{
    "info": {
        "nct_id": "NCT01772472",
        "official_title": "A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy",
        "inclusion_criteria": "* Adult patient, >/= 18 years of age\n* HER2-positive breast cancer\n* Histologically confirmed invasive breast carcinoma\n* Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible)\n* Completion of preoperative systemic chemotherapy and HER2-directed treatment consisting of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy\n* Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol\n* Pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy\n* An interval of no more than 12 weeks between the date of surgery and the date of randomization\n* Known hormone-receptor status\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Adequate hematologic, renal and liver function\n* Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= 55% after completion of neoadjuvant chemotherapy.\n* For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drug\n* Documentation of hepatitis B virus and hepatitis C virus serology is required\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Stage IV (metastatic) breast cancer\n* History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ\n* Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery\n* Progressive disease during preoperative systemic therapy\n* Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment\n* History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned above\n* Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons\n* Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy\n* History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 240 mg/m2; Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) > 480 mg/m2; For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2\n* Cardiopulmonary dysfunction as defined by protocol\n* Prior treatment with trastuzumab emtansine\n* Current severe, uncontrolled systemic disease\n* Pregnant or lactating women\n* Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis\n* Concurrent serious uncontrolled infections requiring treatment or known infection with HIV\n* History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Adult patient, >/= 18 years of age",
                "criterions": [
                    {
                        "exact_snippets": "Adult patient, >/= 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adult patient, >/= 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* HER2-positive breast cancer",
                "criterions": [
                    {
                        "exact_snippets": "HER2-positive breast cancer",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "HER2-positive breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "HER2-positive breast cancer",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "HER2-positive breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Histologically confirmed invasive breast carcinoma",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed invasive breast carcinoma",
                        "criterion": "invasive breast carcinoma",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histologically confirmed invasive breast carcinoma",
                        "criterion": "invasive breast carcinoma",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible)",
                "criterions": [
                    {
                        "exact_snippets": "Clinical stage T1-4/N0-3/M0 at presentation",
                        "criterion": "clinical stage",
                        "requirement": {
                            "requirement_type": "T stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Clinical stage T1-4/N0-3/M0 at presentation",
                        "criterion": "clinical stage",
                        "requirement": {
                            "requirement_type": "N stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Clinical stage T1-4/N0-3/M0 at presentation",
                        "criterion": "clinical stage",
                        "requirement": {
                            "requirement_type": "M stage",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "M"
                            }
                        }
                    },
                    {
                        "exact_snippets": "patients with T1a/bN0 tumors will not be eligible",
                        "criterion": "tumor stage",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": "T1a/bN0"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Clinical stage T1-4/N0-3/M0 at presentation",
                                        "criterion": "clinical stage",
                                        "requirement": {
                                            "requirement_type": "T stage",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": ">=",
                                                        "value": 1,
                                                        "unit": "T"
                                                    },
                                                    {
                                                        "operator": "<=",
                                                        "value": 4,
                                                        "unit": "T"
                                                    }
                                                ]
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Clinical stage T1-4/N0-3/M0 at presentation",
                                        "criterion": "clinical stage",
                                        "requirement": {
                                            "requirement_type": "N stage",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": ">=",
                                                        "value": 0,
                                                        "unit": "N"
                                                    },
                                                    {
                                                        "operator": "<=",
                                                        "value": 3,
                                                        "unit": "N"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Clinical stage T1-4/N0-3/M0 at presentation",
                                "criterion": "clinical stage",
                                "requirement": {
                                    "requirement_type": "M stage",
                                    "expected_value": {
                                        "operator": "=",
                                        "value": 0,
                                        "unit": "M"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "patients with T1a/bN0 tumors will not be eligible",
                            "criterion": "tumor stage",
                            "requirement": {
                                "requirement_type": "exclusion",
                                "expected_value": "T1a/bN0"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Completion of preoperative systemic chemotherapy and HER2-directed treatment consisting of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy",
                "criterions": [
                    {
                        "exact_snippets": "Completion of preoperative systemic chemotherapy",
                        "criterion": "preoperative systemic chemotherapy",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HER2-directed treatment",
                        "criterion": "HER2-directed treatment",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "at least 6 cycles of chemotherapy",
                        "criterion": "chemotherapy cycles",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "cycles"
                            }
                        }
                    },
                    {
                        "exact_snippets": "total duration of at least 16 weeks",
                        "criterion": "chemotherapy duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "at least 9 weeks of trastuzumab",
                        "criterion": "trastuzumab duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "at least 9 weeks of taxane-based therapy",
                        "criterion": "taxane-based therapy duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Completion of preoperative systemic chemotherapy",
                                "criterion": "preoperative systemic chemotherapy",
                                "requirement": {
                                    "requirement_type": "completion",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "HER2-directed treatment",
                                "criterion": "HER2-directed treatment",
                                "requirement": {
                                    "requirement_type": "completion",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "at least 6 cycles of chemotherapy",
                                "criterion": "chemotherapy cycles",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 6,
                                        "unit": "cycles"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "total duration of at least 16 weeks",
                                "criterion": "chemotherapy duration",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 16,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "at least 9 weeks of trastuzumab",
                                "criterion": "trastuzumab duration",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 9,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "at least 9 weeks of taxane-based therapy",
                                "criterion": "taxane-based therapy duration",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 9,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol",
                "criterions": [
                    {
                        "exact_snippets": "surgical removal of all clinically evident disease in the breast",
                        "criterion": "disease in the breast",
                        "requirement": {
                            "requirement_type": "surgical removal",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "surgical removal of all clinically evident disease in the ... lymph nodes",
                        "criterion": "disease in the lymph nodes",
                        "requirement": {
                            "requirement_type": "surgical removal",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "surgical removal of all clinically evident disease in the breast",
                        "criterion": "disease in the breast",
                        "requirement": {
                            "requirement_type": "surgical removal",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "surgical removal of all clinically evident disease in the ... lymph nodes",
                        "criterion": "disease in the lymph nodes",
                        "requirement": {
                            "requirement_type": "surgical removal",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy",
                "criterions": [
                    {
                        "exact_snippets": "Pathological evidence of residual invasive carcinoma in the breast",
                        "criterion": "residual invasive carcinoma in the breast",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Pathological evidence of residual invasive carcinoma in the ... axillary lymph nodes",
                        "criterion": "residual invasive carcinoma in the axillary lymph nodes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Pathological evidence of residual invasive carcinoma in the breast",
                        "criterion": "residual invasive carcinoma in the breast",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Pathological evidence of residual invasive carcinoma in the ... axillary lymph nodes",
                        "criterion": "residual invasive carcinoma in the axillary lymph nodes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* An interval of no more than 12 weeks between the date of surgery and the date of randomization",
                "criterions": [
                    {
                        "exact_snippets": "An interval of no more than 12 weeks between the date of surgery and the date of randomization",
                        "criterion": "interval between surgery and randomization",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "An interval of no more than 12 weeks between the date of surgery and the date of randomization",
                        "criterion": "interval between surgery and randomization",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known hormone-receptor status",
                "criterions": [
                    {
                        "exact_snippets": "Known hormone-receptor status",
                        "criterion": "hormone-receptor status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Known hormone-receptor status",
                        "criterion": "hormone-receptor status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate hematologic, renal and liver function",
                "criterions": [
                    {
                        "exact_snippets": "Adequate hematologic",
                        "criterion": "hematologic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... renal",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... liver function",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate hematologic",
                        "criterion": "hematologic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... renal",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... liver function",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= 55% after completion of neoadjuvant chemotherapy.",
                "criterions": [
                    {
                        "exact_snippets": "Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy",
                        "criterion": "screening LVEF",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "echocardiogram (ECHO)",
                                "multiple-gated acquisition (MUGA)"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy",
                        "criterion": "screening LVEF",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF",
                        "criterion": "LVEF decrease",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 15,
                                "unit": "% absolute points"
                            }
                        }
                    },
                    {
                        "exact_snippets": "if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= 55% after completion of neoadjuvant chemotherapy",
                        "criterion": "screening LVEF without pre-chemotherapy assessment",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 55,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy",
                                                "criterion": "screening LVEF",
                                                "requirement": {
                                                    "requirement_type": "method",
                                                    "expected_value": [
                                                        "echocardiogram (ECHO)",
                                                        "multiple-gated acquisition (MUGA)"
                                                    ]
                                                }
                                            },
                                            {
                                                "exact_snippets": "Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy",
                                                "criterion": "screening LVEF",
                                                "requirement": {
                                                    "requirement_type": "value",
                                                    "expected_value": {
                                                        "operator": ">=",
                                                        "value": 50,
                                                        "unit": "%"
                                                    }
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF",
                                        "criterion": "LVEF decrease",
                                        "requirement": {
                                            "requirement_type": "value",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 15,
                                                "unit": "% absolute points"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= 55% after completion of neoadjuvant chemotherapy",
                        "criterion": "screening LVEF without pre-chemotherapy assessment",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 55,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drug",
                "criterions": [
                    {
                        "exact_snippets": "women who are not postmenopausal or surgically sterile",
                        "criterion": "menopausal or surgical sterility status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "not postmenopausal or surgically sterile"
                        }
                    },
                    {
                        "exact_snippets": "agreement to remain abstinent or use single or combined contraceptive methods",
                        "criterion": "contraceptive agreement",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": "remain abstinent or use contraceptive methods"
                        }
                    },
                    {
                        "exact_snippets": "contraceptive methods that result in a failure rate of < 1% per year",
                        "criterion": "contraceptive method failure rate",
                        "requirement": {
                            "requirement_type": "failure rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "% per year"
                            }
                        }
                    },
                    {
                        "exact_snippets": "during the treatment period and for at least 7 months after the last dose of study drug",
                        "criterion": "contraceptive duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during treatment and 7 months after last dose"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "women who are not postmenopausal or surgically sterile",
                    "criterion": "menopausal or surgical sterility status",
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                        "requirement_type": "status",
                        "expected_value": "not postmenopausal or surgically sterile"
                    }
                },
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                    "and_criteria": [
                        {
                            "exact_snippets": "agreement to remain abstinent or use single or combined contraceptive methods",
                            "criterion": "contraceptive agreement",
                            "requirement": {
                                "requirement_type": "agreement",
                                "expected_value": "remain abstinent or use contraceptive methods"
                            }
                        },
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "contraceptive methods that result in a failure rate of < 1% per year",
                                    "criterion": "contraceptive method failure rate",
                                    "requirement": {
                                        "requirement_type": "failure rate",
                                        "expected_value": {
                                            "operator": "<",
                                            "value": 1,
                                            "unit": "% per year"
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "during the treatment period and for at least 7 months after the last dose of study drug",
                                    "criterion": "contraceptive duration",
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                                        "requirement_type": "duration",
                                        "expected_value": "during treatment and 7 months after last dose"
                                    }
                                }
                            ]
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Documentation of hepatitis B virus and hepatitis C virus serology is required",
                "criterions": [
                    {
                        "exact_snippets": "Documentation of hepatitis B virus ... serology is required",
                        "criterion": "hepatitis B virus serology",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Documentation of ... hepatitis C virus serology is required",
                        "criterion": "hepatitis C virus serology",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Documentation of hepatitis B virus ... serology is required",
                        "criterion": "hepatitis B virus serology",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Documentation of ... hepatitis C virus serology is required",
                        "criterion": "hepatitis C virus serology",
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                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
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                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
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                            "requirement_type": "status",
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
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                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
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                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Stage IV (metastatic) breast cancer",
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                    {
                        "exact_snippets": "Stage IV (metastatic) breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    },
                    {
                        "exact_snippets": "Stage IV (metastatic) breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "metastatic",
                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Stage IV (metastatic) breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    },
                    {
                        "exact_snippets": "Stage IV (metastatic) breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "metastatic",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery",
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                    {
                        "exact_snippets": "clinically evident gross residual or recurrent disease",
                        "criterion": "gross residual or recurrent disease",
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                            "requirement_type": "presence",
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                        }
                    },
                    {
                        "exact_snippets": "following preoperative therapy and surgery",
                        "criterion": "preoperative therapy and surgery",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    }
                ]
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                "and_criteria": [
                    {
                        "exact_snippets": "clinically evident gross residual or recurrent disease",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
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                    {
                        "exact_snippets": "following preoperative therapy and surgery",
                        "criterion": "preoperative therapy and surgery",
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                            "requirement_type": "completion",
                            "expected_value": true
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                    }
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            }
        },
        {
            "identified_line": {
                "line": "* Progressive disease during preoperative systemic therapy",
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                    {
                        "exact_snippets": "Progressive disease during preoperative systemic therapy",
                        "criterion": "progressive disease",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "during preoperative systemic therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Progressive disease during preoperative systemic therapy",
                    "criterion": "progressive disease",
                    "requirement": {
                        "requirement_type": "timing",
                        "expected_value": "during preoperative systemic therapy"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment",
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                    {
                        "exact_snippets": "Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment",
                        "criterion": "anti-cancer investigational drug treatment",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment",
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                    "requirement": {
                        "requirement_type": "time since last treatment",
                        "expected_value": {
                            "operator": "<",
                            "value": 28,
                            "unit": "days"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned above",
                "criterions": [
                    {
                        "exact_snippets": "History of other malignancy within the last 5 years",
                        "criterion": "history of other malignancy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "except for appropriately treated carcinoma in situ of the cervix",
                        "criterion": "appropriately treated carcinoma in situ of the cervix",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
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                    },
                    {
                        "exact_snippets": "except for ... non-melanoma skin carcinoma",
                        "criterion": "non-melanoma skin carcinoma",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except for ... Stage I uterine cancer",
                        "criterion": "Stage I uterine cancer",
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                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except for ... other non-breast malignancies with a similar outcome to those mentioned above",
                        "criterion": "other non-breast malignancies with a similar outcome",
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                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "History of other malignancy within the last 5 years",
                    "criterion": "history of other malignancy",
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                        "requirement_type": "time frame",
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                            "operator": "<=",
                            "value": 5,
                            "unit": "years"
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                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "not_criteria": {
                                "exact_snippets": "except for appropriately treated carcinoma in situ of the cervix",
                                "criterion": "appropriately treated carcinoma in situ of the cervix",
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                                    "expected_value": true
                                }
                            }
                        },
                        {
                            "not_criteria": {
                                "exact_snippets": "except for ... non-melanoma skin carcinoma",
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                                }
                            }
                        },
                        {
                            "not_criteria": {
                                "exact_snippets": "except for ... Stage I uterine cancer",
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                                    "requirement_type": "exclusion",
                                    "expected_value": true
                                }
                            }
                        },
                        {
                            "not_criteria": {
                                "exact_snippets": "except for ... other non-breast malignancies with a similar outcome to those mentioned above",
                                "criterion": "other non-breast malignancies with a similar outcome",
                                "requirement": {
                                    "requirement_type": "exclusion",
                                    "expected_value": true
                                }
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons",
                "criterions": [
                    {
                        "exact_snippets": "radiotherapy would be recommended for breast cancer treatment",
                        "criterion": "radiotherapy recommendation",
                        "requirement": {
                            "requirement_type": "indication",
                            "expected_value": "breast cancer treatment"
                        }
                    },
                    {
                        "exact_snippets": "radiotherapy ... is contraindicated because of medical reasons",
                        "criterion": "radiotherapy contraindication",
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                            "requirement_type": "reason",
                            "expected_value": "medical reasons"
                        }
                    }
                ]
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                        {
                            "exact_snippets": "radiotherapy would be recommended for breast cancer treatment",
                            "criterion": "radiotherapy recommendation",
                            "requirement": {
                                "requirement_type": "indication",
                                "expected_value": "breast cancer treatment"
                            }
                        },
                        {
                            "exact_snippets": "radiotherapy ... is contraindicated because of medical reasons",
                            "criterion": "radiotherapy contraindication",
                            "requirement": {
                                "requirement_type": "reason",
                                "expected_value": "medical reasons"
                            }
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy",
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                    {
                        "exact_snippets": "Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "NCI CTCAE Grade"
                            }
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                ]
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                        "exact_snippets": "Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy",
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                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "NCI CTCAE Grade"
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 240 mg/m2; Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) > 480 mg/m2; For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2",
                "criterions": [
                    {
                        "exact_snippets": "History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 240 mg/m2",
                        "criterion": "doxorubicin exposure",
                        "requirement": {
                            "requirement_type": "cumulative dose",
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                                "operator": ">",
                                "value": 240,
                                "unit": "mg/m2"
                            }
                        }
                    },
                    {
                        "exact_snippets": "History of exposure to the following cumulative doses of anthracyclines: ... Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) > 480 mg/m2",
                        "criterion": "epirubicin or liposomal doxorubicin-hydrochloride exposure",
                        "requirement": {
                            "requirement_type": "cumulative dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 480,
                                "unit": "mg/m2"
                            }
                        }
                    },
                    {
                        "exact_snippets": "History of exposure to the following cumulative doses of anthracyclines: ... For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2",
                        "criterion": "other anthracyclines exposure equivalent to doxorubicin",
                        "requirement": {
                            "requirement_type": "cumulative dose equivalent",
                            "expected_value": {
                                "operator": ">",
                                "value": 240,
                                "unit": "mg/m2"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 240 mg/m2",
                        "criterion": "doxorubicin exposure",
                        "requirement": {
                            "requirement_type": "cumulative dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 240,
                                "unit": "mg/m2"
                            }
                        }
                    },
                    {
                        "exact_snippets": "History of exposure to the following cumulative doses of anthracyclines: ... Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) > 480 mg/m2",
                        "criterion": "epirubicin or liposomal doxorubicin-hydrochloride exposure",
                        "requirement": {
                            "requirement_type": "cumulative dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 480,
                                "unit": "mg/m2"
                            }
                        }
                    },
                    {
                        "exact_snippets": "History of exposure to the following cumulative doses of anthracyclines: ... For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2",
                        "criterion": "other anthracyclines exposure equivalent to doxorubicin",
                        "requirement": {
                            "requirement_type": "cumulative dose equivalent",
                            "expected_value": {
                                "operator": ">",
                                "value": 240,
                                "unit": "mg/m2"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Cardiopulmonary dysfunction as defined by protocol",
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                    {
                        "exact_snippets": "Cardiopulmonary dysfunction",
                        "criterion": "cardiopulmonary dysfunction",
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                            "requirement_type": "definition",
                            "expected_value": "as defined by protocol"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Cardiopulmonary dysfunction",
                    "criterion": "cardiopulmonary dysfunction",
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                        "requirement_type": "definition",
                        "expected_value": "as defined by protocol"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Prior treatment with trastuzumab emtansine",
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                    {
                        "exact_snippets": "Prior treatment with trastuzumab emtansine",
                        "criterion": "trastuzumab emtansine treatment",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Prior treatment with trastuzumab emtansine",
                    "criterion": "trastuzumab emtansine treatment",
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                        "requirement_type": "prior treatment",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Current severe, uncontrolled systemic disease",
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                    {
                        "exact_snippets": "Current severe, uncontrolled systemic disease",
                        "criterion": "systemic disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Current severe, uncontrolled systemic disease",
                        "criterion": "systemic disease",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Current severe, uncontrolled systemic disease",
                        "criterion": "systemic disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Current severe, uncontrolled systemic disease",
                        "criterion": "systemic disease",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pregnant or lactating women",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating women",
                        "criterion": "lactation status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating women",
                        "criterion": "lactation status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis",
                "criterions": [
                    {
                        "exact_snippets": "Any known active liver disease",
                        "criterion": "active liver disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HBV",
                        "criterion": "HBV",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HCV",
                        "criterion": "HCV",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "autoimmune hepatic disorders",
                        "criterion": "autoimmune hepatic disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "sclerosing cholangitis",
                        "criterion": "sclerosing cholangitis",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any known active liver disease",
                                "criterion": "active liver disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "HBV",
                                        "criterion": "HBV",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "HCV",
                                        "criterion": "HCV",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "autoimmune hepatic disorders",
                                        "criterion": "autoimmune hepatic disorders",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "sclerosing cholangitis",
                                        "criterion": "sclerosing cholangitis",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Concurrent serious uncontrolled infections requiring treatment or known infection with HIV",
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                    {
                        "exact_snippets": "Concurrent serious uncontrolled infections requiring treatment",
                        "criterion": "serious uncontrolled infections",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known infection with HIV",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Concurrent serious uncontrolled infections requiring treatment",
                                "criterion": "serious uncontrolled infections",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "known infection with HIV",
                        "criterion": "HIV infection",
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