{
    "info": {
        "nct_id": "NCT01344031",
        "official_title": "A Phase 1 Trial of MK-2206 in Combination With Anastrozole, Fulvestrant, or Anastrozole Plus Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive Metastatic Breast Cancer",
        "inclusion_criteria": "* Patients must have histologically or cytologically confirmed invasive breast cancer that is metastatic stage IV or recurrent metastatic (histologic/cytologic confirmation of recurrence preferred, but not required)\n* Either the primary or the metastatic tumor must be positive for estrogen-receptor (> 1% tumor cell staining by immunohistochemistry or an Allred score of >= 3 by immunohistochemistry)\n* Patient must have measurable or non-measurable lesions (defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria)\n\n  * Note: to be eligible for the FDG PET imaging studies in Phase IA, the presence of measurable lesions of at least 1.5 cm or the presence of bone lesions is required\n* Patients may have undergone any number of prior lines of chemotherapy or endocrine regimens but must not have a history of disease progression on anastrozole (Phase IA and Phase IB), fulvestrant (Arm C), or both anastrozole and fulvestrant (Arm D)\n\n  * Phase IA and IB:\n\n    * Currently being treated with anastrozole with no evidence of disease progression OR\n    * Currently being treated with letrozole or exemestane with no evidence of disease progression and willing to switch to anastrozole for study enrollment OR\n    * Considering switching to anastrozole due to disease progression from the most recent anti-cancer therapy\n  * Arm C:\n\n    * Currently being treated with fulvestrant with no evidence of disease progression OR\n    * Considering switching to fulvestrant due to disease progression from the most recent anti-cancer therapy\n  * Arm D:\n\n    * Currently being treated with either anastrozole or fulvestrant with no evidence of disease progression OR\n    * Currently being treated with letrozole or exemestane with no evidence of disease progression and willing to switch to anastrozole for study enrollment\n    * Considering switching to anastrozole or fulvestrant due to disease progression from the most recent anti-cancer therapy\n* Patients must be postmenopausal women as defined by one of the following:\n\n  * Women > 60 years\n  * Women =< 60 years with spontaneous cessation of menses > 12 months prior to registration\n  * Women =< 60 years with cessation of menses of duration < 12 months or secondary to hysterectomy AND an follicle stimulating hormone (FSH) level in the postmenopausal range according to institutional standards (or > 34.4 IU/L if institutional range is not available) prior to registration\n  * Women =< 60 years on hormonal replacement therapy who have discontinued hormonal therapy AND an FSH level in the postmenopausal range according to institutional standards (or > 34.4 IU/L if institutional range is not available) prior to registration\n  * Status post bilateral surgical oophorectomy\n  * Premenopausal women on a gonadotropin-releasing hormone (GnRH) analog\n* Patients must have a life expectancy greater than 4 months\n* Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)\n* Leukocytes >= 3,000/mcL\n* Absolute neutrophil count (ANC) >= 1,500/mcL\n* Platelet count >= 100,000/mcL\n* Total bilirubin not above the institutional upper limit of normal\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal\n* Creatinine not above the institutional upper limit of normal OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal\n* If patients have diabetes mellitus, fasting glucose must be =< 120 mg/dL and hemoglobin (Hb)A1c =< 8%\n* Women of childbearing potential must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she is participating in this study, the patient should inform the treating physician immediately\n* Patients with known brain metastases are eligible if stable (no evidence of local progression) >= 3 months after local therapy and are off steroid\n* Patients who are eligible for this study may also be eligible for and participate in National Cancer Institute (NCI) Protocol 9167, titled \"Positron Emission Tomography (PET) with 18F-Fluoroestradiol (FES) as a Predictor of Response in Patients with Breast Cancer Scheduled to Be Treated with MK-2206 in Combination with Either an Aromatase Inhibitor or Fulvestrant on NCI Protocol 8762,\" in which case the FES-PET in Protocol 9167 has to be performed a minimum of 48 hours and a maximum of 30 days before the first dose of MK-2206; in addition, all FES-related side effects must have resolved before the first dose of MK-2206\n* Patients must have the ability to understand and the willingness to sign a written informed consent document\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients may not have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study; patient must have recovered from adverse events due to agents administered more than 4 weeks earlier\n* Patients may not be receiving any other investigational agents\n* Patients may not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 or other agents used in the study\n* Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP 450 3A4) are ineligible\n\n  * Note: one week washout period is required in patients who were previously taking strong inhibitors or inducers of CYP450 3A4; patients who are currently taking moderate inhibitors or inducers of CYP450 3A4 are encouraged to switch to other medications that do not interact with CYP450 3A4\n* Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled on oral agents before the patient enters the trial (i.e. HbA1c =< 8% and fasting glucose =< 120 mg/dL)\n* Cardiovascular: baseline QT Fridericia formula (QTcF) > 450 msec (male) or QTcF > 470 msec (female) will exclude patients from entry on study\n* Patients may not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Pregnant or nursing patients are excluded from the study\n* Patients with known human immunodeficiency virus (HIV) positive status are excluded from this study\n* Patients may not have had disease progression on anastrozole (Phase IA and Phase IB), fulvestrant (Arm C), both anastrozole and fulvestrant (Arm D) in either the neoadjuvant, adjuvant (defined as disease recurrence identified within 6 months of adjuvant discontinuation), or metastatic setting\n* Patients may not have had grade 3 or intolerable grade 2 adverse events during run-in aromatase inhibitor (AI) or fulvestrant therapy prior to starting MK-2206\n* Patients may not have had prior therapy with an AKT inhibitor",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients must have histologically or cytologically confirmed invasive breast cancer that is metastatic stage IV or recurrent metastatic (histologic/cytologic confirmation of recurrence preferred, but not required)",
                "criterions": [
                    {
                        "exact_snippets": "histologically or cytologically confirmed invasive breast cancer",
                        "criterion": "invasive breast cancer",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "metastatic stage IV",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "metastatic stage IV"
                        }
                    },
                    {
                        "exact_snippets": "recurrent metastatic",
                        "criterion": "cancer recurrence",
                        "requirement": {
                            "requirement_type": "recurrence",
                            "expected_value": "recurrent metastatic"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "histologically or cytologically confirmed invasive breast cancer",
                                        "criterion": "invasive breast cancer",
                                        "requirement": {
                                            "requirement_type": "confirmation",
                                            "expected_value": [
                                                "histologically",
                                                "cytologically"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "metastatic stage IV",
                                        "criterion": "cancer stage",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": "metastatic stage IV"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "recurrent metastatic",
                                "criterion": "cancer recurrence",
                                "requirement": {
                                    "requirement_type": "recurrence",
                                    "expected_value": "recurrent metastatic"
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "histologically or cytologically confirmed invasive breast cancer",
                                "criterion": "invasive breast cancer",
                                "requirement": {
                                    "requirement_type": "confirmation",
                                    "expected_value": [
                                        "histologically",
                                        "cytologically"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "recurrent metastatic",
                                "criterion": "cancer recurrence",
                                "requirement": {
                                    "requirement_type": "recurrence",
                                    "expected_value": "recurrent metastatic"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Either the primary or the metastatic tumor must be positive for estrogen-receptor (> 1% tumor cell staining by immunohistochemistry or an Allred score of >= 3 by immunohistochemistry)",
                "criterions": [
                    {
                        "exact_snippets": "primary or the metastatic tumor must be positive for estrogen-receptor",
                        "criterion": "estrogen-receptor status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "estrogen-receptor (> 1% tumor cell staining by immunohistochemistry",
                        "criterion": "estrogen-receptor status",
                        "requirement": {
                            "requirement_type": "tumor cell staining",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "estrogen-receptor (> 1% tumor cell staining by immunohistochemistry",
                        "criterion": "estrogen-receptor status",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "immunohistochemistry"
                        }
                    },
                    {
                        "exact_snippets": "estrogen-receptor ... an Allred score of >= 3 by immunohistochemistry",
                        "criterion": "estrogen-receptor status",
                        "requirement": {
                            "requirement_type": "Allred score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "estrogen-receptor ... an Allred score of >= 3 by immunohistochemistry",
                        "criterion": "estrogen-receptor status",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "immunohistochemistry"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "primary or the metastatic tumor must be positive for estrogen-receptor",
                                                "criterion": "estrogen-receptor status",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "estrogen-receptor (> 1% tumor cell staining by immunohistochemistry",
                                                "criterion": "estrogen-receptor status",
                                                "requirement": {
                                                    "requirement_type": "tumor cell staining",
                                                    "expected_value": {
                                                        "operator": ">",
                                                        "value": 1,
                                                        "unit": "%"
                                                    }
                                                }
                                            },
                                            {
                                                "exact_snippets": "estrogen-receptor (> 1% tumor cell staining by immunohistochemistry",
                                                "criterion": "estrogen-receptor status",
                                                "requirement": {
                                                    "requirement_type": "method",
                                                    "expected_value": "immunohistochemistry"
                                                }
                                            }
                                        ]
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "estrogen-receptor ... an Allred score of >= 3 by immunohistochemistry",
                                        "criterion": "estrogen-receptor status",
                                        "requirement": {
                                            "requirement_type": "Allred score",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 3,
                                                "unit": "N/A"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "estrogen-receptor ... an Allred score of >= 3 by immunohistochemistry",
                                        "criterion": "estrogen-receptor status",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": "immunohistochemistry"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Note: to be eligible for the FDG PET imaging studies in Phase IA, the presence of measurable lesions of at least 1.5 cm or the presence of bone lesions is required",
                "criterions": [
                    {
                        "exact_snippets": "presence of measurable lesions of at least 1.5 cm",
                        "criterion": "measurable lesions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "presence of measurable lesions of at least 1.5 cm",
                        "criterion": "measurable lesions",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "presence of bone lesions",
                        "criterion": "bone lesions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "presence of measurable lesions of at least 1.5 cm",
                                "criterion": "measurable lesions",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "presence of measurable lesions of at least 1.5 cm",
                                "criterion": "measurable lesions",
                                "requirement": {
                                    "requirement_type": "size",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1.5,
                                        "unit": "cm"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "presence of bone lesions",
                        "criterion": "bone lesions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients may have undergone any number of prior lines of chemotherapy or endocrine regimens but must not have a history of disease progression on anastrozole (Phase IA and Phase IB), fulvestrant (Arm C), or both anastrozole and fulvestrant (Arm D)",
                "criterions": [
                    {
                        "exact_snippets": "Patients may have undergone any number of prior lines of chemotherapy or endocrine regimens",
                        "criterion": "prior lines of chemotherapy or endocrine regimens",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": "any number"
                        }
                    },
                    {
                        "exact_snippets": "must not have a history of disease progression on anastrozole (Phase IA and Phase IB)",
                        "criterion": "history of disease progression on anastrozole",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "must not have a history of disease progression on ... fulvestrant (Arm C)",
                        "criterion": "history of disease progression on fulvestrant",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "must not have a history of disease progression on ... both anastrozole and fulvestrant (Arm D)",
                        "criterion": "history of disease progression on both anastrozole and fulvestrant",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Patients may have undergone any number of prior lines of chemotherapy or endocrine regimens",
                                                "criterion": "prior lines of chemotherapy or endocrine regimens",
                                                "requirement": {
                                                    "requirement_type": "quantity",
                                                    "expected_value": "any number"
                                                }
                                            },
                                            {
                                                "exact_snippets": "must not have a history of disease progression on anastrozole (Phase IA and Phase IB)",
                                                "criterion": "history of disease progression on anastrozole",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "must not have a history of disease progression on ... fulvestrant (Arm C)",
                                        "criterion": "history of disease progression on fulvestrant",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "must not have a history of disease progression on ... both anastrozole and fulvestrant (Arm D)",
                                "criterion": "history of disease progression on both anastrozole and fulvestrant",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Currently being treated with anastrozole with no evidence of disease progression OR",
                "criterions": [
                    {
                        "exact_snippets": "Currently being treated with anastrozole",
                        "criterion": "treatment with anastrozole",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "no evidence of disease progression",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Currently being treated with anastrozole",
                                "criterion": "treatment with anastrozole",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "no evidence of disease progression",
                                "criterion": "disease progression",
                                "requirement": {
                                    "requirement_type": "evidence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Currently being treated with letrozole or exemestane with no evidence of disease progression and willing to switch to anastrozole for study enrollment OR",
                "criterions": [
                    {
                        "exact_snippets": "Currently being treated with letrozole or exemestane",
                        "criterion": "current treatment",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": [
                                "letrozole",
                                "exemestane"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "no evidence of disease progression",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "willing to switch to anastrozole for study enrollment",
                        "criterion": "willingness to switch medication",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": "anastrozole"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Currently being treated with letrozole or exemestane",
                                "criterion": "current treatment",
                                "requirement": {
                                    "requirement_type": "medication",
                                    "expected_value": [
                                        "letrozole",
                                        "exemestane"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "no evidence of disease progression",
                                "criterion": "disease progression",
                                "requirement": {
                                    "requirement_type": "evidence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "willing to switch to anastrozole for study enrollment",
                                "criterion": "willingness to switch medication",
                                "requirement": {
                                    "requirement_type": "medication",
                                    "expected_value": "anastrozole"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Considering switching to anastrozole due to disease progression from the most recent anti-cancer therapy",
                "criterions": [
                    {
                        "exact_snippets": "disease progression from the most recent anti-cancer therapy",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "disease progression from the most recent anti-cancer therapy",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Currently being treated with fulvestrant with no evidence of disease progression OR",
                "criterions": [
                    {
                        "exact_snippets": "Currently being treated with fulvestrant",
                        "criterion": "fulvestrant treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "no evidence of disease progression",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Currently being treated with fulvestrant",
                                "criterion": "fulvestrant treatment",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "no evidence of disease progression",
                                "criterion": "disease progression",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Considering switching to fulvestrant due to disease progression from the most recent anti-cancer therapy",
                "criterions": [
                    {
                        "exact_snippets": "disease progression from the most recent anti-cancer therapy",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "switching to fulvestrant",
                        "criterion": "fulvestrant treatment",
                        "requirement": {
                            "requirement_type": "consideration",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "disease progression from the most recent anti-cancer therapy",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "switching to fulvestrant",
                        "criterion": "fulvestrant treatment",
                        "requirement": {
                            "requirement_type": "consideration",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Currently being treated with either anastrozole or fulvestrant with no evidence of disease progression OR",
                "criterions": [
                    {
                        "exact_snippets": "Currently being treated with either anastrozole or fulvestrant",
                        "criterion": "current treatment",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": [
                                "anastrozole",
                                "fulvestrant"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "no evidence of disease progression",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Currently being treated with either anastrozole or fulvestrant",
                                "criterion": "current treatment",
                                "requirement": {
                                    "requirement_type": "medication",
                                    "expected_value": [
                                        "anastrozole",
                                        "fulvestrant"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "no evidence of disease progression",
                                "criterion": "disease progression",
                                "requirement": {
                                    "requirement_type": "evidence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Considering switching to anastrozole or fulvestrant due to disease progression from the most recent anti-cancer therapy",
                "criterions": [
                    {
                        "exact_snippets": "disease progression from the most recent anti-cancer therapy",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "switching to anastrozole or fulvestrant",
                        "criterion": "treatment switch",
                        "requirement": {
                            "requirement_type": "options",
                            "expected_value": [
                                "anastrozole",
                                "fulvestrant"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "disease progression from the most recent anti-cancer therapy",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "switching to anastrozole or fulvestrant",
                        "criterion": "treatment switch",
                        "requirement": {
                            "requirement_type": "options",
                            "expected_value": [
                                "anastrozole",
                                "fulvestrant"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must be postmenopausal women as defined by one of the following:",
                "criterions": [
                    {
                        "exact_snippets": "Patients must be postmenopausal women",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    },
                    {
                        "exact_snippets": "Patients must be ... women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients must be postmenopausal women",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    },
                    {
                        "exact_snippets": "Patients must be ... women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women > 60 years",
                "criterions": [
                    {
                        "exact_snippets": "Women > 60 years",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "Women > 60 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Women > 60 years",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "Women > 60 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women =< 60 years with spontaneous cessation of menses > 12 months prior to registration",
                "criterions": [
                    {
                        "exact_snippets": "Women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "=< 60 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "spontaneous cessation of menses > 12 months prior to registration",
                        "criterion": "menstrual status",
                        "requirement": {
                            "requirement_type": "cessation duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "=< 60 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "spontaneous cessation of menses > 12 months prior to registration",
                        "criterion": "menstrual status",
                        "requirement": {
                            "requirement_type": "cessation duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women =< 60 years on hormonal replacement therapy who have discontinued hormonal therapy AND an FSH level in the postmenopausal range according to institutional standards (or > 34.4 IU/L if institutional range is not available) prior to registration",
                "criterions": [
                    {
                        "exact_snippets": "Women =< 60 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hormonal replacement therapy",
                        "criterion": "hormonal replacement therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "discontinued hormonal therapy",
                        "criterion": "discontinuation of hormonal therapy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "discontinued"
                        }
                    },
                    {
                        "exact_snippets": "FSH level in the postmenopausal range according to institutional standards",
                        "criterion": "FSH level",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "postmenopausal range according to institutional standards"
                        }
                    },
                    {
                        "exact_snippets": "FSH level ... > 34.4 IU/L if institutional range is not available",
                        "criterion": "FSH level",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 34.4,
                                "unit": "IU/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Women =< 60 years",
                                                "criterion": "age",
                                                "requirement": {
                                                    "requirement_type": "maximum",
                                                    "expected_value": {
                                                        "operator": "<=",
                                                        "value": 60,
                                                        "unit": "years"
                                                    }
                                                }
                                            },
                                            {
                                                "exact_snippets": "hormonal replacement therapy",
                                                "criterion": "hormonal replacement therapy",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "discontinued hormonal therapy",
                                        "criterion": "discontinuation of hormonal therapy",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "discontinued"
                                        }
                                    }
                                ]
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "FSH level in the postmenopausal range according to institutional standards",
                                        "criterion": "FSH level",
                                        "requirement": {
                                            "requirement_type": "range",
                                            "expected_value": "postmenopausal range according to institutional standards"
                                        }
                                    },
                                    {
                                        "exact_snippets": "FSH level ... > 34.4 IU/L if institutional range is not available",
                                        "criterion": "FSH level",
                                        "requirement": {
                                            "requirement_type": "minimum",
                                            "expected_value": {
                                                "operator": ">",
                                                "value": 34.4,
                                                "unit": "IU/L"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Status post bilateral surgical oophorectomy",
                "criterions": [
                    {
                        "exact_snippets": "Status post bilateral surgical oophorectomy",
                        "criterion": "bilateral surgical oophorectomy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Status post bilateral surgical oophorectomy",
                        "criterion": "bilateral surgical oophorectomy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Premenopausal women on a gonadotropin-releasing hormone (GnRH) analog",
                "criterions": [
                    {
                        "exact_snippets": "Premenopausal women",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "premenopausal"
                        }
                    },
                    {
                        "exact_snippets": "on a gonadotropin-releasing hormone (GnRH) analog",
                        "criterion": "GnRH analog treatment",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Premenopausal women",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "premenopausal"
                        }
                    },
                    {
                        "exact_snippets": "on a gonadotropin-releasing hormone (GnRH) analog",
                        "criterion": "GnRH analog treatment",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must have a life expectancy greater than 4 months",
                "criterions": [
                    {
                        "exact_snippets": "life expectancy greater than 4 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "life expectancy greater than 4 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status =< 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Karnofsky >= 70%",
                        "criterion": "Karnofsky performance status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status =< 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Karnofsky >= 70%",
                        "criterion": "Karnofsky performance status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Leukocytes >= 3,000/mcL",
                "criterions": [
                    {
                        "exact_snippets": "Leukocytes >= 3,000/mcL",
                        "criterion": "leukocytes",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mcL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Leukocytes >= 3,000/mcL",
                        "criterion": "leukocytes",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mcL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count (ANC) >= 1,500/mcL",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) >= 1,500/mcL",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mcL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) >= 1,500/mcL",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mcL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count >= 100,000/mcL",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count >= 100,000/mcL",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mcL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelet count >= 100,000/mcL",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mcL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Total bilirubin not above the institutional upper limit of normal",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin not above the institutional upper limit of normal",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "institutional upper limit of normal"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Total bilirubin not above the institutional upper limit of normal",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "institutional upper limit of normal"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal",
                "criterions": [
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ... =< 2.5 x institutional upper limit of normal",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) ... =< 2.5 x institutional upper limit of normal",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ... =< 2.5 x institutional upper limit of normal",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) ... =< 2.5 x institutional upper limit of normal",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Creatinine not above the institutional upper limit of normal OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal",
                "criterions": [
                    {
                        "exact_snippets": "Creatinine not above the institutional upper limit of normal",
                        "criterion": "creatinine level",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "institutional upper limit of normal"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine clearance >= 60 mL/min/1.73 m^2",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min/1.73 m^2"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Creatinine not above the institutional upper limit of normal",
                                "criterion": "creatinine level",
                                "requirement": {
                                    "requirement_type": "comparison",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "institutional upper limit of normal"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "creatinine clearance >= 60 mL/min/1.73 m^2",
                                "criterion": "creatinine clearance",
                                "requirement": {
                                    "requirement_type": "comparison",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 60,
                                        "unit": "mL/min/1.73 m^2"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
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                                "not_criteria": {
                                    "exact_snippets": "Creatinine not above the institutional upper limit of normal",
                                    "criterion": "creatinine level",
                                    "requirement": {
                                        "requirement_type": "comparison",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 1,
                                            "unit": "institutional upper limit of normal"
                                        }
                                    }
                                }
                            },
                            {
                                "exact_snippets": "creatinine clearance >= 60 mL/min/1.73 m^2",
                                "criterion": "creatinine clearance",
                                "requirement": {
                                    "requirement_type": "comparison",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 60,
                                        "unit": "mL/min/1.73 m^2"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* If patients have diabetes mellitus, fasting glucose must be =< 120 mg/dL and hemoglobin (Hb)A1c =< 8%",
                "criterions": [
                    {
                        "exact_snippets": "patients have diabetes mellitus",
                        "criterion": "diabetes mellitus",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "fasting glucose must be =< 120 mg/dL",
                        "criterion": "fasting glucose",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hemoglobin (Hb)A1c =< 8%",
                        "criterion": "hemoglobin (Hb)A1c",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "patients have diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "fasting glucose must be =< 120 mg/dL",
                            "criterion": "fasting glucose",
                            "requirement": {
                                "requirement_type": "level",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 120,
                                    "unit": "mg/dL"
                                }
                            }
                        },
                        {
                            "exact_snippets": "hemoglobin (Hb)A1c =< 8%",
                            "criterion": "hemoglobin (Hb)A1c",
                            "requirement": {
                                "requirement_type": "level",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 8,
                                    "unit": "%"
                                }
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Women of childbearing potential must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she is participating in this study, the patient should inform the treating physician immediately",
                "criterions": [
                    {
                        "exact_snippets": "Women of childbearing potential",
                        "criterion": "childbearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must use two forms of contraception (hormonal or barrier method of birth control; abstinence)",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "forms"
                            }
                        }
                    },
                    {
                        "exact_snippets": "should a woman become pregnant or suspect she is pregnant while she is participating in this study, the patient should inform the treating physician immediately",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "notification",
                            "expected_value": "inform the treating physician immediately"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Women of childbearing potential",
                                "criterion": "childbearing potential",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "must use two forms of contraception (hormonal or barrier method of birth control; abstinence)",
                                "criterion": "contraception use",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "forms"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "condition": {
                            "exact_snippets": "should a woman become pregnant or suspect she is pregnant while she is participating in this study, the patient should inform the treating physician immediately",
                            "criterion": "pregnancy status",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        "then_criteria": {
                            "exact_snippets": "should a woman become pregnant or suspect she is pregnant while she is participating in this study, the patient should inform the treating physician immediately",
                            "criterion": "pregnancy status",
                            "requirement": {
                                "requirement_type": "notification",
                                "expected_value": "inform the treating physician immediately"
                            }
                        },
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with known brain metastases are eligible if stable (no evidence of local progression) >= 3 months after local therapy and are off steroid",
                "criterions": [
                    {
                        "exact_snippets": "known brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "stable (no evidence of local progression) >= 3 months after local therapy",
                        "criterion": "stability of brain metastases",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "stable (no evidence of local progression) >= 3 months after local therapy",
                        "criterion": "stability of brain metastases",
                        "requirement": {
                            "requirement_type": "time since local therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "off steroid",
                        "criterion": "steroid use",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "known brain metastases",
                                "criterion": "brain metastases",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "stable (no evidence of local progression) >= 3 months after local therapy",
                                        "criterion": "stability of brain metastases",
                                        "requirement": {
                                            "requirement_type": "stability",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "stable (no evidence of local progression) >= 3 months after local therapy",
                                        "criterion": "stability of brain metastases",
                                        "requirement": {
                                            "requirement_type": "time since local therapy",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 3,
                                                "unit": "months"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "off steroid",
                        "criterion": "steroid use",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients who are eligible for this study may also be eligible for and participate in National Cancer Institute (NCI) Protocol 9167, titled \"Positron Emission Tomography (PET) with 18F-Fluoroestradiol (FES) as a Predictor of Response in Patients with Breast Cancer Scheduled to Be Treated with MK-2206 in Combination with Either an Aromatase Inhibitor or Fulvestrant on NCI Protocol 8762,\" in which case the FES-PET in Protocol 9167 has to be performed a minimum of 48 hours and a maximum of 30 days before the first dose of MK-2206; in addition, all FES-related side effects must have resolved before the first dose of MK-2206",
                "criterions": [
                    {
                        "exact_snippets": "FES-PET in Protocol 9167 has to be performed a minimum of 48 hours and a maximum of 30 days before the first dose of MK-2206",
                        "criterion": "FES-PET timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 48,
                                        "unit": "hours"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "all FES-related side effects must have resolved before the first dose of MK-2206",
                        "criterion": "FES-related side effects",
                        "requirement": {
                            "requirement_type": "resolution",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "FES-PET in Protocol 9167 has to be performed a minimum of 48 hours and a maximum of 30 days before the first dose of MK-2206",
                                "criterion": "FES-PET timing",
                                "requirement": {
                                    "requirement_type": "timing",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 48,
                                                "unit": "hours"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 30,
                                                "unit": "days"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "all FES-related side effects must have resolved before the first dose of MK-2206",
                                "criterion": "FES-related side effects",
                                "requirement": {
                                    "requirement_type": "resolution",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must have the ability to understand and the willingness to sign a written informed consent document",
                "criterions": [
                    {
                        "exact_snippets": "ability to understand",
                        "criterion": "cognitive ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent document",
                        "criterion": "willingness to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ability to understand",
                        "criterion": "cognitive ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent document",
                        "criterion": "willingness to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "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": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "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"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Phase IA and IB:",
                "criterions": [
                    {
                        "exact_snippets": "Phase IA",
                        "criterion": "trial phase",
                        "requirement": {
                            "requirement_type": "phase",
                            "expected_value": "IA"
                        }
                    },
                    {
                        "exact_snippets": "Phase IB",
                        "criterion": "trial phase",
                        "requirement": {
                            "requirement_type": "phase",
                            "expected_value": "IB"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Phase IA",
                        "criterion": "trial phase",
                        "requirement": {
                            "requirement_type": "phase",
                            "expected_value": "IA"
                        }
                    },
                    {
                        "exact_snippets": "Phase IB",
                        "criterion": "trial phase",
                        "requirement": {
                            "requirement_type": "phase",
                            "expected_value": "IB"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Arm C:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "* Arm D:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients may not have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study; patient must have recovered from adverse events due to agents administered more than 4 weeks earlier",
                "criterions": [
                    {
                        "exact_snippets": "Patients may not have had chemotherapy or radiotherapy within 4 weeks",
                        "criterion": "recent chemotherapy or radiotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "6 weeks for nitrosoureas or mitomycin C",
                        "criterion": "recent nitrosoureas or mitomycin C treatment",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "patient must have recovered from adverse events due to agents administered more than 4 weeks earlier",
                        "criterion": "recovery from adverse events",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients may not have had chemotherapy or radiotherapy within 4 weeks",
                                        "criterion": "recent chemotherapy or radiotherapy",
                                        "requirement": {
                                            "requirement_type": "time since last treatment",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "patient must have recovered from adverse events due to agents administered more than 4 weeks earlier",
                                        "criterion": "recovery from adverse events",
                                        "requirement": {
                                            "requirement_type": "recovery",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "6 weeks for nitrosoureas or mitomycin C",
                                        "criterion": "recent nitrosoureas or mitomycin C treatment",
                                        "requirement": {
                                            "requirement_type": "time since last treatment",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 6,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "patient must have recovered from adverse events due to agents administered more than 4 weeks earlier",
                                        "criterion": "recovery from adverse events",
                                        "requirement": {
                                            "requirement_type": "recovery",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients may not be receiving any other investigational agents",
                "criterions": [
                    {
                        "exact_snippets": "Patients may not be receiving any other investigational agents",
                        "criterion": "receiving investigational agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients may not be receiving any other investigational agents",
                        "criterion": "receiving investigational agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients may not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 or other agents used in the study",
                "criterions": [
                    {
                        "exact_snippets": "history of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 or other agents used in the study",
                        "criterion": "allergic reactions to compounds",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "history of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 or other agents used in the study",
                    "criterion": "allergic reactions to compounds",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP 450 3A4) are ineligible",
                "criterions": [
                    {
                        "exact_snippets": "Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP 450 3A4)",
                        "criterion": "medications or substances affecting CYP 450 3A4",
                        "requirement": {
                            "requirement_type": "effect",
                            "expected_value": [
                                "strong inhibitor",
                                "strong inducer"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP 450 3A4)",
                    "criterion": "medications or substances affecting CYP 450 3A4",
                    "requirement": {
                        "requirement_type": "effect",
                        "expected_value": [
                            "strong inhibitor",
                            "strong inducer"
                        ]
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Note: one week washout period is required in patients who were previously taking strong inhibitors or inducers of CYP450 3A4; patients who are currently taking moderate inhibitors or inducers of CYP450 3A4 are encouraged to switch to other medications that do not interact with CYP450 3A4",
                "criterions": [
                    {
                        "exact_snippets": "one week washout period is required in patients who were previously taking strong inhibitors or inducers of CYP450 3A4",
                        "criterion": "previous use of strong inhibitors or inducers of CYP450 3A4",
                        "requirement": {
                            "requirement_type": "washout period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    },
                    {
                        "exact_snippets": "patients who are currently taking moderate inhibitors or inducers of CYP450 3A4 are encouraged to switch to other medications that do not interact with CYP450 3A4",
                        "criterion": "current use of moderate inhibitors or inducers of CYP450 3A4",
                        "requirement": {
                            "requirement_type": "medication switch",
                            "expected_value": "encouraged"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "condition": {
                            "exact_snippets": "one week washout period is required in patients who were previously taking strong inhibitors or inducers of CYP450 3A4",
                            "criterion": "previous use of strong inhibitors or inducers of CYP450 3A4",
                            "requirement": {
                                "requirement_type": "washout period",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 1,
                                    "unit": "week"
                                }
                            }
                        },
                        "then_criteria": null,
                        "else_criteria": {
                            "exact_snippets": "one week washout period is required in patients who were previously taking strong inhibitors or inducers of CYP450 3A4",
                            "criterion": "previous use of strong inhibitors or inducers of CYP450 3A4",
                            "requirement": {
                                "requirement_type": "washout period",
                                "expected_value": {
                                    "operator": "<",
                                    "value": 1,
                                    "unit": "week"
                                }
                            }
                        }
                    },
                    {
                        "exact_snippets": "patients who are currently taking moderate inhibitors or inducers of CYP450 3A4 are encouraged to switch to other medications that do not interact with CYP450 3A4",
                        "criterion": "current use of moderate inhibitors or inducers of CYP450 3A4",
                        "requirement": {
                            "requirement_type": "medication switch",
                            "expected_value": "encouraged"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled on oral agents before the patient enters the trial (i.e. HbA1c =< 8% and fasting glucose =< 120 mg/dL)",
                "criterions": [
                    {
                        "exact_snippets": "Patients with diabetes",
                        "criterion": "diabetes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "risk for hyperglycemia",
                        "criterion": "risk for hyperglycemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hyperglycemia should be well controlled on oral agents",
                        "criterion": "hyperglycemia control",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "well controlled on oral agents"
                        }
                    },
                    {
                        "exact_snippets": "HbA1c =< 8%",
                        "criterion": "HbA1c",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "fasting glucose =< 120 mg/dL",
                        "criterion": "fasting glucose",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "or_criteria": [
                        {
                            "exact_snippets": "Patients with diabetes",
                            "criterion": "diabetes",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "risk for hyperglycemia",
                            "criterion": "risk for hyperglycemia",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "not_criteria": {
                        "and_criteria": [
                            {
                                "exact_snippets": "hyperglycemia should be well controlled on oral agents",
                                "criterion": "hyperglycemia control",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": "well controlled on oral agents"
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "HbA1c =< 8%",
                                        "criterion": "HbA1c",
                                        "requirement": {
                                            "requirement_type": "level",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 8,
                                                "unit": "%"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "fasting glucose =< 120 mg/dL",
                                        "criterion": "fasting glucose",
                                        "requirement": {
                                            "requirement_type": "level",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 120,
                                                "unit": "mg/dL"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Pregnant or nursing patients are excluded from the study",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant ... are excluded from the study",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "nursing patients are excluded from the study",
                        "criterion": "nursing",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnant ... are excluded from the study",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "nursing patients are excluded from the study",
                        "criterion": "nursing",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with known human immunodeficiency virus (HIV) positive status are excluded from this study",
                "criterions": [
                    {
                        "exact_snippets": "known human immunodeficiency virus (HIV) positive status",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "known human immunodeficiency virus (HIV) positive status",
                    "criterion": "HIV status",
                    "requirement": {
                        "requirement_type": "status",
                        "expected_value": "positive"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients may not have had grade 3 or intolerable grade 2 adverse events during run-in aromatase inhibitor (AI) or fulvestrant therapy prior to starting MK-2206",
                "criterions": [
                    {
                        "exact_snippets": "Patients may not have had grade 3 or intolerable grade 2 adverse events during run-in aromatase inhibitor (AI) or fulvestrant therapy",
                        "criterion": "adverse events during run-in AI or fulvestrant therapy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "not grade 3",
                                "not intolerable grade 2"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Patients may not have had grade 3 or intolerable grade 2 adverse events during run-in aromatase inhibitor (AI) or fulvestrant therapy",
                            "criterion": "adverse events during run-in AI or fulvestrant therapy",
                            "requirement": {
                                "requirement_type": "severity",
                                "expected_value": [
                                    "not grade 3",
                                    "not intolerable grade 2"
                                ]
                            }
                        }
                    ]
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients may not have had prior therapy with an AKT inhibitor",
                "criterions": [
                    {
                        "exact_snippets": "Patients may not have had prior therapy with an AKT inhibitor",
                        "criterion": "prior therapy with an AKT inhibitor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients may not have had prior therapy with an AKT inhibitor",
                        "criterion": "prior therapy with an AKT inhibitor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Cardiovascular: baseline QT Fridericia formula (QTcF) > 450 msec (male) or QTcF > 470 msec (female) will exclude patients from entry on study",
                "criterions": [
                    {
                        "exact_snippets": "baseline QT Fridericia formula (QTcF) > 450 msec (male)",
                        "criterion": "QTcF (male)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "msec"
                            }
                        }
                    },
                    {
                        "exact_snippets": "baseline QT Fridericia formula (QTcF) > 470 msec (female)",
                        "criterion": "QTcF (female)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "msec"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "baseline QT Fridericia formula (QTcF) > 450 msec (male)",
                                "criterion": "QTcF (male)",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 450,
                                        "unit": "msec"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "baseline QT Fridericia formula (QTcF) > 470 msec (female)",
                                "criterion": "QTcF (female)",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 470,
                                        "unit": "msec"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Patient must have measurable or non-measurable lesions (defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria)",
                "criterions": [
                    {
                        "exact_snippets": "Patient must have measurable or non-measurable lesions (defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria)",
                        "criterion": "lesions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patient must have measurable or non-measurable lesions (defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria)",
                        "criterion": "lesions",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "non-measurable"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Patient must have measurable or non-measurable lesions (defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria)",
                        "criterion": "lesions",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": "measurable"
                        }
                    },
                    {
                        "exact_snippets": "Patient must have measurable or non-measurable lesions (defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria)",
                        "criterion": "lesions",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": "non-measurable"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Currently being treated with letrozole or exemestane with no evidence of disease progression and willing to switch to anastrozole for study enrollment",
                "criterions": [
                    {
                        "exact_snippets": "Currently being treated with letrozole or exemestane",
                        "criterion": "current treatment",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": [
                                "letrozole",
                                "exemestane"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "no evidence of disease progression",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "willing to switch to anastrozole for study enrollment",
                        "criterion": "willingness to switch medication",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Currently being treated with letrozole or exemestane",
                                        "criterion": "current treatment",
                                        "requirement": {
                                            "requirement_type": "medication",
                                            "expected_value": "letrozole"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Currently being treated with letrozole or exemestane",
                                        "criterion": "current treatment",
                                        "requirement": {
                                            "requirement_type": "medication",
                                            "expected_value": "exemestane"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "no evidence of disease progression",
                                "criterion": "disease progression",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "willing to switch to anastrozole for study enrollment",
                        "criterion": "willingness to switch medication",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women =< 60 years with cessation of menses of duration < 12 months or secondary to hysterectomy AND an follicle stimulating hormone (FSH) level in the postmenopausal range according to institutional standards (or > 34.4 IU/L if institutional range is not available) prior to registration",
                "criterions": [
                    {
                        "exact_snippets": "Women =< 60 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "cessation of menses of duration < 12 months",
                        "criterion": "cessation of menses duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "cessation of menses ... secondary to hysterectomy",
                        "criterion": "cessation of menses cause",
                        "requirement": {
                            "requirement_type": "cause",
                            "expected_value": "secondary to hysterectomy"
                        }
                    },
                    {
                        "exact_snippets": "follicle stimulating hormone (FSH) level in the postmenopausal range according to institutional standards",
                        "criterion": "FSH level",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "postmenopausal range according to institutional standards"
                        }
                    },
                    {
                        "exact_snippets": "FSH level ... > 34.4 IU/L if institutional range is not available",
                        "criterion": "FSH level",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 34.4,
                                "unit": "IU/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Patients may not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements",
                "criterions": [
                    {
                        "exact_snippets": "uncontrolled intercurrent illness ... ongoing or active infection",
                        "criterion": "ongoing or active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled intercurrent illness ... symptomatic congestive heart failure",
                        "criterion": "symptomatic congestive heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled intercurrent illness ... unstable angina pectoris",
                        "criterion": "unstable angina pectoris",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled intercurrent illness ... cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled intercurrent illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                        "criterion": "psychiatric illness/social situations",
                        "requirement": {
                            "requirement_type": "impact on compliance",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "and_criteria": [
                                        {
                                            "exact_snippets": "uncontrolled intercurrent illness ... ongoing or active infection",
                                            "criterion": "ongoing or active infection",
                                            "requirement": {
                                                "requirement_type": "presence",
                                                "expected_value": true
                                            }
                                        },
                                        {
                                            "exact_snippets": "uncontrolled intercurrent illness ... symptomatic congestive heart failure",
                                            "criterion": "symptomatic congestive heart failure",
                                            "requirement": {
                                                "requirement_type": "presence",
                                                "expected_value": true
                                            }
                                        },
                                        {
                                            "exact_snippets": "uncontrolled intercurrent illness ... unstable angina pectoris",
                                            "criterion": "unstable angina pectoris",
                                            "requirement": {
                                                "requirement_type": "presence",
                                                "expected_value": true
                                            }
                                        },
                                        {
                                            "exact_snippets": "uncontrolled intercurrent illness ... cardiac arrhythmia",
                                            "criterion": "cardiac arrhythmia",
                                            "requirement": {
                                                "requirement_type": "presence",
                                                "expected_value": true
                                            }
                                        },
                                        {
                                            "exact_snippets": "uncontrolled intercurrent illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                                            "criterion": "psychiatric illness/social situations",
                                            "requirement": {
                                                "requirement_type": "impact on compliance",
                                                "expected_value": true
                                            }
                                        }
                                    ]
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients may not have had disease progression on anastrozole (Phase IA and Phase IB), fulvestrant (Arm C), both anastrozole and fulvestrant (Arm D) in either the neoadjuvant, adjuvant (defined as disease recurrence identified within 6 months of adjuvant discontinuation), or metastatic setting",
                "criterions": [
                    {
                        "exact_snippets": "Patients may not have had disease progression on anastrozole (Phase IA and Phase IB)",
                        "criterion": "disease progression on anastrozole",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients may not have had disease progression on ... fulvestrant (Arm C)",
                        "criterion": "disease progression on fulvestrant",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients may not have had disease progression on ... both anastrozole and fulvestrant (Arm D)",
                        "criterion": "disease progression on both anastrozole and fulvestrant",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "in either the neoadjuvant, adjuvant ... or metastatic setting",
                        "criterion": "treatment setting",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "neoadjuvant",
                                "adjuvant",
                                "metastatic"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "exact_snippets": "Patients may not have had disease progression on anastrozole (Phase IA and Phase IB)",
                                                        "criterion": "disease progression on anastrozole",
                                                        "requirement": {
                                                            "requirement_type": "presence",
                                                            "expected_value": false
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "in either the neoadjuvant, adjuvant ... or metastatic setting",
                                                        "criterion": "treatment setting",
                                                        "requirement": {
                                                            "requirement_type": "presence",
                                                            "expected_value": [
                                                                "neoadjuvant",
                                                                "adjuvant",
                                                                "metastatic"
                                                            ]
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "in either the neoadjuvant, adjuvant ... or metastatic setting",
                                                "criterion": "treatment setting",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": [
                                                        "neoadjuvant",
                                                        "adjuvant",
                                                        "metastatic"
                                                    ]
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "in either the neoadjuvant, adjuvant ... or metastatic setting",
                                        "criterion": "treatment setting",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": [
                                                "neoadjuvant",
                                                "adjuvant",
                                                "metastatic"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "in either the neoadjuvant, adjuvant ... or metastatic setting",
                                "criterion": "treatment setting",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": [
                                        "neoadjuvant",
                                        "adjuvant",
                                        "metastatic"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Patients may not have had disease progression on ... fulvestrant (Arm C)",
                                                "criterion": "disease progression on fulvestrant",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": false
                                                }
                                            },
                                            {
                                                "exact_snippets": "in either the neoadjuvant, adjuvant ... or metastatic setting",
                                                "criterion": "treatment setting",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": [
                                                        "neoadjuvant",
                                                        "adjuvant",
                                                        "metastatic"
                                                    ]
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "in either the neoadjuvant, adjuvant ... or metastatic setting",
                                        "criterion": "treatment setting",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": [
                                                "neoadjuvant",
                                                "adjuvant",
                                                "metastatic"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "in either the neoadjuvant, adjuvant ... or metastatic setting",
                                "criterion": "treatment setting",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": [
                                        "neoadjuvant",
                                        "adjuvant",
                                        "metastatic"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "in either the neoadjuvant, adjuvant ... or metastatic setting",
                        "criterion": "treatment setting",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "neoadjuvant",
                                "adjuvant",
                                "metastatic"
                            ]
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}