{
    "info": {
        "nct_id": "NCT00622401",
        "official_title": "Vaccination of Patients With Breast Cancer With Dendritic Cell/Tumor Fusions and IL-12",
        "inclusion_criteria": "* Stage IV breast cancer with measurable disease and accessible tumor\n* ECOG Performance Status 0-2 with greater than six week life expectancy\n* 18 years of age or older\n* Laboratory values as outlined in the protocol\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients must not have received other immunotherapy treatment in the three months prior to the initial vaccination\n* Patients may not be on herceptin therapy during this protocol and may not have received it for four weeks prior to initial vaccination\n* Patients must not have received weekly chemotherapy or hormonal treatment for two weeks prior to the initial vaccination and must not have received monthly chemotherapy for four weeks prior to the initial vaccination\n* Clinical evidence of CNS disease\n* Clinically significant autoimmune disease\n* Patients who are HIV+\n* Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure\n* Pregnant of lactating women will be excluded, all premenopausal women must undergo pregnancy testing",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Stage IV breast cancer with measurable disease and accessible tumor",
            "criterions": [
                {
                    "exact_snippets": "Stage IV breast cancer",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "accessible tumor",
                    "criterion": "tumor accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG Performance Status 0-2 with greater than six week life expectancy",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance Status 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"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "greater than six week life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 years of age or older",
            "criterions": [
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Laboratory values as outlined in the protocol",
            "criterions": [
                {
                    "exact_snippets": "Laboratory values",
                    "criterion": "laboratory values",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": "* Patients must not have received other immunotherapy treatment in the three months prior to the initial vaccination",
            "criterions": [
                {
                    "exact_snippets": "Patients must not have received other immunotherapy treatment",
                    "criterion": "immunotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "in the three months prior to the initial vaccination",
                    "criterion": "time since last immunotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients may not be on herceptin therapy during this protocol and may not have received it for four weeks prior to initial vaccination",
            "criterions": [
                {
                    "exact_snippets": "Patients may not be on herceptin therapy during this protocol",
                    "criterion": "herceptin therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "may not have received it for four weeks prior to initial vaccination",
                    "criterion": "herceptin therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical evidence of CNS disease",
            "criterions": [
                {
                    "exact_snippets": "Clinical evidence of CNS disease",
                    "criterion": "CNS disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant autoimmune disease",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are HIV+",
            "criterions": [
                {
                    "exact_snippets": "HIV+",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "Serious intercurrent illness such as infection requiring IV antibiotics",
                    "criterion": "serious intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "infection"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "IV antibiotics"
                        }
                    ]
                },
                {
                    "exact_snippets": "significant cardiac disease characterized by significant arrhythmia",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "characterization",
                            "expected_value": "arrhythmia"
                        }
                    ]
                },
                {
                    "exact_snippets": "significant cardiac disease characterized by ... ischemic coronary disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "characterization",
                            "expected_value": "ischemic coronary disease"
                        }
                    ]
                },
                {
                    "exact_snippets": "significant cardiac disease characterized by ... congestive heart failure",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "characterization",
                            "expected_value": "congestive heart failure"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant of lactating women will be excluded, all premenopausal women must undergo pregnancy testing",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not lactating"
                        }
                    ]
                },
                {
                    "exact_snippets": "premenopausal women must undergo pregnancy testing",
                    "criterion": "premenopausal women",
                    "requirements": [
                        {
                            "requirement_type": "pregnancy testing",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Patients must not have received weekly chemotherapy or hormonal treatment for two weeks prior to the initial vaccination and must not have received monthly chemotherapy for four weeks prior to the initial vaccination",
            "criterions": [
                {
                    "exact_snippets": "Patients must not have received weekly chemotherapy ... two weeks prior to the initial vaccination",
                    "criterion": "weekly chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must not have received ... hormonal treatment for two weeks prior to the initial vaccination",
                    "criterion": "hormonal treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must not have received monthly chemotherapy for four weeks prior to the initial vaccination",
                    "criterion": "monthly chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}