{
    "info": {
        "nct_id": "NCT00898573",
        "official_title": "Study of Resistance Mechanisms Against Lapatinib in Patients With ErbB-2-Positive Breast Cancers",
        "inclusion_criteria": "Healthy volunteers allowed",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Pathologically confirmed invasive breast cancer\n\n  * ErbB2-positive disease\n* Has received or is currently receiving lapatinib ditosylate\n\n  * Documented clinical benefit while receiving lapatinib ditosylate (e.g., stable disease of ≥ 12 weeks duration OR a radiographic response)\n* Must have tumor tissue samples available for research studies\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Menopausal status not specified\n* Not pregnant*\n* Coagulation profile normal*\n* Platelet count > 100,000/mm³* NOTE: *For patients requiring a post-treatment biopsy\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Concurrent chemotherapy or trastuzumab (Herceptin®) allowed\n* No concurrent anticoagulants, including warfarin or low-molecular weight heparin*\n* No concurrent antiplatelet therapy, including aspirin, clopidogrel, or other antiplatelet agents* NOTE: *For patients requiring a post-treatment biopsy"
    },
    "inclusion_lines": [
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                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
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                        "criterion": "volunteer health status",
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                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
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                "line": "* Pathologically confirmed invasive breast cancer",
                "criterions": [
                    {
                        "exact_snippets": "Pathologically confirmed invasive breast cancer",
                        "criterion": "invasive breast cancer",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "pathologically confirmed"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Pathologically confirmed invasive breast cancer",
                        "criterion": "invasive breast cancer",
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                            "requirement_type": "confirmation method",
                            "expected_value": "pathologically confirmed"
                        }
                    }
                ]
            }
        },
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                "line": "* ErbB2-positive disease",
                "criterions": [
                    {
                        "exact_snippets": "ErbB2-positive disease",
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                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ErbB2-positive disease",
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                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
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                        "criterion": "clinical benefit while receiving lapatinib ditosylate",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "stable disease of ≥ 12 weeks duration",
                        "criterion": "stable disease",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "radiographic response",
                        "criterion": "radiographic response",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Documented clinical benefit while receiving lapatinib ditosylate",
                                "criterion": "clinical benefit while receiving lapatinib ditosylate",
                                "requirement": {
                                    "requirement_type": "documentation",
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                                }
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                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "stable disease of ≥ 12 weeks duration",
                                        "criterion": "stable disease",
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                                            "requirement_type": "duration",
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                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "radiographic response",
                                        "criterion": "radiographic response",
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                                            "requirement_type": "presence",
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                                        }
                                    }
                                ]
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                        ]
                    }
                ]
            }
        },
        {
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                "line": "* Must have tumor tissue samples available for research studies",
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                    {
                        "exact_snippets": "tumor tissue samples available",
                        "criterion": "tumor tissue samples",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    }
                ]
            },
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                        "exact_snippets": "tumor tissue samples available",
                        "criterion": "tumor tissue samples",
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                            "requirement_type": "availability",
                            "expected_value": true
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                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hormone receptor status not specified",
                "criterions": [
                    {
                        "exact_snippets": "Hormone receptor status",
                        "criterion": "hormone receptor status",
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                            "requirement_type": "specification",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Hormone receptor status",
                        "criterion": "hormone receptor status",
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                            "requirement_type": "specification",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Menopausal status not specified",
                "criterions": [
                    {
                        "exact_snippets": "Menopausal status",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "specification",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Menopausal status",
                    "criterion": "menopausal status",
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                        "requirement_type": "specification",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Coagulation profile normal*",
                "criterions": [
                    {
                        "exact_snippets": "Coagulation profile normal",
                        "criterion": "coagulation profile",
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                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Coagulation profile normal",
                        "criterion": "coagulation profile",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count > 100,000/mm³* NOTE: *For patients requiring a post-treatment biopsy",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count > 100,000/mm³",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm³"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "For patients requiring a post-treatment biopsy",
                    "criterion": "post-treatment biopsy requirement",
                    "requirement": {
                        "requirement_type": "necessity",
                        "expected_value": true
                    }
                },
                "then_criteria": {
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                            "exact_snippets": "Platelet count > 100,000/mm³",
                            "criterion": "platelet count",
                            "requirement": {
                                "requirement_type": "quantity",
                                "expected_value": {
                                    "operator": ">",
                                    "value": 100000,
                                    "unit": "mm³"
                                }
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "PRIOR CONCURRENT THERAPY:",
                "criterions": [
                    {
                        "exact_snippets": "PRIOR CONCURRENT THERAPY",
                        "criterion": "prior concurrent therapy",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "PRIOR CONCURRENT THERAPY",
                        "criterion": "prior concurrent therapy",
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* See Disease Characteristics",
                "criterions": [
                    {
                        "exact_snippets": "Disease Characteristics",
                        "criterion": "disease characteristics",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "See Disease Characteristics"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Disease Characteristics",
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                            "requirement_type": "N/A",
                            "expected_value": "See Disease Characteristics"
                        }
                    }
                ]
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        {
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                            "requirement_type": "allowance",
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                    },
                    {
                        "exact_snippets": "Concurrent ... trastuzumab (Herceptin®) allowed",
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                            "requirement_type": "allowance",
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                        "criterion": "concurrent anticoagulants",
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                            "requirement_type": "specific types",
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                                "warfarin",
                                "low-molecular weight heparin"
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                        "exact_snippets": "No concurrent anticoagulants, including warfarin or low-molecular weight heparin",
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                    }
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                            "expected_value": false
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                "else_criteria": null
            }
        },
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    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
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                "line": "* Has received or is currently receiving lapatinib ditosylate",
                "criterions": [
                    {
                        "exact_snippets": "Has received or is currently receiving lapatinib ditosylate",
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                        "criterion": "lapatinib ditosylate treatment",
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                            "requirement_type": "status",
                            "expected_value": "currently receiving"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Not pregnant*",
                "criterions": [
                    {
                        "exact_snippets": "Not pregnant",
                        "criterion": "pregnancy",
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                            "requirement_type": "status",
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                        }
                    }
                ]
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            "logical_structure": {
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                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy",
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                    }
                }
            }
        }
    ]
}