{
    "info": {
        "nct_id": "NCT05983094",
        "official_title": "Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer",
        "inclusion_criteria": "1. Female patients who will receive initial treatment, 18-70 years of age；\n2. Newly diagnosed high-risk early stage (T1c-2, N1; T2, N0) and locally advanced (T1c-2, N2-3; T3-4, N0-3) breast cancer (tumor stage II, III), in which HR+/HER2- T2, N0 patients need to be accompanied by high-risk factors (histological grade 3 or Ki67 ≥ 20%). Triple negative breast cancer(TNBC), HER2 positive (Immunohistochemical(IHC)3+; IHC 2+, FISH amplification) breast cancer, HR negative HER2 IHC 2+ and undetermined result of FISH, HR positive HER2 negative (IHC 0,1+; 2+, FISH amplification) breast cancer confirmed by pathological test.\n3. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1\n4. The blood routine examination was basically normal (CTCAE ≤ 1) within one week before enrollment (based on the normal values of each research center laboratory). No Human Granulocyte Colony Stimulating Factor(rhGCSF) or blood transfusion/erythropoietin(EPO) or other drugs were used within 14 days prior to enrollment.\n\n   White blood cell count (WBC) ≥ 4 x109 / L; Neutrophil count (ANC) > 1.5x109 / L; Platelet count (PLT) ≥ 100×109/L Hemoglobin(Hb) ≥ 100g/L.\n5. The blood biochemistry examination was basically normal (CTCAE ≤ 1) within one week before enrollment (based on the normal values of each research center laboratory) Serum total bilirubin ≤ Upper limit of normal value(ULN)； Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 1.5×ULN； Alkaline phosphatase ≤ 2.5×ULN； Serum creatinine ≤ 1.5×ULN.\n6. Color Doppler echocardiography left ventricular Ejection fraction (LVEF) ≥ 55%\n7. Female patients with fertility must agree to use effective contraceptive methods during the study period and within 6 months of the last study medication. The Pregnancy test (urine or serum) must be negative\n8. Be willing and able to provide written informed consent/assent for the trial.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "1. Primary stage IV breast cancer；\n2. Inflammatory breast cancer;\n3. Bilateral primary breast cancer (including invasive cancer and carcinoma in situ)；\n4. Previous anti-cancer treatment or radiotherapy for any malignant tumor, excluding cured cervical Carcinoma in situ, skin Basal-cell carcinoma and squamous cell carcinoma.\n5. Receive any sex hormone treatment (such as contraceptives, ovarian hormone replacement therapy, etc.), except for Ovarian function suppression（OFS）fertility protection, or any hormone drugs (such as Raloxifene, tamoxifen, or other selective estrogen receptor modulators) to treat osteoporosis or prevent breast cancer；\n6. The patient has undergone major surgery unrelated to breast cancer within 4 weeks before treatment or has not yet fully recovered;\n7. Symptomatic peripheral neuropathy CTCAE 5.0 grade ≥ 2\n8. Serious cardio cerebral Vascular disease, including but not limited to the followings:\n9. History of congestive heart failure or systolic dysfunction (LVEF<50%);\n10. Angina pectoris requiring anti angina drugs;\n11. High risk uncontrolled arrhythmias or severe conduction abnormalities, such as ventricular arrhythmias that require clinical intervention, II-III degree atrioventricular block, etc; Under resting state, the average corrected Q-T interval(QTcF) of three 12 lead electrocardiogram examinations is>470ms;\n12. Clinically significant heart valve disease with cardiac dysfunction;\n13. Hypertension that cannot be controlled;\n14. History of myocardial infarction\n15. Allergic to any component of any drug in this protocol.\n16. Those who are not suitable for using Corticosteroid.\n17. Individuals with active infections who currently require systematic anti infection treatment.\n18. History of immune deficiency disease, including positive of HIV/AIDS, or other acquired or congenital immune deficiency diseases, or having a history of organ transplantation.\n19. Who had participated in other drug intervention clinical trials within the 28 days of randomization, or who is participating in another clinical trial or is using other investigational treatments.\n20. Individuals in pregnancy (positive Pregnancy test) and lactation.\n21. Any other comorbidities that interfere with the implementation of the treatment plan, or the researcher evaluate that the subject has a history of other serious systemic diseases, or other reasons lead to the patients is unsuitable to participate in this trial.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Female patients who will receive initial treatment, 18-70 years of age；",
                "criterions": [
                    {
                        "exact_snippets": "Female patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "18-70 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Female patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "18-70 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. The blood routine examination was basically normal (CTCAE ≤ 1) within one week before enrollment (based on the normal values of each research center laboratory). No Human Granulocyte Colony Stimulating Factor(rhGCSF) or blood transfusion/erythropoietin(EPO) or other drugs were used within 14 days prior to enrollment.",
                "criterions": [
                    {
                        "exact_snippets": "The blood routine examination was basically normal (CTCAE ≤ 1) within one week before enrollment",
                        "criterion": "blood routine examination",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "CTCAE"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No Human Granulocyte Colony Stimulating Factor(rhGCSF) ... used within 14 days prior to enrollment",
                        "criterion": "Human Granulocyte Colony Stimulating Factor (rhGCSF) usage",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... blood transfusion ... used within 14 days prior to enrollment",
                        "criterion": "blood transfusion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... erythropoietin(EPO) ... used within 14 days prior to enrollment",
                        "criterion": "erythropoietin (EPO) usage",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... other drugs were used within 14 days prior to enrollment",
                        "criterion": "other drug usage",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "The blood routine examination was basically normal (CTCAE ≤ 1) within one week before enrollment",
                                "criterion": "blood routine examination",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "CTCAE"
                                    }
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "No Human Granulocyte Colony Stimulating Factor(rhGCSF) ... used within 14 days prior to enrollment",
                                        "criterion": "Human Granulocyte Colony Stimulating Factor (rhGCSF) usage",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "No ... blood transfusion ... used within 14 days prior to enrollment",
                                        "criterion": "blood transfusion",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "No ... erythropoietin(EPO) ... used within 14 days prior to enrollment",
                                        "criterion": "erythropoietin (EPO) usage",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "No ... other drugs were used within 14 days prior to enrollment",
                                        "criterion": "other drug usage",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "White blood cell count (WBC) ≥ 4 x109 / L; Neutrophil count (ANC) > 1.5x109 / L; Platelet count (PLT) ≥ 100×109/L Hemoglobin(Hb) ≥ 100g/L.",
                "criterions": [
                    {
                        "exact_snippets": "White blood cell count (WBC) ≥ 4 x109 / L",
                        "criterion": "white blood cell count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "x10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Neutrophil count (ANC) > 1.5x109 / L",
                        "criterion": "neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelet count (PLT) ≥ 100×109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hemoglobin(Hb) ≥ 100g/L",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "g/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "White blood cell count (WBC) ≥ 4 x109 / L",
                        "criterion": "white blood cell count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "x10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Neutrophil count (ANC) > 1.5x109 / L",
                        "criterion": "neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelet count (PLT) ≥ 100×109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hemoglobin(Hb) ≥ 100g/L",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "g/L"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. The blood biochemistry examination was basically normal (CTCAE ≤ 1) within one week before enrollment (based on the normal values of each research center laboratory) Serum total bilirubin ≤ Upper limit of normal value(ULN)； Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 1.5×ULN； Alkaline phosphatase ≤ 2.5×ULN； Serum creatinine ≤ 1.5×ULN.",
                "criterions": [
                    {
                        "exact_snippets": "blood biochemistry examination was basically normal (CTCAE ≤ 1)",
                        "criterion": "blood biochemistry",
                        "requirement": {
                            "requirement_type": "normality",
                            "expected_value": "CTCAE ≤ 1"
                        }
                    },
                    {
                        "exact_snippets": "Serum total bilirubin ≤ Upper limit of normal value(ULN)",
                        "criterion": "serum total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 1.5×ULN",
                        "criterion": "Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alkaline phosphatase ≤ 2.5×ULN",
                        "criterion": "Alkaline phosphatase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Serum creatinine ≤ 1.5×ULN",
                        "criterion": "Serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "blood biochemistry examination was basically normal (CTCAE ≤ 1)",
                        "criterion": "blood biochemistry",
                        "requirement": {
                            "requirement_type": "normality",
                            "expected_value": "CTCAE ≤ 1"
                        }
                    },
                    {
                        "exact_snippets": "Serum total bilirubin ≤ Upper limit of normal value(ULN)",
                        "criterion": "serum total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 1.5×ULN",
                        "criterion": "Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alkaline phosphatase ≤ 2.5×ULN",
                        "criterion": "Alkaline phosphatase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Serum creatinine ≤ 1.5×ULN",
                        "criterion": "Serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Color Doppler echocardiography left ventricular Ejection fraction (LVEF) ≥ 55%",
                "criterions": [
                    {
                        "exact_snippets": "Color Doppler echocardiography left ventricular Ejection fraction (LVEF) ≥ 55%",
                        "criterion": "left ventricular ejection fraction (LVEF)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 55,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Color Doppler echocardiography left ventricular Ejection fraction (LVEF) ≥ 55%",
                        "criterion": "left ventricular ejection fraction (LVEF)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 55,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Female patients with fertility must agree to use effective contraceptive methods during the study period and within 6 months of the last study medication. The Pregnancy test (urine or serum) must be negative",
                "criterions": [
                    {
                        "exact_snippets": "Female patients with fertility",
                        "criterion": "gender and fertility",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "Female patients with fertility",
                        "criterion": "gender and fertility",
                        "requirement": {
                            "requirement_type": "fertility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must agree to use effective contraceptive methods during the study period and within 6 months of the last study medication",
                        "criterion": "contraceptive use",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must agree to use effective contraceptive methods during the study period and within 6 months of the last study medication",
                        "criterion": "contraceptive use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during the study period and within 6 months of the last study medication"
                        }
                    },
                    {
                        "exact_snippets": "The Pregnancy test (urine or serum) must be negative",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Female patients with fertility",
                                "criterion": "gender and fertility",
                                "requirement": {
                                    "requirement_type": "gender",
                                    "expected_value": "female"
                                }
                            },
                            {
                                "exact_snippets": "Female patients with fertility",
                                "criterion": "gender and fertility",
                                "requirement": {
                                    "requirement_type": "fertility",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "must agree to use effective contraceptive methods during the study period and within 6 months of the last study medication",
                                "criterion": "contraceptive use",
                                "requirement": {
                                    "requirement_type": "agreement",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "must agree to use effective contraceptive methods during the study period and within 6 months of the last study medication",
                                "criterion": "contraceptive use",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": "during the study period and within 6 months of the last study medication"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "The Pregnancy test (urine or serum) must be negative",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Be willing and able to provide written informed consent/assent for the trial.",
                "criterions": [
                    {
                        "exact_snippets": "willing and able to provide written informed consent/assent",
                        "criterion": "informed consent/assent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing and able to provide written informed consent/assent",
                        "criterion": "informed consent/assent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "willing and able to provide written informed consent/assent",
                        "criterion": "informed consent/assent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing and able to provide written informed consent/assent",
                        "criterion": "informed consent/assent",
                        "requirement": {
                            "requirement_type": "ability",
                            "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": "N/A",
                            "expected_value": "FEMALE"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "FEMALE"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 70 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Primary stage IV breast cancer；",
                "criterions": [
                    {
                        "exact_snippets": "Primary stage IV breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Primary stage IV breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Inflammatory breast cancer;",
                "criterions": [
                    {
                        "exact_snippets": "Inflammatory breast cancer",
                        "criterion": "inflammatory breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Inflammatory breast cancer",
                    "criterion": "inflammatory breast cancer",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Bilateral primary breast cancer (including invasive cancer and carcinoma in situ)；",
                "criterions": [
                    {
                        "exact_snippets": "Bilateral primary breast cancer",
                        "criterion": "bilateral primary breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "invasive cancer",
                        "criterion": "invasive cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "carcinoma in situ",
                        "criterion": "carcinoma in situ",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Bilateral primary breast cancer",
                                "criterion": "bilateral primary breast cancer",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "invasive cancer",
                                "criterion": "invasive cancer",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Bilateral primary breast cancer",
                                "criterion": "bilateral primary breast cancer",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "carcinoma in situ",
                                "criterion": "carcinoma in situ",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Previous anti-cancer treatment or radiotherapy for any malignant tumor, excluding cured cervical Carcinoma in situ, skin Basal-cell carcinoma and squamous cell carcinoma.",
                "criterions": [
                    {
                        "exact_snippets": "Previous anti-cancer treatment",
                        "criterion": "previous anti-cancer treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "radiotherapy for any malignant tumor",
                        "criterion": "previous radiotherapy for malignant tumor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "excluding cured cervical Carcinoma in situ",
                        "criterion": "cured cervical carcinoma in situ",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "excluding ... skin Basal-cell carcinoma",
                        "criterion": "cured skin basal-cell carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "excluding ... squamous cell carcinoma",
                        "criterion": "cured squamous cell carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Previous anti-cancer treatment",
                                        "criterion": "previous anti-cancer treatment",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "excluding cured cervical Carcinoma in situ",
                                        "criterion": "cured cervical carcinoma in situ",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "excluding ... skin Basal-cell carcinoma",
                                        "criterion": "cured skin basal-cell carcinoma",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "excluding ... squamous cell carcinoma",
                                        "criterion": "cured squamous cell carcinoma",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "radiotherapy for any malignant tumor",
                                        "criterion": "previous radiotherapy for malignant tumor",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "excluding cured cervical Carcinoma in situ",
                                        "criterion": "cured cervical carcinoma in situ",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "excluding ... skin Basal-cell carcinoma",
                                        "criterion": "cured skin basal-cell carcinoma",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "excluding ... squamous cell carcinoma",
                                        "criterion": "cured squamous cell carcinoma",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Receive any sex hormone treatment (such as contraceptives, ovarian hormone replacement therapy, etc.), except for Ovarian function suppression（OFS）fertility protection, or any hormone drugs (such as Raloxifene, tamoxifen, or other selective estrogen receptor modulators) to treat osteoporosis or prevent breast cancer；",
                "criterions": [
                    {
                        "exact_snippets": "Receive any sex hormone treatment (such as contraceptives, ovarian hormone replacement therapy, etc.)",
                        "criterion": "sex hormone treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "any hormone drugs (such as Raloxifene, tamoxifen, or other selective estrogen receptor modulators) to treat osteoporosis or prevent breast cancer",
                        "criterion": "hormone drugs for osteoporosis or breast cancer prevention",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Receive any sex hormone treatment (such as contraceptives, ovarian hormone replacement therapy, etc.)",
                                "criterion": "sex hormone treatment",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "Ovarian function suppression（OFS）fertility protection",
                                    "criterion": "Ovarian function suppression fertility protection",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "any hormone drugs (such as Raloxifene, tamoxifen, or other selective estrogen receptor modulators) to treat osteoporosis or prevent breast cancer",
                        "criterion": "hormone drugs for osteoporosis or breast cancer prevention",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. The patient has undergone major surgery unrelated to breast cancer within 4 weeks before treatment or has not yet fully recovered;",
                "criterions": [
                    {
                        "exact_snippets": "undergone major surgery unrelated to breast cancer within 4 weeks before treatment",
                        "criterion": "major surgery unrelated to breast cancer",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "has not yet fully recovered",
                        "criterion": "recovery from surgery",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "undergone major surgery unrelated to breast cancer within 4 weeks before treatment",
                                "criterion": "major surgery unrelated to breast cancer",
                                "requirement": {
                                    "requirement_type": "time since surgery",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "has not yet fully recovered",
                                "criterion": "recovery from surgery",
                                "requirement": {
                                    "requirement_type": "recovery status",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "has not yet fully recovered",
                        "criterion": "recovery from surgery",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Symptomatic peripheral neuropathy CTCAE 5.0 grade ≥ 2",
                "criterions": [
                    {
                        "exact_snippets": "Symptomatic peripheral neuropathy CTCAE 5.0 grade ≥ 2",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "symptom presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Symptomatic peripheral neuropathy CTCAE 5.0 grade ≥ 2",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "CTCAE grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Symptomatic peripheral neuropathy CTCAE 5.0 grade ≥ 2",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "symptom presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Symptomatic peripheral neuropathy CTCAE 5.0 grade ≥ 2",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "CTCAE grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Serious cardio cerebral Vascular disease, including but not limited to the followings:",
                "criterions": [
                    {
                        "exact_snippets": "Serious cardio cerebral Vascular disease",
                        "criterion": "cardio cerebral vascular disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Serious cardio cerebral Vascular disease",
                        "criterion": "cardio cerebral vascular disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. History of congestive heart failure or systolic dysfunction (LVEF<50%);",
                "criterions": [
                    {
                        "exact_snippets": "History of congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "systolic dysfunction (LVEF<50%)",
                        "criterion": "systolic dysfunction",
                        "requirement": {
                            "requirement_type": "LVEF",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "History of congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "systolic dysfunction (LVEF<50%)",
                        "criterion": "systolic dysfunction",
                        "requirement": {
                            "requirement_type": "LVEF",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Angina pectoris requiring anti angina drugs;",
                "criterions": [
                    {
                        "exact_snippets": "Angina pectoris requiring anti angina drugs",
                        "criterion": "angina pectoris",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "anti angina drugs"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Angina pectoris requiring anti angina drugs",
                    "criterion": "angina pectoris",
                    "requirement": {
                        "requirement_type": "treatment",
                        "expected_value": "anti angina drugs"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "11. High risk uncontrolled arrhythmias or severe conduction abnormalities, such as ventricular arrhythmias that require clinical intervention, II-III degree atrioventricular block, etc; Under resting state, the average corrected Q-T interval(QTcF) of three 12 lead electrocardiogram examinations is>470ms;",
                "criterions": [
                    {
                        "exact_snippets": "High risk uncontrolled arrhythmias",
                        "criterion": "uncontrolled arrhythmias",
                        "requirement": {
                            "requirement_type": "risk level",
                            "expected_value": "high"
                        }
                    },
                    {
                        "exact_snippets": "severe conduction abnormalities",
                        "criterion": "conduction abnormalities",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "ventricular arrhythmias that require clinical intervention",
                        "criterion": "ventricular arrhythmias",
                        "requirement": {
                            "requirement_type": "clinical intervention",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "II-III degree atrioventricular block",
                        "criterion": "atrioventricular block",
                        "requirement": {
                            "requirement_type": "degree",
                            "expected_value": [
                                "II",
                                "III"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Under resting state, the average corrected Q-T interval(QTcF) of three 12 lead electrocardiogram examinations is>470ms",
                        "criterion": "corrected Q-T interval (QTcF)",
                        "requirement": {
                            "requirement_type": "average value",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "High risk uncontrolled arrhythmias",
                                "criterion": "uncontrolled arrhythmias",
                                "requirement": {
                                    "requirement_type": "risk level",
                                    "expected_value": "high"
                                }
                            },
                            {
                                "exact_snippets": "severe conduction abnormalities",
                                "criterion": "conduction abnormalities",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "ventricular arrhythmias that require clinical intervention",
                        "criterion": "ventricular arrhythmias",
                        "requirement": {
                            "requirement_type": "clinical intervention",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "II-III degree atrioventricular block",
                        "criterion": "atrioventricular block",
                        "requirement": {
                            "requirement_type": "degree",
                            "expected_value": [
                                "II",
                                "III"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Under resting state, the average corrected Q-T interval(QTcF) of three 12 lead electrocardiogram examinations is>470ms",
                        "criterion": "corrected Q-T interval (QTcF)",
                        "requirement": {
                            "requirement_type": "average value",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Clinically significant heart valve disease with cardiac dysfunction;",
                "criterions": [
                    {
                        "exact_snippets": "Clinically significant heart valve disease",
                        "criterion": "heart valve disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "cardiac dysfunction",
                        "criterion": "cardiac dysfunction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Clinically significant heart valve disease",
                        "criterion": "heart valve disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "cardiac dysfunction",
                        "criterion": "cardiac dysfunction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. Hypertension that cannot be controlled;",
                "criterions": [
                    {
                        "exact_snippets": "Hypertension that cannot be controlled",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Hypertension that cannot be controlled",
                    "criterion": "hypertension",
                    "requirement": {
                        "requirement_type": "control",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "14. History of myocardial infarction",
                "criterions": [
                    {
                        "exact_snippets": "History of myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "History of myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "15. Allergic to any component of any drug in this protocol.",
                "criterions": [
                    {
                        "exact_snippets": "Allergic to any component of any drug in this protocol.",
                        "criterion": "allergy to drug components",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Allergic to any component of any drug in this protocol.",
                    "criterion": "allergy to drug components",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "16. Those who are not suitable for using Corticosteroid.",
                "criterions": [
                    {
                        "exact_snippets": "not suitable for using Corticosteroid",
                        "criterion": "Corticosteroid suitability",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "not suitable for using Corticosteroid",
                        "criterion": "Corticosteroid suitability",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "17. Individuals with active infections who currently require systematic anti infection treatment.",
                "criterions": [
                    {
                        "exact_snippets": "active infections",
                        "criterion": "active infections",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "require systematic anti infection treatment",
                        "criterion": "systematic anti infection treatment",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "active infections",
                        "criterion": "active infections",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "require systematic anti infection treatment",
                        "criterion": "systematic anti infection treatment",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "18. History of immune deficiency disease, including positive of HIV/AIDS, or other acquired or congenital immune deficiency diseases, or having a history of organ transplantation.",
                "criterions": [
                    {
                        "exact_snippets": "History of immune deficiency disease",
                        "criterion": "immune deficiency disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "positive of HIV/AIDS",
                        "criterion": "HIV/AIDS",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "acquired or congenital immune deficiency diseases",
                        "criterion": "acquired or congenital immune deficiency 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": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "History of immune deficiency disease",
                                        "criterion": "immune deficiency disease",
                                        "requirement": {
                                            "requirement_type": "history",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "acquired or congenital immune deficiency diseases",
                                        "criterion": "acquired or congenital immune deficiency diseases",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "positive of HIV/AIDS",
                                "criterion": "HIV/AIDS",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "positive"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "history of organ transplantation",
                        "criterion": "organ transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "19. Who had participated in other drug intervention clinical trials within the 28 days of randomization, or who is participating in another clinical trial or is using other investigational treatments.",
                "criterions": [
                    {
                        "exact_snippets": "participated in other drug intervention clinical trials within the 28 days of randomization",
                        "criterion": "participation in other drug intervention clinical trials",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "participating in another clinical trial",
                        "criterion": "participation in another clinical trial",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "using other investigational treatments",
                        "criterion": "use of other investigational treatments",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "participated in other drug intervention clinical trials within the 28 days of randomization",
                                "criterion": "participation in other drug intervention clinical trials",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "participating in another clinical trial",
                        "criterion": "participation in another clinical trial",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "using other investigational treatments",
                        "criterion": "use of other investigational treatments",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "20. Individuals in pregnancy (positive Pregnancy test) and lactation.",
                "criterions": [
                    {
                        "exact_snippets": "Individuals in pregnancy (positive Pregnancy test)",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "lactation",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Individuals in pregnancy (positive Pregnancy test)",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "lactation",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "21. Any other comorbidities that interfere with the implementation of the treatment plan, or the researcher evaluate that the subject has a history of other serious systemic diseases, or other reasons lead to the patients is unsuitable to participate in this trial.",
                "criterions": [
                    {
                        "exact_snippets": "Any other comorbidities that interfere with the implementation of the treatment plan",
                        "criterion": "comorbidities",
                        "requirement": {
                            "requirement_type": "interference with treatment plan",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "the researcher evaluate that the subject has a history of other serious systemic diseases",
                        "criterion": "history of serious systemic diseases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other reasons lead to the patients is unsuitable to participate in this trial",
                        "criterion": "suitability to participate in trial",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any other comorbidities that interfere with the implementation of the treatment plan",
                                "criterion": "comorbidities",
                                "requirement": {
                                    "requirement_type": "interference with treatment plan",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "the researcher evaluate that the subject has a history of other serious systemic diseases",
                                "criterion": "history of serious systemic diseases",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "other reasons lead to the patients is unsuitable to participate in this trial",
                                "criterion": "suitability to participate in trial",
                                "requirement": {
                                    "requirement_type": "suitability",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "2. Newly diagnosed high-risk early stage (T1c-2, N1; T2, N0) and locally advanced (T1c-2, N2-3; T3-4, N0-3) breast cancer (tumor stage II, III), in which HR+/HER2- T2, N0 patients need to be accompanied by high-risk factors (histological grade 3 or Ki67 ≥ 20%). Triple negative breast cancer(TNBC), HER2 positive (Immunohistochemical(IHC)3+; IHC 2+, FISH amplification) breast cancer, HR negative HER2 IHC 2+ and undetermined result of FISH, HR positive HER2 negative (IHC 0,1+; 2+, FISH amplification) breast cancer confirmed by pathological test.",
                "criterions": [
                    {
                        "exact_snippets": "Newly diagnosed high-risk early stage (T1c-2, N1; T2, N0) and locally advanced (T1c-2, N2-3; T3-4, N0-3) breast cancer",
                        "criterion": "breast cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T1c-2, N1",
                                "T2, N0",
                                "T1c-2, N2-3",
                                "T3-4, N0-3"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "HR+/HER2- T2, N0 patients need to be accompanied by high-risk factors (histological grade 3 or Ki67 ≥ 20%)",
                        "criterion": "HR+/HER2- T2, N0 breast cancer",
                        "requirement": {
                            "requirement_type": "high-risk factors",
                            "expected_value": [
                                "histological grade 3",
                                "Ki67 ≥ 20%"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Triple negative breast cancer(TNBC)",
                        "criterion": "triple negative breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HER2 positive (Immunohistochemical(IHC)3+; IHC 2+, FISH amplification) breast cancer",
                        "criterion": "HER2 positive breast cancer",
                        "requirement": {
                            "requirement_type": "IHC",
                            "expected_value": "3+"
                        }
                    },
                    {
                        "exact_snippets": "HER2 positive (Immunohistochemical(IHC)3+; IHC 2+, FISH amplification) breast cancer",
                        "criterion": "HER2 positive breast cancer",
                        "requirement": {
                            "requirement_type": "IHC",
                            "expected_value": "2+, FISH amplification"
                        }
                    },
                    {
                        "exact_snippets": "HR negative HER2 IHC 2+ and undetermined result of FISH",
                        "criterion": "HR negative HER2 IHC 2+",
                        "requirement": {
                            "requirement_type": "FISH result",
                            "expected_value": "undetermined"
                        }
                    },
                    {
                        "exact_snippets": "HR positive HER2 negative (IHC 0,1+; 2+, FISH amplification) breast cancer confirmed by pathological test",
                        "criterion": "HR positive HER2 negative breast cancer",
                        "requirement": {
                            "requirement_type": "IHC",
                            "expected_value": [
                                "0,1+",
                                "2+, FISH amplification"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}