{
    "info": {
        "nct_id": "NCT03575520",
        "official_title": "A Phase II Study to Evaluate the Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients Receiving Dose-dense Doxorubicin/Cyclophosphamide",
        "inclusion_criteria": "* Histological or cytological diagnosis of a primary breast cancer (stage I-III)\n* Age > 18 years of age and Age < 66 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 1\n* Patients who have plan to receive neoadjuvant or adjuvant dose-dense AC chemotherapy\n* Adequate organ functions\n\n  1. ANC ≥1500 cells/mm3\n  2. PLT ≥100,000 cells/mm3\n  3. CCr ≥50 mL/min, or Serum Cr <1.5 x (upper limit of normal, ULN)\n  4. Total bilirubin ≤1.5 x ULN\n  5. AST (SGOT) ≤2.5 x ULN\n  6. ALT (SGPT) ≤2.5 x ULN\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 19 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "* Previous chemotherapy history\n* Previous bone marrow transplantation history\n* Sickle cell anemia\n* Radiation therapy within 4 weeks from enrollment\n* Previous pegfilgrastim, filgrastim or other colony-stimulating factor treatment within 4 weeks from enrollment\n* Clinically significant systemic illness (serious infection, liver, kidney, heart disease)\n* Pregnant, breast feeding women",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histological or cytological diagnosis of a primary breast cancer (stage I-III)",
            "criterions": [
                {
                    "exact_snippets": "Histological or cytological diagnosis of a primary breast cancer",
                    "criterion": "primary breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis method",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "primary breast cancer (stage I-III)",
                    "criterion": "primary breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age > 18 years of age and Age < 66 years of age",
            "criterions": [
                {
                    "exact_snippets": "Age > 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Age < 66 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<",
                                "value": 66,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 1",
                    "criterion": "ECOG performance status score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have plan to receive neoadjuvant or adjuvant dose-dense AC chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "plan to receive neoadjuvant or adjuvant dose-dense AC chemotherapy",
                    "criterion": "chemotherapy plan",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "neoadjuvant",
                                "adjuvant"
                            ]
                        },
                        {
                            "requirement_type": "regimen",
                            "expected_value": "dose-dense AC"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ functions",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ functions",
                    "criterion": "organ functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. ANC ≥1500 cells/mm3",
            "criterions": [
                {
                    "exact_snippets": "ANC ≥1500 cells/mm3",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "cells/mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. PLT ≥100,000 cells/mm3",
            "criterions": [
                {
                    "exact_snippets": "PLT ≥100,000 cells/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "cells/mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. CCr ≥50 mL/min, or Serum Cr <1.5 x (upper limit of normal, ULN)",
            "criterions": [
                {
                    "exact_snippets": "CCr ≥50 mL/min",
                    "criterion": "creatinine clearance (CCr)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum Cr <1.5 x (upper limit of normal, ULN)",
                    "criterion": "serum creatinine (Serum Cr)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Total bilirubin ≤1.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤1.5 x ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. AST (SGOT) ≤2.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "AST (SGOT) ≤2.5 x ULN",
                    "criterion": "AST (SGOT) level",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. ALT (SGPT) ≤2.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "ALT (SGPT) ≤2.5 x ULN",
                    "criterion": "ALT (SGPT) level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "N/A",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 19 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 19 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Previous chemotherapy history",
            "criterions": [
                {
                    "exact_snippets": "Previous chemotherapy history",
                    "criterion": "chemotherapy history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous bone marrow transplantation history",
            "criterions": [
                {
                    "exact_snippets": "Previous bone marrow transplantation history",
                    "criterion": "bone marrow transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sickle cell anemia",
            "criterions": [
                {
                    "exact_snippets": "Sickle cell anemia",
                    "criterion": "sickle cell anemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiation therapy within 4 weeks from enrollment",
            "criterions": [
                {
                    "exact_snippets": "Radiation therapy within 4 weeks from enrollment",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous pegfilgrastim, filgrastim or other colony-stimulating factor treatment within 4 weeks from enrollment",
            "criterions": [
                {
                    "exact_snippets": "Previous pegfilgrastim, filgrastim or other colony-stimulating factor treatment within 4 weeks from enrollment",
                    "criterion": "colony-stimulating factor treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant systemic illness (serious infection, liver, kidney, heart disease)",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant systemic illness (serious infection",
                    "criterion": "systemic illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "liver",
                    "criterion": "liver disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "kidney",
                    "criterion": "kidney disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "heart disease",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant, breast feeding women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}