{
    "info": {
        "nct_id": "NCT01743560",
        "official_title": "A Phase IV Multicentre, Open Label Study of Postmenopausal Women With Oestrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Treated With Everolimus (RAD001) in Combination With Exemestane, With Exploratory Epigenetic Marker Analysis",
        "inclusion_criteria": "* Histological or cytological confirmation of oestrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.\n* Availability of archival tumour tissue (the tissue block or slides will be sent to the central laboratory for analysis).\n* Postmenopausal women. The investigator must confirm postmenopausal status. Postmenopausal status is defined either by:\n\n  * Age ≥ 55 years and one year or more of amenorrhea\n  * Age < 55 years and one year or more of amenorrhea and postmenopausal levels of FSH and LH per local institutional standards\n  * Prior hysterectomy and has postmenopausal levels of Follicle stimulating hormone (FSH) and Luteinizing Hormone (LH) per local institutional standards Surgical menopause with bilateral oophorectomy\n* Disease progression following prior therapy with NSAI, defined as:\n\n  * Recurrence while on or after completion of an adjuvant treatment including letrozole or anastrozole, or\n  * Progression while on or following the completion of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer\n\nNote: Non-steroidal aromatase inhibitors (i.e. letrozole or anastrozole) do not have to be the last treatment prior to enrollment. Other prior anticancer therapy, e.g. tamoxifen, fulvestrant, exemestane are also allowed. Patients must have recovered to grade 1 or better from any adverse events (except alopecia) related to previous therapy prior to enrollment.\n\n- Radiological evidence of recurrence or progression on last systemic therapy prior to enrollment.\n\nPatients must have:\n\n* At least one lesion that can be accurately measured or\n* Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease\n\n  - Adequate bone marrow and coagulation function as shown by:\n* Absolute neutrophil count (ANC) ≥ 1.5 109/L\n* Platelets ≥ 100 ×109/L\n* Hemoglobin (Hb) ≥ 9.0 g/dL\n* International Normalized Ratio (INR) ≤ 2 .\n\n  - Adequate liver function as shown by:\n* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN (or ≤ 5 if hepatic metastases are present)\n* Total serum bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients known to have Gilbert Syndrome)\n\n  - Adequate renal function as shown by:\n* Serum creatinine ≤ 1.5 × ULN\n\n  * Fasting serum cholesterol ≤ 300 mg/dl or 7.75 mmol/L and fasting triglycerides ≤ 2.5 × ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achieved\n  * Eastern Cooperative Oncology Group (ECOG) performance status of PS </ 2\n  * Written informed consent obtained before any screening procedure and according to local guidelines.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).\n* Pre-menopausal, pregnant, lactating women.\n* Known hypersensitivity to mammilian target of Rapamycin (mTOR) inhibitors, e.g. sirolimus (rapamycin) or to their excipients.\n* Known hypersensitivity to exemestane, to the active substance or to any of the excipients.\n* Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.\n* Radiotherapy within four weeks prior to enrollment except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. Patients must have recovered from radiotherapy toxicities prior to enrollment.\n* Currently receiving hormone replacement therapy, unless discontinued prior to enrollment.\n* Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use, at the time of study entry except in cases outlined below:\n\nProlonged systemic corticosteroid treatment during study, except for topical applications (e.g. rash),inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) should not be given. However:\n\n* short duration (<2 weeks) of systemic corticosteroids is allowed (e.g. chronic obstructive pulmonary disease, anti-emetic)\n* low doses of corticosteroids for brain metastasis treatment is allowed\n* Patients with symptomatic visceral metastasis (e.g. significant dyspnoea related to pulmonary lymphangitic carcinomatosis and lung metastases or clinically meaningful symptomatic liver metastasis)\n* Symptomatic brain or other Central Nervous system (CNS) metastases.\n* Active, bleeding diathesis, or on oral anti-vitamin K medication (except low dose warfarin, low molecular weight heparin (LMWH) and acetylsalicylic acid or equivalent, as long as the INR is 2.0)\n* Any severe and / or uncontrolled medical conditions such as:\n\n  * Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to enrollment, serious uncontrolled cardiac arrhythmia\n  * Uncontrolled diabetes as defined by fasting serum glucose > 1.5 × ULN\n  * Acute and chronic, active infectious disorders (except for Hep B and Hep C positive patients) and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy\n  * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome)\n  * Significant symptomatic deterioration of lung function. If clinically indicated, pulmonary function tests including measures of predicted lung volumes, DLco, O2 saturation at rest on room air should be considered to exclude restrictive pulmonary disease, pneumonitis or pulmonary infiltrates.\n* Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, telithromycin) within the last 5 days prior to enrollment\n* History of non-compliance to medical regimens\n* Patients unwilling to or unable to comply with the protocol\n* Another malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histological or cytological confirmation of oestrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "Histological or cytological confirmation of oestrogen receptor positive (ER+)",
                    "criterion": "oestrogen receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histological or cytological confirmation of ... progesterone receptor positive (PgR+)",
                    "criterion": "progesterone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histological or cytological confirmation of ... human epidermal growth factor receptor 2 (HER2) negative",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histological or cytological confirmation of ... breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Availability of archival tumour tissue (the tissue block or slides will be sent to the central laboratory for analysis).",
            "criterions": [
                {
                    "exact_snippets": "Availability of archival tumour tissue",
                    "criterion": "archival tumour tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Postmenopausal women. The investigator must confirm postmenopausal status. Postmenopausal status is defined either by:",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal women",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "menopausal status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 55 years and one year or more of amenorrhea",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 55 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 55,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "one year or more of amenorrhea",
                    "criterion": "amenorrhea",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age < 55 years and one year or more of amenorrhea and postmenopausal levels of FSH and LH per local institutional standards",
            "criterions": [
                {
                    "exact_snippets": "Age < 55 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 55,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "one year or more of amenorrhea",
                    "criterion": "amenorrhea duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "postmenopausal levels of FSH and LH per local institutional standards",
                    "criterion": "FSH and LH levels",
                    "requirements": [
                        {
                            "requirement_type": "postmenopausal levels",
                            "expected_value": "per local institutional standards"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior hysterectomy and has postmenopausal levels of Follicle stimulating hormone (FSH) and Luteinizing Hormone (LH) per local institutional standards Surgical menopause with bilateral oophorectomy",
            "criterions": [
                {
                    "exact_snippets": "Prior hysterectomy",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "postmenopausal levels of Follicle stimulating hormone (FSH)",
                    "criterion": "Follicle stimulating hormone (FSH) levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "postmenopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "postmenopausal levels of ... Luteinizing Hormone (LH)",
                    "criterion": "Luteinizing Hormone (LH) levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "postmenopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Surgical menopause with bilateral oophorectomy",
                    "criterion": "surgical menopause",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": "bilateral oophorectomy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease progression following prior therapy with NSAI, defined as:",
            "criterions": [
                {
                    "exact_snippets": "Disease progression following prior therapy with NSAI",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "prior therapy",
                            "expected_value": "NSAI"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recurrence while on or after completion of an adjuvant treatment including letrozole or anastrozole, or",
            "criterions": [
                {
                    "exact_snippets": "Recurrence while on or after completion of an adjuvant treatment",
                    "criterion": "recurrence",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "while on or after completion of an adjuvant treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "adjuvant treatment including letrozole or anastrozole",
                    "criterion": "adjuvant treatment",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "letrozole",
                                "anastrozole"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progression while on or following the completion of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Progression while on or following the completion of letrozole or anastrozole treatment",
                    "criterion": "progression on letrozole or anastrozole",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic breast cancer",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Non-steroidal aromatase inhibitors (i.e. letrozole or anastrozole) do not have to be the last treatment prior to enrollment. Other prior anticancer therapy, e.g. tamoxifen, fulvestrant, exemestane are also allowed. Patients must have recovered to grade 1 or better from any adverse events (except alopecia) related to previous therapy prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Non-steroidal aromatase inhibitors (i.e. letrozole or anastrozole) do not have to be the last treatment prior to enrollment.",
                    "criterion": "last treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Other prior anticancer therapy, e.g. tamoxifen, fulvestrant, exemestane are also allowed.",
                    "criterion": "prior anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must have recovered to grade 1 or better from any adverse events (except alopecia) related to previous therapy prior to enrollment.",
                    "criterion": "recovery from adverse events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "- Radiological evidence of recurrence or progression on last systemic therapy prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Radiological evidence of recurrence or progression",
                    "criterion": "recurrence or progression",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "radiological"
                        }
                    ]
                },
                {
                    "exact_snippets": "last systemic therapy prior to enrollment",
                    "criterion": "systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one lesion that can be accurately measured or",
            "criterions": [
                {
                    "exact_snippets": "At least one lesion that can be accurately measured",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease",
            "criterions": [
                {
                    "exact_snippets": "Bone lesions: lytic or mixed (lytic + sclerotic)",
                    "criterion": "bone lesions",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "lytic",
                                "mixed (lytic + sclerotic)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of measurable disease",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) ≥ 1.5 109/L",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5 109/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "109/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥ 100 ×109/L",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥ 100 ×109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin (Hb) ≥ 9.0 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin (Hb) ≥ 9.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* International Normalized Ratio (INR) ≤ 2 .",
            "criterions": [
                {
                    "exact_snippets": "International Normalized Ratio (INR) ≤ 2",
                    "criterion": "International Normalized Ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "- Adequate liver function as shown by:",
            "criterions": [
                {
                    "exact_snippets": "Adequate liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total serum bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients known to have Gilbert Syndrome)",
            "criterions": [
                {
                    "exact_snippets": "Total serum bilirubin ≤ 1.5 × ULN",
                    "criterion": "total serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "≤ 3 × ULN for patients known to have Gilbert Syndrome",
                    "criterion": "total serum bilirubin for patients with Gilbert Syndrome",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "- Adequate renal function as shown by:",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine ≤ 1.5 × ULN",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤ 1.5 × ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fasting serum cholesterol ≤ 300 mg/dl or 7.75 mmol/L and fasting triglycerides ≤ 2.5 × ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achieved",
            "criterions": [
                {
                    "exact_snippets": "Fasting serum cholesterol ≤ 300 mg/dl or 7.75 mmol/L",
                    "criterion": "fasting serum cholesterol",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 300,
                                        "unit": "mg/dl"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 7.75,
                                        "unit": "mmol/L"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "fasting triglycerides ≤ 2.5 × ULN",
                    "criterion": "fasting triglycerides",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "× ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of PS </ 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of PS </ 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent obtained before any screening procedure and according to local guidelines.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "before any screening procedure",
                    "criterion": "timing of informed consent",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "before screening"
                        }
                    ]
                },
                {
                    "exact_snippets": "according to local guidelines",
                    "criterion": "compliance with local guidelines",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).",
            "criterions": [
                {
                    "exact_snippets": "HER2-overexpressing patients",
                    "criterion": "HER2 expression",
                    "requirements": [
                        {
                            "requirement_type": "expression level",
                            "expected_value": "overexpressing"
                        }
                    ]
                },
                {
                    "exact_snippets": "IHC 3+ staining",
                    "criterion": "IHC staining",
                    "requirements": [
                        {
                            "requirement_type": "staining level",
                            "expected_value": "3+"
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ hybridization positive",
                    "criterion": "in situ hybridization",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pre-menopausal, pregnant, lactating women.",
            "criterions": [
                {
                    "exact_snippets": "Pre-menopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "pre-menopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "lactating"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hypersensitivity to mammilian target of Rapamycin (mTOR) inhibitors, e.g. sirolimus (rapamycin) or to their excipients.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to mammilian target of Rapamycin (mTOR) inhibitors",
                    "criterion": "hypersensitivity to mTOR inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity ... to their excipients",
                    "criterion": "hypersensitivity to excipients of mTOR inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hypersensitivity to exemestane, to the active substance or to any of the excipients.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to exemestane",
                    "criterion": "hypersensitivity to exemestane",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity ... to the active substance",
                    "criterion": "hypersensitivity to the active substance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity ... to any of the excipients",
                    "criterion": "hypersensitivity to any of the excipients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.",
            "criterions": [
                {
                    "exact_snippets": "rare hereditary problems of galactose intolerance",
                    "criterion": "galactose intolerance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rare hereditary problems of ... Lapp lactase deficiency",
                    "criterion": "Lapp lactase deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rare hereditary problems of ... glucose galactose malabsorption",
                    "criterion": "glucose galactose malabsorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiotherapy within four weeks prior to enrollment except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. Patients must have recovered from radiotherapy toxicities prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy within four weeks prior to enrollment",
                    "criterion": "radiotherapy timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture ... completed within two weeks prior to enrollment",
                    "criterion": "localized radiotherapy timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must have recovered from radiotherapy toxicities prior to enrollment",
                    "criterion": "recovery from radiotherapy toxicities",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently receiving hormone replacement therapy, unless discontinued prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Currently receiving hormone replacement therapy",
                    "criterion": "hormone replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use, at the time of study entry except in cases outlined below:",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving concomitant immunosuppressive agents",
                    "criterion": "concomitant immunosuppressive agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic corticosteroids use, at the time of study entry",
                    "criterion": "chronic corticosteroids use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Prolonged systemic corticosteroid treatment during study, except for topical applications (e.g. rash),inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) should not be given. However:",
            "criterions": [
                {
                    "exact_snippets": "Prolonged systemic corticosteroid treatment during study",
                    "criterion": "systemic corticosteroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "prolonged"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "during study"
                        }
                    ]
                },
                {
                    "exact_snippets": "except for topical applications (e.g. rash)",
                    "criterion": "topical corticosteroid applications",
                    "requirements": [
                        {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "rash"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "inhaled sprays (e.g. obstructive airways diseases)",
                    "criterion": "inhaled corticosteroid sprays",
                    "requirements": [
                        {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "obstructive airways diseases"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "eye drops",
                    "criterion": "corticosteroid eye drops",
                    "requirements": [
                        {
                            "requirement_type": "exceptions",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "local injections (e.g. intra-articular)",
                    "criterion": "local corticosteroid injections",
                    "requirements": [
                        {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "intra-articular"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* short duration (<2 weeks) of systemic corticosteroids is allowed (e.g. chronic obstructive pulmonary disease, anti-emetic)",
            "criterions": [
                {
                    "exact_snippets": "short duration (<2 weeks) of systemic corticosteroids is allowed",
                    "criterion": "systemic corticosteroids duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* low doses of corticosteroids for brain metastasis treatment is allowed",
            "criterions": [
                {
                    "exact_snippets": "low doses of corticosteroids for brain metastasis treatment is allowed",
                    "criterion": "corticosteroids for brain metastasis treatment",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": "low"
                        },
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with symptomatic visceral metastasis (e.g. significant dyspnoea related to pulmonary lymphangitic carcinomatosis and lung metastases or clinically meaningful symptomatic liver metastasis)",
            "criterions": [
                {
                    "exact_snippets": "symptomatic visceral metastasis",
                    "criterion": "visceral metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptom presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "significant dyspnoea related to pulmonary lymphangitic carcinomatosis and lung metastases",
                    "criterion": "pulmonary lymphangitic carcinomatosis and lung metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptom presence",
                            "expected_value": "significant dyspnoea"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically meaningful symptomatic liver metastasis",
                    "criterion": "liver metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptom presence",
                            "expected_value": "clinically meaningful"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic brain or other Central Nervous system (CNS) metastases.",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic brain or other Central Nervous system (CNS) metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Symptomatic brain or other Central Nervous system (CNS) metastases",
                    "criterion": "Central Nervous system (CNS) metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active, bleeding diathesis, or on oral anti-vitamin K medication (except low dose warfarin, low molecular weight heparin (LMWH) and acetylsalicylic acid or equivalent, as long as the INR is 2.0)",
            "criterions": [
                {
                    "exact_snippets": "Active, bleeding diathesis",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "on oral anti-vitamin K medication",
                    "criterion": "oral anti-vitamin K medication",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "low dose warfarin",
                    "criterion": "low dose warfarin",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "low molecular weight heparin (LMWH)",
                    "criterion": "low molecular weight heparin (LMWH)",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acetylsalicylic acid or equivalent",
                    "criterion": "acetylsalicylic acid or equivalent",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "INR is 2.0",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "=",
                                "value": 2.0,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any severe and / or uncontrolled medical conditions such as:",
            "criterions": [
                {
                    "exact_snippets": "severe and / or uncontrolled medical conditions",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to enrollment, serious uncontrolled cardiac arrhythmia",
            "criterions": [
                {
                    "exact_snippets": "Unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction ≤6 months prior to enrollment",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serious uncontrolled cardiac arrhythmia",
                    "criterion": "serious uncontrolled cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled diabetes as defined by fasting serum glucose > 1.5 × ULN",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled diabetes as defined by fasting serum glucose > 1.5 × ULN",
                    "criterion": "fasting serum glucose",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute and chronic, active infectious disorders (except for Hep B and Hep C positive patients) and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy",
            "criterions": [
                {
                    "exact_snippets": "Acute and chronic, active infectious disorders",
                    "criterion": "infectious disorders",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Hep B and Hep C positive patients",
                    "criterion": "Hepatitis B and C status",
                    "requirements": [
                        {
                            "requirement_type": "positivity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "nonmalignant medical illnesses that are uncontrolled",
                    "criterion": "nonmalignant medical illnesses",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome)",
            "criterions": [
                {
                    "exact_snippets": "Impairment of gastrointestinal function",
                    "criterion": "gastrointestinal function",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "gastrointestinal disease that may significantly alter the absorption of study drugs",
                    "criterion": "gastrointestinal disease",
                    "requirements": [
                        {
                            "requirement_type": "impact on drug absorption",
                            "expected_value": "significant alteration"
                        }
                    ]
                },
                {
                    "exact_snippets": "ulcerative disease",
                    "criterion": "ulcerative disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled nausea",
                    "criterion": "nausea",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "vomiting",
                    "criterion": "vomiting",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diarrhoea",
                    "criterion": "diarrhoea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant symptomatic deterioration of lung function. If clinically indicated, pulmonary function tests including measures of predicted lung volumes, DLco, O2 saturation at rest on room air should be considered to exclude restrictive pulmonary disease, pneumonitis or pulmonary infiltrates.",
            "criterions": [
                {
                    "exact_snippets": "Significant symptomatic deterioration of lung function",
                    "criterion": "lung function",
                    "requirements": [
                        {
                            "requirement_type": "deterioration",
                            "expected_value": "significant symptomatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary function tests including measures of predicted lung volumes",
                    "criterion": "predicted lung volumes",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": "pulmonary function tests"
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary function tests including measures of ... DLco",
                    "criterion": "DLco",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": "pulmonary function tests"
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary function tests including measures of ... O2 saturation at rest on room air",
                    "criterion": "O2 saturation at rest on room air",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": "pulmonary function tests"
                        }
                    ]
                },
                {
                    "exact_snippets": "exclude restrictive pulmonary disease",
                    "criterion": "restrictive pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exclude ... pneumonitis",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exclude ... pulmonary infiltrates",
                    "criterion": "pulmonary infiltrates",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, telithromycin) within the last 5 days prior to enrollment",
            "criterions": [
                {
                    "exact_snippets": "Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A",
                    "criterion": "treatment with strong inhibitors or inducers of CYP3A",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the last 5 days prior to enrollment",
                    "criterion": "time since last treatment with strong inhibitors or inducers of CYP3A",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of non-compliance to medical regimens",
            "criterions": [
                {
                    "exact_snippets": "History of non-compliance to medical regimens",
                    "criterion": "non-compliance to medical regimens",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients unwilling to or unable to comply with the protocol",
            "criterions": [
                {
                    "exact_snippets": "Patients unwilling to ... comply with the protocol",
                    "criterion": "willingness to comply with protocol",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients ... unable to comply with the protocol",
                    "criterion": "ability to comply with protocol",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Another malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer",
            "criterions": [
                {
                    "exact_snippets": "Another malignancy within 5 years prior to randomization",
                    "criterion": "another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer",
                    "criterion": "adequately treated in-situ carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer",
                    "criterion": "adequately treated basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer",
                    "criterion": "adequately treated squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer",
                    "criterion": "adequately treated non-melanomatous skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Patients must have:",
            "criterions": []
        },
        {
            "line": "- Adequate bone marrow and coagulation function as shown by:",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... coagulation function",
                    "criterion": "coagulation function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN (or ≤ 5 if hepatic metastases are present)",
            "criterions": [
                {
                    "exact_snippets": "Serum aspartate aminotransferase (AST) ... ≤ 2.5 ULN (or ≤ 5 if hepatic metastases are present)",
                    "criterion": "serum aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum alanine aminotransferase (ALT) ... ≤ 2.5 ULN (or ≤ 5 if hepatic metastases are present)",
                    "criterion": "serum alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "≤ 5 if hepatic metastases are present",
                    "criterion": "hepatic metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}