{
    "info": {
        "nct_id": "NCT03588091",
        "official_title": "A Randomized, Muticenter Double-blind Phase III Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Docetaxel Compared With Placebo Plus Trastuzumab and Docetaxel in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer",
        "inclusion_criteria": "* female patients, 18 years ≤ age ≤ 75 years；\n* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1\n* Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter\n* HER2 positive (HER2+++ by IHC or FISH+)\n* Known hormone receptor status.\n* Cardiovascular:Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO\n* Signed informed consent form (ICF)\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* metastatic disease (Stage IV) or inflammatory breast cancer\n* Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.\n* clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);\n* Unable or unwilling to swallow tablets.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* female patients, 18 years ≤ age ≤ 75 years；",
            "criterions": [
                {
                    "exact_snippets": "female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "18 years ≤ age ≤ 75 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1",
            "criterions": [
                {
                    "exact_snippets": "Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1",
                    "criterion": "Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "Eastern Cooperative Oncology Group (ECOG)"
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "ECOG"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "ECOG"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed invasive breast cancer",
                    "criterion": "invasive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Primary tumour greater than 2 cm diameter",
                    "criterion": "primary tumour size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HER2 positive (HER2+++ by IHC or FISH+)",
            "criterions": [
                {
                    "exact_snippets": "HER2 positive (HER2+++ by IHC or FISH+)",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "testing method",
                            "expected_value": [
                                "IHC",
                                "FISH"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hormone receptor status.",
            "criterions": [
                {
                    "exact_snippets": "Known hormone receptor status.",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiovascular:Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO",
            "criterions": [
                {
                    "exact_snippets": "Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 55,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent form (ICF)",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent form (ICF)",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "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": "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": "* metastatic disease (Stage IV) or inflammatory breast cancer",
            "criterions": [
                {
                    "exact_snippets": "metastatic disease (Stage IV)",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "inflammatory breast cancer",
                    "criterion": "inflammatory breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable or unwilling to swallow tablets.",
            "criterions": [
                {
                    "exact_snippets": "Unable or unwilling to swallow tablets.",
                    "criterion": "ability to swallow tablets",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.",
            "criterions": [
                {
                    "exact_snippets": "Previous or current history of malignant neoplasms",
                    "criterion": "malignant neoplasms",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated: Basal and squamous cell carcinoma of the skin",
                    "criterion": "curatively treated basal and squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated: ... Carcinoma in situ of the cervix",
                    "criterion": "curatively treated carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);",
            "criterions": [
                {
                    "exact_snippets": "clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "symptomatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically relevant cardiovascular disease: ... clinically significant arrhythmias",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically relevant cardiovascular disease: ... congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically relevant cardiovascular disease: ... transmural myocardial infarction",
                    "criterion": "transmural myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically relevant cardiovascular disease: ... uncontrolled hypertension ≥180/110",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 180,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}