{
    "info": {
        "nct_id": "NCT00820872",
        "official_title": "Phase II Safety Study of Docetaxel and Carboplatin in Combination With Trastuzumab and Lapatinib in Early Breast Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary invasive adenocarcinoma of the breast fulfilling the following criteria:\n\n  * Nonmetastatic disease\n  * Operable and adequately excised\n\n    * Patients with nonresectable deep margin invasion are eligible provided they have had or will receive radiotherapy to the region\n    * Patients with histologically documented infiltration of the skin (pT4) are eligible provided they have undergone or will receive radiotherapy encompassing the tumor bed\n  * Node-positive OR -negative and determined eligible to receive adjuvant trastuzumab (Herceptin®)\n* No positive or suspicious internal mammary nodes by SNS that have not been or will not be irradiated\n* No supraclavicular lymph node involvement (confirmed by fine needle aspiration or biopsy)\n* Over expression and/or amplification of HER2 in the invasive component of the primary tumor, according to one of the following:\n\n  * 3+ over-expression by IHC (> 30% of invasive tumor cells)\n  * 2+ or 3+ (in 30% or less neoplastic cells) over-expression by IHC AND in situ hybridization (FISH/CISH) test demonstrating HER2 gene amplification\n  * HER2 gene amplification by FISH/CISH (> 6 HER2 gene copies per nucleus, or a FISH ratio [HER2 gene copies to chromosome 17 signals] of > 2.2.)\n\n    * Negative or equivocal overall result (FISH test ratio of < 2.2, < 6.0 HER2-gene copies per nucleus) and staining scores of 0, 1+, 2+, or 3+ (in 30% or less neoplastic cells) by IHC not allowed\n* Hormone receptor status known (estrogen receptor with or without progesterone receptor)\n\nPATIENT CHARACTERISTICS:\n\n* Menopausal status not specified\n* ECOG performance status 0-1\n* Hemoglobin ≥ 10.0 g/dL\n* ANC ≥ 1,500/mm^3\n* Platelet count ≥ 100,000/mm^3\n* Serum creatinine ≤ 2.0 times upper limit of normal (ULN)\n* AST and ALT ≤ 2.5 times ULN\n* Alkaline phosphatase ≤ 2.5 times ULN\n* Bilirubin ≤ 1.5 times ULN (≤ 2.0 times ULN if known Gilbert syndrome)\n* Baseline LVEF ≥ 50% measured by ECHO or MUGA scan\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No serious cardiac illness or medical condition including, but not limited to, any of the following:\n\n  * History of documented congestive heart failure (any NYHA class) or systolic dysfunction (LVEF < 50%)\n  * High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade atrioventricular-block [second degree or higher], or supraventricular arrhythmias that are not adequately rate-controlled)\n  * Angina pectoris requiring antianginal medication\n  * Clinically significant valvular heart disease\n  * Evidence of transmural infarction on ECG\n  * Poorly controlled hypertension (any reading of systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg)\n* No other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions or illness\n* None of the following:\n\n  * Ulcerative colitis\n  * Malabsorption syndrome\n  * Any disease significantly affecting gastrointestinal function\n  * Inability to swallow oral medication\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior mediastinal irradiation except internal mammary-node irradiation for the present breast cancer\n* No prior anti-HER2 therapy for any reason\n* No prior biologic or immunotherapy for breast cancer\n* No prior resection of the stomach or small bowel\n* No other concurrent anticancer therapy including chemotherapeutic agents, biologic agents, or radiotherapy\n* No concurrent anticancer treatment in another investigational trial with hormone therapy or immunotherapy unless approved by the study chair\n* No concurrent CYP3A4 inhibitors or inducers\n* No concurrent epoetin alfa, including darbepoetin alfa\n* No concurrent oprelvekin"
    },
    "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 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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Histologically confirmed primary invasive adenocarcinoma of the breast fulfilling the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed primary invasive adenocarcinoma of the breast",
                    "criterion": "adenocarcinoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically"
                        },
                        {
                            "requirement_type": "invasiveness",
                            "expected_value": "invasive"
                        },
                        {
                            "requirement_type": "primary",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Nonmetastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Nonmetastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Operable and adequately excised",
            "criterions": [
                {
                    "exact_snippets": "Operable",
                    "criterion": "operability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "operable"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately excised",
                    "criterion": "excision adequacy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "adequately excised"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with nonresectable deep margin invasion are eligible provided they have had or will receive radiotherapy to the region",
            "criterions": [
                {
                    "exact_snippets": "nonresectable deep margin invasion",
                    "criterion": "deep margin invasion",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "provided they have had or will receive radiotherapy to the region",
                    "criterion": "radiotherapy to the region",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with histologically documented infiltration of the skin (pT4) are eligible provided they have undergone or will receive radiotherapy encompassing the tumor bed",
            "criterions": [
                {
                    "exact_snippets": "histologically documented infiltration of the skin (pT4)",
                    "criterion": "skin infiltration",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "histologically documented"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "pT4"
                        }
                    ]
                },
                {
                    "exact_snippets": "undergone or will receive radiotherapy encompassing the tumor bed",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "radiotherapy encompassing the tumor bed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Node-positive OR -negative and determined eligible to receive adjuvant trastuzumab (Herceptin®)",
            "criterions": [
                {
                    "exact_snippets": "Node-positive OR -negative",
                    "criterion": "node status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "positive",
                                "negative"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "determined eligible to receive adjuvant trastuzumab (Herceptin®)",
                    "criterion": "eligibility for adjuvant trastuzumab",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No positive or suspicious internal mammary nodes by SNS that have not been or will not be irradiated",
            "criterions": [
                {
                    "exact_snippets": "No positive or suspicious internal mammary nodes",
                    "criterion": "internal mammary nodes",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "not positive",
                                "not suspicious"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "that have not been or will not be irradiated",
                    "criterion": "irradiation of internal mammary nodes",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No supraclavicular lymph node involvement (confirmed by fine needle aspiration or biopsy)",
            "criterions": [
                {
                    "exact_snippets": "No supraclavicular lymph node involvement",
                    "criterion": "supraclavicular lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed by fine needle aspiration or biopsy",
                    "criterion": "confirmation method for lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "fine needle aspiration",
                                "biopsy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Over expression and/or amplification of HER2 in the invasive component of the primary tumor, according to one of the following:",
            "criterions": [
                {
                    "exact_snippets": "Over expression ... of HER2",
                    "criterion": "HER2",
                    "requirements": [
                        {
                            "requirement_type": "expression",
                            "expected_value": "over"
                        }
                    ]
                },
                {
                    "exact_snippets": "amplification of HER2",
                    "criterion": "HER2",
                    "requirements": [
                        {
                            "requirement_type": "amplification",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "invasive component of the primary tumor",
                    "criterion": "invasive component of the primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 3+ over-expression by IHC (> 30% of invasive tumor cells)",
            "criterions": [
                {
                    "exact_snippets": "3+ over-expression by IHC (> 30% of invasive tumor cells)",
                    "criterion": "3+ over-expression by IHC",
                    "requirements": [
                        {
                            "requirement_type": "percentage of invasive tumor cells",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 2+ or 3+ (in 30% or less neoplastic cells) over-expression by IHC AND in situ hybridization (FISH/CISH) test demonstrating HER2 gene amplification",
            "criterions": [
                {
                    "exact_snippets": "2+ or 3+ (in 30% or less neoplastic cells) over-expression by IHC",
                    "criterion": "HER2 over-expression",
                    "requirements": [
                        {
                            "requirement_type": "expression level",
                            "expected_value": [
                                "2+",
                                "3+"
                            ]
                        },
                        {
                            "requirement_type": "cell percentage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "method",
                            "expected_value": "IHC"
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ hybridization (FISH/CISH) test demonstrating HER2 gene amplification",
                    "criterion": "HER2 gene amplification",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "FISH",
                                "CISH"
                            ]
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HER2 gene amplification by FISH/CISH (> 6 HER2 gene copies per nucleus, or a FISH ratio [HER2 gene copies to chromosome 17 signals] of > 2.2.)",
            "criterions": [
                {
                    "exact_snippets": "HER2 gene amplification by FISH/CISH (> 6 HER2 gene copies per nucleus",
                    "criterion": "HER2 gene amplification",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "FISH",
                                "CISH"
                            ]
                        },
                        {
                            "requirement_type": "gene copies per nucleus",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "HER2 gene copies"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "FISH ratio [HER2 gene copies to chromosome 17 signals] of > 2.2.",
                    "criterion": "FISH ratio",
                    "requirements": [
                        {
                            "requirement_type": "ratio",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative or equivocal overall result (FISH test ratio of < 2.2, < 6.0 HER2-gene copies per nucleus) and staining scores of 0, 1+, 2+, or 3+ (in 30% or less neoplastic cells) by IHC not allowed",
            "criterions": [
                {
                    "exact_snippets": "Negative or equivocal overall result (FISH test ratio of < 2.2, < 6.0 HER2-gene copies per nucleus)",
                    "criterion": "FISH test result",
                    "requirements": [
                        {
                            "requirement_type": "overall result",
                            "expected_value": {
                                "operator": "!=",
                                "value": 0,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "FISH test ratio",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.2,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "HER2-gene copies per nucleus",
                            "expected_value": {
                                "operator": "<",
                                "value": 6.0,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "staining scores of 0, 1+, 2+, or 3+ (in 30% or less neoplastic cells) by IHC not allowed",
                    "criterion": "IHC staining score",
                    "requirements": [
                        {
                            "requirement_type": "staining score",
                            "expected_value": [
                                "0",
                                "1+",
                                "2+",
                                "3+"
                            ]
                        },
                        {
                            "requirement_type": "neoplastic cells percentage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormone receptor status known (estrogen receptor with or without progesterone receptor)",
            "criterions": [
                {
                    "exact_snippets": "Hormone receptor status known (estrogen receptor with or without progesterone receptor)",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "knowledge",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Menopausal status not specified",
            "criterions": [
                {
                    "exact_snippets": "Menopausal status",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 10.0 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 10.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ANC ≥ 1,500/mm^3",
            "criterions": [
                {
                    "exact_snippets": "ANC ≥ 1,500/mm^3",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥ 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine ≤ 2.0 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤ 2.0 times upper limit of normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST and ALT ≤ 2.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "AST and ALT ≤ 2.5 times ULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT ≤ 2.5 times ULN",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline phosphatase ≤ 2.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase ≤ 2.5 times ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin ≤ 1.5 times ULN (≤ 2.0 times ULN if known Gilbert syndrome)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin ≤ 1.5 times ULN",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Bilirubin ... ≤ 2.0 times ULN if known Gilbert syndrome",
                    "criterion": "bilirubin level with Gilbert syndrome",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Baseline LVEF ≥ 50% measured by ECHO or MUGA scan",
            "criterions": [
                {
                    "exact_snippets": "Baseline LVEF ≥ 50%",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "baseline measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "measured by ECHO or MUGA scan",
                    "criterion": "measurement method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "ECHO",
                                "MUGA scan"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No serious cardiac illness or medical condition including, but not limited to, any of the following:",
            "criterions": [
                {
                    "exact_snippets": "serious cardiac illness",
                    "criterion": "cardiac illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "medical condition",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of documented congestive heart failure (any NYHA class) or systolic dysfunction (LVEF < 50%)",
            "criterions": [
                {
                    "exact_snippets": "History of documented congestive heart failure (any NYHA class)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systolic dysfunction (LVEF < 50%)",
                    "criterion": "systolic dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "LVEF",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade atrioventricular-block [second degree or higher], or supraventricular arrhythmias that are not adequately rate-controlled)",
            "criterions": [
                {
                    "exact_snippets": "High-risk uncontrolled arrhythmias",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "high-risk"
                        },
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular tachycardia",
                    "criterion": "ventricular tachycardia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "high-grade atrioventricular-block [second degree or higher]",
                    "criterion": "atrioventricular-block",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": ">= second degree"
                        }
                    ]
                },
                {
                    "exact_snippets": "supraventricular arrhythmias that are not adequately rate-controlled",
                    "criterion": "supraventricular arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "not adequately rate-controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Angina pectoris requiring antianginal medication",
            "criterions": [
                {
                    "exact_snippets": "Angina pectoris requiring antianginal medication",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "antianginal medication"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant valvular heart disease",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant valvular heart disease",
                    "criterion": "valvular heart disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of transmural infarction on ECG",
            "criterions": [
                {
                    "exact_snippets": "Evidence of transmural infarction on ECG",
                    "criterion": "transmural infarction",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Poorly controlled hypertension (any reading of systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg)",
            "criterions": [
                {
                    "exact_snippets": "Poorly controlled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "systolic BP > 180 mm Hg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 180,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic BP > 100 mm Hg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions or illness",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent serious diseases",
                    "criterion": "concurrent serious diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe pulmonary conditions",
                    "criterion": "severe pulmonary conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "illness",
                    "criterion": "illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ulcerative colitis",
            "criterions": [
                {
                    "exact_snippets": "Ulcerative colitis",
                    "criterion": "ulcerative colitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Malabsorption syndrome",
            "criterions": [
                {
                    "exact_snippets": "Malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any disease significantly affecting gastrointestinal function",
            "criterions": [
                {
                    "exact_snippets": "disease significantly affecting gastrointestinal function",
                    "criterion": "gastrointestinal function",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to swallow oral medication",
            "criterions": [
                {
                    "exact_snippets": "Inability to swallow oral medication",
                    "criterion": "ability to swallow oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* No prior mediastinal irradiation except internal mammary-node irradiation for the present breast cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior mediastinal irradiation",
                    "criterion": "prior mediastinal irradiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "internal mammary-node irradiation for the present breast cancer",
                    "criterion": "internal mammary-node irradiation",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "present breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior anti-HER2 therapy for any reason",
            "criterions": [
                {
                    "exact_snippets": "No prior anti-HER2 therapy",
                    "criterion": "anti-HER2 therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior biologic or immunotherapy for breast cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior biologic ... for breast cancer",
                    "criterion": "biologic therapy for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... immunotherapy for breast cancer",
                    "criterion": "immunotherapy for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior resection of the stomach or small bowel",
            "criterions": [
                {
                    "exact_snippets": "No prior resection of the stomach",
                    "criterion": "stomach resection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior resection of the ... small bowel",
                    "criterion": "small bowel resection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent anticancer therapy including chemotherapeutic agents, biologic agents, or radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent anticancer therapy including chemotherapeutic agents",
                    "criterion": "concurrent anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other concurrent anticancer therapy including ... biologic agents",
                    "criterion": "concurrent biologic agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other concurrent anticancer therapy including ... radiotherapy",
                    "criterion": "concurrent radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent anticancer treatment in another investigational trial with hormone therapy or immunotherapy unless approved by the study chair",
            "criterions": [
                {
                    "exact_snippets": "No concurrent anticancer treatment in another investigational trial",
                    "criterion": "concurrent anticancer treatment in another investigational trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hormone therapy",
                    "criterion": "hormone therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrent treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "immunotherapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrent treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent epoetin alfa, including darbepoetin alfa",
            "criterions": [
                {
                    "exact_snippets": "No concurrent epoetin alfa",
                    "criterion": "epoetin alfa",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "including darbepoetin alfa",
                    "criterion": "darbepoetin alfa",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent oprelvekin",
            "criterions": [
                {
                    "exact_snippets": "No concurrent oprelvekin",
                    "criterion": "oprelvekin",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* None of the following:",
            "criterions": []
        },
        {
            "line": "* No concurrent CYP3A4 inhibitors or inducers",
            "criterions": [
                {
                    "exact_snippets": "No concurrent CYP3A4 inhibitors",
                    "criterion": "CYP3A4 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent ... CYP3A4 inducers",
                    "criterion": "CYP3A4 inducers",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ]
}