{
    "info": {
        "nct_id": "NCT03703427",
        "official_title": "Randomised, Multicenter Phase II Study in Patients With High Risk Breast Cancer With Capecitabine Versus Vinorelbine With Pathologic Residual Tumors After Preoperative Chemotherapy Secondary ID",
        "inclusion_criteria": "* 1. Female patient with primary, infiltrative breast cancer who has been diagnosed on a histological basis. 2. Stage I-IIIB at the first diagnosis and underwent curative resection. 3. The patient was non-pCR after preoperative chemotherapy including anthracycline agents and paclitaxel or docetaxel; that is, she had undergone primary tumor resection and pathologically confirmed to have residual cancer cells.The previously adminstered preoperative chemotherapy must have involved 8 cycles of EC-T or 6 cycles of TEC.If HER-2 is positive, trastuzumab is applied with T chemotherapy 4. The patient has high risk: young;triple negtive breast caner; positive axillary lymphnode;HER-2 positive;ect 5. The patient's general performance status is 0 to 1. 6. The patient must have no carry-over of efficacy from any previous treatment. 7. The patient has maintained sufficient organ function to permit valid evaluation. 8. The patient must have no adverse drug reactions of grade 2 or higher carried over from previous treatment. 9. The patient's creatinine clearance is higher than 50 ml/min 10. The patient has personally given written, informed consent to participate in this study.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 20 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* 1. The patient is considered to require postoperative chemotherapy other than capecitabine and vinorelbine. 2. The patient has previously been treated with oral 5-FU agents (however, previous treatment with iv 5-FU is acceptable). 3. The patient has either simultaneous or non-simultaneous bilateral breast cancer. 4. The patient has a history of other malignancies or synchronic multiple cancers. However, lesions corresponding to carcinoma in situ or intramucosal carcinoma healed by topical therapy are eligible. 5. The patient is pregnant, has the potential and/or wishes to become pregnant, or is breastfeeding. 6. The patient has previously had an organ transplant. 7. The patient shows hypersensitivity to fluoropyrimidine agents; has previously suffered severe adverse drug reactions with fluoropyrimidine agents; or has a history of serious hypersensitivity to LHRH analogs, tamoxifen, letrozole, anastrozole, and/or exemestane. 8. The patient is currently suffering from serious complications or associated disorders, such as malignant hypertension, congestive heart failure, coronary failure, arrhythmias requiring treatment, infectious diseases, and/or hemorrhagic tendency, and/or has suffered a myocardial infarction within the previous 6 months. 9. The patient has a fever, and there is the possibility that she has an infection. 10. The patient has been shown to have metastasis to other organs. 11. The patient requires treatment for epilepsy and/or central nervous system disorders. 12. The patient is currently being treated for, or has a history of, psychiatric disease. 13. It would be difficult to orally administer drugs to the patient, and/or she suffers from functional insufficiency of the upper gastrointestinal tract and/or malabsorption syndrome. 14. For any other reason, the investigator or sub-investigator has judged the patient to be ineligible for participation.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 20 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 20 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 20 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 75 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* 1. The patient is considered to require postoperative chemotherapy other than capecitabine and vinorelbine. 2. The patient has previously been treated with oral 5-FU agents (however, previous treatment with iv 5-FU is acceptable). 3. The patient has either simultaneous or non-simultaneous bilateral breast cancer. 4. The patient has a history of other malignancies or synchronic multiple cancers. However, lesions corresponding to carcinoma in situ or intramucosal carcinoma healed by topical therapy are eligible. 5. The patient is pregnant, has the potential and/or wishes to become pregnant, or is breastfeeding. 6. The patient has previously had an organ transplant. 7. The patient shows hypersensitivity to fluoropyrimidine agents; has previously suffered severe adverse drug reactions with fluoropyrimidine agents; or has a history of serious hypersensitivity to LHRH analogs, tamoxifen, letrozole, anastrozole, and/or exemestane. 8. The patient is currently suffering from serious complications or associated disorders, such as malignant hypertension, congestive heart failure, coronary failure, arrhythmias requiring treatment, infectious diseases, and/or hemorrhagic tendency, and/or has suffered a myocardial infarction within the previous 6 months. 9. The patient has a fever, and there is the possibility that she has an infection. 10. The patient has been shown to have metastasis to other organs. 11. The patient requires treatment for epilepsy and/or central nervous system disorders. 12. The patient is currently being treated for, or has a history of, psychiatric disease. 13. It would be difficult to orally administer drugs to the patient, and/or she suffers from functional insufficiency of the upper gastrointestinal tract and/or malabsorption syndrome. 14. For any other reason, the investigator or sub-investigator has judged the patient to be ineligible for participation.",
                "criterions": [
                    {
                        "exact_snippets": "The patient is considered to require postoperative chemotherapy other than capecitabine and vinorelbine.",
                        "criterion": "postoperative chemotherapy requirement",
                        "requirement": {
                            "requirement_type": "specific drugs",
                            "expected_value": [
                                "capecitabine",
                                "vinorelbine"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "The patient has previously been treated with oral 5-FU agents (however, previous treatment with iv 5-FU is acceptable).",
                        "criterion": "previous treatment with oral 5-FU agents",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "The patient has either simultaneous or non-simultaneous bilateral breast cancer.",
                        "criterion": "bilateral breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "The patient has a history of other malignancies or synchronic multiple cancers. However, lesions corresponding to carcinoma in situ or intramucosal carcinoma healed by topical therapy are eligible.",
                        "criterion": "history of other malignancies or synchronic multiple cancers",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "The patient is pregnant, has the potential and/or wishes to become pregnant, or is breastfeeding.",
                        "criterion": "pregnancy or breastfeeding status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "The patient has previously had an organ transplant.",
                        "criterion": "previous organ transplant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "The patient shows hypersensitivity to fluoropyrimidine agents; has previously suffered severe adverse drug reactions with fluoropyrimidine agents; or has a history of serious hypersensitivity to LHRH analogs, tamoxifen, letrozole, anastrozole, and/or exemestane.",
                        "criterion": "hypersensitivity to specific agents",
                        "requirement": {
                            "requirement_type": "hypersensitivity",
                            "expected_value": [
                                "fluoropyrimidine agents",
                                "LHRH analogs",
                                "tamoxifen",
                                "letrozole",
                                "anastrozole",
                                "exemestane"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "The patient is currently suffering from serious complications or associated disorders, such as malignant hypertension, congestive heart failure, coronary failure, arrhythmias requiring treatment, infectious diseases, and/or hemorrhagic tendency, and/or has suffered a myocardial infarction within the previous 6 months.",
                        "criterion": "serious complications or associated disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "malignant hypertension",
                                "congestive heart failure",
                                "coronary failure",
                                "arrhythmias",
                                "infectious diseases",
                                "hemorrhagic tendency",
                                "myocardial infarction within the previous 6 months"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "The patient has a fever, and there is the possibility that she has an infection.",
                        "criterion": "fever with possible infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "The patient has been shown to have metastasis to other organs.",
                        "criterion": "metastasis to other organs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "The patient requires treatment for epilepsy and/or central nervous system disorders.",
                        "criterion": "treatment for epilepsy or CNS disorders",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "The patient is currently being treated for, or has a history of, psychiatric disease.",
                        "criterion": "psychiatric disease",
                        "requirement": {
                            "requirement_type": "treatment or history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "It would be difficult to orally administer drugs to the patient, and/or she suffers from functional insufficiency of the upper gastrointestinal tract and/or malabsorption syndrome.",
                        "criterion": "difficulty in oral drug administration",
                        "requirement": {
                            "requirement_type": "difficulty",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "For any other reason, the investigator or sub-investigator has judged the patient to be ineligible for participation.",
                        "criterion": "investigator judgment of ineligibility",
                        "requirement": {
                            "requirement_type": "judgment",
                            "expected_value": "ineligible"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "The patient is considered to require postoperative chemotherapy other than capecitabine and vinorelbine.",
                                    "criterion": "postoperative chemotherapy requirement",
                                    "requirement": {
                                        "requirement_type": "specific drugs",
                                        "expected_value": [
                                            "capecitabine",
                                            "vinorelbine"
                                        ]
                                    }
                                },
                                {
                                    "exact_snippets": "The patient has previously been treated with oral 5-FU agents (however, previous treatment with iv 5-FU is acceptable).",
                                    "criterion": "previous treatment with oral 5-FU agents",
                                    "requirement": {
                                        "requirement_type": "treatment history",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "The patient has either simultaneous or non-simultaneous bilateral breast cancer.",
                                    "criterion": "bilateral breast cancer",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "The patient has a history of other malignancies or synchronic multiple cancers. However, lesions corresponding to carcinoma in situ or intramucosal carcinoma healed by topical therapy are eligible.",
                                                "criterion": "history of other malignancies or synchronic multiple cancers",
                                                "requirement": {
                                                    "requirement_type": "history",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "The patient has a history of other malignancies or synchronic multiple cancers. However, lesions corresponding to carcinoma in situ or intramucosal carcinoma healed by topical therapy are eligible.",
                                                "criterion": "carcinoma in situ or intramucosal carcinoma healed by topical therapy",
                                                "requirement": {
                                                    "requirement_type": "eligibility",
                                                    "expected_value": true
                                                }
                                            }
                                        ]
                                    }
                                },
                                {
                                    "exact_snippets": "The patient is pregnant, has the potential and/or wishes to become pregnant, or is breastfeeding.",
                                    "criterion": "pregnancy or breastfeeding status",
                                    "requirement": {
                                        "requirement_type": "status",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "The patient has previously had an organ transplant.",
                                    "criterion": "previous organ transplant",
                                    "requirement": {
                                        "requirement_type": "history",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "or_criteria": [
                                        {
                                            "exact_snippets": "The patient shows hypersensitivity to fluoropyrimidine agents; has previously suffered severe adverse drug reactions with fluoropyrimidine agents; or has a history of serious hypersensitivity to LHRH analogs, tamoxifen, letrozole, anastrozole, and/or exemestane.",
                                            "criterion": "hypersensitivity to specific agents",
                                            "requirement": {
                                                "requirement_type": "hypersensitivity",
                                                "expected_value": [
                                                    "fluoropyrimidine agents",
                                                    "LHRH analogs",
                                                    "tamoxifen",
                                                    "letrozole",
                                                    "anastrozole",
                                                    "exemestane"
                                                ]
                                            }
                                        }
                                    ]
                                },
                                {
                                    "exact_snippets": "The patient is currently suffering from serious complications or associated disorders, such as malignant hypertension, congestive heart failure, coronary failure, arrhythmias requiring treatment, infectious diseases, and/or hemorrhagic tendency, and/or has suffered a myocardial infarction within the previous 6 months.",
                                    "criterion": "serious complications or associated disorders",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": [
                                            "malignant hypertension",
                                            "congestive heart failure",
                                            "coronary failure",
                                            "arrhythmias",
                                            "infectious diseases",
                                            "hemorrhagic tendency",
                                            "myocardial infarction within the previous 6 months"
                                        ]
                                    }
                                },
                                {
                                    "exact_snippets": "The patient has a fever, and there is the possibility that she has an infection.",
                                    "criterion": "fever with possible infection",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "The patient has been shown to have metastasis to other organs.",
                                    "criterion": "metastasis to other organs",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "The patient requires treatment for epilepsy and/or central nervous system disorders.",
                                    "criterion": "treatment for epilepsy or CNS disorders",
                                    "requirement": {
                                        "requirement_type": "treatment requirement",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "The patient is currently being treated for, or has a history of, psychiatric disease.",
                                    "criterion": "psychiatric disease",
                                    "requirement": {
                                        "requirement_type": "treatment or history",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "It would be difficult to orally administer drugs to the patient, and/or she suffers from functional insufficiency of the upper gastrointestinal tract and/or malabsorption syndrome.",
                                    "criterion": "difficulty in oral drug administration",
                                    "requirement": {
                                        "requirement_type": "difficulty",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "For any other reason, the investigator or sub-investigator has judged the patient to be ineligible for participation.",
                                    "criterion": "investigator judgment of ineligibility",
                                    "requirement": {
                                        "requirement_type": "judgment",
                                        "expected_value": "ineligible"
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* 1. Female patient with primary, infiltrative breast cancer who has been diagnosed on a histological basis. 2. Stage I-IIIB at the first diagnosis and underwent curative resection. 3. The patient was non-pCR after preoperative chemotherapy including anthracycline agents and paclitaxel or docetaxel; that is, she had undergone primary tumor resection and pathologically confirmed to have residual cancer cells.The previously adminstered preoperative chemotherapy must have involved 8 cycles of EC-T or 6 cycles of TEC.If HER-2 is positive, trastuzumab is applied with T chemotherapy 4. The patient has high risk: young;triple negtive breast caner; positive axillary lymphnode;HER-2 positive;ect 5. The patient's general performance status is 0 to 1. 6. The patient must have no carry-over of efficacy from any previous treatment. 7. The patient has maintained sufficient organ function to permit valid evaluation. 8. The patient must have no adverse drug reactions of grade 2 or higher carried over from previous treatment. 9. The patient's creatinine clearance is higher than 50 ml/min 10. The patient has personally given written, informed consent to participate in this study.",
                "criterions": [
                    {
                        "exact_snippets": "Female patient",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "primary, infiltrative breast cancer",
                        "criterion": "breast cancer type",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "primary, infiltrative"
                        }
                    },
                    {
                        "exact_snippets": "diagnosed on a histological basis",
                        "criterion": "diagnosis method",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "histological"
                        }
                    },
                    {
                        "exact_snippets": "Stage I-IIIB at the first diagnosis",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "Stage I-IIIB"
                        }
                    },
                    {
                        "exact_snippets": "underwent curative resection",
                        "criterion": "surgical treatment",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "curative resection"
                        }
                    },
                    {
                        "exact_snippets": "non-pCR after preoperative chemotherapy",
                        "criterion": "pathological complete response",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "non-pCR"
                        }
                    },
                    {
                        "exact_snippets": "preoperative chemotherapy including anthracycline agents and paclitaxel or docetaxel",
                        "criterion": "chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": [
                                "anthracycline agents",
                                "paclitaxel",
                                "docetaxel"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "8 cycles of EC-T or 6 cycles of TEC",
                        "criterion": "chemotherapy cycles",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": [
                                "8 cycles of EC-T",
                                "6 cycles of TEC"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "HER-2 is positive, trastuzumab is applied with T chemotherapy",
                        "criterion": "HER-2 status and treatment",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "HER-2 positive, trastuzumab applied"
                        }
                    },
                    {
                        "exact_snippets": "high risk: young;triple negtive breast caner; positive axillary lymphnode;HER-2 positive",
                        "criterion": "high risk factors",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": [
                                "young",
                                "triple negative breast cancer",
                                "positive axillary lymph node",
                                "HER-2 positive"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "general performance status is 0 to 1",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "no carry-over of efficacy from any previous treatment",
                        "criterion": "carry-over efficacy",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "none"
                        }
                    },
                    {
                        "exact_snippets": "sufficient organ function to permit valid evaluation",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "sufficient"
                        }
                    },
                    {
                        "exact_snippets": "no adverse drug reactions of grade 2 or higher carried over from previous treatment",
                        "criterion": "adverse drug reactions",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "less than grade 2"
                        }
                    },
                    {
                        "exact_snippets": "creatinine clearance is higher than 50 ml/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    },
                    {
                        "exact_snippets": "personally given written, informed consent to participate in this study",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "given"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}