9 cells/L; platelets greater or equal 100 x 10^9 cells/L; hemoglobin (Hgb) greater or equal to 9g/dL.\n* Patients have the following blood chemistry levels at Baseline: aspartate aminotransferase (AST or SGOT), alanine aminotransferase (ALT or SGPT) less than or equal 2.5x upper limit of normal (ULN) range (less than or equal 5x ULN if patient has known liver metastases); total bilirubin greater than or equal to ULN; creatinine greater or equal to 1.5mg/dL.\n* if female of childbearing potential, pregnancy test is negative within 72 hours of first dose of study drug.\n* if fertile, the patient agrees to use an effective method to avoid pregnancy for the duration of the study.\n* Informed consent has been obtained.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* No prior chemotherapy for metastatic or locally recurrent disease is allowed.\n* Prio neo-adjuvant chemotherapy is allowed, and patients must have recovered from the acute toxicity of such therapies.\n\n  * if a taxane was part of the adjuvant regimen, at least 12 months must have elapsed between the last dose of the taxane and the date of diagnosis of metastatic disease.\n  * if a non-taxane-based adjuvant therapy was administered, at least six months must have elapsed between the last dose of the non- taxane-containing chemotherapy and the date of diagnosis of metastatic disease.\n* Concurrent immunotherapy or hormonal therapy.\n* Parenchymal brain metastases, including leptomeningeal involvement.\n* Uncontrolled hypertension (defined as blood pressure of > 150/100 mmHg)\n* NYHA Grade 2 or greater congestive heart failure\n* History of coagulopathy, bleeding diathesis, therapeutic anticoagulation other than low dose or chronic ASA greater than or equal to 325 mg per day. Low dose coumadin for anticoagulation of venous access device or low dose molecular weight heparin (LMWH)for deep vein thrombosis prophylaxis or low dose (325 mg or less) ASA prophylaxis are allowed, but are best avoided if the treating physician feels it is safe to do so.\n* Urine protein:creatinine ratio less than or equal to 1.0 at screening.\n* No history of cerebrovascular accident within six months of study entry.\n* Active symptomatic peripheral vascular disease (e.g. aortic aneurysm, claudication) within six months of study entry.\n* Uncontrolled or severe cardiovascular disease including myocardial infarction or unstable angina within six months of study entry.\n* No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal process within six months of study entry.\n* No serious non-healing wound, ulcer, or bone fracture\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to first dose, or anticipation of need for major surgical procedure during the course of the study. No minor surgical procedure within seven days of study entry. Serious intercurrent medical or psychiatric illness, including serious active infection.\n* History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.\n* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.\n* Pregnant or nursing women.\n* Patients with current sensory neuropathy of > Grade 1 will be excluded.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Pathologically confirmed adenocarcinoma of the breast.",
            "criterions": [
                {
                    "exact_snippets": "Pathologically confirmed adenocarcinoma of the breast.",
                    "criterion": "adenocarcinoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage IV disease.",
            "criterions": [
                {
                    "exact_snippets": "Stage IV disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease (defined as the presence of at least one lesion that can be accurately measured in at least one dimension with longest diameter greater or = 1.0 cm with spiral computed tomography (CT) scan).",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease (defined as the presence of at least one lesion that can be accurately measured in at least one dimension with longest diameter greater or = 1.0 cm with spiral computed tomography (CT) scan)",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.0,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must not be a candidate for Herceptin therapy (i.e., patients with HER-2 positive disease (gene amplification by fluorescence in situ hybridization (FISH) or 3 + overexpression by ICH) and patients with unknown HER-2 status are ineligible unless the treating physicians has determined that Herceptin-based therapy would be inappropriate or not indicated).",
            "criterions": [
                {
                    "exact_snippets": "HER-2 positive disease (gene amplification by fluorescence in situ hybridization (FISH) or 3 + overexpression by ICH)",
                    "criterion": "HER-2 status",
                    "requirements": [
                        {
                            "requirement_type": "gene amplification",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "overexpression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with unknown HER-2 status",
                    "criterion": "HER-2 status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "unknown"
                        }
                    ]
                },
                {
                    "exact_snippets": "treating physicians has determined that Herceptin-based therapy would be inappropriate or not indicated",
                    "criterion": "Herceptin-based therapy appropriateness",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For subjects with prior anthracycline exposure, normal cardiac function including a baseline left ventricle ejection fraction >50% or above institution's lower limit of normal and a normal electrocardiogram (ECG) (as assessed by the investigator).",
            "criterions": [
                {
                    "exact_snippets": "prior anthracycline exposure",
                    "criterion": "prior anthracycline exposure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "normal cardiac function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "baseline left ventricle ejection fraction >50% or above institution's lower limit of normal",
                    "criterion": "left ventricle ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 50,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "institution's lower limit of normal"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "normal electrocardiogram (ECG)",
                    "criterion": "electrocardiogram (ECG)",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 2 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease within the radiation portal.",
            "criterions": [
                {
                    "exact_snippets": "At least 2 weeks since radiotherapy",
                    "criterion": "time since radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "full recovery",
                    "criterion": "recovery from radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": "full"
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable disease must be completely outside the radiation portal",
                    "criterion": "measurable disease location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "completely outside the radiation portal"
                        }
                    ]
                },
                {
                    "exact_snippets": "pathologic proof of progressive disease within the radiation portal",
                    "criterion": "progressive disease within radiation portal",
                    "requirements": [
                        {
                            "requirement_type": "proof",
                            "expected_value": "pathologic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* International Normalized Ratio (INR) < 1.5 and activated partial thromboplastin time within normal limits (APTT WNL).",
            "criterions": [
                {
                    "exact_snippets": "International Normalized Ratio (INR) < 1.5",
                    "criterion": "International Normalized Ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "activated partial thromboplastin time within normal limits (APTT WNL)",
                    "criterion": "activated partial thromboplastin time (APTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "within normal limits"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female > 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "> 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients have the following blood counts at Baseline: absolute neutrophil count (ANC) greater or equal to 1.5 x 10^9 cells/L; platelets greater or equal 100 x 10^9 cells/L; hemoglobin (Hgb) greater or equal to 9g/dL.",
            "criterions": [
                {
                    "exact_snippets": "absolute neutrophil count (ANC) greater or equal to 1.5 x 10^9 cells/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9 cells/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets greater or equal 100 x 10^9 cells/L",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9 cells/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin (Hgb) greater or equal to 9g/dL",
                    "criterion": "hemoglobin (Hgb)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients have the following blood chemistry levels at Baseline: aspartate aminotransferase (AST or SGOT), alanine aminotransferase (ALT or SGPT) less than or equal 2.5x upper limit of normal (ULN) range (less than or equal 5x ULN if patient has known liver metastases); total bilirubin greater than or equal to ULN; creatinine greater or equal to 1.5mg/dL.",
            "criterions": [
                {
                    "exact_snippets": "aspartate aminotransferase (AST or SGOT) ... less than or equal 2.5x upper limit of normal (ULN) range (less than or equal 5x ULN if patient has known liver metastases)",
                    "criterion": "aspartate aminotransferase (AST or SGOT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT or SGPT) ... less than or equal 2.5x upper limit of normal (ULN) range (less than or equal 5x ULN if patient has known liver metastases)",
                    "criterion": "alanine aminotransferase (ALT or SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin greater than or equal to ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine greater or equal to 1.5mg/dL",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1.5,
                                        "unit": "mg/dL"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* if female of childbearing potential, pregnancy test is negative within 72 hours of first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "female of childbearing potential",
                    "criterion": "female of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnancy test is negative",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 72 hours of first dose of study drug",
                    "criterion": "timing of pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 72 hours of first dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* if fertile, the patient agrees to use an effective method to avoid pregnancy for the duration of the study.",
            "criterions": [
                {
                    "exact_snippets": "if fertile",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agrees to use an effective method to avoid pregnancy",
                    "criterion": "use of contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Informed consent has been obtained.",
            "criterions": [
                {
                    "exact_snippets": "Informed consent has been obtained.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "obtained",
                            "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": "* No prior chemotherapy for metastatic or locally recurrent disease is allowed.",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy for metastatic or locally recurrent disease is allowed.",
                    "criterion": "prior chemotherapy for metastatic or locally recurrent disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prio neo-adjuvant chemotherapy is allowed, and patients must have recovered from the acute toxicity of such therapies.",
            "criterions": [
                {
                    "exact_snippets": "Prio neo-adjuvant chemotherapy is allowed",
                    "criterion": "prior neo-adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients must have recovered from the acute toxicity of such therapies",
                    "criterion": "recovery from acute toxicity of neo-adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* if a taxane was part of the adjuvant regimen, at least 12 months must have elapsed between the last dose of the taxane and the date of diagnosis of metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "if a taxane was part of the adjuvant regimen",
                    "criterion": "taxane in adjuvant regimen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 12 months must have elapsed between the last dose of the taxane and the date of diagnosis of metastatic disease",
                    "criterion": "time elapsed since last taxane dose",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent immunotherapy or hormonal therapy.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent immunotherapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent ... hormonal therapy",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Parenchymal brain metastases, including leptomeningeal involvement.",
            "criterions": [
                {
                    "exact_snippets": "Parenchymal brain metastases",
                    "criterion": "parenchymal brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "leptomeningeal involvement",
                    "criterion": "leptomeningeal involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension (defined as blood pressure of > 150/100 mmHg)",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension (defined as blood pressure of > 150/100 mmHg)",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "blood pressure of > 150/100 mmHg",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 150,
                                        "unit": "mmHg"
                                    },
                                    {
                                        "operator": ">",
                                        "value": 100,
                                        "unit": "mmHg"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NYHA Grade 2 or greater congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "NYHA Grade 2 or greater congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "NYHA Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Urine protein:creatinine ratio less than or equal to 1.0 at screening.",
            "criterions": [
                {
                    "exact_snippets": "Urine protein:creatinine ratio less than or equal to 1.0",
                    "criterion": "urine protein:creatinine ratio",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.0,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of cerebrovascular accident within six months of study entry.",
            "criterions": [
                {
                    "exact_snippets": "No history of cerebrovascular accident within six months of study entry.",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active symptomatic peripheral vascular disease (e.g. aortic aneurysm, claudication) within six months of study entry.",
            "criterions": [
                {
                    "exact_snippets": "Active symptomatic peripheral vascular disease",
                    "criterion": "peripheral vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within six months of study entry",
                    "criterion": "time since diagnosis or symptom onset",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled or severe cardiovascular disease including myocardial infarction or unstable angina within six months of study entry.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled or severe cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "uncontrolled or severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction ... within six months of study entry",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina within six months of study entry",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal process within six months of study entry.",
            "criterions": [
                {
                    "exact_snippets": "No history of abdominal fistula",
                    "criterion": "abdominal fistula",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of ... gastrointestinal perforation",
                    "criterion": "gastrointestinal perforation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of ... intra-abdominal process within six months of study entry",
                    "criterion": "intra-abdominal process",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within six months of study entry"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No serious non-healing wound, ulcer, or bone fracture",
            "criterions": [
                {
                    "exact_snippets": "No serious non-healing wound",
                    "criterion": "non-healing wound",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "No serious non-healing ... ulcer",
                    "criterion": "non-healing ulcer",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "No serious non-healing ... bone fracture",
                    "criterion": "non-healing bone fracture",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to first dose, or anticipation of need for major surgical procedure during the course of the study. No minor surgical procedure within seven days of study entry. Serious intercurrent medical or psychiatric illness, including serious active infection.",
            "criterions": [
                {
                    "exact_snippets": "Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to first dose",
                    "criterion": "major surgical procedure, open biopsy, or significant traumatic injury",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "anticipation of need for major surgical procedure during the course of the study",
                    "criterion": "need for major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "anticipated during study",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No minor surgical procedure within seven days of study entry",
                    "criterion": "minor surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 7,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious intercurrent medical or psychiatric illness, including serious active infection",
                    "criterion": "serious intercurrent medical or psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious intercurrent medical or psychiatric illness, including serious active infection",
                    "criterion": "serious active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "History of other malignancy within the last 5 years",
                    "criterion": "history of other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.",
            "criterions": [
                {
                    "exact_snippets": "Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.",
                    "criterion": "participation in an experimental drug study",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": [
                                "current",
                                "recent (within 4 weeks of the first infusion of this study)",
                                "planned"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or nursing women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing women",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with current sensory neuropathy of > Grade 1 will be excluded.",
            "criterions": [
                {
                    "exact_snippets": "current sensory neuropathy of > Grade 1",
                    "criterion": "sensory neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* if a non-taxane-based adjuvant therapy was administered, at least six months must have elapsed between the last dose of the non- taxane-containing chemotherapy and the date of diagnosis of metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "non-taxane-based adjuvant therapy was administered",
                    "criterion": "non-taxane-based adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least six months must have elapsed between the last dose of the non-taxane-containing chemotherapy and the date of diagnosis of metastatic disease",
                    "criterion": "time elapsed since last dose of non-taxane-containing chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of coagulopathy, bleeding diathesis, therapeutic anticoagulation other than low dose or chronic ASA greater than or equal to 325 mg per day. Low dose coumadin for anticoagulation of venous access device or low dose molecular weight heparin (LMWH)for deep vein thrombosis prophylaxis or low dose (325 mg or less) ASA prophylaxis are allowed, but are best avoided if the treating physician feels it is safe to do so.",
            "criterions": [
                {
                    "exact_snippets": "History of coagulopathy",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bleeding diathesis",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "therapeutic anticoagulation other than low dose or chronic ASA greater than or equal to 325 mg per day",
                    "criterion": "therapeutic anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "other than low dose or chronic ASA"
                        },
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 325,
                                "unit": "mg per day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Low dose coumadin for anticoagulation of venous access device",
                    "criterion": "low dose coumadin",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "anticoagulation of venous access device"
                        }
                    ]
                },
                {
                    "exact_snippets": "low dose molecular weight heparin (LMWH) for deep vein thrombosis prophylaxis",
                    "criterion": "low dose molecular weight heparin (LMWH)",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "deep vein thrombosis prophylaxis"
                        }
                    ]
                },
                {
                    "exact_snippets": "low dose (325 mg or less) ASA prophylaxis",
                    "criterion": "low dose ASA",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 325,
                                "unit": "mg"
                            }
                        },
                        {
                            "requirement_type": "purpose",
                            "expected_value": "prophylaxis"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}