{
    "info": {
        "nct_id": "NCT01232062",
        "official_title": "Study of High-dose Chemotherapy Combined With Adoptive Cellular Therapy With Dentritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients",
        "inclusion_criteria": "* Failure to anthracycline and/or taxol chemotherapy;\n* metastatic tumor is histologically confirmed by immunohistochemical staining to be ER-negative and PR-negative. FISH testing for her-2-negative;\n* Metastatic tumor can not be removed through surgery procedure;\n* Metastatic tumor measured by PET-CT scan is at least 1cm;\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n* Normal cardiac, hepatic, renal and bone marrow functions;\n* Life expectancy ≥3 months.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 45 Years",
        "exclusion_criteria": "* Do not finish twice PET-CT scan;\n* Central nervous system metastases;\n* Serious or uncontrolled concurrent medical illness;\n* History of other malignancies;\n* Having been enrolled in some other clinal trials within a month;",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Failure to anthracycline and/or taxol chemotherapy;",
            "criterions": [
                {
                    "exact_snippets": "Failure to anthracycline",
                    "criterion": "anthracycline chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "failure"
                        }
                    ]
                },
                {
                    "exact_snippets": "Failure to ... taxol chemotherapy",
                    "criterion": "taxol chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "failure"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* metastatic tumor is histologically confirmed by immunohistochemical staining to be ER-negative and PR-negative. FISH testing for her-2-negative;",
            "criterions": [
                {
                    "exact_snippets": "metastatic tumor is histologically confirmed",
                    "criterion": "metastatic tumor",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "immunohistochemical staining to be ER-negative",
                    "criterion": "ER status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "immunohistochemical staining to be ... PR-negative",
                    "criterion": "PR status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "FISH testing for her-2-negative",
                    "criterion": "HER-2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic tumor can not be removed through surgery procedure;",
            "criterions": [
                {
                    "exact_snippets": "Metastatic tumor can not be removed through surgery procedure",
                    "criterion": "metastatic tumor",
                    "requirements": [
                        {
                            "requirement_type": "removability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic tumor measured by PET-CT scan is at least 1cm;",
            "criterions": [
                {
                    "exact_snippets": "Metastatic tumor measured by PET-CT scan is at least 1cm",
                    "criterion": "metastatic tumor size",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal cardiac, hepatic, renal and bone marrow functions;",
            "criterions": [
                {
                    "exact_snippets": "Normal cardiac ... functions",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Normal ... hepatic ... functions",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Normal ... renal ... functions",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Normal ... bone marrow functions",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy ≥3 months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥3 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 45 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 45 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 45,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Do not finish twice PET-CT scan;",
            "criterions": [
                {
                    "exact_snippets": "finish twice PET-CT scan",
                    "criterion": "PET-CT scan",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "times"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Central nervous system metastases;",
            "criterions": [
                {
                    "exact_snippets": "Central nervous system metastases",
                    "criterion": "central nervous system metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious or uncontrolled concurrent medical illness;",
            "criterions": [
                {
                    "exact_snippets": "Serious or uncontrolled concurrent medical illness",
                    "criterion": "concurrent medical illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of other malignancies;",
            "criterions": [
                {
                    "exact_snippets": "History of other malignancies",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Having been enrolled in some other clinal trials within a month;",
            "criterions": [
                {
                    "exact_snippets": "Having been enrolled in some other clinical trials within a month",
                    "criterion": "enrollment in other clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "month"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}