{
    "info": {
        "nct_id": "NCT00002866",
        "official_title": "A Phase I/II Study of Docetaxel and Epirubicin as First-Line Therapy for Metastatic Breast Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 16 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically or cytologically confirmed breast cancer Newly diagnosed or progressive metastatic disease with at least 1 metastatic target lesion No known clinical brain or leptomeningeal metastasis Phase I entry: Measurable and/or evaluable disease with an indicator lesion outside prior radiotherapy field Phase II entry: (closed as of 03/27/2000) Bidimensionally measurable disease with an indicator lesion outside prior radiotherapy field At least 1 x 1 cm on chest x-ray At least 2 x 2 cm on CT scan or ultrasound Skin lesion or node at least 1 x 1 cm No bone-only lesion Hormone receptor status: Not specified\n\nPATIENT CHARACTERISTICS: Age: 16 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Hematopoietic: Absolute granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than the upper limit of normal (ULN) AST/ALT no greater than 1.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN (no greater than 5.0 times ULN if AST/ALT normal) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: Left ventricular ejection fraction at least 50% at rest by MUGA or echocardiogram No congestive heart failure No angina pectoris (even if controlled) No myocardial infarction within the past year No uncontrolled arrhythmia No uncontrolled hypertension Other: No active infection No grade 2 or greater symptomatic peripheral neuropathy No significant neurologic or psychiatric disorder, including dementia or seizures No peptic ulcer, unstable diabetes mellitus, or other contraindication to dexamethasone No prior malignancy except nonmelanomatous skin cancer or excised carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception Geographically accessible\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent supportive colony-stimulating factors (e.g., filgrastim (G -CSF)) (Prophylactic treatment during the second step of phase I allowed) Chemotherapy: Phase I patients: At least 12 months since prior adjuvant chemotherapy Prior neoadjuvant chemotherapy allowed Prior cumulative dose of doxorubicin no greater than 300 mg/m2 Prior cumulative dose of epirubicin no greater than 500 mg/m2 If epirubicin dose level at least 90 mg/m2: Prior cumulative dose of doxorubicin no greater than 200 mg/m2 Prior cumulative dose of epirubicin no greater than 300 mg/m2 Phase II patients: (closed as of 03/27/2000) No prior neoadjuvant or adjuvant chemotherapy regimen other than cyclophosphamide, methotrexate, and fluorouracil, or doxorubicin and cyclophosphamide given for a maximum of 4 courses All patients: No prior chemotherapy for metastatic disease No prior taxanes Endocrine therapy: Prior hormonal therapy in the adjuvant and/or metastatic setting allowed if subsequent disease progression No more than 2 prior hormonal therapy regimens for metastatic disease No concurrent corticosteroids (except for premedication or hypersensitivity reaction) Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy (unless single fractions for palliation) Concurrent local palliative radiotherapy for control of bone pain or for other reasons with no curative intent allowed Concurrent whole-brain radiotherapy for brain metastasis allowed No concurrent radiotherapy to sole measurable lesion Surgery: Not specified Other: No other concurrent investigational drugs or anticancer therapy No concurrent preventive IV antibiotics"
    },
    "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": "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 16 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 16 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 16 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "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": "DISEASE CHARACTERISTICS: Histologically or cytologically confirmed breast cancer Newly diagnosed or progressive metastatic disease with at least 1 metastatic target lesion No known clinical brain or leptomeningeal metastasis Phase I entry: Measurable and/or evaluable disease with an indicator lesion outside prior radiotherapy field Phase II entry: (closed as of 03/27/2000) Bidimensionally measurable disease with an indicator lesion outside prior radiotherapy field At least 1 x 1 cm on chest x-ray At least 2 x 2 cm on CT scan or ultrasound Skin lesion or node at least 1 x 1 cm No bone-only lesion Hormone receptor status: Not specified",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Newly diagnosed or progressive metastatic disease",
                        "criterion": "metastatic disease",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "newly diagnosed",
                                "progressive"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "at least 1 metastatic target lesion",
                        "criterion": "metastatic target lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No known clinical brain or leptomeningeal metastasis",
                        "criterion": "brain or leptomeningeal metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Phase I entry: Measurable and/or evaluable disease with an indicator lesion outside prior radiotherapy field",
                        "criterion": "indicator lesion outside prior radiotherapy field",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Phase II entry: (closed as of 03/27/2000) Bidimensionally measurable disease with an indicator lesion outside prior radiotherapy field",
                        "criterion": "bidimensionally measurable disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "At least 1 x 1 cm on chest x-ray",
                        "criterion": "lesion size on chest x-ray",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 2 x 2 cm on CT scan or ultrasound",
                        "criterion": "lesion size on CT scan or ultrasound",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Skin lesion or node at least 1 x 1 cm",
                        "criterion": "skin lesion or node size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No bone-only lesion",
                        "criterion": "bone-only lesion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Hormone receptor status: Not specified",
                        "criterion": "hormone receptor status",
                        "requirement": {
                            "requirement_type": "specification",
                            "expected_value": "Not specified"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "and_criteria": [
                                                                    {
                                                                        "and_criteria": [
                                                                            {
                                                                                "and_criteria": [
                                                                                    {
                                                                                        "and_criteria": [
                                                                                            {
                                                                                                "and_criteria": [
                                                                                                    {
                                                                                                        "exact_snippets": "Histologically or cytologically confirmed breast cancer",
                                                                                                        "criterion": "breast cancer",
                                                                                                        "requirement": {
                                                                                                            "requirement_type": "confirmation method",
                                                                                                            "expected_value": [
                                                                                                                "histologically",
                                                                                                                "cytologically"
                                                                                                            ]
                                                                                                        }
                                                                                                    },
                                                                                                    {
                                                                                                        "exact_snippets": "Newly diagnosed or progressive metastatic disease",
                                                                                                        "criterion": "metastatic disease",
                                                                                                        "requirement": {
                                                                                                            "requirement_type": "status",
                                                                                                            "expected_value": [
                                                                                                                "newly diagnosed",
                                                                                                                "progressive"
                                                                                                            ]
                                                                                                        }
                                                                                                    }
                                                                                                ]
                                                                                            },
                                                                                            {
                                                                                                "exact_snippets": "at least 1 metastatic target lesion",
                                                                                                "criterion": "metastatic target lesion",
                                                                                                "requirement": {
                                                                                                    "requirement_type": "quantity",
                                                                                                    "expected_value": {
                                                                                                        "operator": ">=",
                                                                                                        "value": 1,
                                                                                                        "unit": "lesion"
                                                                                                    }
                                                                                                }
                                                                                            }
                                                                                        ]
                                                                                    },
                                                                                    {
                                                                                        "exact_snippets": "No known clinical brain or leptomeningeal metastasis",
                                                                                        "criterion": "brain or leptomeningeal metastasis",
                                                                                        "requirement": {
                                                                                            "requirement_type": "presence",
                                                                                            "expected_value": false
                                                                                        }
                                                                                    }
                                                                                ]
                                                                            },
                                                                            {
                                                                                "exact_snippets": "Phase I entry: Measurable and/or evaluable disease with an indicator lesion outside prior radiotherapy field",
                                                                                "criterion": "indicator lesion outside prior radiotherapy field",
                                                                                "requirement": {
                                                                                    "requirement_type": "presence",
                                                                                    "expected_value": true
                                                                                }
                                                                            }
                                                                        ]
                                                                    },
                                                                    {
                                                                        "exact_snippets": "Phase II entry: (closed as of 03/27/2000) Bidimensionally measurable disease with an indicator lesion outside prior radiotherapy field",
                                                                        "criterion": "bidimensionally measurable disease",
                                                                        "requirement": {
                                                                            "requirement_type": "presence",
                                                                            "expected_value": true
                                                                        }
                                                                    }
                                                                ]
                                                            },
                                                            {
                                                                "or_criteria": [
                                                                    {
                                                                        "exact_snippets": "At least 1 x 1 cm on chest x-ray",
                                                                        "criterion": "lesion size on chest x-ray",
                                                                        "requirement": {
                                                                            "requirement_type": "size",
                                                                            "expected_value": {
                                                                                "operator": ">=",
                                                                                "value": 1,
                                                                                "unit": "cm"
                                                                            }
                                                                        }
                                                                    },
                                                                    {
                                                                        "exact_snippets": "At least 2 x 2 cm on CT scan or ultrasound",
                                                                        "criterion": "lesion size on CT scan or ultrasound",
                                                                        "requirement": {
                                                                            "requirement_type": "size",
                                                                            "expected_value": {
                                                                                "operator": ">=",
                                                                                "value": 2,
                                                                                "unit": "cm"
                                                                            }
                                                                        }
                                                                    },
                                                                    {
                                                                        "exact_snippets": "Skin lesion or node at least 1 x 1 cm",
                                                                        "criterion": "skin lesion or node size",
                                                                        "requirement": {
                                                                            "requirement_type": "size",
                                                                            "expected_value": {
                                                                                "operator": ">=",
                                                                                "value": 1,
                                                                                "unit": "cm"
                                                                            }
                                                                        }
                                                                    }
                                                                ]
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "No bone-only lesion",
                                                        "criterion": "bone-only lesion",
                                                        "requirement": {
                                                            "requirement_type": "presence",
                                                            "expected_value": false
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "Hormone receptor status: Not specified",
                                                "criterion": "hormone receptor status",
                                                "requirement": {
                                                    "requirement_type": "specification",
                                                    "expected_value": "Not specified"
                                                }
                                            }
                                        ]
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Phase II entry: (closed as of 03/27/2000) Bidimensionally measurable disease with an indicator lesion outside prior radiotherapy field",
                                "criterion": "bidimensionally measurable disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "At least 1 x 1 cm on chest x-ray",
                                "criterion": "lesion size on chest x-ray",
                                "requirement": {
                                    "requirement_type": "size",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "cm"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "At least 2 x 2 cm on CT scan or ultrasound",
                                "criterion": "lesion size on CT scan or ultrasound",
                                "requirement": {
                                    "requirement_type": "size",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "cm"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Skin lesion or node at least 1 x 1 cm",
                                "criterion": "skin lesion or node size",
                                "requirement": {
                                    "requirement_type": "size",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "cm"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "PATIENT CHARACTERISTICS: Age: 16 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Hematopoietic: Absolute granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than the upper limit of normal (ULN) AST/ALT no greater than 1.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN (no greater than 5.0 times ULN if AST/ALT normal) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: Left ventricular ejection fraction at least 50% at rest by MUGA or echocardiogram No congestive heart failure No angina pectoris (even if controlled) No myocardial infarction within the past year No uncontrolled arrhythmia No uncontrolled hypertension Other: No active infection No grade 2 or greater symptomatic peripheral neuropathy No significant neurologic or psychiatric disorder, including dementia or seizures No peptic ulcer, unstable diabetes mellitus, or other contraindication to dexamethasone No prior malignancy except nonmelanomatous skin cancer or excised carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception Geographically accessible",
                "criterions": [
                    {
                        "exact_snippets": "Age: 16 and over",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Sex: Female",
                        "criterion": "sex",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "Performance status: ECOG 0-2",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "ECOG"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "ECOG"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Absolute granulocyte count at least 2,000/mm3",
                        "criterion": "absolute granulocyte count",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2000,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelet count at least 100,000/mm3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hemoglobin at least 10 g/dL",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Bilirubin no greater than the upper limit of normal (ULN)",
                        "criterion": "bilirubin",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": "ULN"
                        }
                    },
                    {
                        "exact_snippets": "AST/ALT no greater than 1.5 times ULN",
                        "criterion": "AST/ALT",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alkaline phosphatase no greater than 2.5 times ULN (no greater than 5.0 times ULN if AST/ALT normal)",
                        "criterion": "alkaline phosphatase",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alkaline phosphatase no greater than 2.5 times ULN (no greater than 5.0 times ULN if AST/ALT normal)",
                        "criterion": "alkaline phosphatase",
                        "requirement": {
                            "requirement_type": "conditional maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5.0,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Creatinine no greater than 1.5 times ULN",
                        "criterion": "creatinine",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Left ventricular ejection fraction at least 50% at rest by MUGA or echocardiogram",
                        "criterion": "left ventricular ejection fraction",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No angina pectoris (even if controlled)",
                        "criterion": "angina pectoris",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No myocardial infarction within the past year",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No uncontrolled arrhythmia",
                        "criterion": "uncontrolled arrhythmia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No uncontrolled hypertension",
                        "criterion": "uncontrolled hypertension",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No active infection",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No grade 2 or greater symptomatic peripheral neuropathy",
                        "criterion": "symptomatic peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No significant neurologic or psychiatric disorder, including dementia or seizures",
                        "criterion": "significant neurologic or psychiatric disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No peptic ulcer, unstable diabetes mellitus, or other contraindication to dexamethasone",
                        "criterion": "peptic ulcer, unstable diabetes mellitus, or other contraindication to dexamethasone",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior malignancy except nonmelanomatous skin cancer or excised carcinoma in situ of the cervix",
                        "criterion": "prior malignancy",
                        "requirement": {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "nonmelanomatous skin cancer",
                                "excised carcinoma in situ of the cervix"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Not pregnant or nursing",
                        "criterion": "pregnancy or nursing",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Fertile patients must use effective contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": "fertile patients"
                        }
                    },
                    {
                        "exact_snippets": "Geographically accessible",
                        "criterion": "geographical accessibility",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent supportive colony-stimulating factors (e.g., filgrastim (G -CSF)) (Prophylactic treatment during the second step of phase I allowed) Chemotherapy: Phase I patients: At least 12 months since prior adjuvant chemotherapy Prior neoadjuvant chemotherapy allowed Prior cumulative dose of doxorubicin no greater than 300 mg/m2 Prior cumulative dose of epirubicin no greater than 500 mg/m2 If epirubicin dose level at least 90 mg/m2: Prior cumulative dose of doxorubicin no greater than 200 mg/m2 Prior cumulative dose of epirubicin no greater than 300 mg/m2 Phase II patients: (closed as of 03/27/2000) No prior neoadjuvant or adjuvant chemotherapy regimen other than cyclophosphamide, methotrexate, and fluorouracil, or doxorubicin and cyclophosphamide given for a maximum of 4 courses All patients: No prior chemotherapy for metastatic disease No prior taxanes Endocrine therapy: Prior hormonal therapy in the adjuvant and/or metastatic setting allowed if subsequent disease progression No more than 2 prior hormonal therapy regimens for metastatic disease No concurrent corticosteroids (except for premedication or hypersensitivity reaction) Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy (unless single fractions for palliation) Concurrent local palliative radiotherapy for control of bone pain or for other reasons with no curative intent allowed Concurrent whole-brain radiotherapy for brain metastasis allowed No concurrent radiotherapy to sole measurable lesion Surgery: Not specified Other: No other concurrent investigational drugs or anticancer therapy No concurrent preventive IV antibiotics",
                "criterions": [
                    {
                        "exact_snippets": "No concurrent supportive colony-stimulating factors (e.g., filgrastim (G -CSF))",
                        "criterion": "concurrent supportive colony-stimulating factors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Phase I patients: At least 12 months since prior adjuvant chemotherapy",
                        "criterion": "time since prior adjuvant chemotherapy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Prior cumulative dose of doxorubicin no greater than 300 mg/m2",
                        "criterion": "cumulative dose of doxorubicin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 300,
                                "unit": "mg/m2"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Prior cumulative dose of epirubicin no greater than 500 mg/m2",
                        "criterion": "cumulative dose of epirubicin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 500,
                                "unit": "mg/m2"
                            }
                        }
                    },
                    {
                        "exact_snippets": "If epirubicin dose level at least 90 mg/m2: Prior cumulative dose of doxorubicin no greater than 200 mg/m2",
                        "criterion": "cumulative dose of doxorubicin with epirubicin dose level at least 90 mg/m2",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 200,
                                "unit": "mg/m2"
                            }
                        }
                    },
                    {
                        "exact_snippets": "If epirubicin dose level at least 90 mg/m2: Prior cumulative dose of epirubicin no greater than 300 mg/m2",
                        "criterion": "cumulative dose of epirubicin with epirubicin dose level at least 90 mg/m2",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 300,
                                "unit": "mg/m2"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Phase II patients: (closed as of 03/27/2000) No prior neoadjuvant or adjuvant chemotherapy regimen other than cyclophosphamide, methotrexate, and fluorouracil, or doxorubicin and cyclophosphamide given for a maximum of 4 courses",
                        "criterion": "prior neoadjuvant or adjuvant chemotherapy regimen for Phase II patients",
                        "requirement": {
                            "requirement_type": "allowed regimens",
                            "expected_value": [
                                "cyclophosphamide, methotrexate, and fluorouracil",
                                "doxorubicin and cyclophosphamide"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Phase II patients: (closed as of 03/27/2000) No prior neoadjuvant or adjuvant chemotherapy regimen other than cyclophosphamide, methotrexate, and fluorouracil, or doxorubicin and cyclophosphamide given for a maximum of 4 courses",
                        "criterion": "prior neoadjuvant or adjuvant chemotherapy regimen for Phase II patients",
                        "requirement": {
                            "requirement_type": "maximum courses",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "courses"
                            }
                        }
                    },
                    {
                        "exact_snippets": "All patients: No prior chemotherapy for metastatic disease",
                        "criterion": "prior chemotherapy for metastatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior taxanes",
                        "criterion": "prior taxanes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Prior hormonal therapy in the adjuvant and/or metastatic setting allowed if subsequent disease progression",
                        "criterion": "prior hormonal therapy in the adjuvant and/or metastatic setting",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "allowed if subsequent disease progression"
                        }
                    },
                    {
                        "exact_snippets": "No more than 2 prior hormonal therapy regimens for metastatic disease",
                        "criterion": "prior hormonal therapy regimens for metastatic disease",
                        "requirement": {
                            "requirement_type": "maximum regimens",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "regimens"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No concurrent corticosteroids (except for premedication or hypersensitivity reaction)",
                        "criterion": "concurrent corticosteroids",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent corticosteroids (except for premedication or hypersensitivity reaction)",
                        "criterion": "concurrent corticosteroids",
                        "requirement": {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "premedication",
                                "hypersensitivity reaction"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "At least 4 weeks since prior radiotherapy (unless single fractions for palliation)",
                        "criterion": "time since prior radiotherapy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 4 weeks since prior radiotherapy (unless single fractions for palliation)",
                        "criterion": "time since prior radiotherapy",
                        "requirement": {
                            "requirement_type": "exceptions",
                            "expected_value": "single fractions for palliation"
                        }
                    },
                    {
                        "exact_snippets": "Concurrent local palliative radiotherapy for control of bone pain or for other reasons with no curative intent allowed",
                        "criterion": "concurrent local palliative radiotherapy",
                        "requirement": {
                            "requirement_type": "intent",
                            "expected_value": "no curative intent"
                        }
                    },
                    {
                        "exact_snippets": "Concurrent whole-brain radiotherapy for brain metastasis allowed",
                        "criterion": "concurrent whole-brain radiotherapy for brain metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "No concurrent radiotherapy to sole measurable lesion",
                        "criterion": "concurrent radiotherapy to sole measurable lesion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No other concurrent investigational drugs or anticancer therapy",
                        "criterion": "concurrent investigational drugs or anticancer therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent preventive IV antibiotics",
                        "criterion": "concurrent preventive IV antibiotics",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ]
}