{
    "info": {
        "nct_id": "NCT06135194",
        "official_title": "Efficacy and Safety of T-Dxd in the Treatment of HER2-positive Breast Cancer With Brain Metastases After Prior Pyrotinib Treatment",
        "inclusion_criteria": "(1) Women ≥18 years of age :(2) pathological diagnosis of HER2-positive breast cancer, defined as positive immunohistochemistry detection (+++) or FISH(Fluorescent In Situ Hybridization); (3) Imaging evidence of brain metastases; (4) Progression of brain metastases after prior treatment with pyrotinib, defined as progression of new or pre-existing brain metastases during treatment with pyrotinib; (5)ECOG score ≤3 points; (6) The efficacy of T-DXd should be evaluated at least once after treatment; (7) Bone marrow and organ functions are basically normal; (8) Complete medical records\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Has uncontrolled or significant cardiovascular disease\n* Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening\n* Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "(1) Women ≥18 years of age :(2) pathological diagnosis of HER2-positive breast cancer, defined as positive immunohistochemistry detection (+++) or FISH(Fluorescent In Situ Hybridization); (3) Imaging evidence of brain metastases; (4) Progression of brain metastases after prior treatment with pyrotinib, defined as progression of new or pre-existing brain metastases during treatment with pyrotinib; (5)ECOG score ≤3 points; (6) The efficacy of T-DXd should be evaluated at least once after treatment; (7) Bone marrow and organ functions are basically normal; (8) Complete medical records",
                "criterions": [
                    {
                        "exact_snippets": "Women ≥18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "pathological diagnosis of HER2-positive breast cancer",
                        "criterion": "HER2-positive breast cancer",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "positive immunohistochemistry detection (+++) or FISH(Fluorescent In Situ Hybridization)",
                        "criterion": "HER2-positive breast cancer",
                        "requirement": {
                            "requirement_type": "detection method",
                            "expected_value": [
                                "immunohistochemistry (+++)",
                                "FISH (Fluorescent In Situ Hybridization)"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Imaging evidence of brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "imaging evidence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Progression of brain metastases after prior treatment with pyrotinib",
                        "criterion": "progression of brain metastases",
                        "requirement": {
                            "requirement_type": "after treatment with pyrotinib",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ECOG score ≤3 points",
                        "criterion": "ECOG score",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "points"
                            }
                        }
                    },
                    {
                        "exact_snippets": "The efficacy of T-DXd should be evaluated at least once after treatment",
                        "criterion": "efficacy evaluation of T-DXd",
                        "requirement": {
                            "requirement_type": "evaluation frequency",
                            "expected_value": "at least once after treatment"
                        }
                    },
                    {
                        "exact_snippets": "Bone marrow and organ functions are basically normal",
                        "criterion": "bone marrow and organ functions",
                        "requirement": {
                            "requirement_type": "normality",
                            "expected_value": "basically normal"
                        }
                    },
                    {
                        "exact_snippets": "Complete medical records",
                        "criterion": "medical records",
                        "requirement": {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "and_criteria": [
                                                                    {
                                                                        "and_criteria": [
                                                                            {
                                                                                "and_criteria": [
                                                                                    {
                                                                                        "exact_snippets": "Women ≥18 years of age",
                                                                                        "criterion": "age",
                                                                                        "requirement": {
                                                                                            "requirement_type": "minimum",
                                                                                            "expected_value": {
                                                                                                "operator": ">=",
                                                                                                "value": 18,
                                                                                                "unit": "years"
                                                                                            }
                                                                                        }
                                                                                    },
                                                                                    {
                                                                                        "exact_snippets": "pathological diagnosis of HER2-positive breast cancer",
                                                                                        "criterion": "HER2-positive breast cancer",
                                                                                        "requirement": {
                                                                                            "requirement_type": "diagnosis",
                                                                                            "expected_value": true
                                                                                        }
                                                                                    }
                                                                                ]
                                                                            },
                                                                            {
                                                                                "exact_snippets": "positive immunohistochemistry detection (+++) or FISH(Fluorescent In Situ Hybridization)",
                                                                                "criterion": "HER2-positive breast cancer",
                                                                                "requirement": {
                                                                                    "requirement_type": "detection method",
                                                                                    "expected_value": [
                                                                                        "immunohistochemistry (+++)",
                                                                                        "FISH (Fluorescent In Situ Hybridization)"
                                                                                    ]
                                                                                }
                                                                            }
                                                                        ]
                                                                    },
                                                                    {
                                                                        "exact_snippets": "Imaging evidence of brain metastases",
                                                                        "criterion": "brain metastases",
                                                                        "requirement": {
                                                                            "requirement_type": "imaging evidence",
                                                                            "expected_value": true
                                                                        }
                                                                    }
                                                                ]
                                                            },
                                                            {
                                                                "exact_snippets": "Progression of brain metastases after prior treatment with pyrotinib",
                                                                "criterion": "progression of brain metastases",
                                                                "requirement": {
                                                                    "requirement_type": "after treatment with pyrotinib",
                                                                    "expected_value": true
                                                                }
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "ECOG score ≤3 points",
                                                        "criterion": "ECOG score",
                                                        "requirement": {
                                                            "requirement_type": "maximum",
                                                            "expected_value": {
                                                                "operator": "<=",
                                                                "value": 3,
                                                                "unit": "points"
                                                            }
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "The efficacy of T-DXd should be evaluated at least once after treatment",
                                                "criterion": "efficacy evaluation of T-DXd",
                                                "requirement": {
                                                    "requirement_type": "evaluation frequency",
                                                    "expected_value": "at least once after treatment"
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "Bone marrow and organ functions are basically normal",
                                        "criterion": "bone marrow and organ functions",
                                        "requirement": {
                                            "requirement_type": "normality",
                                            "expected_value": "basically normal"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Complete medical records",
                                "criterion": "medical records",
                                "requirement": {
                                    "requirement_type": "completeness",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "positive immunohistochemistry detection (+++) or FISH(Fluorescent In Situ Hybridization)",
                        "criterion": "HER2-positive breast cancer",
                        "requirement": {
                            "requirement_type": "detection method",
                            "expected_value": [
                                "immunohistochemistry (+++)",
                                "FISH (Fluorescent In Situ Hybridization)"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "FEMALE"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "FEMALE"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 80 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 80 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 80 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Has uncontrolled or significant cardiovascular disease",
                "criterions": [
                    {
                        "exact_snippets": "uncontrolled or significant cardiovascular disease",
                        "criterion": "cardiovascular disease",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled or significant cardiovascular disease",
                        "criterion": "cardiovascular disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "uncontrolled or significant cardiovascular disease",
                        "criterion": "cardiovascular disease",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled or significant cardiovascular disease",
                        "criterion": "cardiovascular disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening",
                "criterions": [
                    {
                        "exact_snippets": "Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids",
                        "criterion": "history of interstitial lung disease (ILD)/pneumonitis",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "required steroids"
                        }
                    },
                    {
                        "exact_snippets": "has current ILD/pneumonitis",
                        "criterion": "current interstitial lung disease (ILD)/pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening",
                        "criterion": "suspected interstitial lung disease (ILD)/pneumonitis",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "cannot be ruled out by imaging at screening"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids",
                                "criterion": "history of interstitial lung disease (ILD)/pneumonitis",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "required steroids"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "has current ILD/pneumonitis",
                        "criterion": "current interstitial lung disease (ILD)/pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening",
                        "criterion": "suspected interstitial lung disease (ILD)/pneumonitis",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "cannot be ruled out by imaging at screening"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study",
                "criterions": [
                    {
                        "exact_snippets": "any medical history or condition",
                        "criterion": "medical history or condition",
                        "requirement": {
                            "requirement_type": "appropriateness for the study",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "any medical history or condition",
                        "criterion": "medical history or condition",
                        "requirement": {
                            "requirement_type": "appropriateness for the study",
                            "expected_value": false
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}