{
    "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": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Pathologically confirmed invasive breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Pathologically confirmed invasive breast cancer",
                    "criterion": "invasive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "pathologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ErbB2-positive disease",
            "criterions": [
                {
                    "exact_snippets": "ErbB2-positive disease",
                    "criterion": "ErbB2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received or is currently receiving lapatinib ditosylate",
            "criterions": [
                {
                    "exact_snippets": "Has received or is currently receiving lapatinib ditosylate",
                    "criterion": "lapatinib ditosylate treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "received",
                                "currently receiving"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documented clinical benefit while receiving lapatinib ditosylate (e.g., stable disease of ≥ 12 weeks duration OR a radiographic response)",
            "criterions": [
                {
                    "exact_snippets": "Documented clinical benefit while receiving lapatinib ditosylate",
                    "criterion": "clinical benefit while receiving lapatinib ditosylate",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stable disease of ≥ 12 weeks duration",
                    "criterion": "stable disease",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiographic response",
                    "criterion": "radiographic response",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have tumor tissue samples available for research studies",
            "criterions": [
                {
                    "exact_snippets": "tumor tissue samples available",
                    "criterion": "tumor tissue samples",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormone receptor status not specified",
            "criterions": [
                {
                    "exact_snippets": "Hormone receptor status",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Menopausal status not specified",
            "criterions": [
                {
                    "exact_snippets": "Menopausal status",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not pregnant*",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Coagulation profile normal*",
            "criterions": [
                {
                    "exact_snippets": "Coagulation profile normal",
                    "criterion": "coagulation profile",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "See Disease Characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent chemotherapy or trastuzumab (Herceptin®) allowed",
            "criterions": [
                {
                    "exact_snippets": "Concurrent chemotherapy ... allowed",
                    "criterion": "concurrent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent ... trastuzumab (Herceptin®) allowed",
                    "criterion": "concurrent trastuzumab (Herceptin®)",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent anticoagulants, including warfarin or low-molecular weight heparin*",
            "criterions": [
                {
                    "exact_snippets": "No concurrent anticoagulants, including warfarin or low-molecular weight heparin",
                    "criterion": "concurrent anticoagulants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "specific types",
                            "expected_value": [
                                "warfarin",
                                "low-molecular weight heparin"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent antiplatelet therapy, including aspirin, clopidogrel, or other antiplatelet agents* NOTE: *For patients requiring a post-treatment biopsy",
            "criterions": [
                {
                    "exact_snippets": "No concurrent antiplatelet therapy, including aspirin, clopidogrel, or other antiplatelet agents",
                    "criterion": "concurrent antiplatelet therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        }
    ]
}