{
    "info": {
        "nct_id": "NCT06510465",
        "official_title": "Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA): A Multi-center, Prospective Study",
        "inclusion_criteria": "1. Age ≥18 years old;\n2. Primary invasive breast cancer confirmed by pathology; Before neoadjuvant therapy, the primary breast lesion was larger than 2cm(cT2-T4a-d, according to the anatomical staging of AJCC 8th edition), or the clinical images of lymph nodes considered metastasis or pathologically confirmed metastasis (CN+); or patients whose primary breast lesions are more than 1cm and less than 2cm, and whose lymph nodes have not metastasized (cT1cN0) must meet one of the following conditions: hormone receptor negative, HER2 positive, or ki67 greater than 20%. If bilateral breast cancer is found at the same time, it can be admitted to the group, but it is necessary to determine which side of the lesion is to be evaluated before taking the drug;\n3. According to the RECIST version 1.1 standard (see Annex I), there is at least one measurable lesion before neoadjuvant therapy;\n4. The score of ECOG is 0 or 1;\n5. During neoadjuvant therapy, ovarian function suppression can be given at the same time;\n6. The hematological examination and blood biochemical examination should meet the following requirements: white blood cell count (WBC)≥3.0×109/L, neutrophil count (ANC)≥1.5×109/L and platelet count (PLT) ≥ 75× 109/L; Hemoglobin (HB) ≥ 80g/L; Total bilirubin (TBIL)≤1.5× upper limit of normal value (ULN), AST(sGOT), ALT(sGPT)≤2×ULN and creatinine (Cr) ≤ 1.5× ULN;\n7. creatinine clearance rate ≥50mL/min(Cockcroft-Gault formula);\n8. Subjects voluntarily joined the study, signed the informed consent form, and had good compliance and cooperated with the follow-up.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients during pregnancy and lactation, patients with fertility and positive baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period;\n2. There is distant metastasis of breast cancer confirmed by imaging or pathology before enrollment;\n3. There is evidence of sensory or motor nerve diseases;\n4. Severe cardiopulmonary insufficiency, severe hepatic and renal insufficiency, severe concomitant disease or active infection, including known HIV infection;\n5. allergic to the research drug or its auxiliary materials;\n6. Arterial/venous thrombotic events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, occurred within 6 months before the start of the study;\n7. Previous history of other malignant tumors, except the cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and the second primary malignant tumor with high 5-year recurrence-free survival rate determined by researchers;\n8. According to the researcher's judgment, there are accompanying diseases (including but not limited to uncontrollable hypertension, severe diabetes, active infection, thyroid disease, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study, and any other circumstances that the researcher judges that the patient is not suitable for participating in this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age ≥18 years old;",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Primary invasive breast cancer confirmed by pathology; Before neoadjuvant therapy, the primary breast lesion was larger than 2cm(cT2-T4a-d, according to the anatomical staging of AJCC 8th edition), or the clinical images of lymph nodes considered metastasis or pathologically confirmed metastasis (CN+); or patients whose primary breast lesions are more than 1cm and less than 2cm, and whose lymph nodes have not metastasized (cT1cN0) must meet one of the following conditions: hormone receptor negative, HER2 positive, or ki67 greater than 20%. If bilateral breast cancer is found at the same time, it can be admitted to the group, but it is necessary to determine which side of the lesion is to be evaluated before taking the drug;",
            "criterions": [
                {
                    "exact_snippets": "Primary invasive breast cancer confirmed by pathology",
                    "criterion": "primary invasive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathology"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary breast lesion was larger than 2cm",
                    "criterion": "primary breast lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical images of lymph nodes considered metastasis",
                    "criterion": "lymph node metastasis",
                    "requirements": [
                        {
                            "requirement_type": "clinical imaging",
                            "expected_value": "considered metastasis"
                        }
                    ]
                },
                {
                    "exact_snippets": "pathologically confirmed metastasis (CN+)",
                    "criterion": "lymph node metastasis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary breast lesions are more than 1cm and less than 2cm",
                    "criterion": "primary breast lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 1,
                                        "unit": "cm"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 2,
                                        "unit": "cm"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lymph nodes have not metastasized (cT1cN0)",
                    "criterion": "lymph node metastasis",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not metastasized"
                        }
                    ]
                },
                {
                    "exact_snippets": "hormone receptor negative",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 positive",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "ki67 greater than 20%",
                    "criterion": "ki67",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "bilateral breast cancer is found at the same time",
                    "criterion": "bilateral breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. According to the RECIST version 1.1 standard (see Annex I), there is at least one measurable lesion before neoadjuvant therapy;",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable lesion before neoadjuvant therapy",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. The score of ECOG is 0 or 1;",
            "criterions": [
                {
                    "exact_snippets": "score of ECOG is 0 or 1",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. During neoadjuvant therapy, ovarian function suppression can be given at the same time;",
            "criterions": [
                {
                    "exact_snippets": "During neoadjuvant therapy",
                    "criterion": "neoadjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ovarian function suppression can be given",
                    "criterion": "ovarian function suppression",
                    "requirements": [
                        {
                            "requirement_type": "concurrent administration",
                            "expected_value": "neoadjuvant therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. The hematological examination and blood biochemical examination should meet the following requirements: white blood cell count (WBC)≥3.0×109/L, neutrophil count (ANC)≥1.5×109/L and platelet count (PLT) ≥ 75× 109/L; Hemoglobin (HB) ≥ 80g/L; Total bilirubin (TBIL)≤1.5× upper limit of normal value (ULN), AST(sGOT), ALT(sGPT)≤2×ULN and creatinine (Cr) ≤ 1.5× ULN;",
            "criterions": [
                {
                    "exact_snippets": "white blood cell count (WBC)≥3.0×109/L",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.0,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "neutrophil count (ANC)≥1.5×109/L",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count (PLT) ≥ 75× 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin (HB) ≥ 80g/L",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin (TBIL)≤1.5× upper limit of normal value (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST(sGOT), ALT(sGPT)≤2×ULN",
                    "criterion": "AST and ALT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine (Cr) ≤ 1.5× ULN",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. creatinine clearance rate ≥50mL/min(Cockcroft-Gault formula);",
            "criterions": [
                {
                    "exact_snippets": "creatinine clearance rate ≥50mL/min",
                    "criterion": "creatinine clearance rate",
                    "requirements": [
                        {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Subjects voluntarily joined the study, signed the informed consent form, and had good compliance and cooperated with the follow-up.",
            "criterions": [
                {
                    "exact_snippets": "voluntarily joined the study",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "signed the informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "had good compliance",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "good"
                        }
                    ]
                },
                {
                    "exact_snippets": "cooperated with the follow-up",
                    "criterion": "follow-up cooperation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients during pregnancy and lactation, patients with fertility and positive baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period;",
            "criterions": [
                {
                    "exact_snippets": "Patients during pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "fertility",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "positive baseline pregnancy test",
                    "criterion": "baseline pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period",
                    "criterion": "contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. There is distant metastasis of breast cancer confirmed by imaging or pathology before enrollment;",
            "criterions": [
                {
                    "exact_snippets": "distant metastasis of breast cancer confirmed by imaging or pathology",
                    "criterion": "distant metastasis of breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "imaging",
                                "pathology"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. There is evidence of sensory or motor nerve diseases;",
            "criterions": [
                {
                    "exact_snippets": "evidence of sensory or motor nerve diseases",
                    "criterion": "sensory nerve diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of sensory or motor nerve diseases",
                    "criterion": "motor nerve diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Severe cardiopulmonary insufficiency, severe hepatic and renal insufficiency, severe concomitant disease or active infection, including known HIV infection;",
            "criterions": [
                {
                    "exact_snippets": "Severe cardiopulmonary insufficiency",
                    "criterion": "cardiopulmonary insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe hepatic ... insufficiency",
                    "criterion": "hepatic insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe ... renal insufficiency",
                    "criterion": "renal insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe concomitant disease",
                    "criterion": "concomitant disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "known HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. allergic to the research drug or its auxiliary materials;",
            "criterions": [
                {
                    "exact_snippets": "allergic to the research drug",
                    "criterion": "allergy to research drug",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to ... its auxiliary materials",
                    "criterion": "allergy to auxiliary materials",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Arterial/venous thrombotic events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, occurred within 6 months before the start of the study;",
            "criterions": [
                {
                    "exact_snippets": "Arterial/venous thrombotic events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism",
                    "criterion": "arterial/venous thrombotic events",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "occurred within 6 months before the start of the study",
                    "criterion": "time since thrombotic event",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Previous history of other malignant tumors, except the cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and the second primary malignant tumor with high 5-year recurrence-free survival rate determined by researchers;",
            "criterions": [
                {
                    "exact_snippets": "Previous history of other malignant tumors",
                    "criterion": "history of malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except the cured basal cell carcinoma of the skin",
                    "criterion": "cured basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... second primary malignant tumor with high 5-year recurrence-free survival rate determined by researchers",
                    "criterion": "second primary malignant tumor with high 5-year recurrence-free survival rate",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. According to the researcher's judgment, there are accompanying diseases (including but not limited to uncontrollable hypertension, severe diabetes, active infection, thyroid disease, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study, and any other circumstances that the researcher judges that the patient is not suitable for participating in this study.",
            "criterions": [
                {
                    "exact_snippets": "uncontrollable hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "thyroid disease",
                    "criterion": "thyroid disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "circumstances that the researcher judges that the patient is not suitable for participating in this study",
                    "criterion": "suitability for study participation",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "researcher's judgment"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}