{
    "info": {
        "nct_id": "NCT00006682",
        "official_title": "An Open-Label Phase II Study of Navelbine (Vinorelbine Tartrate) and Taxotere (Docetaxel) as First-Line Therapy for Metastatic Breast Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IV breast cancer Disease progression following prior adjuvant chemotherapy (no disease progression during treatment with prior doxorubicin) Bidimensionally measurable disease Prior radiotherapy allowed if disease completely outside radiation port or histologic evidence of measured area indicating malignancy and not radiation fibrosis No CNS metastases Brain metastases previously treated with radiotherapy or surgical excision allowed if no evidence of residual metastases on brain CT or MRI Hormone receptor status: Not specified\n\nPATIENT CHARACTERISTICS: Age: Over 18 Sex: Female Menopausal status: Premenopausal or postmenopausal Performance status: ECOG 0-1 Life expectancy: Greater than 16 weeks Hematopoietic: WBC at least 2,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase less than 2.5 times ULN Renal: Not specified Cardiovascular: No symptomatic New York Heart Association class II or greater congestive heart failure No significant arrhythmia requiring drug therapy No myocardial infarction within the past 6 months No uncontrolled cardiac disease or unstable angina Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No preexisting clinically significant peripheral neuropathy (no prior neuropathy of any grade if previously treated with paclitaxel) No unstable, preexisting medical condition No serious active infection No other underlying medical, psychological, familial, sociologic, or geographic condition that would preclude study\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: At least 7 days since prior hematopoietic growth factors (filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa) At least 7 days since prior platelet transfusion Chemotherapy: See Disease Characteristics No prior vinca alkaloids (including vinorelbine or docetaxel) No other concurrent antineoplastic agents Endocrine therapy: No concurrent anticancer hormonal agents Radiotherapy: See Disease Characteristics No concurrent palliative radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational drug or device"
    },
    "inclusion_lines": [
        {
            "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": "value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "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 120 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 120 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 120 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "PATIENT CHARACTERISTICS: Age: Over 18 Sex: Female Menopausal status: Premenopausal or postmenopausal Performance status: ECOG 0-1 Life expectancy: Greater than 16 weeks Hematopoietic: WBC at least 2,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase less than 2.5 times ULN Renal: Not specified Cardiovascular: No symptomatic New York Heart Association class II or greater congestive heart failure No significant arrhythmia requiring drug therapy No myocardial infarction within the past 6 months No uncontrolled cardiac disease or unstable angina Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No preexisting clinically significant peripheral neuropathy (no prior neuropathy of any grade if previously treated with paclitaxel) No unstable, preexisting medical condition No serious active infection No other underlying medical, psychological, familial, sociologic, or geographic condition that would preclude study",
                "criterions": [
                    {
                        "exact_snippets": "Age: Over 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Sex: Female",
                        "criterion": "sex",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "Menopausal status: Premenopausal or postmenopausal",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "premenopausal",
                                "postmenopausal"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Performance status: ECOG 0-1",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "scale",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ECOG"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Life expectancy: Greater than 16 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 16,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hematopoietic: WBC at least 2,000/mm3",
                        "criterion": "WBC",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2000,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelet count greater than 100,000/mm3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hemoglobin greater than 9 g/dL",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hepatic: Bilirubin less than 2.0 mg/dL",
                        "criterion": "bilirubin",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "SGOT/SGPT less than 1.5 times upper limit of normal (ULN)",
                        "criterion": "SGOT/SGPT",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alkaline phosphatase less than 2.5 times ULN",
                        "criterion": "alkaline phosphatase",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Cardiovascular: No symptomatic New York Heart Association class II or greater congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": "symptomatic New York Heart Association class II or greater"
                        }
                    },
                    {
                        "exact_snippets": "No significant arrhythmia requiring drug therapy",
                        "criterion": "arrhythmia",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": "significant requiring drug therapy"
                        }
                    },
                    {
                        "exact_snippets": "No myocardial infarction within the past 6 months",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": "within the past 6 months"
                        }
                    },
                    {
                        "exact_snippets": "No uncontrolled cardiac disease or unstable angina",
                        "criterion": "cardiac disease or unstable angina",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "Not pregnant or nursing",
                        "criterion": "pregnancy or nursing",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Negative pregnancy test",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "Fertile patients must use effective contraception",
                        "criterion": "contraception",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": "effective"
                        }
                    },
                    {
                        "exact_snippets": "No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix",
                        "criterion": "other malignancy",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": "within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix"
                        }
                    },
                    {
                        "exact_snippets": "No preexisting clinically significant peripheral neuropathy (no prior neuropathy of any grade if previously treated with paclitaxel)",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "No unstable, preexisting medical condition",
                        "criterion": "unstable medical condition",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "No serious active infection",
                        "criterion": "serious active infection",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "No other underlying medical, psychological, familial, sociologic, or geographic condition that would preclude study",
                        "criterion": "underlying condition",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": "that would preclude study"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age: Over 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Sex: Female",
                        "criterion": "sex",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "Menopausal status: Premenopausal or postmenopausal",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "premenopausal",
                                "postmenopausal"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Performance status: ECOG 0-1",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "scale",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ECOG"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Life expectancy: Greater than 16 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 16,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hematopoietic: WBC at least 2,000/mm3",
                        "criterion": "WBC",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2000,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelet count greater than 100,000/mm3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hemoglobin greater than 9 g/dL",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hepatic: Bilirubin less than 2.0 mg/dL",
                        "criterion": "bilirubin",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "SGOT/SGPT less than 1.5 times upper limit of normal (ULN)",
                        "criterion": "SGOT/SGPT",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alkaline phosphatase less than 2.5 times ULN",
                        "criterion": "alkaline phosphatase",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Cardiovascular: No symptomatic New York Heart Association class II or greater congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": "symptomatic New York Heart Association class II or greater"
                        }
                    },
                    {
                        "exact_snippets": "No significant arrhythmia requiring drug therapy",
                        "criterion": "arrhythmia",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": "significant requiring drug therapy"
                        }
                    },
                    {
                        "exact_snippets": "No myocardial infarction within the past 6 months",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": "within the past 6 months"
                        }
                    },
                    {
                        "exact_snippets": "No uncontrolled cardiac disease or unstable angina",
                        "criterion": "cardiac disease or unstable angina",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "Not pregnant or nursing",
                        "criterion": "pregnancy or nursing",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Negative pregnancy test",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "Fertile patients must use effective contraception",
                        "criterion": "contraception",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": "effective"
                        }
                    },
                    {
                        "exact_snippets": "No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix",
                        "criterion": "other malignancy",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": "within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix"
                        }
                    },
                    {
                        "exact_snippets": "No preexisting clinically significant peripheral neuropathy (no prior neuropathy of any grade if previously treated with paclitaxel)",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "No unstable, preexisting medical condition",
                        "criterion": "unstable medical condition",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "No serious active infection",
                        "criterion": "serious active infection",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "No other underlying medical, psychological, familial, sociologic, or geographic condition that would preclude study",
                        "criterion": "underlying condition",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": "that would preclude study"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: At least 7 days since prior hematopoietic growth factors (filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa) At least 7 days since prior platelet transfusion Chemotherapy: See Disease Characteristics No prior vinca alkaloids (including vinorelbine or docetaxel) No other concurrent antineoplastic agents Endocrine therapy: No concurrent anticancer hormonal agents Radiotherapy: See Disease Characteristics No concurrent palliative radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational drug or device",
                "criterions": [
                    {
                        "exact_snippets": "At least 7 days since prior hematopoietic growth factors (filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa)",
                        "criterion": "prior hematopoietic growth factors",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 7 days since prior platelet transfusion",
                        "criterion": "prior platelet transfusion",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No prior vinca alkaloids (including vinorelbine or docetaxel)",
                        "criterion": "prior vinca alkaloids",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No other concurrent antineoplastic agents",
                        "criterion": "concurrent antineoplastic agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent anticancer hormonal agents",
                        "criterion": "concurrent anticancer hormonal agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent palliative radiotherapy",
                        "criterion": "concurrent palliative radiotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No other concurrent investigational drug or device",
                        "criterion": "concurrent investigational drug or device",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "At least 7 days since prior hematopoietic growth factors (filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa)",
                                "criterion": "prior hematopoietic growth factors",
                                "requirement": {
                                    "requirement_type": "time since last administration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 7,
                                        "unit": "days"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "At least 7 days since prior platelet transfusion",
                                "criterion": "prior platelet transfusion",
                                "requirement": {
                                    "requirement_type": "time since last administration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 7,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "No prior vinca alkaloids (including vinorelbine or docetaxel)",
                        "criterion": "prior vinca alkaloids",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No other concurrent antineoplastic agents",
                        "criterion": "concurrent antineoplastic agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent anticancer hormonal agents",
                        "criterion": "concurrent anticancer hormonal agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent palliative radiotherapy",
                        "criterion": "concurrent palliative radiotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No other concurrent investigational drug or device",
                        "criterion": "concurrent investigational drug or device",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IV breast cancer Disease progression following prior adjuvant chemotherapy (no disease progression during treatment with prior doxorubicin) Bidimensionally measurable disease Prior radiotherapy allowed if disease completely outside radiation port or histologic evidence of measured area indicating malignancy and not radiation fibrosis No CNS metastases Brain metastases previously treated with radiotherapy or surgical excision allowed if no evidence of residual metastases on brain CT or MRI Hormone receptor status: Not specified",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed stage IV breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically or cytologically"
                        }
                    },
                    {
                        "exact_snippets": "Histologically or cytologically confirmed stage IV breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    },
                    {
                        "exact_snippets": "Disease progression following prior adjuvant chemotherapy",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "following prior adjuvant chemotherapy"
                        }
                    },
                    {
                        "exact_snippets": "no disease progression during treatment with prior doxorubicin",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": "during treatment with prior doxorubicin"
                        }
                    },
                    {
                        "exact_snippets": "Bidimensionally measurable disease",
                        "criterion": "disease measurability",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "bidimensional"
                        }
                    },
                    {
                        "exact_snippets": "Prior radiotherapy allowed if disease completely outside radiation port",
                        "criterion": "prior radiotherapy",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "disease completely outside radiation port"
                        }
                    },
                    {
                        "exact_snippets": "histologic evidence of measured area indicating malignancy and not radiation fibrosis",
                        "criterion": "histologic evidence",
                        "requirement": {
                            "requirement_type": "indication",
                            "expected_value": "malignancy and not radiation fibrosis"
                        }
                    },
                    {
                        "exact_snippets": "No CNS metastases",
                        "criterion": "CNS metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Brain metastases previously treated with radiotherapy or surgical excision allowed if no evidence of residual metastases on brain CT or MRI",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": [
                                "radiotherapy",
                                "surgical excision"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Brain metastases previously treated with radiotherapy or surgical excision allowed if no evidence of residual metastases on brain CT or MRI",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "residual evidence",
                            "expected_value": "no evidence on brain CT or MRI"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ]
}