{
    "info": {
        "nct_id": "NCT05359120",
        "official_title": "A Nationwide Multicenter, Ambispective Real-world Study of Pyrotinib Combined With Capecitabine in Patients With HER-2 Positive Advanced Breast Cancer and Brain Metastases (Post-PERMEATE)",
        "inclusion_criteria": "1. Pathologically diagnosed patients with HER-2 expression-positive advanced breast cancer; Note: Positive HER2 expression refers to at least one tumor cell immunohistochemical staining intensity of 3+ or fluorescence in situ hybridization [FISH] in the pathological detection/recheck of the primary or metastatic lesions performed by the pathology department of the participating central hospital confirmed positive;\n2. Brain metastases are diagnosed by MRI/enhanced CT imaging, according to RECIST 1.1 criteria, with or without measurable lesions and with or without symptoms of brain metastases;\n3. Pyrotinib combined with capecitabine in the treatment of brain metastases with non-PD evaluation at the first treatment, at least ≥ 2 continuous imaging reports or assessments\n4. For previous treatment regimens, no previous use of capecitabine or progression after capecitabine discontinuation for 6 months, or progression after discontinuation of capecitabine adjuvant therapy for one year or more;\n5. There are traceable medical history data.\nHealthy volunteers allowed",
        "exclusion_criteria": "1. Patients enrolled in the previous PERMEATE study;\n2. The research program is receiving other anti-tumor drug treatment at the same time;\n3. The initial dose of pyrotinib is lower than the minimum dose in the instructions (240 mg), and the capecitabine is 50% lower than the standard dose;\n4. Pyrotinib combined with capecitabine in the treatment of non-brain metastases and progressive patients;\n5. The investigator believes that the patient is not suitable to enter this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Pathologically diagnosed patients with HER-2 expression-positive advanced breast cancer; Note: Positive HER2 expression refers to at least one tumor cell immunohistochemical staining intensity of 3+ or fluorescence in situ hybridization [FISH] in the pathological detection/recheck of the primary or metastatic lesions performed by the pathology department of the participating central hospital confirmed positive;",
            "criterions": [
                {
                    "exact_snippets": "Pathologically diagnosed patients",
                    "criterion": "pathological diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HER-2 expression-positive advanced breast cancer",
                    "criterion": "HER-2 expression",
                    "requirements": [
                        {
                            "requirement_type": "expression",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 expression refers to at least one tumor cell immunohistochemical staining intensity of 3+",
                    "criterion": "immunohistochemical staining intensity",
                    "requirements": [
                        {
                            "requirement_type": "intensity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "fluorescence in situ hybridization [FISH] in the pathological detection/recheck of the primary or metastatic lesions",
                    "criterion": "FISH test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Brain metastases are diagnosed by MRI/enhanced CT imaging, according to RECIST 1.1 criteria, with or without measurable lesions and with or without symptoms of brain metastases;",
            "criterions": [
                {
                    "exact_snippets": "Brain metastases are diagnosed by MRI/enhanced CT imaging",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis method",
                            "expected_value": [
                                "MRI",
                                "enhanced CT imaging"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "according to RECIST 1.1 criteria",
                    "criterion": "RECIST 1.1 criteria",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without measurable lesions",
                    "criterion": "measurable lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "with or without"
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without symptoms of brain metastases",
                    "criterion": "symptoms of brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "with or without"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Pyrotinib combined with capecitabine in the treatment of brain metastases with non-PD evaluation at the first treatment, at least ≥ 2 continuous imaging reports or assessments",
            "criterions": [
                {
                    "exact_snippets": "brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-PD evaluation at the first treatment",
                    "criterion": "non-PD evaluation at the first treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "non-PD"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least ≥ 2 continuous imaging reports or assessments",
                    "criterion": "continuous imaging reports or assessments",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. For previous treatment regimens, no previous use of capecitabine or progression after capecitabine discontinuation for 6 months, or progression after discontinuation of capecitabine adjuvant therapy for one year or more;",
            "criterions": [
                {
                    "exact_snippets": "no previous use of capecitabine",
                    "criterion": "previous use of capecitabine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "progression after capecitabine discontinuation for 6 months",
                    "criterion": "progression after capecitabine discontinuation",
                    "requirements": [
                        {
                            "requirement_type": "time since discontinuation",
                            "expected_value": {
                                "operator": "=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "progression after discontinuation of capecitabine adjuvant therapy for one year or more",
                    "criterion": "progression after discontinuation of capecitabine adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since discontinuation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. There are traceable medical history data.",
            "criterions": [
                {
                    "exact_snippets": "traceable medical history data",
                    "criterion": "medical history data",
                    "requirements": [
                        {
                            "requirement_type": "traceability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients enrolled in the previous PERMEATE study;",
            "criterions": [
                {
                    "exact_snippets": "Patients enrolled in the previous PERMEATE study",
                    "criterion": "enrollment in PERMEATE study",
                    "requirements": [
                        {
                            "requirement_type": "enrollment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. The research program is receiving other anti-tumor drug treatment at the same time;",
            "criterions": [
                {
                    "exact_snippets": "receiving other anti-tumor drug treatment",
                    "criterion": "anti-tumor drug treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. The initial dose of pyrotinib is lower than the minimum dose in the instructions (240 mg), and the capecitabine is 50% lower than the standard dose;",
            "criterions": [
                {
                    "exact_snippets": "The initial dose of pyrotinib is lower than the minimum dose in the instructions (240 mg)",
                    "criterion": "initial dose of pyrotinib",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 240,
                                "unit": "mg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "the capecitabine is 50% lower than the standard dose",
                    "criterion": "dose of capecitabine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "50% lower than the standard dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Pyrotinib combined with capecitabine in the treatment of non-brain metastases and progressive patients;",
            "criterions": [
                {
                    "exact_snippets": "Pyrotinib combined with capecitabine",
                    "criterion": "treatment regimen",
                    "requirements": [
                        {
                            "requirement_type": "components",
                            "expected_value": [
                                "Pyrotinib",
                                "capecitabine"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "non-brain metastases",
                    "criterion": "metastasis location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "non-brain"
                        }
                    ]
                },
                {
                    "exact_snippets": "progressive patients",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "progressive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. The investigator believes that the patient is not suitable to enter this study.",
            "criterions": [
                {
                    "exact_snippets": "The investigator believes that the patient is not suitable to enter this study.",
                    "criterion": "suitability for study",
                    "requirements": [
                        {
                            "requirement_type": "investigator's belief",
                            "expected_value": "not suitable"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}