{
    "info": {
        "nct_id": "NCT01613482",
        "official_title": "Interest of the Prophylactic Cerebral Radiotherapy in the Metastatic Breast Cancer Expressing HER2/NEU Treated by Trastuzumab",
        "inclusion_criteria": "* Patients with breast cancer, expressing HER2-NEU (score +++ in ICH or ++ and amplification on FISH or CISH, SISH)\n* Visceral metastasis, only or multiple\n* First line metastasis treatment by Trastuzumab in association with chemotherapy\n* Good general conditions: OMS=<2 or Karnofsky >=70%\n* Age > 18 years and < 70 years\n* Life expectancy >=3 mois\n* No Trastuzumab since more of 6 months\n* No cerebral metastasis (MRI)\n* Efficacy contraception for women with genital capacities\n* Consent signed by the patient\n\nExclusion Criteria\n\n* Contraindication to IRM\n* Psychiatric decease\n* Prior cerebral radiotherapy,\n* Geographical constraint, compromising the fallow of patients\n* Infectious or other serious pathology, likely to stop the treatment\n* Positive serology (HIV, hBC, hBS)\n* Inclusion in an other clinical trial or in the 4 weeks before th inclusion\n* Pregnant or breastfeeding women\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients with breast cancer, expressing HER2-NEU (score +++ in ICH or ++ and amplification on FISH or CISH, SISH)",
                "criterions": [
                    {
                        "exact_snippets": "Patients with breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "expressing HER2-NEU",
                        "criterion": "HER2-NEU expression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "score +++ in ICH",
                        "criterion": "HER2-NEU ICH score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": "+++"
                        }
                    },
                    {
                        "exact_snippets": "++ and amplification on FISH or CISH, SISH",
                        "criterion": "HER2-NEU FISH/CISH/SISH score and amplification",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": "++"
                        }
                    },
                    {
                        "exact_snippets": "++ and amplification on FISH or CISH, SISH",
                        "criterion": "HER2-NEU FISH/CISH/SISH score and amplification",
                        "requirement": {
                            "requirement_type": "amplification",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients with breast cancer",
                                "criterion": "breast cancer",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "expressing HER2-NEU",
                                "criterion": "HER2-NEU expression",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "score +++ in ICH",
                                "criterion": "HER2-NEU ICH score",
                                "requirement": {
                                    "requirement_type": "score",
                                    "expected_value": "+++"
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "++ and amplification on FISH or CISH, SISH",
                                        "criterion": "HER2-NEU FISH/CISH/SISH score and amplification",
                                        "requirement": {
                                            "requirement_type": "score",
                                            "expected_value": "++"
                                        }
                                    },
                                    {
                                        "exact_snippets": "++ and amplification on FISH or CISH, SISH",
                                        "criterion": "HER2-NEU FISH/CISH/SISH score and amplification",
                                        "requirement": {
                                            "requirement_type": "amplification",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* First line metastasis treatment by Trastuzumab in association with chemotherapy",
                "criterions": [
                    {
                        "exact_snippets": "First line metastasis treatment",
                        "criterion": "treatment line",
                        "requirement": {
                            "requirement_type": "line",
                            "expected_value": "first"
                        }
                    },
                    {
                        "exact_snippets": "metastasis",
                        "criterion": "metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Trastuzumab",
                        "criterion": "Trastuzumab",
                        "requirement": {
                            "requirement_type": "association",
                            "expected_value": "chemotherapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "First line metastasis treatment",
                        "criterion": "treatment line",
                        "requirement": {
                            "requirement_type": "line",
                            "expected_value": "first"
                        }
                    },
                    {
                        "exact_snippets": "metastasis",
                        "criterion": "metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Trastuzumab",
                        "criterion": "Trastuzumab",
                        "requirement": {
                            "requirement_type": "association",
                            "expected_value": "chemotherapy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Good general conditions: OMS=<2 or Karnofsky >=70%",
                "criterions": [
                    {
                        "exact_snippets": "OMS=<2",
                        "criterion": "OMS score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Karnofsky >=70%",
                        "criterion": "Karnofsky performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "OMS=<2",
                        "criterion": "OMS score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Karnofsky >=70%",
                        "criterion": "Karnofsky performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age > 18 years and < 70 years",
                "criterions": [
                    {
                        "exact_snippets": "Age > 18 years and < 70 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age > 18 years and < 70 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Life expectancy >=3 mois",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy >=3 mois",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "mois"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy >=3 mois",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "mois"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No Trastuzumab since more of 6 months",
                "criterions": [
                    {
                        "exact_snippets": "No Trastuzumab since more of 6 months",
                        "criterion": "Trastuzumab treatment",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No Trastuzumab since more of 6 months",
                        "criterion": "Trastuzumab treatment",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No cerebral metastasis (MRI)",
                "criterions": [
                    {
                        "exact_snippets": "No cerebral metastasis",
                        "criterion": "cerebral metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "(MRI)",
                        "criterion": "MRI",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "MRI"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No cerebral metastasis",
                        "criterion": "cerebral metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "(MRI)",
                        "criterion": "MRI",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "MRI"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Efficacy contraception for women with genital capacities",
                "criterions": [
                    {
                        "exact_snippets": "Efficacy contraception for women with genital capacities",
                        "criterion": "contraception",
                        "requirement": {
                            "requirement_type": "efficacy",
                            "expected_value": "for women with genital capacities"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Efficacy contraception for women with genital capacities",
                        "criterion": "contraception",
                        "requirement": {
                            "requirement_type": "efficacy",
                            "expected_value": "for women with genital capacities"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Consent signed by the patient",
                "criterions": [
                    {
                        "exact_snippets": "Consent signed by the patient",
                        "criterion": "consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Consent signed by the patient",
                        "criterion": "consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Contraindication to IRM",
                "criterions": [
                    {
                        "exact_snippets": "Contraindication to IRM",
                        "criterion": "IRM",
                        "requirement": {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Contraindication to IRM",
                        "criterion": "IRM",
                        "requirement": {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Psychiatric decease",
                "criterions": [
                    {
                        "exact_snippets": "Psychiatric decease",
                        "criterion": "psychiatric disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Psychiatric decease",
                        "criterion": "psychiatric disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior cerebral radiotherapy,",
                "criterions": [
                    {
                        "exact_snippets": "Prior cerebral radiotherapy",
                        "criterion": "cerebral radiotherapy",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior cerebral radiotherapy",
                        "criterion": "cerebral radiotherapy",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Geographical constraint, compromising the fallow of patients",
                "criterions": [
                    {
                        "exact_snippets": "Geographical constraint",
                        "criterion": "geographical constraint",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Geographical constraint",
                        "criterion": "geographical constraint",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Infectious or other serious pathology, likely to stop the treatment",
                "criterions": [
                    {
                        "exact_snippets": "Infectious or other serious pathology",
                        "criterion": "pathology",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "Infectious or other serious pathology",
                        "criterion": "pathology",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "infectious",
                                "other"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "likely to stop the treatment",
                        "criterion": "treatment interruption likelihood",
                        "requirement": {
                            "requirement_type": "probability",
                            "expected_value": "likely"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Infectious or other serious pathology",
                                        "criterion": "pathology",
                                        "requirement": {
                                            "requirement_type": "severity",
                                            "expected_value": "serious"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Infectious or other serious pathology",
                                        "criterion": "pathology",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": [
                                                "infectious",
                                                "other"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "likely to stop the treatment",
                                "criterion": "treatment interruption likelihood",
                                "requirement": {
                                    "requirement_type": "probability",
                                    "expected_value": "likely"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Positive serology (HIV, hBC, hBS)",
                "criterions": [
                    {
                        "exact_snippets": "Positive serology (HIV",
                        "criterion": "HIV serology",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "Positive serology ... hBC",
                        "criterion": "hBC serology",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "Positive serology ... hBS",
                        "criterion": "hBS serology",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Positive serology (HIV",
                        "criterion": "HIV serology",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "Positive serology ... hBC",
                        "criterion": "hBC serology",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "Positive serology ... hBS",
                        "criterion": "hBS serology",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Inclusion in an other clinical trial or in the 4 weeks before th inclusion",
                "criterions": [
                    {
                        "exact_snippets": "Inclusion in an other clinical trial",
                        "criterion": "inclusion in another clinical trial",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "in the 4 weeks before th inclusion",
                        "criterion": "inclusion in another clinical trial",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Inclusion in an other clinical trial",
                        "criterion": "inclusion in another clinical trial",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "in the 4 weeks before th inclusion",
                        "criterion": "inclusion in another clinical trial",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pregnant or breastfeeding women",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding women",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding women",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 70 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Exclusion Criteria",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Visceral metastasis, only or multiple",
                "criterions": [
                    {
                        "exact_snippets": "Visceral metastasis, only or multiple",
                        "criterion": "visceral metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Visceral metastasis, only or multiple",
                        "criterion": "visceral metastasis",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": [
                                "only",
                                "multiple"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Visceral metastasis, only or multiple",
                                "criterion": "visceral metastasis",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Visceral metastasis, only or multiple",
                                        "criterion": "visceral metastasis",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": "only"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Visceral metastasis, only or multiple",
                                        "criterion": "visceral metastasis",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": "multiple"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}