{
    "info": {
        "nct_id": "NCT04929548",
        "official_title": "Exploratory Study of Triple-targeted Neoadjuvant Treatment of HER2-positive Breast Cancer With Pyrotinib in Combination With Trastuzumab and Pertuzumab",
        "inclusion_criteria": "* Female patients aged 18-70 years.\n* ECOG score must be 0 or 1.\n* Patients with clinical stage II to III new breast cancer, all diagnosed by hollow-core needle aspiration biopsy pathological histology prior to treatment and surgically resectable breast cancer with positive immunohistochemical staining (IHC) for HER2 (3+) or HER2 (2+) supplemented with fluorescence in situ hybridization technique (FISH).\n* The presence of at least one measurable lesion according to RECIST 1.1 criteria.\n* Exclusion of distant metastases by abdominal B-ultrasound, chest X-ray and whole-body bone scan prior to neoadjuvant chemotherapy, and for lymph nodes in the enlarged area fine needle aspiration cytology is required to clarify the presence of tumor metastases without a history of remaining malignancies.\n* Expected survival of not less than 12 weeks.\n* No previous treatment, including chemotherapy, radiotherapy, targeted therapy, and biologic therapy. -Exclusion Criteria\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* Female patients of childbearing age who are pregnant, breastfeeding, or unwilling to use effective contraception throughout the trial period.\n* Patients with combined severe cardiac, hepatic, renal, or endocrine system diseases and with expected survival of < 2 years for the above diseases.\n* Inability to swallow, intestinal obstruction, the presence of other factors affecting drug administration and absorption or a history of allergy to this drug\n* Karnofsky scale score below 60\n* Patients with metastatic breast cancer or bilateral breast cancer.\n* Patients with inflammatory breast cancer.\n* Those with a left ventricular ejection fraction (LVEF) <55% on echocardiography\n* Those who are deemed by the personnel to be otherwise unsuitable for clinical trials.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Female patients aged 18-70 years.",
            "criterions": [
                {
                    "exact_snippets": "Female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged 18-70 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG score must be 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG score must be 0 or 1.",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with clinical stage II to III new breast cancer, all diagnosed by hollow-core needle aspiration biopsy pathological histology prior to treatment and surgically resectable breast cancer with positive immunohistochemical staining (IHC) for HER2 (3+) or HER2 (2+) supplemented with fluorescence in situ hybridization technique (FISH).",
            "criterions": [
                {
                    "exact_snippets": "clinical stage II to III new breast cancer",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed by hollow-core needle aspiration biopsy pathological histology",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "hollow-core needle aspiration biopsy pathological histology"
                        }
                    ]
                },
                {
                    "exact_snippets": "surgically resectable breast cancer",
                    "criterion": "surgical resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive immunohistochemical staining (IHC) for HER2 (3+) or HER2 (2+) supplemented with fluorescence in situ hybridization technique (FISH)",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "IHC staining",
                            "expected_value": [
                                "HER2 (3+)",
                                "HER2 (2+)"
                            ]
                        },
                        {
                            "requirement_type": "FISH supplementation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The presence of at least one measurable lesion according to RECIST 1.1 criteria.",
            "criterions": [
                {
                    "exact_snippets": "The presence of at least one measurable lesion according to RECIST 1.1 criteria.",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Exclusion of distant metastases by abdominal B-ultrasound, chest X-ray and whole-body bone scan prior to neoadjuvant chemotherapy, and for lymph nodes in the enlarged area fine needle aspiration cytology is required to clarify the presence of tumor metastases without a history of remaining malignancies.",
            "criterions": [
                {
                    "exact_snippets": "Exclusion of distant metastases by abdominal B-ultrasound, chest X-ray and whole-body bone scan",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lymph nodes in the enlarged area fine needle aspiration cytology is required to clarify the presence of tumor metastases",
                    "criterion": "tumor metastases in lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "without a history of remaining malignancies",
                    "criterion": "history of remaining malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Expected survival of not less than 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Expected survival of not less than 12 weeks.",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No previous treatment, including chemotherapy, radiotherapy, targeted therapy, and biologic therapy. -Exclusion Criteria",
            "criterions": [
                {
                    "exact_snippets": "No previous treatment, including chemotherapy",
                    "criterion": "previous chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No previous treatment, including ... radiotherapy",
                    "criterion": "previous radiotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No previous treatment, including ... targeted therapy",
                    "criterion": "previous targeted therapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No previous treatment, including ... biologic therapy",
                    "criterion": "previous biologic therapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Female patients of childbearing age who are pregnant, breastfeeding, or unwilling to use effective contraception throughout the trial period.",
            "criterions": [
                {
                    "exact_snippets": "Female patients of childbearing age",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing age"
                        }
                    ]
                },
                {
                    "exact_snippets": "who are pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unwilling to use effective contraception throughout the trial period",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with combined severe cardiac, hepatic, renal, or endocrine system diseases and with expected survival of < 2 years for the above diseases.",
            "criterions": [
                {
                    "exact_snippets": "severe cardiac ... diseases",
                    "criterion": "cardiac diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe ... hepatic ... diseases",
                    "criterion": "hepatic diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe ... renal ... diseases",
                    "criterion": "renal diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe ... endocrine system diseases",
                    "criterion": "endocrine system diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "expected survival of < 2 years for the above diseases",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to swallow, intestinal obstruction, the presence of other factors affecting drug administration and absorption or a history of allergy to this drug",
            "criterions": [
                {
                    "exact_snippets": "Inability to swallow",
                    "criterion": "ability to swallow",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intestinal obstruction",
                    "criterion": "intestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the presence of other factors affecting drug administration and absorption",
                    "criterion": "factors affecting drug administration and absorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a history of allergy to this drug",
                    "criterion": "allergy to this drug",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky scale score below 60",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky scale score below 60",
                    "criterion": "Karnofsky scale score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with metastatic breast cancer or bilateral breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "metastatic breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "metastasis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bilateral breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "laterality",
                            "expected_value": "bilateral"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with inflammatory breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "inflammatory breast cancer",
                    "criterion": "inflammatory breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Those with a left ventricular ejection fraction (LVEF) <55% on echocardiography",
            "criterions": [
                {
                    "exact_snippets": "left ventricular ejection fraction (LVEF) <55%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 55,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Those who are deemed by the personnel to be otherwise unsuitable for clinical trials.",
            "criterions": [
                {
                    "exact_snippets": "deemed by the personnel to be otherwise unsuitable for clinical trials",
                    "criterion": "suitability for clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}