{
    "info": {
        "nct_id": "NCT06235931",
        "official_title": "Prospective, Single-arm, Single-center Clinical Study of Darcilil Combined With AI Combined With Pyrrotinib in the Treatment of Elderly Advanced Triple-positive Breast Cancer.",
        "inclusion_criteria": "* 1.Age: ≥65 years old; 2. Histologically confirmed stage IV TPBC; 3. Without prior treatment, adjuvant endocrine therapy and anti-HER2 therapy should be completed for more than one year; 4.TPBC is defined as HER2-positive (3+ by immunohistochemistry, or 2+ by fluorescence in situ hybridization), ER-positive (more than 10% of tumor cells expressed estrogen receptor by immunohistochemistry), and PR-positive (at least 1% of tumor cells expressed progesterone receptor by immunohistochemistry) breast cancer; 5.ECOG score is 0-3 points; 6. Expected survival ≥12 weeks; 7. Normal function of major organs:\n\n  1. Blood routine:\n\n     Neutrophil (ANC) ≥1.5×109/L; Platelet count (PLT) ≥75×109/L; Hemoglobin (Hb) ≥90 g/L;\n  2. Blood biochemistry:\n\n     Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0×ULN; Alkaline phosphatase ≤2.5×ULN; Urea or urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN;\n  3. Heart color ultrasound:\n\nLeft ventricular ejection fraction (LVEF) ≥50%.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 65 Years",
        "exclusion_criteria": "* 1. Breast cancer with no evaluable lesions such as inflammation or occult; 2. Other malignancies within five years 3. Received other tyrosine kinase inhibitors, anti-HER2 treatment and T-DM1 treatment less than one year ago; 4. Patients with intestinal obstruction or fasting, gastrointestinal history, with diarrhea as the main symptom; 5. Suffering from mental illness or psychotropic substance abuse, unable to cooperate; 6. Pregnant or lactating women; 7. Participants considered unsuitable for inclusion by the researchers.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 1.Age: ≥65 years old; 2. Histologically confirmed stage IV TPBC; 3. Without prior treatment, adjuvant endocrine therapy and anti-HER2 therapy should be completed for more than one year; 4.TPBC is defined as HER2-positive (3+ by immunohistochemistry, or 2+ by fluorescence in situ hybridization), ER-positive (more than 10% of tumor cells expressed estrogen receptor by immunohistochemistry), and PR-positive (at least 1% of tumor cells expressed progesterone receptor by immunohistochemistry) breast cancer; 5.ECOG score is 0-3 points; 6. Expected survival ≥12 weeks; 7. Normal function of major organs:",
            "criterions": [
                {
                    "exact_snippets": "Age: ≥65 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 65,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed stage IV TPBC",
                    "criterion": "stage IV TPBC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Without prior treatment, adjuvant endocrine therapy and anti-HER2 therapy should be completed for more than one year",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adjuvant endocrine therapy and anti-HER2 therapy should be completed for more than one year",
                    "criterion": "adjuvant endocrine therapy and anti-HER2 therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "TPBC is defined as HER2-positive (3+ by immunohistochemistry, or 2+ by fluorescence in situ hybridization)",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "positivity",
                            "expected_value": [
                                "3+ by immunohistochemistry",
                                "2+ by fluorescence in situ hybridization"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "ER-positive (more than 10% of tumor cells expressed estrogen receptor by immunohistochemistry)",
                    "criterion": "ER status",
                    "requirements": [
                        {
                            "requirement_type": "positivity",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "% of tumor cells"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PR-positive (at least 1% of tumor cells expressed progesterone receptor by immunohistochemistry)",
                    "criterion": "PR status",
                    "requirements": [
                        {
                            "requirement_type": "positivity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "% of tumor cells"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG score is 0-3 points",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "points"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "points"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Expected survival ≥12 weeks",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "minimum duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Normal function of major organs",
                    "criterion": "major organ function",
                    "requirements": [
                        {
                            "requirement_type": "normal function",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Blood routine:",
            "criterions": [
                {
                    "exact_snippets": "Blood routine",
                    "criterion": "blood routine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Neutrophil (ANC) ≥1.5×109/L; Platelet count (PLT) ≥75×109/L; Hemoglobin (Hb) ≥90 g/L;",
            "criterions": [
                {
                    "exact_snippets": "Neutrophil (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) ≥90 g/L",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Blood biochemistry:",
            "criterions": [
                {
                    "exact_snippets": "Blood biochemistry",
                    "criterion": "blood biochemistry",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0×ULN; Alkaline phosphatase ≤2.5×ULN; Urea or urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN;",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN)",
                    "criterion": "total bilirubin (TBIL)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alanine aminotransferase (ALT) ... ≤3.0×ULN",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) ≤3.0×ULN",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alkaline phosphatase ≤2.5×ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Urea or urea nitrogen (BUN) ... ≤1.5×ULN",
                    "criterion": "urea or urea nitrogen (BUN)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine (Cr) ≤1.5×ULN",
                    "criterion": "creatinine (Cr)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Heart color ultrasound:",
            "criterions": [
                {
                    "exact_snippets": "Heart color ultrasound",
                    "criterion": "heart color ultrasound",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Left ventricular ejection fraction (LVEF) ≥50%.",
            "criterions": [
                {
                    "exact_snippets": "Left ventricular ejection fraction (LVEF) ≥50%.",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* 1. Breast cancer with no evaluable lesions such as inflammation or occult; 2. Other malignancies within five years 3. Received other tyrosine kinase inhibitors, anti-HER2 treatment and T-DM1 treatment less than one year ago; 4. Patients with intestinal obstruction or fasting, gastrointestinal history, with diarrhea as the main symptom; 5. Suffering from mental illness or psychotropic substance abuse, unable to cooperate; 6. Pregnant or lactating women; 7. Participants considered unsuitable for inclusion by the researchers.",
            "criterions": [
                {
                    "exact_snippets": "Breast cancer with no evaluable lesions such as inflammation or occult",
                    "criterion": "breast cancer evaluable lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Other malignancies within five years",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received other tyrosine kinase inhibitors, anti-HER2 treatment and T-DM1 treatment less than one year ago",
                    "criterion": "tyrosine kinase inhibitors, anti-HER2 treatment, T-DM1 treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with intestinal obstruction or fasting, gastrointestinal history, with diarrhea as the main symptom",
                    "criterion": "intestinal obstruction or fasting, gastrointestinal history with diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Suffering from mental illness or psychotropic substance abuse, unable to cooperate",
                    "criterion": "mental illness or psychotropic substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "cooperation ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Pregnant or lactating women",
                    "criterion": "pregnancy or lactation",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants considered unsuitable for inclusion by the researchers",
                    "criterion": "suitability for inclusion",
                    "requirements": [
                        {
                            "requirement_type": "researcher assessment",
                            "expected_value": "unsuitable"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}