{
    "info": {
        "nct_id": "NCT00404066",
        "official_title": "Phase II Neoadjuvant Chemotherapy Trial in Clinical Stage II/III Her2Neu Positive Breast Cancer With Sequential AC -> Docetaxel With Concurrent Dual EGFR Kinase Blockade by GW572016 (Lapatinib) Followed by 1 Year Adjuvant Trastuzumab",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "INCLUSION CRITERIA\n\n* Female\n* Histologically-confirmed Her2neu positive breast cancer, by either Immunohistochemistry (IHC) 3+ or Fluorescence In Situ Hybridization (FISH)+\n* Stage II/III breast cancer including any large primary tumor (> 2 cm), tumors of any size associated with skin or chest wall involvement, tumors of any size with axillary lymph node involvement, (T2-T4, N0-N2) and those with ipsilateral subclavicular or supraclavicular lymph nodes).\n* At least one bi-dimensional, measurable indicator lesion.\n* Between 18 and 70 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 / Karnofsky ≥ 60% at screening and on the first day of treatment.\n* Informed consent must be obtained prior to registration.\n* Cardiac ejection fraction within the institutional range of normal as measured by multigated acquisition (MUGA) or echocardiography (ECHO) scan.\n* Absolute neutrophil count > 1,500/mm³\n* Hemoglobin > 8.0 g/dL\n* Platelet count > 100,000/mm³\n* Creatinine within normal institutional limits\n* Total Bilirubin equal to or less than institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST); alanine aminotransferase (ALT); and alkaline phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.\n* Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of GW572016 will be determined following review of their use by the Principal Investigator\n\n  * Antacid use is prohibited 1 hour before and 1 hour after GW572016 dosing.\n  * All herbal (alternative) medicines are prohibited.\n  * Medications prohibited during the administration of lapatinib .\n* Women of child-bearing potential must have negative pregnancy test and must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation.\n* Peripheral neuropathy: must be < grade 1\n* Able to swallow and retain oral medication\n\nEXCLUSION CRITERIA\n\n* Evidence of disease outside the breast or chest wall, except for ipsilateral axillary , supraclavicular, or infraclavicular lymph nodes.\n* Prior chemotherapy, immunotherapy, or hormonal therapy for breast cancer.\n* More than 3 months between histologic diagnosis and registration on this study.\n* History of other malignancy within the last 5years, except curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.\n* Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol. Those who are medically-unstable, including but not limited to active infection, acute hepatitis, deep vein thrombosis requiring anticoagulant therapy, gastrointestinal bleeding, uncontrolled hypercalcemia, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome, and those whose circumstances do not permit completion of the study or the required follow-up.\n* Congestive heart failure, abnormal left ventricular ejection fraction (LVEF), angina pectoris, uncontrolled cardiac arrhythmias, or other significant heart disease, or who have had a myocardial infarction within the past year.\n* Pregnant or lactating\n* Of childbearing potential and not employing adequate contraception\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016.\n* HIV-positive and receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.\n* GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).\n* History of severe hypersensitivity reaction to taxotere or other drugs formulated with polysorbate 80.\n* Current active hepatic or biliary disease (with exception of patients with Gilberts syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment )."
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Female",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically-confirmed Her2neu positive breast cancer, by either Immunohistochemistry (IHC) 3+ or Fluorescence In Situ Hybridization (FISH)+",
            "criterions": [
                {
                    "exact_snippets": "Histologically-confirmed Her2neu positive breast cancer",
                    "criterion": "Her2neu status",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically-confirmed"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "by either Immunohistochemistry (IHC) 3+",
                    "criterion": "Immunohistochemistry (IHC) score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Fluorescence In Situ Hybridization (FISH)+",
                    "criterion": "Fluorescence In Situ Hybridization (FISH) status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage II/III breast cancer including any large primary tumor (> 2 cm), tumors of any size associated with skin or chest wall involvement, tumors of any size with axillary lymph node involvement, (T2-T4, N0-N2) and those with ipsilateral subclavicular or supraclavicular lymph nodes).",
            "criterions": [
                {
                    "exact_snippets": "Stage II/III breast cancer",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "II",
                                "III"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "large primary tumor (> 2 cm)",
                    "criterion": "primary tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors of any size associated with skin or chest wall involvement",
                    "criterion": "tumor involvement",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": [
                                "skin",
                                "chest wall"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors of any size with axillary lymph node involvement",
                    "criterion": "axillary lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "(T2-T4, N0-N2)",
                    "criterion": "tumor and node classification",
                    "requirements": [
                        {
                            "requirement_type": "tumor classification",
                            "expected_value": [
                                "T2",
                                "T3",
                                "T4"
                            ]
                        },
                        {
                            "requirement_type": "node classification",
                            "expected_value": [
                                "N0",
                                "N1",
                                "N2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "ipsilateral subclavicular or supraclavicular lymph nodes",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": [
                                "ipsilateral subclavicular",
                                "supraclavicular"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one bi-dimensional, measurable indicator lesion.",
            "criterions": [
                {
                    "exact_snippets": "At least one bi-dimensional, measurable indicator lesion.",
                    "criterion": "indicator lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "dimensionality",
                            "expected_value": "bi-dimensional"
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Between 18 and 70 years of age",
            "criterions": [
                {
                    "exact_snippets": "Between 18 and 70 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 / Karnofsky ≥ 60% at screening and on the first day of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky ≥ 60%",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Informed consent must be obtained prior to registration.",
            "criterions": [
                {
                    "exact_snippets": "Informed consent must be obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "obtained",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiac ejection fraction within the institutional range of normal as measured by multigated acquisition (MUGA) or echocardiography (ECHO) scan.",
            "criterions": [
                {
                    "exact_snippets": "Cardiac ejection fraction within the institutional range of normal",
                    "criterion": "cardiac ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within the institutional range of normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "as measured by multigated acquisition (MUGA) or echocardiography (ECHO) scan",
                    "criterion": "measurement method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "multigated acquisition (MUGA)",
                                "echocardiography (ECHO) scan"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count > 1,500/mm³",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count > 1,500/mm³",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin > 8.0 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin > 8.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 8.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count > 100,000/mm³",
            "criterions": [
                {
                    "exact_snippets": "Platelet count > 100,000/mm³",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine within normal institutional limits",
            "criterions": [
                {
                    "exact_snippets": "Creatinine within normal institutional limits",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "within normal institutional limits"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total Bilirubin equal to or less than institutional upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Total Bilirubin equal to or less than institutional upper limit of normal (ULN)",
                    "criterion": "Total Bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate aminotransferase (AST); alanine aminotransferase (ALT); and alkaline phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST); alanine aminotransferase (ALT); and alkaline phosphatase must be within the range allowing for eligibility.",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within the range allowing for eligibility"
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate aminotransferase (AST); alanine aminotransferase (ALT); and alkaline phosphatase must be within the range allowing for eligibility.",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within the range allowing for eligibility"
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate aminotransferase (AST); alanine aminotransferase (ALT); and alkaline phosphatase must be within the range allowing for eligibility.",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within the range allowing for eligibility"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of GW572016 will be determined following review of their use by the Principal Investigator",
            "criterions": [
                {
                    "exact_snippets": "receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of GW572016",
                    "criterion": "medications or substances affecting GW572016",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Antacid use is prohibited 1 hour before and 1 hour after GW572016 dosing.",
            "criterions": [
                {
                    "exact_snippets": "Antacid use is prohibited 1 hour before and 1 hour after GW572016 dosing.",
                    "criterion": "antacid use",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prohibited 1 hour before and 1 hour after GW572016 dosing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All herbal (alternative) medicines are prohibited.",
            "criterions": [
                {
                    "exact_snippets": "All herbal (alternative) medicines are prohibited.",
                    "criterion": "herbal medicines",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medications prohibited during the administration of lapatinib .",
            "criterions": [
                {
                    "exact_snippets": "Medications prohibited during the administration of lapatinib",
                    "criterion": "medications",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of child-bearing potential must have negative pregnancy test and must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation.",
            "criterions": [
                {
                    "exact_snippets": "Women of child-bearing potential",
                    "criterion": "child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence)",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "hormonal",
                                "barrier method of birth control",
                                "abstinence"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Peripheral neuropathy: must be < grade 1",
            "criterions": [
                {
                    "exact_snippets": "Peripheral neuropathy: must be < grade 1",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to swallow and retain oral medication",
            "criterions": [
                {
                    "exact_snippets": "Able to swallow",
                    "criterion": "ability to swallow",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "retain oral medication",
                    "criterion": "ability to retain oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of disease outside the breast or chest wall, except for ipsilateral axillary , supraclavicular, or infraclavicular lymph nodes.",
            "criterions": [
                {
                    "exact_snippets": "Evidence of disease outside the breast or chest wall",
                    "criterion": "disease location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "outside the breast or chest wall"
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ipsilateral axillary , supraclavicular, or infraclavicular lymph nodes",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "ipsilateral axillary",
                                "supraclavicular",
                                "infraclavicular"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior chemotherapy, immunotherapy, or hormonal therapy for breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy ... for breast cancer.",
                    "criterion": "prior chemotherapy for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior ... immunotherapy ... for breast cancer.",
                    "criterion": "prior immunotherapy for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior ... hormonal therapy for breast cancer.",
                    "criterion": "prior hormonal therapy for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 3 months between histologic diagnosis and registration on this study.",
            "criterions": [
                {
                    "exact_snippets": "More than 3 months between histologic diagnosis and registration on this study.",
                    "criterion": "time since histologic diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of other malignancy within the last 5years, except curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.",
            "criterions": [
                {
                    "exact_snippets": "History of other malignancy within the last 5years",
                    "criterion": "history of other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except curatively treated basal cell carcinoma of the skin",
                    "criterion": "curatively treated basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol. Those who are medically-unstable, including but not limited to active infection, acute hepatitis, deep vein thrombosis requiring anticoagulant therapy, gastrointestinal bleeding, uncontrolled hypercalcemia, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome, and those whose circumstances do not permit completion of the study or the required follow-up.",
            "criterions": [
                {
                    "exact_snippets": "Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol.",
                    "criterion": "conditions affecting follow-up and compliance",
                    "requirements": [
                        {
                            "requirement_type": "impact on follow-up and compliance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "medically-unstable, including but not limited to active infection, acute hepatitis, deep vein thrombosis requiring anticoagulant therapy, gastrointestinal bleeding, uncontrolled hypercalcemia, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome",
                    "criterion": "medical stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "those whose circumstances do not permit completion of the study or the required follow-up",
                    "criterion": "circumstances permitting study completion",
                    "requirements": [
                        {
                            "requirement_type": "ability to complete study",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Congestive heart failure, abnormal left ventricular ejection fraction (LVEF), angina pectoris, uncontrolled cardiac arrhythmias, or other significant heart disease, or who have had a myocardial infarction within the past year.",
            "criterions": [
                {
                    "exact_snippets": "Congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal left ventricular ejection fraction (LVEF)",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "normality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled cardiac arrhythmias",
                    "criterion": "cardiac arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other significant heart disease",
                    "criterion": "significant heart disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within the past year",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Of childbearing potential and not employing adequate contraception",
            "criterions": [
                {
                    "exact_snippets": "Of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not employing adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016.",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016.",
                    "criterion": "allergic reactions",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "attribution",
                            "expected_value": "compounds of similar chemical or biologic composition to GW572016"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HIV-positive and receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.",
            "criterions": [
                {
                    "exact_snippets": "HIV-positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving combination anti-retroviral therapy",
                    "criterion": "combination anti-retroviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).",
            "criterions": [
                {
                    "exact_snippets": "GI tract disease resulting in an inability to take oral medication",
                    "criterion": "GI tract disease",
                    "requirements": [
                        {
                            "requirement_type": "resulting condition",
                            "expected_value": "inability to take oral medication"
                        }
                    ]
                },
                {
                    "exact_snippets": "malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a requirement for IV alimentation",
                    "criterion": "IV alimentation",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior surgical procedures affecting absorption",
                    "criterion": "prior surgical procedures",
                    "requirements": [
                        {
                            "requirement_type": "effect",
                            "expected_value": "affecting absorption"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)",
                    "criterion": "uncontrolled inflammatory GI disease",
                    "requirements": [
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "Crohn's",
                                "ulcerative colitis"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of severe hypersensitivity reaction to taxotere or other drugs formulated with polysorbate 80.",
            "criterions": [
                {
                    "exact_snippets": "History of severe hypersensitivity reaction to taxotere",
                    "criterion": "hypersensitivity reaction to taxotere",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of severe hypersensitivity reaction to ... other drugs formulated with polysorbate 80",
                    "criterion": "hypersensitivity reaction to drugs formulated with polysorbate 80",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current active hepatic or biliary disease (with exception of patients with Gilberts syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment ).",
            "criterions": [
                {
                    "exact_snippets": "Current active hepatic or biliary disease",
                    "criterion": "hepatic or biliary disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Gilberts syndrome",
                    "criterion": "Gilberts syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic gallstones",
                    "criterion": "asymptomatic gallstones",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stable chronic liver disease per investigator assessment",
                    "criterion": "stable chronic liver disease",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "INCLUSION CRITERIA",
            "criterions": []
        },
        {
            "line": "EXCLUSION CRITERIA",
            "criterions": []
        }
    ]
}