{
    "info": {
        "nct_id": "NCT05042791",
        "official_title": "SRT Versus WBRT Combined With Pyrrotinib and Capecitabine in the Treatment of HER2-positive Advanced Breast Cancer Patients With Brain Metastases: A Randomized Controlled, Prospective Clinical Study",
        "inclusion_criteria": "1. Age> 18 years old, female\n2. KPS≥70\n3. HER2-positive breast cancer is confirmed by the pathology laboratory with an immunohistochemical (IHC) score of 3+ and/or 2+ and a positive in situ hybridization (ISH) test (ISH amplification rate ≥ 2.0)\n4. Brain metastasis confirmed by MRI, in line with the indications for whole brain radiotherapy\n5. At least one measurable brain lesion exists according to the RECIST 1.1 standard\n6. Unlimited number of previous chemotherapy lines\n7. Have not used capecitabine in the past, or progressed 6 months after capecitabine stopped, or progressed after capecitabine as adjuvant therapy stopped for one year\n8. The expected survival period is more than 12 weeks\n9. Patients must have adequate organ function, criteria as follows.\n\n   1. Blood routine examination：Absolute Neutrophil Count (ANC)≥1.5×109/L；PLT ≥100×109/L； Hb ≥90g/L\n   2. Blood chemistry test：TBIL ≤1.5 times the upper limit of normal (ULN); ALT and AST≤3 times ULN; For patients with liver metastases, ALT and AST≤5×ULN; BUN and Cr≤1×ULN and creatinine clearance ≥50mL/min (CockcroftGault formula);\n   3. Ultrasonic cardiogram: LVEF≥50%\n   4. 12-lead ECG: The QT interval (QTcF) corrected by Fridericia's method is < 470 ms\n10. Patients with known hormone receptor status\n11. Patients need to voluntarily join this study after they fully understand and sign the informed consent form. Patients need to have good compliance and be willing to cooperate with follow-up.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Patients with brain metastases with extensive meningeal metastasis\n2. Brain metastases within 5 mm of the hippocampus\n3. There are many factors that affect the administration and absorption of drugs, for example: inability to swallow, chronic diarrhea and intestinal obstruction\n4. Those who have received chemotherapy, surgical treatment (excluding local puncture) or molecular targeted therapy within 4 weeks before enrollment; those who have received anti-tumor endocrine therapy after the screening period\n5. Participated in other drug clinical trials within 4 weeks before enrollment\n6. Have used or are currently using HER2 tyrosine kinase inhibitors (lapatinib, niratinib, pyrotinib, etc.)\n7. Suffered from other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma\n8. Receive any other anti-tumor therapy at the same time\n9. Those who are known to have a history of allergies to the drug; have a history of immunodeficiency, including positive HIV tests, HCV, active hepatitis B, or other acquired or congenital immunodeficiency diseases, or organ transplants history\n10. Have ever suffered from any heart disease, including: (1) arrhythmia requiring medication or clinical significance; (2) myocardial infarction; (3) heart failure; (4) anyone judged by the researcher as unsuitable for participation becase of other heart diseases in this trial, etc.\n11. Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period\n12. According to the judgment of the investigator, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.)\n13. The patient has not recovered from the toxicity of the previous treatment to grade 0-1 (except for hair loss)\n14. Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia\n15. Concomitant use of CYP3A4 inhibitors or inducers or drugs that prolong the QT interval\n16. Any other circumstances that are not suitable for inclusion in this study (investigator assessment)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age> 18 years old, female",
            "criterions": [
                {
                    "exact_snippets": "Age> 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. KPS≥70",
            "criterions": [
                {
                    "exact_snippets": "KPS≥70",
                    "criterion": "Karnofsky Performance Status (KPS)",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. HER2-positive breast cancer is confirmed by the pathology laboratory with an immunohistochemical (IHC) score of 3+ and/or 2+ and a positive in situ hybridization (ISH) test (ISH amplification rate ≥ 2.0)",
            "criterions": [
                {
                    "exact_snippets": "HER2-positive breast cancer is confirmed by the pathology laboratory",
                    "criterion": "HER2-positive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "immunohistochemical (IHC) score of 3+ and/or 2+",
                    "criterion": "IHC score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": [
                                "3+",
                                "2+"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "positive in situ hybridization (ISH) test",
                    "criterion": "ISH test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "ISH amplification rate ≥ 2.0",
                    "criterion": "ISH amplification rate",
                    "requirements": [
                        {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.0,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Brain metastasis confirmed by MRI, in line with the indications for whole brain radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Brain metastasis confirmed by MRI",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "MRI"
                        }
                    ]
                },
                {
                    "exact_snippets": "in line with the indications for whole brain radiotherapy",
                    "criterion": "indications for whole brain radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "alignment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. At least one measurable brain lesion exists according to the RECIST 1.1 standard",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable brain lesion exists",
                    "criterion": "measurable brain lesion",
                    "requirements": [
                        {
                            "requirement_type": "existence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "according to the RECIST 1.1 standard",
                    "criterion": "RECIST 1.1 standard",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Unlimited number of previous chemotherapy lines",
            "criterions": [
                {
                    "exact_snippets": "Unlimited number of previous chemotherapy lines",
                    "criterion": "previous chemotherapy lines",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "unlimited"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Have not used capecitabine in the past, or progressed 6 months after capecitabine stopped, or progressed after capecitabine as adjuvant therapy stopped for one year",
            "criterions": [
                {
                    "exact_snippets": "Have not used capecitabine in the past",
                    "criterion": "capecitabine usage",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "progressed 6 months after capecitabine stopped",
                    "criterion": "progression after capecitabine",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "progressed after capecitabine as adjuvant therapy stopped for one year",
                    "criterion": "progression after capecitabine as adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. The expected survival period is more than 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "expected survival period is more than 12 weeks",
                    "criterion": "expected survival period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients must have adequate organ function, criteria as follows.",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Blood routine examination：Absolute Neutrophil Count (ANC)≥1.5×109/L；PLT ≥100×109/L； Hb ≥90g/L",
            "criterions": [
                {
                    "exact_snippets": "Absolute Neutrophil Count (ANC)≥1.5×109/L",
                    "criterion": "Absolute Neutrophil Count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PLT ≥100×109/L",
                    "criterion": "Platelet count (PLT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hb ≥90g/L",
                    "criterion": "Hemoglobin (Hb)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Blood chemistry test：TBIL ≤1.5 times the upper limit of normal (ULN); ALT and AST≤3 times ULN; For patients with liver metastases, ALT and AST≤5×ULN; BUN and Cr≤1×ULN and creatinine clearance ≥50mL/min (CockcroftGault formula);",
            "criterions": [
                {
                    "exact_snippets": "TBIL ≤1.5 times the upper limit of normal (ULN)",
                    "criterion": "total bilirubin (TBIL)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT and AST≤3 times ULN",
                    "criterion": "alanine aminotransferase (ALT) and aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "For patients with liver metastases, ALT and AST≤5×ULN",
                    "criterion": "alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in patients with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "BUN and Cr≤1×ULN",
                    "criterion": "blood urea nitrogen (BUN) and creatinine (Cr)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance ≥50mL/min (CockcroftGault formula)",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Ultrasonic cardiogram: LVEF≥50%",
            "criterions": [
                {
                    "exact_snippets": "Ultrasonic cardiogram: LVEF≥50%",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. 12-lead ECG: The QT interval (QTcF) corrected by Fridericia's method is < 470 ms",
            "criterions": [
                {
                    "exact_snippets": "12-lead ECG: The QT interval (QTcF) corrected by Fridericia's method is < 470 ms",
                    "criterion": "QT interval (QTcF)",
                    "requirements": [
                        {
                            "requirement_type": "correction method",
                            "expected_value": "Fridericia's method"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients with known hormone receptor status",
            "criterions": [
                {
                    "exact_snippets": "known hormone receptor status",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "knowledge",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patients need to voluntarily join this study after they fully understand and sign the informed consent form. Patients need to have good compliance and be willing to cooperate with follow-up.",
            "criterions": [
                {
                    "exact_snippets": "voluntarily join this study",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fully understand and sign the informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "good compliance",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "good"
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to cooperate with follow-up",
                    "criterion": "willingness to cooperate with follow-up",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "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": "1. Patients with brain metastases with extensive meningeal metastasis",
            "criterions": [
                {
                    "exact_snippets": "brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "extensive meningeal metastasis",
                    "criterion": "meningeal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": "extensive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Brain metastases within 5 mm of the hippocampus",
            "criterions": [
                {
                    "exact_snippets": "Brain metastases within 5 mm of the hippocampus",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "within 5 mm of the hippocampus"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. There are many factors that affect the administration and absorption of drugs, for example: inability to swallow, chronic diarrhea and intestinal obstruction",
            "criterions": [
                {
                    "exact_snippets": "inability to swallow",
                    "criterion": "swallowing ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic diarrhea",
                    "criterion": "chronic diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intestinal obstruction",
                    "criterion": "intestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Participated in other drug clinical trials within 4 weeks before enrollment",
            "criterions": [
                {
                    "exact_snippets": "Participated in other drug clinical trials within 4 weeks before enrollment",
                    "criterion": "participation in other drug clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Have used or are currently using HER2 tyrosine kinase inhibitors (lapatinib, niratinib, pyrotinib, etc.)",
            "criterions": [
                {
                    "exact_snippets": "Have used or are currently using HER2 tyrosine kinase inhibitors (lapatinib, niratinib, pyrotinib, etc.)",
                    "criterion": "HER2 tyrosine kinase inhibitors usage",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Suffered from other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Suffered from other malignant tumors in the past 5 years",
                    "criterion": "history of malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma",
                    "criterion": "type of previous cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "cured cervical carcinoma in situ",
                                "skin basal cell carcinoma",
                                "skin squamous cell carcinoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Receive any other anti-tumor therapy at the same time",
            "criterions": [
                {
                    "exact_snippets": "Receive any other anti-tumor therapy",
                    "criterion": "anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrent treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Those who are known to have a history of allergies to the drug; have a history of immunodeficiency, including positive HIV tests, HCV, active hepatitis B, or other acquired or congenital immunodeficiency diseases, or organ transplants history",
            "criterions": [
                {
                    "exact_snippets": "history of allergies to the drug",
                    "criterion": "allergies to the drug",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive HIV tests",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HCV",
                    "criterion": "HCV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "other acquired or congenital immunodeficiency diseases",
                    "criterion": "acquired or congenital immunodeficiency diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "organ transplants history",
                    "criterion": "organ transplants",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Have ever suffered from any heart disease, including: (1) arrhythmia requiring medication or clinical significance; (2) myocardial infarction; (3) heart failure; (4) anyone judged by the researcher as unsuitable for participation becase of other heart diseases in this trial, etc.",
            "criterions": [
                {
                    "exact_snippets": "heart disease, including: (1) arrhythmia requiring medication or clinical significance",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "requiring medication or clinical significance"
                        }
                    ]
                },
                {
                    "exact_snippets": "heart disease, including: ... (2) myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "heart disease, including: ... (3) heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "heart disease, including: ... (4) anyone judged by the researcher as unsuitable for participation becase of other heart diseases",
                    "criterion": "other heart diseases",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": "judged by the researcher as unsuitable for participation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period",
            "criterions": [
                {
                    "exact_snippets": "Female patients during pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "female patients with fertility",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive baseline pregnancy test",
                    "criterion": "baseline pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "female patients of childbearing age",
                    "criterion": "childbearing age",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unwilling to take effective contraceptive measures during the entire trial period",
                    "criterion": "contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. According to the judgment of the investigator, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.)",
            "criterions": [
                {
                    "exact_snippets": "accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study",
                    "criterion": "accompanying diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "seriously endanger the safety of the patient or affect the completion of the study"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe hypertension that cannot be controlled by drugs",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "cannot be controlled by drugs"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. The patient has not recovered from the toxicity of the previous treatment to grade 0-1 (except for hair loss)",
            "criterions": [
                {
                    "exact_snippets": "The patient has not recovered from the toxicity of the previous treatment to grade 0-1",
                    "criterion": "recovery from treatment toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 0,
                                        "unit": "grade"
                                    },
                                    {
                                        "operator": "=",
                                        "value": 1,
                                        "unit": "grade"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for hair loss",
                    "criterion": "hair loss",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia",
            "criterions": [
                {
                    "exact_snippets": "neurological or psychiatric disorders",
                    "criterion": "neurological or psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "epilepsy",
                    "criterion": "epilepsy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "dementia",
                    "criterion": "dementia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Concomitant use of CYP3A4 inhibitors or inducers or drugs that prolong the QT interval",
            "criterions": [
                {
                    "exact_snippets": "Concomitant use of CYP3A4 inhibitors",
                    "criterion": "CYP3A4 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "concomitant use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant use of ... inducers",
                    "criterion": "CYP3A4 inducers",
                    "requirements": [
                        {
                            "requirement_type": "concomitant use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant use of ... drugs that prolong the QT interval",
                    "criterion": "drugs that prolong the QT interval",
                    "requirements": [
                        {
                            "requirement_type": "concomitant use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Any other circumstances that are not suitable for inclusion in this study (investigator assessment)",
            "criterions": [
                {
                    "exact_snippets": "Any other circumstances that are not suitable for inclusion in this study (investigator assessment)",
                    "criterion": "suitability for inclusion",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "investigator assessment"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "4. Those who have received chemotherapy, surgical treatment (excluding local puncture) or molecular targeted therapy within 4 weeks before enrollment; those who have received anti-tumor endocrine therapy after the screening period",
            "criterions": [
                {
                    "exact_snippets": "received chemotherapy ... within 4 weeks before enrollment",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "received surgical treatment (excluding local puncture) ... within 4 weeks before enrollment",
                    "criterion": "surgical treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "received molecular targeted therapy within 4 weeks before enrollment",
                    "criterion": "molecular targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "received anti-tumor endocrine therapy after the screening period",
                    "criterion": "anti-tumor endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": "after the screening period"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}