{
    "info": {
        "nct_id": "NCT01439191",
        "official_title": "An Open-Label Randomized Phase II Study of Cipterbin® or Cipterbin® in Combination With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer (MBC)",
        "inclusion_criteria": "* pathologic diagnosis breast cancer\n* HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1 measurable lesion as per RECIST criteria\n* Adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)\n* Adequate liver (bilirubin <1.0 times upper limit of normal and SGOT/SGPT <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)\n* Adequate cardiac function (LVEF>50%). Normal electrocardiogram and absence of significant heart disease\n* age from 18 to 70y\n* Karnofsky performance score ≥ 60\n* Life expectancy of greater than 3 months\n* Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.\n* signed ICF\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* prior exposure vinorelbine for breast cancer\n* prior exposure trastuzumab for breast cancer\n* Prior chemotherapy and radiation therapy within the last 4 weeks before enrollment\n* use of any other investigational agents within the last 4 weeks before enrollment\n* symptomatic, central nervous system metastases\n* Hypersensitivity to trial medications\n* breastfeeding or pregnant",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* pathologic diagnosis breast cancer",
            "criterions": [
                {
                    "exact_snippets": "pathologic diagnosis breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "pathologic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1 measurable lesion as per RECIST criteria",
            "criterions": [
                {
                    "exact_snippets": "HER2+ status defined as IHC3+ Staining or in situ hybridization positive",
                    "criterion": "HER2+ status",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": [
                                "IHC3+ Staining",
                                "in situ hybridization positive"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 1 measurable lesion as per RECIST criteria",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow function (absolute neutrophil count >1500/mm3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate bone marrow function ... platelet count >100.000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate bone marrow function ... hemoglobin >10gr/mm3",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "gr/mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate liver (bilirubin <1.0 times upper limit of normal and SGOT/SGPT <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)",
            "criterions": [
                {
                    "exact_snippets": "bilirubin <1.0 times upper limit of normal",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.0,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "SGOT/SGPT <2.5 times upper limit of normal",
                    "criterion": "SGOT/SGPT levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine <1.5mg/dl",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate cardiac function (LVEF>50%). Normal electrocardiogram and absence of significant heart disease",
            "criterions": [
                {
                    "exact_snippets": "Adequate cardiac function (LVEF>50%)",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "LVEF",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Normal electrocardiogram",
                    "criterion": "electrocardiogram",
                    "requirements": [
                        {
                            "requirement_type": "normality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of significant heart disease",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* age from 18 to 70y",
            "criterions": [
                {
                    "exact_snippets": "age from 18 to 70y",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "y"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "y"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky performance score ≥ 60",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky performance score ≥ 60",
                    "criterion": "Karnofsky performance score",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of greater than 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of greater than 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.",
            "criterions": [
                {
                    "exact_snippets": "Negative HCG pregnancy test",
                    "criterion": "HCG pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "premenopausal women of reproductive capacity",
                    "criterion": "premenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "premenopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "women less than 12 months after the menopause",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "time since menopause",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* signed ICF",
            "criterions": [
                {
                    "exact_snippets": "signed ICF",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* prior exposure vinorelbine for breast cancer",
            "criterions": [
                {
                    "exact_snippets": "prior exposure vinorelbine for breast cancer",
                    "criterion": "prior exposure to vinorelbine",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* prior exposure trastuzumab for breast cancer",
            "criterions": [
                {
                    "exact_snippets": "prior exposure trastuzumab for breast cancer",
                    "criterion": "trastuzumab exposure",
                    "requirements": [
                        {
                            "requirement_type": "prior exposure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior chemotherapy and radiation therapy within the last 4 weeks before enrollment",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy ... within the last 4 weeks before enrollment",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior ... radiation therapy within the last 4 weeks before enrollment",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* use of any other investigational agents within the last 4 weeks before enrollment",
            "criterions": [
                {
                    "exact_snippets": "use of any other investigational agents within the last 4 weeks before enrollment",
                    "criterion": "use of investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* symptomatic, central nervous system metastases",
            "criterions": [
                {
                    "exact_snippets": "symptomatic, central nervous system metastases",
                    "criterion": "central nervous system metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypersensitivity to trial medications",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity to trial medications",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* breastfeeding or pregnant",
            "criterions": [
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}