{
    "info": {
        "nct_id": "NCT00005980",
        "official_title": "A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically proven progressive or recurrent metastatic breast cancer\n* Bidimensionally measurable disease with at least one target lesion\n\n  * If previously irradiated lesions:\n\n    * No preirradiated only lesions\n    * Clear progression prior to study\n    * New lesions in a previously irradiated region allowed\n* Refusal of or medical contraindication to standard anthracycline containing regimen\n* Hormone receptor status:\n\n  * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Any age\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Neutrophil count at least 1,500/mm^3\n* Platelet count at least 100,000/mm^3\n\nHepatic:\n\n* Bilirubin normal\n* Transaminases less than 2 times upper limit of normal\n\nRenal:\n\n* Creatinine normal\n\nCardiovascular:\n\n* Left ventricular ejection fraction normal by echocardiography or MUGA scan\n* No significant cardiac history including:\n\n  * Clinically significant atrial or ventricular arrhythmias requiring treatment\n  * Medically controlled congestive heart failure\n  * Significant angina or clinically and/or electrocardiographically documented myocardial infarction within the past year\n  * Clinically significant valvular disease\n\nOther:\n\n* No other prior or concurrent malignancy within the past 5 years except contralateral breast cancer, or adequately treated basal cell skin cancer or carcinoma in situ of the cervix\n* No psychological, familial, sociological, or geographical condition that would preclude study\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* Prior adjuvant chemotherapy allowed if total doxorubicin dose is no greater than 300 mg/m2, total epirubicin dose is no greater than 450 mg/m^2, and total mitoxantrone dose is no greater than 75 mg/m^2\n* No greater than one regimen of prior chemotherapy for metastatic disease\n* No prior anthracyclines for metastatic disease\n* No other concurrent cytotoxic therapy\n\nEndocrine therapy:\n\n* No concurrent hormonal therapy\n* At least 4 weeks since prior progestins, estrogens, or androgens\n\nRadiotherapy:\n\n* See Disease Characteristics\n* Concurrent palliative radiotherapy allowed if sole target lesion is outside irradiated field\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* Concurrent bisphosphonates for metastatic bone disease and hypercalcemia secondary to malignancy allowed if bony lesions not only target lesion\n* No other concurrent investigational therapy"
    },
    "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",
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                            "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",
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                            "expected_value": "female"
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "DISEASE CHARACTERISTICS:",
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                    {
                        "exact_snippets": "DISEASE CHARACTERISTICS",
                        "criterion": "disease characteristics",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "DISEASE CHARACTERISTICS",
                        "criterion": "disease characteristics",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Bidimensionally measurable disease with at least one target lesion",
                "criterions": [
                    {
                        "exact_snippets": "Bidimensionally measurable disease",
                        "criterion": "disease measurability",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": "bidimensional"
                        }
                    },
                    {
                        "exact_snippets": "at least one target lesion",
                        "criterion": "target lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Bidimensionally measurable disease",
                        "criterion": "disease measurability",
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                        }
                    },
                    {
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                                "unit": "lesion"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* If previously irradiated lesions:",
                "criterions": [
                    {
                        "exact_snippets": "previously irradiated lesions",
                        "criterion": "irradiated lesions",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "previously irradiated lesions",
                    "criterion": "irradiated lesions",
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                        "requirement_type": "history",
                        "expected_value": true
                    }
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* No preirradiated only lesions",
                "criterions": [
                    {
                        "exact_snippets": "No preirradiated only lesions",
                        "criterion": "preirradiated lesions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    "criterion": "preirradiated lesions",
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                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Clear progression prior to study",
                "criterions": [
                    {
                        "exact_snippets": "Clear progression prior to study",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "clear"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Clear progression prior to study",
                        "criterion": "disease progression",
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                            "requirement_type": "status",
                            "expected_value": "clear"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* New lesions in a previously irradiated region allowed",
                "criterions": [
                    {
                        "exact_snippets": "New lesions in a previously irradiated region allowed",
                        "criterion": "new lesions in previously irradiated region",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "New lesions in a previously irradiated region allowed",
                        "criterion": "new lesions in previously irradiated region",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Female",
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                    {
                        "exact_snippets": "Female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Menopausal status:",
                "criterions": [
                    {
                        "exact_snippets": "Menopausal status",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Menopausal status",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Performance status:",
                "criterions": [
                    {
                        "exact_snippets": "Performance status:",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Performance status:",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ECOG 0-2",
                "criterions": [
                    {
                        "exact_snippets": "ECOG 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Life expectancy:",
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                    {
                        "exact_snippets": "Life expectancy",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Hematopoietic:",
                "criterions": [
                    {
                        "exact_snippets": "Hematopoietic:",
                        "criterion": "hematopoietic system",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hematopoietic:",
                        "criterion": "hematopoietic system",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Neutrophil count at least 1,500/mm^3",
                "criterions": [
                    {
                        "exact_snippets": "Neutrophil count at least 1,500/mm^3",
                        "criterion": "neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Neutrophil count at least 1,500/mm^3",
                        "criterion": "neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count at least 100,000/mm^3",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count at least 100,000/mm^3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelet count at least 100,000/mm^3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Hepatic:",
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                    {
                        "exact_snippets": "Hepatic",
                        "criterion": "hepatic function",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
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                        "exact_snippets": "Hepatic",
                        "criterion": "hepatic function",
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Bilirubin normal",
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                    {
                        "exact_snippets": "Bilirubin normal",
                        "criterion": "bilirubin level",
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                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "Bilirubin normal",
                        "criterion": "bilirubin level",
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                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Transaminases less than 2 times upper limit of normal",
                "criterions": [
                    {
                        "exact_snippets": "Transaminases less than 2 times upper limit of normal",
                        "criterion": "transaminases",
                        "requirement": {
                            "requirement_type": "level",
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                                "operator": "<",
                                "value": 2,
                                "unit": "times upper limit of normal"
                            }
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                ]
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            "logical_structure": {
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                        "exact_snippets": "Transaminases less than 2 times upper limit of normal",
                        "criterion": "transaminases",
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                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "times upper limit of normal"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Renal:",
                "criterions": [
                    {
                        "exact_snippets": "Renal:",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "Renal:",
                        "criterion": "renal function",
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                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Creatinine normal",
                "criterions": [
                    {
                        "exact_snippets": "Creatinine normal",
                        "criterion": "creatinine level",
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                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "exact_snippets": "Creatinine normal",
                        "criterion": "creatinine level",
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                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Cardiovascular:",
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                    {
                        "exact_snippets": "Cardiovascular:",
                        "criterion": "cardiovascular condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
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                        "exact_snippets": "Cardiovascular:",
                        "criterion": "cardiovascular condition",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No significant cardiac history including:",
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                    {
                        "exact_snippets": "No significant cardiac history",
                        "criterion": "cardiac history",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "not significant"
                        }
                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "No significant cardiac history",
                        "criterion": "cardiac history",
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                            "requirement_type": "severity",
                            "expected_value": "not significant"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Clinically significant atrial or ventricular arrhythmias requiring treatment",
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                    {
                        "exact_snippets": "Clinically significant atrial or ventricular arrhythmias requiring treatment",
                        "criterion": "atrial or ventricular arrhythmias",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "Clinically significant atrial or ventricular arrhythmias requiring treatment",
                        "criterion": "atrial or ventricular arrhythmias",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    }
                ]
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                        "exact_snippets": "Clinically significant atrial or ventricular arrhythmias requiring treatment",
                        "criterion": "atrial or ventricular arrhythmias",
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                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "Clinically significant atrial or ventricular arrhythmias requiring treatment",
                        "criterion": "atrial or ventricular arrhythmias",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Medically controlled congestive heart failure",
                "criterions": [
                    {
                        "exact_snippets": "Medically controlled congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "medically controlled"
                        }
                    }
                ]
            },
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                        "exact_snippets": "Medically controlled congestive heart failure",
                        "criterion": "congestive heart failure",
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                            "requirement_type": "control",
                            "expected_value": "medically controlled"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Significant angina or clinically and/or electrocardiographically documented myocardial infarction within the past year",
                "criterions": [
                    {
                        "exact_snippets": "Significant angina",
                        "criterion": "angina",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    },
                    {
                        "exact_snippets": "clinically and/or electrocardiographically documented myocardial infarction within the past year",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": [
                                "clinical",
                                "electrocardiographic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "clinically and/or electrocardiographically documented myocardial infarction within the past year",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within the past year"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Significant angina",
                                "criterion": "angina",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "significant"
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "clinically and/or electrocardiographically documented myocardial infarction within the past year",
                                        "criterion": "myocardial infarction",
                                        "requirement": {
                                            "requirement_type": "documentation",
                                            "expected_value": [
                                                "clinical",
                                                "electrocardiographic"
                                            ]
                                        }
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                                    {
                                        "exact_snippets": "clinically and/or electrocardiographically documented myocardial infarction within the past year",
                                        "criterion": "myocardial infarction",
                                        "requirement": {
                                            "requirement_type": "time frame",
                                            "expected_value": "within the past year"
                                        }
                                    }
                                ]
                            }
                        ]
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                ]
            }
        },
        {
            "identified_line": {
                "line": "* Clinically significant valvular disease",
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                    {
                        "exact_snippets": "Clinically significant valvular disease",
                        "criterion": "valvular disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Clinically significant valvular disease",
                        "criterion": "valvular disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No other prior or concurrent malignancy within the past 5 years except contralateral breast cancer, or adequately treated basal cell skin cancer or carcinoma in situ of the cervix",
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                    {
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                        "exact_snippets": "except ... adequately treated basal cell skin cancer",
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                "or_criteria": [
                    {
                        "and_criteria": [
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                                                    "operator": "<",
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                "line": "* No psychological, familial, sociological, or geographical condition that would preclude study",
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                        "exact_snippets": "No psychological ... condition that would preclude study",
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                        "exact_snippets": "No ... familial ... condition that would preclude study",
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                        "exact_snippets": "No ... sociological ... condition that would preclude study",
                        "criterion": "sociological condition",
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                            "requirement_type": "presence",
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                        "exact_snippets": "No ... geographical condition that would preclude study",
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                        "exact_snippets": "No ... familial ... condition that would preclude study",
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                        }
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                        "exact_snippets": "No ... sociological ... condition that would preclude study",
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                        "exact_snippets": "No ... geographical condition that would preclude study",
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            "identified_line": {
                "line": "* Fertile patients must use effective contraception",
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                    {
                        "exact_snippets": "Fertile patients",
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                            "requirement_type": "status",
                            "expected_value": "fertile"
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                        "exact_snippets": "must use effective contraception",
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                            "requirement_type": "necessity",
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                        "exact_snippets": "must use effective contraception",
                        "criterion": "contraception use",
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                            "requirement_type": "effectiveness",
                            "expected_value": "effective"
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                    }
                ]
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                "condition": {
                    "exact_snippets": "Fertile patients",
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                        "requirement_type": "status",
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                        {
                            "exact_snippets": "must use effective contraception",
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                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "must use effective contraception",
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                                "requirement_type": "effectiveness",
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                    ]
                },
                "else_criteria": null
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        {
            "identified_line": {
                "line": "PRIOR CONCURRENT THERAPY:",
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                    {
                        "exact_snippets": "PRIOR CONCURRENT THERAPY",
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                            "requirement_type": "presence",
                            "expected_value": true
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                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "PRIOR CONCURRENT THERAPY",
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                            "requirement_type": "presence",
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                        }
                    }
                ]
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        },
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            "identified_line": {
                "line": "Biologic therapy:",
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                    {
                        "exact_snippets": "Biologic therapy",
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                            "requirement_type": "presence",
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                        "exact_snippets": "Biologic therapy",
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            "identified_line": {
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                    {
                        "exact_snippets": "Chemotherapy",
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                        "exact_snippets": "Chemotherapy",
                        "criterion": "chemotherapy",
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        },
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            "identified_line": {
                "line": "* See Disease Characteristics",
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                        "exact_snippets": "Disease Characteristics",
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                ]
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            "identified_line": {
                "line": "* Prior adjuvant chemotherapy allowed if total doxorubicin dose is no greater than 300 mg/m2, total epirubicin dose is no greater than 450 mg/m^2, and total mitoxantrone dose is no greater than 75 mg/m^2",
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                        "exact_snippets": "Prior adjuvant chemotherapy allowed",
                        "criterion": "prior adjuvant chemotherapy",
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                                "value": 450,
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                                "operator": "<=",
                                "value": 75,
                                "unit": "mg/m^2"
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                            "exact_snippets": "total epirubicin dose is no greater than 450 mg/m^2",
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                            "exact_snippets": "total mitoxantrone dose is no greater than 75 mg/m^2",
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                        }
                    ]
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                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* No greater than one regimen of prior chemotherapy for metastatic disease",
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                    {
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                            "requirement_type": "quantity",
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                                "value": 1,
                                "unit": "regimen"
                            }
                        }
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                        "exact_snippets": "No greater than one regimen of prior chemotherapy for metastatic disease",
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                                "value": 1,
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        },
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            "identified_line": {
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                    {
                        "exact_snippets": "No prior anthracyclines for metastatic disease",
                        "criterion": "prior anthracyclines for metastatic disease",
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                    "exact_snippets": "No prior anthracyclines for metastatic disease",
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                        "requirement_type": "presence",
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                }
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        },
        {
            "identified_line": {
                "line": "* No other concurrent cytotoxic therapy",
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                    {
                        "exact_snippets": "No other concurrent cytotoxic therapy",
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                            "requirement_type": "presence",
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                ]
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            "logical_structure": {
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                    "exact_snippets": "No other concurrent cytotoxic therapy",
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                        "requirement_type": "presence",
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                }
            }
        },
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            "identified_line": {
                "line": "Endocrine therapy:",
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                        "exact_snippets": "Endocrine therapy",
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                        "exact_snippets": "Endocrine therapy",
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            "identified_line": {
                "line": "* At least 4 weeks since prior progestins, estrogens, or androgens",
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                        "criterion": "time since prior progestins",
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                            "requirement_type": "duration",
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                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
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                    },
                    {
                        "exact_snippets": "At least 4 weeks since prior ... estrogens",
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                            "requirement_type": "duration",
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                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
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                    {
                        "exact_snippets": "At least 4 weeks since prior ... androgens",
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                            "requirement_type": "duration",
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                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
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                ]
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            "logical_structure": {
                "or_criteria": [
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                        "and_criteria": [
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                                    "requirement_type": "duration",
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                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
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                                    "requirement_type": "duration",
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                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
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                                }
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                                "operator": ">=",
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                        "exact_snippets": "Radiotherapy",
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                        "exact_snippets": "Radiotherapy",
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        },
        {
            "identified_line": {
                "line": "* See Disease Characteristics",
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                        "exact_snippets": "Disease Characteristics",
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                            "requirement_type": "N/A",
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                ]
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        },
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            "identified_line": {
                "line": "* Concurrent palliative radiotherapy allowed if sole target lesion is outside irradiated field",
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                    {
                        "exact_snippets": "sole target lesion is outside irradiated field",
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                            "requirement_type": "location",
                            "expected_value": "outside irradiated field"
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        {
            "identified_line": {
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                    {
                        "exact_snippets": "Surgery",
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            "logical_structure": {
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                    {
                        "exact_snippets": "Surgery",
                        "criterion": "surgery",
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                            "requirement_type": "presence",
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        },
        {
            "identified_line": {
                "line": "Other:",
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                    {
                        "exact_snippets": "Other:",
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                        "exact_snippets": "Other:",
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            }
        },
        {
            "identified_line": {
                "line": "* No other concurrent investigational therapy",
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                    {
                        "exact_snippets": "No other concurrent investigational therapy",
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                            "requirement_type": "presence",
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                ]
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                    "exact_snippets": "No other concurrent investigational therapy",
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        },
        {
            "identified_line": {
                "line": "* Not specified",
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            },
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                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "PATIENT CHARACTERISTICS:",
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                "and_criteria": []
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        },
        {
            "identified_line": {
                "line": "* Not specified",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "* Not specified",
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            },
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                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "Other:",
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                    {
                        "exact_snippets": "Tissue from tumor must be available",
                        "criterion": "tumor tissue",
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                            "requirement_type": "availability",
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                    },
                    {
                        "exact_snippets": "> 2 cm in diameter",
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                            "requirement_type": "size",
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                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "Tissue from tumor must be available",
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                            "requirement_type": "availability",
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                    },
                    {
                        "exact_snippets": "> 2 cm in diameter",
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                            "requirement_type": "size",
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                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    }
                ]
            }
        },
        {
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                "line": "* Not pregnant or nursing",
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                        "criterion": "pregnancy status",
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    "failed_exclusion": [],
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                        "exact_snippets": "Histologically proven",
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                        "exact_snippets": "metastatic breast cancer",
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                ]
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        {
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                        "exact_snippets": "Concurrent bisphosphonates for ... hypercalcemia secondary to malignancy",
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                            "requirement_type": "indication",
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                        "exact_snippets": "bony lesions not only target lesion",
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                            "requirement_type": "target lesion",
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}