{
    "info": {
        "nct_id": "NCT05638594",
        "official_title": "A Randomized Controlled, Open-label, Multicenter Clinical Study of Pyrotinib Maleate Combined With Trastuzumab,Dalpiciclib, and Letrozole Versus Trastuzumab Combined With Pertuzumab, Docetaxel, and Carboplatin as Neoadjuvant Therapy for Stage II-III HR +/HER2 + Breast Cancer",
        "inclusion_criteria": "1. Female patients aged 18 -75 ;\n2. Willing to receive LHRH agonist therapy (premenopausal patients only);\n3. All patients were histopathologically confirmed to be estrogen receptor (ER) -positive and HER2-positive.\n4. Treatment-naïve stage II-III patients with tumor stage meeting AJCC version 8 criteria;\n5. ECOG score 0-1;\n6. Organ function level must meet the following requirements:\n\n(1) bone marrow function • ANC ≥ 1.5 x 109/L ; • PLT ≥ 100 × 109/L • Hb ≥ 90 g/L ; (2) hepatic and renal function • TBIL ≤ 1.5 × ULN; • AL and AST ≤ 3 × ULN (ALT and AST ≤ 5 × ULN in patients with liver metastases); • BUN and Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min; (Cockcroft-Gault formula) (3) Echocardiography: LVEF ≥ 50%; (4) 12-lead ECG: QT interval ≤ 480 ms; 7. Able to undergo needle biopsy; 8. Voluntarily join this study to sign informed consent, have good compliance and 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. Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);\n2. Received any other anti-tumor therapy at the same time;\n3. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer;\n4. Stage IV breast cancer;\n5. Breast cancer without histopathological diagnosis;\n6. Other malignant tumors in the past 5 years, except cured cutaneous basal cell carcinoma and cervical carcinoma in situ;\n7. Severe heart, liver and kidney and other vital organ dysfunction;\n8. Inability to swallow, chronic diarrhea and intestinal obstruction, there are a variety of factors affecting drug administration and absorption;\n9. Participated in other drug clinical trials within 4 weeks before enrollment;\n10. Known history of hypersensitivity to the drug components of this protocol; history of immunodeficiency, including positive HIV test, HCV, active viral hepatitis B or other acquired, congenital immunodeficiency diseases, or history of organ transplantation;\n11. Had any cardiac disease, including: (1) cardiac arrhythmia requiring medication or clinically significant; (2) myocardial infarction; (3) heart failure; (4) any other cardiac disease judged by the investigator to be inappropriate for participation in this trial;\n12. Female patients who are pregnant or lactating, female patients of childbearing potential with a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;\n13. According to the investigator 's judgment, there are concomitant diseases that seriously jeopardize the patient' s safety or affect the patient 's completion of the study (including but not limited to uncontrolled severe hypertension, severe diabetes, active infection, etc.);\n14. Had a documented history of neurological or psychiatric disorders, including epilepsy or dementia.Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Female patients aged 18 -75 ;",
                "criterions": [
                    {
                        "exact_snippets": "Female patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "aged 18 -75",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Female patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "aged 18 -75",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Willing to receive LHRH agonist therapy (premenopausal patients only);",
                "criterions": [
                    {
                        "exact_snippets": "Willing to receive LHRH agonist therapy",
                        "criterion": "LHRH agonist therapy",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "premenopausal patients only",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "premenopausal"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "premenopausal patients only",
                    "criterion": "menopausal status",
                    "requirement": {
                        "requirement_type": "status",
                        "expected_value": "premenopausal"
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Willing to receive LHRH agonist therapy",
                    "criterion": "LHRH agonist therapy",
                    "requirement": {
                        "requirement_type": "willingness",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "3. All patients were histopathologically confirmed to be estrogen receptor (ER) -positive and HER2-positive.",
                "criterions": [
                    {
                        "exact_snippets": "histopathologically confirmed to be estrogen receptor (ER) -positive",
                        "criterion": "estrogen receptor (ER) status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "histopathologically confirmed to be ... HER2-positive",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "histopathologically confirmed to be estrogen receptor (ER) -positive",
                        "criterion": "estrogen receptor (ER) status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "histopathologically confirmed to be ... HER2-positive",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. ECOG score 0-1;",
                "criterions": [
                    {
                        "exact_snippets": "ECOG score 0-1",
                        "criterion": "ECOG score",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG score 0-1",
                        "criterion": "ECOG score",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Organ function level must meet the following requirements:",
                "criterions": [
                    {
                        "exact_snippets": "Organ function level must meet the following requirements",
                        "criterion": "organ function level",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "must meet the following requirements"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Organ function level must meet the following requirements",
                        "criterion": "organ function level",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "must meet the following requirements"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "(1) bone marrow function • ANC ≥ 1.5 x 109/L ; • PLT ≥ 100 × 109/L • Hb ≥ 90 g/L ; (2) hepatic and renal function • TBIL ≤ 1.5 × ULN; • AL and AST ≤ 3 × ULN (ALT and AST ≤ 5 × ULN in patients with liver metastases); • BUN and Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min; (Cockcroft-Gault formula) (3) Echocardiography: LVEF ≥ 50%; (4) 12-lead ECG: QT interval ≤ 480 ms; 7. Able to undergo needle biopsy; 8. Voluntarily join this study to sign informed consent, have good compliance and willing to cooperate with follow-up.",
                "criterions": [
                    {
                        "exact_snippets": "bone marrow function • ANC ≥ 1.5 x 109/L",
                        "criterion": "ANC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "bone marrow function • ... PLT ≥ 100 × 109/L",
                        "criterion": "PLT",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "bone marrow function • ... Hb ≥ 90 g/L",
                        "criterion": "Hb",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hepatic and renal function • TBIL ≤ 1.5 × ULN",
                        "criterion": "TBIL",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hepatic and renal function • ... AL and AST ≤ 3 × ULN",
                        "criterion": "AL and AST",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hepatic and renal function • ... ALT and AST ≤ 5 × ULN in patients with liver metastases",
                        "criterion": "ALT and AST in patients with liver metastases",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hepatic and renal function • ... BUN and Cr ≤ 1.5 × ULN",
                        "criterion": "BUN and Cr",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hepatic and renal function • ... creatinine clearance ≥ 50 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Echocardiography: LVEF ≥ 50%",
                        "criterion": "LVEF",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "12-lead ECG: QT interval ≤ 480 ms",
                        "criterion": "QT interval",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 480,
                                "unit": "ms"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Able to undergo needle biopsy",
                        "criterion": "ability to undergo needle biopsy",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Voluntarily join this study to sign informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "voluntary participation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "have good compliance and willing to cooperate with follow-up",
                        "criterion": "compliance and cooperation",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "bone marrow function • ANC ≥ 1.5 x 109/L",
                                        "criterion": "ANC",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 1.5,
                                                "unit": "x 10^9/L"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "bone marrow function • ... PLT ≥ 100 × 109/L",
                                        "criterion": "PLT",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 100,
                                                "unit": "x 10^9/L"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "bone marrow function • ... Hb ≥ 90 g/L",
                                        "criterion": "Hb",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 90,
                                                "unit": "g/L"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "or_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "hepatic and renal function • TBIL ≤ 1.5 × ULN",
                                                "criterion": "TBIL",
                                                "requirement": {
                                                    "requirement_type": "quantity",
                                                    "expected_value": {
                                                        "operator": "<=",
                                                        "value": 1.5,
                                                        "unit": "x ULN"
                                                    }
                                                }
                                            },
                                            {
                                                "exact_snippets": "hepatic and renal function • ... AL and AST ≤ 3 × ULN",
                                                "criterion": "AL and AST",
                                                "requirement": {
                                                    "requirement_type": "quantity",
                                                    "expected_value": {
                                                        "operator": "<=",
                                                        "value": 3,
                                                        "unit": "x ULN"
                                                    }
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "hepatic and renal function • TBIL ≤ 1.5 × ULN",
                                                "criterion": "TBIL",
                                                "requirement": {
                                                    "requirement_type": "quantity",
                                                    "expected_value": {
                                                        "operator": "<=",
                                                        "value": 1.5,
                                                        "unit": "x ULN"
                                                    }
                                                }
                                            },
                                            {
                                                "exact_snippets": "hepatic and renal function • ... ALT and AST ≤ 5 × ULN in patients with liver metastases",
                                                "criterion": "ALT and AST in patients with liver metastases",
                                                "requirement": {
                                                    "requirement_type": "quantity",
                                                    "expected_value": {
                                                        "operator": "<=",
                                                        "value": 5,
                                                        "unit": "x ULN"
                                                    }
                                                }
                                            }
                                        ]
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "hepatic and renal function • ... BUN and Cr ≤ 1.5 × ULN",
                                        "criterion": "BUN and Cr",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1.5,
                                                "unit": "x ULN"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "hepatic and renal function • ... creatinine clearance ≥ 50 mL/min",
                                        "criterion": "creatinine clearance",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 50,
                                                "unit": "mL/min"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Echocardiography: LVEF ≥ 50%",
                        "criterion": "LVEF",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "12-lead ECG: QT interval ≤ 480 ms",
                        "criterion": "QT interval",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 480,
                                "unit": "ms"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Able to undergo needle biopsy",
                        "criterion": "ability to undergo needle biopsy",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Voluntarily join this study to sign informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "voluntary participation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "have good compliance and willing to cooperate with follow-up",
                        "criterion": "compliance and cooperation",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "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": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "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 75 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);",
                "criterions": [
                    {
                        "exact_snippets": "Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)",
                        "criterion": "anti-tumor therapy",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)",
                    "criterion": "anti-tumor therapy",
                    "requirement": {
                        "requirement_type": "receipt",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Received any other anti-tumor therapy at the same time;",
                "criterions": [
                    {
                        "exact_snippets": "Received any other anti-tumor therapy at the same time",
                        "criterion": "anti-tumor therapy",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "at the same time"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Received any other anti-tumor therapy at the same time",
                        "criterion": "anti-tumor therapy",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "at the same time"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer;",
                "criterions": [
                    {
                        "exact_snippets": "Bilateral breast cancer",
                        "criterion": "bilateral breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "inflammatory breast cancer",
                        "criterion": "inflammatory breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "occult breast cancer",
                        "criterion": "occult breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Bilateral breast cancer",
                        "criterion": "bilateral breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "inflammatory breast cancer",
                        "criterion": "inflammatory breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "occult breast cancer",
                        "criterion": "occult breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Stage IV breast cancer;",
                "criterions": [
                    {
                        "exact_snippets": "Stage IV breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Stage IV breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Breast cancer without histopathological diagnosis;",
                "criterions": [
                    {
                        "exact_snippets": "Breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "without histopathological diagnosis",
                        "criterion": "histopathological diagnosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "without histopathological diagnosis",
                        "criterion": "histopathological diagnosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Severe heart, liver and kidney and other vital organ dysfunction;",
                "criterions": [
                    {
                        "exact_snippets": "Severe heart ... dysfunction",
                        "criterion": "heart dysfunction",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Severe ... liver ... dysfunction",
                        "criterion": "liver dysfunction",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Severe ... kidney ... dysfunction",
                        "criterion": "kidney dysfunction",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Severe ... other vital organ dysfunction",
                        "criterion": "other vital organ dysfunction",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Severe heart ... dysfunction",
                                "criterion": "heart dysfunction",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "Severe ... liver ... dysfunction",
                                "criterion": "liver dysfunction",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "Severe ... kidney ... dysfunction",
                                "criterion": "kidney dysfunction",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Severe ... other vital organ dysfunction",
                        "criterion": "other vital organ dysfunction",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Inability to swallow, chronic diarrhea and intestinal obstruction, there are a variety of factors affecting drug administration and absorption;",
                "criterions": [
                    {
                        "exact_snippets": "Inability to swallow",
                        "criterion": "ability to swallow",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "chronic diarrhea",
                        "criterion": "chronic diarrhea",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "intestinal obstruction",
                        "criterion": "intestinal obstruction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Inability to swallow",
                            "criterion": "ability to swallow",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "exact_snippets": "chronic diarrhea",
                        "criterion": "chronic diarrhea",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "intestinal obstruction",
                        "criterion": "intestinal obstruction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. 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",
                        "requirement": {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Participated in other drug clinical trials within 4 weeks before enrollment",
                    "criterion": "participation in other drug clinical trials",
                    "requirement": {
                        "requirement_type": "time since last participation",
                        "expected_value": {
                            "operator": "<=",
                            "value": 4,
                            "unit": "weeks"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "10. Known history of hypersensitivity to the drug components of this protocol; history of immunodeficiency, including positive HIV test, HCV, active viral hepatitis B or other acquired, congenital immunodeficiency diseases, or history of organ transplantation;",
                "criterions": [
                    {
                        "exact_snippets": "Known history of hypersensitivity to the drug components of this protocol",
                        "criterion": "hypersensitivity to drug components",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of immunodeficiency",
                        "criterion": "immunodeficiency",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "positive HIV test",
                        "criterion": "HIV",
                        "requirement": {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "HCV",
                        "criterion": "HCV",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active viral hepatitis B",
                        "criterion": "active viral hepatitis B",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other acquired, congenital immunodeficiency diseases",
                        "criterion": "acquired or congenital immunodeficiency diseases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of organ transplantation",
                        "criterion": "organ transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "history of immunodeficiency",
                                "criterion": "immunodeficiency",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "positive HIV test",
                                        "criterion": "HIV",
                                        "requirement": {
                                            "requirement_type": "test result",
                                            "expected_value": "positive"
                                        }
                                    },
                                    {
                                        "exact_snippets": "HCV",
                                        "criterion": "HCV",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "active viral hepatitis B",
                                        "criterion": "active viral hepatitis B",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "other acquired, congenital immunodeficiency diseases",
                                        "criterion": "acquired or congenital immunodeficiency diseases",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Known history of hypersensitivity to the drug components of this protocol",
                        "criterion": "hypersensitivity to drug components",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of organ transplantation",
                        "criterion": "organ transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Had any cardiac disease, including: (1) cardiac arrhythmia requiring medication or clinically significant; (2) myocardial infarction; (3) heart failure; (4) any other cardiac disease judged by the investigator to be inappropriate for participation in this trial;",
                "criterions": [
                    {
                        "exact_snippets": "cardiac arrhythmia requiring medication or clinically significant",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "requiring medication or clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "heart failure",
                        "criterion": "heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "any other cardiac disease judged by the investigator to be inappropriate for participation in this trial",
                        "criterion": "other cardiac disease",
                        "requirement": {
                            "requirement_type": "appropriateness for participation",
                            "expected_value": "judged by the investigator to be inappropriate"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "cardiac arrhythmia requiring medication or clinically significant",
                                "criterion": "cardiac arrhythmia",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "requiring medication or clinically significant"
                                }
                            },
                            {
                                "exact_snippets": "myocardial infarction",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "heart failure",
                                "criterion": "heart failure",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "any other cardiac disease judged by the investigator to be inappropriate for participation in this trial",
                                "criterion": "other cardiac disease",
                                "requirement": {
                                    "requirement_type": "appropriateness for participation",
                                    "expected_value": "judged by the investigator to be inappropriate"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Female patients who are pregnant or lactating, female patients of childbearing potential with a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;",
                "criterions": [
                    {
                        "exact_snippets": "Female patients who are pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "female patients of childbearing potential with a positive baseline pregnancy test",
                        "criterion": "baseline pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial",
                        "criterion": "willingness to take contraceptive measures",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Female patients who are pregnant",
                                "criterion": "pregnancy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "lactating",
                                "criterion": "lactation",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "female patients of childbearing potential with a positive baseline pregnancy test",
                        "criterion": "baseline pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial",
                        "criterion": "willingness to take contraceptive measures",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. According to the investigator 's judgment, there are concomitant diseases that seriously jeopardize the patient' s safety or affect the patient 's completion of the study (including but not limited to uncontrolled severe hypertension, severe diabetes, active infection, etc.);",
                "criterions": [
                    {
                        "exact_snippets": "concomitant diseases that seriously jeopardize the patient' s safety or affect the patient 's completion of the study",
                        "criterion": "concomitant diseases",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "seriously jeopardize the patient's safety or affect the patient's completion of the study"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled severe hypertension",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled severe hypertension",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "severe diabetes",
                        "criterion": "diabetes",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "active infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "uncontrolled severe hypertension",
                                        "criterion": "hypertension",
                                        "requirement": {
                                            "requirement_type": "control",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "uncontrolled severe hypertension",
                                        "criterion": "hypertension",
                                        "requirement": {
                                            "requirement_type": "severity",
                                            "expected_value": "severe"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "severe diabetes",
                                "criterion": "diabetes",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "active infection",
                                "criterion": "infection",
                                "requirement": {
                                    "requirement_type": "activity",
                                    "expected_value": "active"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "concomitant diseases that seriously jeopardize the patient' s safety or affect the patient 's completion of the study",
                        "criterion": "concomitant diseases",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "seriously jeopardize the patient's safety or affect the patient's completion of the study"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "14. Had a documented history of neurological or psychiatric disorders, including epilepsy or dementia.Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.",
                "criterions": [
                    {
                        "exact_snippets": "documented history of neurological or psychiatric disorders",
                        "criterion": "neurological or psychiatric disorders",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "epilepsy",
                        "criterion": "epilepsy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "dementia",
                        "criterion": "dementia",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Any other condition ... in the opinion of the investigator",
                        "criterion": "any other condition",
                        "requirement": {
                            "requirement_type": "appropriateness",
                            "expected_value": "inappropriate for participation"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "documented history of neurological or psychiatric disorders",
                                        "criterion": "neurological or psychiatric disorders",
                                        "requirement": {
                                            "requirement_type": "history",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "or_criteria": [
                                            {
                                                "exact_snippets": "epilepsy",
                                                "criterion": "epilepsy",
                                                "requirement": {
                                                    "requirement_type": "history",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "dementia",
                                                "criterion": "dementia",
                                                "requirement": {
                                                    "requirement_type": "history",
                                                    "expected_value": true
                                                }
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Any other condition ... in the opinion of the investigator",
                        "criterion": "any other condition",
                        "requirement": {
                            "requirement_type": "appropriateness",
                            "expected_value": "inappropriate for participation"
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "4. Treatment-naïve stage II-III patients with tumor stage meeting AJCC version 8 criteria;",
                "criterions": [
                    {
                        "exact_snippets": "Treatment-naïve",
                        "criterion": "treatment history",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "naïve"
                        }
                    },
                    {
                        "exact_snippets": "stage II-III patients",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "tumor stage meeting AJCC version 8 criteria",
                        "criterion": "tumor stage",
                        "requirement": {
                            "requirement_type": "standard",
                            "expected_value": "AJCC version 8"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Treatment-na\u0013fve",
                        "criterion": "treatment history",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "na\u0013fve"
                        }
                    },
                    {
                        "exact_snippets": "stage II-III patients",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "tumor stage meeting AJCC version 8 criteria",
                        "criterion": "tumor stage",
                        "requirement": {
                            "requirement_type": "standard",
                            "expected_value": "AJCC version 8"
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "6. Other malignant tumors in the past 5 years, except cured cutaneous basal cell carcinoma and cervical carcinoma in situ;",
                "criterions": [
                    {
                        "exact_snippets": "Other malignant tumors in the past 5 years",
                        "criterion": "malignant tumors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "except cured cutaneous basal cell carcinoma and cervical carcinoma in situ",
                        "criterion": "cured cutaneous basal cell carcinoma and cervical carcinoma in situ",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Other malignant tumors in the past 5 years",
                                    "criterion": "malignant tumors",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "except cured cutaneous basal cell carcinoma and cervical carcinoma in situ",
                                        "criterion": "cured cutaneous basal cell carcinoma and cervical carcinoma in situ",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}