{
    "info": {
        "nct_id": "NCT01950182",
        "official_title": "A Multicentre, Randomized Study of Trastuzumab Combined With Chemotherapy or Endocrine Therapy as the First Line Treatment for Patients With Metastatic Luminal B2 Breast Cancer Subtype",
        "inclusion_criteria": "1. Age 18 years or older.\n2. Patients with an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.\n3. Histologically confirmed metastatic or local recurrence of breast cancer.\n4. ER positive and/or progesterone receptor (PR) positive, HER-2+ defined as immuno-histochemistry3+ staining or FISH+.\n5. Prior adjuvant Trastuzumab therapy is permitted, but disease-free interval (DFI) must be more than 12 months.\n6. Patients must have measurable or evaluable disease.\n7. Adequate bone marrow reserve with neutrophils > 1000 and platelets > 100,000.\n8. Adequate renal function with serum creatinine < 2.0.\n9. Adequate hepatic reserve with serum bilirubin < 2.0, alanine transaminase(ALT) < 3 times the upper limit of normal, and alkaline phosphatase < 5 times the upper limit of normal.\n10. Adequate cardiac reserve with at least 45% of Left ventricular ejection fraction (LVEF) by echocardiogram.\n11. Able to give informed consent.\n12. Life expectancy of at least 12 weeks.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Pregnant or breast feeding.\n2. ECOG score ≧2\n3. DFI <12 months.\n4. LVEF < 45% by echocardiogram.\n5. Uncontrolled medical problems.\n6. Evidence of active acute or chronic infection.\n7. Hepatic, renal, or bone marrow dysfunction as detailed above.\n8. Concurrent malignancy or history of other malignancy within the last five years except as noted above.\n9. Known severe hypersensitivity to Trastuzumab.\n10. Patients were unable or unwilling to comply with program requirements.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age 18 years or older.",
            "criterions": [
                {
                    "exact_snippets": "Age 18 years or older.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) score of 0 or 1",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Histologically confirmed metastatic or local recurrence of breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed metastatic ... breast cancer.",
                    "criterion": "metastatic breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed ... local recurrence of breast cancer.",
                    "criterion": "local recurrence of breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. ER positive and/or progesterone receptor (PR) positive, HER-2+ defined as immuno-histochemistry3+ staining or FISH+.",
            "criterions": [
                {
                    "exact_snippets": "ER positive",
                    "criterion": "estrogen receptor (ER) status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "progesterone receptor (PR) positive",
                    "criterion": "progesterone receptor (PR) status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER-2+",
                    "criterion": "HER-2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "immuno-histochemistry3+ staining",
                    "criterion": "immuno-histochemistry staining",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "3+"
                        }
                    ]
                },
                {
                    "exact_snippets": "FISH+",
                    "criterion": "FISH test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Prior adjuvant Trastuzumab therapy is permitted, but disease-free interval (DFI) must be more than 12 months.",
            "criterions": [
                {
                    "exact_snippets": "Prior adjuvant Trastuzumab therapy is permitted",
                    "criterion": "prior adjuvant Trastuzumab therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "disease-free interval (DFI) must be more than 12 months",
                    "criterion": "disease-free interval (DFI)",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients must have measurable or evaluable disease.",
            "criterions": [
                {
                    "exact_snippets": "measurable or evaluable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Adequate bone marrow reserve with neutrophils > 1000 and platelets > 100,000.",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow reserve",
                    "criterion": "bone marrow reserve",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "neutrophils > 1000",
                    "criterion": "neutrophils",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 1000,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets > 100,000",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Adequate renal function with serum creatinine < 2.0.",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine < 2.0",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Adequate hepatic reserve with serum bilirubin < 2.0, alanine transaminase(ALT) < 3 times the upper limit of normal, and alkaline phosphatase < 5 times the upper limit of normal.",
            "criterions": [
                {
                    "exact_snippets": "Adequate hepatic reserve",
                    "criterion": "hepatic reserve",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serum bilirubin < 2.0",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine transaminase(ALT) < 3 times the upper limit of normal",
                    "criterion": "alanine transaminase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase < 5 times the upper limit of normal",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Adequate cardiac reserve with at least 45% of Left ventricular ejection fraction (LVEF) by echocardiogram.",
            "criterions": [
                {
                    "exact_snippets": "Adequate cardiac reserve",
                    "criterion": "cardiac reserve",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 45% of Left ventricular ejection fraction (LVEF) by echocardiogram",
                    "criterion": "Left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Able to give informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Able to give informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Life expectancy of at least 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 12 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "expected_value",
                            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Pregnant or breast feeding.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. ECOG score ≧2",
            "criterions": [
                {
                    "exact_snippets": "ECOG score ≧2",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. DFI <12 months.",
            "criterions": [
                {
                    "exact_snippets": "DFI <12 months",
                    "criterion": "disease-free interval (DFI)",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. LVEF < 45% by echocardiogram.",
            "criterions": [
                {
                    "exact_snippets": "LVEF < 45% by echocardiogram",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": "<",
                                "value": 45,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Uncontrolled medical problems.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled medical problems",
                    "criterion": "medical problems",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Evidence of active acute or chronic infection.",
            "criterions": [
                {
                    "exact_snippets": "Evidence of active acute or chronic infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Hepatic, renal, or bone marrow dysfunction as detailed above.",
            "criterions": [
                {
                    "exact_snippets": "Hepatic ... dysfunction",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "dysfunction"
                        }
                    ]
                },
                {
                    "exact_snippets": "renal ... dysfunction",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "dysfunction"
                        }
                    ]
                },
                {
                    "exact_snippets": "bone marrow dysfunction",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "dysfunction"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Concurrent malignancy or history of other malignancy within the last five years except as noted above.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent malignancy",
                    "criterion": "concurrent malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of other malignancy within the last five years",
                    "criterion": "history of other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Known severe hypersensitivity to Trastuzumab.",
            "criterions": [
                {
                    "exact_snippets": "Known severe hypersensitivity to Trastuzumab",
                    "criterion": "hypersensitivity to Trastuzumab",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients were unable or unwilling to comply with program requirements.",
            "criterions": [
                {
                    "exact_snippets": "unable or unwilling to comply with program requirements",
                    "criterion": "compliance with program requirements",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}