{
    "info": {
        "nct_id": "NCT02154776",
        "official_title": "A Phase 1 Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole for the Treatment of HR+, HER2-negative Post-menopausal Women With Locally Advanced or Metastatic Breast Cancer.",
        "inclusion_criteria": "1. Women with advanced (recurrent or metastatic) breast cancer who received no prior therapy for advanced disease.\n2. Patient is postmenopausal.\n3. Patient may have received ≤ 2 lines of chemotherapy for metastatic or recurrent breast cancer in the dose-escalation phase.\n4. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.\n5. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.\n6. Patient must have either:\n\n   * Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria or at least one predominantly lytic bone lesion\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patient who received any CDK4/6 or PI3K inhibitor.\n2. Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:\n\n   * History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry\n   * History of documented congestive heart failure (New York Heart Association functional classification III-IV)\n   * Documented cardiomyopathy\n   * Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)\n   * History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months.\n   * On screening, any of the following cardiac parameters: bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval >109 msec, or QTcF >450 msec.\n\n   Systolic blood pressure >160 or <90 mmHg\n3. Patient is currently receiving any of the following medications:\n\n   * That are known strong inducers or inhibitors of CYP3A4.\n   * That have a known risk to prolong the QT interval or induce Torsades de Pointes.\n   * That have a narrow therapeutic window and are predominantly metabolized through CYP3A4.\n4. Certain scores on an anxiety and depression mood questionnaires",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Women with advanced (recurrent or metastatic) breast cancer who received no prior therapy for advanced disease.",
                "criterions": [
                    {
                        "exact_snippets": "Women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "advanced (recurrent or metastatic) breast cancer",
                        "criterion": "breast cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "recurrent",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "no prior therapy for advanced disease",
                        "criterion": "prior therapy for advanced disease",
                        "requirement": {
                            "requirement_type": "history of treatment",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "advanced (recurrent or metastatic) breast cancer",
                        "criterion": "breast cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "recurrent",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "no prior therapy for advanced disease",
                        "criterion": "prior therapy for advanced disease",
                        "requirement": {
                            "requirement_type": "history of treatment",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Patient is postmenopausal.",
                "criterions": [
                    {
                        "exact_snippets": "Patient is postmenopausal",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patient is postmenopausal",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Patient may have received ≤ 2 lines of chemotherapy for metastatic or recurrent breast cancer in the dose-escalation phase.",
                "criterions": [
                    {
                        "exact_snippets": "≤ 2 lines of chemotherapy for metastatic or recurrent breast cancer",
                        "criterion": "lines of chemotherapy",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "≤ 2 lines of chemotherapy for metastatic or recurrent breast cancer",
                        "criterion": "lines of chemotherapy",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Patient must have either:",
                "criterions": [
                    {
                        "exact_snippets": "Patient must have either",
                        "criterion": "condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patient must have either",
                        "criterion": "condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria or at least one predominantly lytic bone lesion",
                "criterions": [
                    {
                        "exact_snippets": "Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST 1.1"
                        }
                    },
                    {
                        "exact_snippets": "at least one predominantly lytic bone lesion",
                        "criterion": "predominantly lytic bone lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria",
                                "criterion": "measurable lesion",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "lesion"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria",
                                "criterion": "measurable lesion",
                                "requirement": {
                                    "requirement_type": "measurement standard",
                                    "expected_value": "RECIST 1.1"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "at least one predominantly lytic bone lesion",
                        "criterion": "predominantly lytic bone lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "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",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Patient who received any CDK4/6 or PI3K inhibitor.",
                "criterions": [
                    {
                        "exact_snippets": "Patient who received any CDK4/6 or PI3K inhibitor.",
                        "criterion": "CDK4/6 inhibitor",
                        "requirement": {
                            "requirement_type": "received",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patient who received any CDK4/6 or PI3K inhibitor.",
                        "criterion": "PI3K inhibitor",
                        "requirement": {
                            "requirement_type": "received",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Patient who received any CDK4/6 or PI3K inhibitor.",
                        "criterion": "CDK4/6 inhibitor",
                        "requirement": {
                            "requirement_type": "received",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patient who received any CDK4/6 or PI3K inhibitor.",
                        "criterion": "PI3K inhibitor",
                        "requirement": {
                            "requirement_type": "received",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:",
                "criterions": [
                    {
                        "exact_snippets": "Patient has active cardiac disease",
                        "criterion": "active cardiac disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of cardiac dysfunction",
                        "criterion": "history of cardiac dysfunction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Patient has active cardiac disease",
                        "criterion": "active cardiac disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of cardiac dysfunction",
                        "criterion": "history of cardiac dysfunction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry",
                "criterions": [
                    {
                        "exact_snippets": "History of angina pectoris",
                        "criterion": "angina pectoris",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... symptomatic pericarditis",
                        "criterion": "symptomatic pericarditis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... myocardial infarction within 12 months prior to study entry",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... myocardial infarction within 12 months prior to study entry",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of angina pectoris",
                                "criterion": "angina pectoris",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of ... symptomatic pericarditis",
                                "criterion": "symptomatic pericarditis",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of ... myocardial infarction within 12 months prior to study entry",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of ... myocardial infarction within 12 months prior to study entry",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of documented congestive heart failure (New York Heart Association functional classification III-IV)",
                "criterions": [
                    {
                        "exact_snippets": "History of documented congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "New York Heart Association functional classification III-IV",
                        "criterion": "New York Heart Association functional classification",
                        "requirement": {
                            "requirement_type": "classification",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "History of documented congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "New York Heart Association functional classification III-IV",
                        "criterion": "New York Heart Association functional classification",
                        "requirement": {
                            "requirement_type": "classification",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Documented cardiomyopathy",
                "criterions": [
                    {
                        "exact_snippets": "Documented cardiomyopathy",
                        "criterion": "cardiomyopathy",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Documented cardiomyopathy",
                    "criterion": "cardiomyopathy",
                    "requirement": {
                        "requirement_type": "documentation",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months.",
                "criterions": [
                    {
                        "exact_snippets": "History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality",
                        "criterion": "cardiac arrhythmias",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of any ... conduction abnormality",
                        "criterion": "conduction abnormality",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "in the previous 12 months",
                        "criterion": "time frame for cardiac conditions",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality",
                                        "criterion": "cardiac arrhythmias",
                                        "requirement": {
                                            "requirement_type": "history",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "History of any ... conduction abnormality",
                                        "criterion": "conduction abnormality",
                                        "requirement": {
                                            "requirement_type": "history",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "in the previous 12 months",
                                "criterion": "time frame for cardiac conditions",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* On screening, any of the following cardiac parameters: bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval >109 msec, or QTcF >450 msec.",
                "criterions": [
                    {
                        "exact_snippets": "bradycardia (heart rate < 50 at rest)",
                        "criterion": "bradycardia",
                        "requirement": {
                            "requirement_type": "heart rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "bpm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "tachycardia (heart rate > 90 at rest)",
                        "criterion": "tachycardia",
                        "requirement": {
                            "requirement_type": "heart rate",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "bpm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "PR interval > 220 msec",
                        "criterion": "PR interval",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 220,
                                "unit": "msec"
                            }
                        }
                    },
                    {
                        "exact_snippets": "QRS interval >109 msec",
                        "criterion": "QRS interval",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 109,
                                "unit": "msec"
                            }
                        }
                    },
                    {
                        "exact_snippets": "QTcF >450 msec",
                        "criterion": "QTcF",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "msec"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "bradycardia (heart rate < 50 at rest)",
                        "criterion": "bradycardia",
                        "requirement": {
                            "requirement_type": "heart rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "bpm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "tachycardia (heart rate > 90 at rest)",
                        "criterion": "tachycardia",
                        "requirement": {
                            "requirement_type": "heart rate",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "bpm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "PR interval > 220 msec",
                        "criterion": "PR interval",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 220,
                                "unit": "msec"
                            }
                        }
                    },
                    {
                        "exact_snippets": "QRS interval >109 msec",
                        "criterion": "QRS interval",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 109,
                                "unit": "msec"
                            }
                        }
                    },
                    {
                        "exact_snippets": "QTcF >450 msec",
                        "criterion": "QTcF",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "msec"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Systolic blood pressure >160 or <90 mmHg",
                "criterions": [
                    {
                        "exact_snippets": "Systolic blood pressure >160",
                        "criterion": "systolic blood pressure",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 160,
                                "unit": "mmHg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Systolic blood pressure ... <90 mmHg",
                        "criterion": "systolic blood pressure",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Systolic blood pressure >160",
                        "criterion": "systolic blood pressure",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 160,
                                "unit": "mmHg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Systolic blood pressure ... <90 mmHg",
                        "criterion": "systolic blood pressure",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Patient is currently receiving any of the following medications:",
                "criterions": [
                    {
                        "exact_snippets": "currently receiving any of the following medications",
                        "criterion": "medication",
                        "requirement": {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "currently receiving any of the following medications",
                        "criterion": "medication",
                        "requirement": {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* That are known strong inducers or inhibitors of CYP3A4.",
                "criterions": [
                    {
                        "exact_snippets": "known strong inducers or inhibitors of CYP3A4",
                        "criterion": "CYP3A4 interaction",
                        "requirement": {
                            "requirement_type": "interaction type",
                            "expected_value": [
                                "strong inducer",
                                "strong inhibitor"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "known strong inducers or inhibitors of CYP3A4",
                    "criterion": "CYP3A4 interaction",
                    "requirement": {
                        "requirement_type": "interaction type",
                        "expected_value": [
                            "strong inducer",
                            "strong inhibitor"
                        ]
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* That have a known risk to prolong the QT interval or induce Torsades de Pointes.",
                "criterions": [
                    {
                        "exact_snippets": "known risk to prolong the QT interval",
                        "criterion": "risk to prolong QT interval",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known risk to ... induce Torsades de Pointes",
                        "criterion": "risk to induce Torsades de Pointes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "known risk to prolong the QT interval",
                        "criterion": "risk to prolong QT interval",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known risk to ... induce Torsades de Pointes",
                        "criterion": "risk to induce Torsades de Pointes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* That have a narrow therapeutic window and are predominantly metabolized through CYP3A4.",
                "criterions": [
                    {
                        "exact_snippets": "narrow therapeutic window",
                        "criterion": "therapeutic window",
                        "requirement": {
                            "requirement_type": "width",
                            "expected_value": "narrow"
                        }
                    },
                    {
                        "exact_snippets": "predominantly metabolized through CYP3A4",
                        "criterion": "CYP3A4 metabolism",
                        "requirement": {
                            "requirement_type": "predominance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "narrow therapeutic window",
                        "criterion": "therapeutic window",
                        "requirement": {
                            "requirement_type": "width",
                            "expected_value": "narrow"
                        }
                    },
                    {
                        "exact_snippets": "predominantly metabolized through CYP3A4",
                        "criterion": "CYP3A4 metabolism",
                        "requirement": {
                            "requirement_type": "predominance",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "4. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.",
                "criterions": [
                    {
                        "exact_snippets": "histologically and/or cytologically confirmed diagnosis",
                        "criterion": "breast cancer diagnosis confirmation",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "estrogen-receptor positive",
                        "criterion": "estrogen-receptor status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "progesterone receptor positive",
                        "criterion": "progesterone receptor status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "histologically and/or cytologically confirmed diagnosis",
                                        "criterion": "breast cancer diagnosis confirmation",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": "histologically"
                                        }
                                    },
                                    {
                                        "exact_snippets": "histologically and/or cytologically confirmed diagnosis",
                                        "criterion": "breast cancer diagnosis confirmation",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": "cytologically"
                                        }
                                    }
                                ]
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "estrogen-receptor positive",
                                        "criterion": "estrogen-receptor status",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "positive"
                                        }
                                    },
                                    {
                                        "exact_snippets": "progesterone receptor positive",
                                        "criterion": "progesterone receptor status",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "positive"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.",
                "criterions": [
                    {
                        "exact_snippets": "HER2-negative breast cancer",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "negative in situ hybridization test",
                        "criterion": "in situ hybridization test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "IHC status of 0, 1+ or 2+",
                        "criterion": "IHC status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1+",
                                "2+"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required",
                        "criterion": "IHC status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "2+"
                        }
                    },
                    {
                        "exact_snippets": "If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required",
                        "criterion": "in situ hybridization test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "IHC status of 0, 1+ or 2+",
                                        "criterion": "IHC status",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "0"
                                        }
                                    },
                                    {
                                        "exact_snippets": "negative in situ hybridization test",
                                        "criterion": "in situ hybridization test",
                                        "requirement": {
                                            "requirement_type": "result",
                                            "expected_value": "negative"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "IHC status of 0, 1+ or 2+",
                                        "criterion": "IHC status",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "1+"
                                        }
                                    },
                                    {
                                        "exact_snippets": "negative in situ hybridization test",
                                        "criterion": "in situ hybridization test",
                                        "requirement": {
                                            "requirement_type": "result",
                                            "expected_value": "negative"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "IHC status of 0, 1+ or 2+",
                                        "criterion": "IHC status",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "2+"
                                        }
                                    },
                                    {
                                        "exact_snippets": "If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required",
                                        "criterion": "in situ hybridization test",
                                        "requirement": {
                                            "requirement_type": "result",
                                            "expected_value": "negative"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "HER2-negative breast cancer",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)",
                "criterions": [
                    {
                        "exact_snippets": "Left Ventricular Ejection Fraction (LVEF) < 50%",
                        "criterion": "Left Ventricular Ejection Fraction (LVEF)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)",
                        "criterion": "method of determination for LVEF",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "Multiple Gated acquisition (MUGA) scan",
                                "echocardiogram (ECHO)"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Left Ventricular Ejection Fraction (LVEF) < 50%",
                                "criterion": "Left Ventricular Ejection Fraction (LVEF)",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 50,
                                        "unit": "%"
                                    }
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)",
                                        "criterion": "method of determination for LVEF",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": "Multiple Gated acquisition (MUGA) scan"
                                        }
                                    },
                                    {
                                        "exact_snippets": "as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)",
                                        "criterion": "method of determination for LVEF",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": "echocardiogram (ECHO)"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Certain scores on an anxiety and depression mood questionnaires",
                "criterions": [
                    {
                        "exact_snippets": "scores on an anxiety ... questionnaires",
                        "criterion": "anxiety score",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "scores on ... depression mood questionnaires",
                        "criterion": "depression mood score",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}