{
    "info": {
        "nct_id": "NCT00295620",
        "official_title": "A Prospective, Randomized, Open, Multicentre Phase III-study to Assess the Efficacy of Secondary Adjuvant Endocrine Anastrozole Therapy for 2 Further Yrs vs 5 Further Yrs in Patients With HR +ve Breast Cancer After 5-yr Primary Adjuvant Endocrine Therapy",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria:\n\n1. Postmenopausal patients with histologically confirmed, local radically treated invasive or minimal-invasiv Mammacarcinom with or without previous chemotherapie and/or radiotherapie.\n2. No distant metastasis at randomization\n3. No relapse at randomization\n4. TNM- classification at time of diagnosis: T1-3, N0 and N+, M0\n5. Estrogen- and or progesterone positive before the beginningof primary endocrine therapy\n6. Endocrine therapy for 5 years (maximum deviation ±12 months)\n7. Therapy break (from the preliminary therapie) maximum 12 months.\n8. Informed Consent before the randomisation\n\nExclusion criteria:\n\n1. Premenopausal patients or patients with non definable menopausal statusat time of randomisation\n2. Apparent secondary malignant tumor or status after secondary malignant tumor (Exceptions: simultaniously appearing bilateral breast carcinoma, estrogen- and or progesteronereceptor positive on both sides at the time of diagnosis; in situ carcinomaof the cervix and basal cell carcinoma of the skin)\n3. General contraindication respectively hypersensitivity to Anastrozol.\n4. In-situ carcinoma of any size with or without Mb. Paget of the Mamilla respectively T4 tumor at the time of first diagnosis.\n5. Receptor unknown or negative at time of diagnosis respectively at beginning of primary endocrine therapy\n6. Known liver- and/or kidneyinsufficiency\n7. Performance Index >2 according to WHO\n8. Regular intake of hormon supplement as well as Hormone Replacement Therapy (HRT) more than 6 months since primary surgery of the mamma carcinoma\n9. Serious accessory disease, that prevents the adjuvant therapy according to protocol and/or the regular follow-up care.\n10. Lacking compliance of the patient\n11. Legal incompetence and/or other circumstances, that prevent the patient from understanding the nature, meaning and consequences of the clinical trial\n12. Existing psychiatrical diseaseaccording to ICD (especially alcohol addiction) et the time of admission into the study"
    },
    "inclusion_lines": [
        {
            "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": "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 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "2. No distant metastasis at randomization",
            "criterions": [
                {
                    "exact_snippets": "No distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. No relapse at randomization",
            "criterions": [
                {
                    "exact_snippets": "No relapse at randomization",
                    "criterion": "relapse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. TNM- classification at time of diagnosis: T1-3, N0 and N+, M0",
            "criterions": [
                {
                    "exact_snippets": "TNM- classification at time of diagnosis: T1-3",
                    "criterion": "tumor size (T)",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "TNM- classification at time of diagnosis: ... N0 and N+",
                    "criterion": "regional lymph nodes (N)",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "N0",
                                "N+"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "TNM- classification at time of diagnosis: ... M0",
                    "criterion": "distant metastasis (M)",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "M0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Estrogen- and or progesterone positive before the beginningof primary endocrine therapy",
            "criterions": [
                {
                    "exact_snippets": "Estrogen- and or progesterone positive",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "estrogen positive",
                                "progesterone positive"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Endocrine therapy for 5 years (maximum deviation ±12 months)",
            "criterions": [
                {
                    "exact_snippets": "Endocrine therapy for 5 years (maximum deviation ±12 months)",
                    "criterion": "endocrine therapy duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Therapy break (from the preliminary therapie) maximum 12 months.",
            "criterions": [
                {
                    "exact_snippets": "Therapy break ... maximum 12 months.",
                    "criterion": "therapy break duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Informed Consent before the randomisation",
            "criterions": [
                {
                    "exact_snippets": "Informed Consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Premenopausal patients or patients with non definable menopausal statusat time of randomisation",
            "criterions": [
                {
                    "exact_snippets": "Premenopausal patients",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "premenopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with non definable menopausal status",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "non definable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. General contraindication respectively hypersensitivity to Anastrozol.",
            "criterions": [
                {
                    "exact_snippets": "General contraindication",
                    "criterion": "general contraindication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to Anastrozol",
                    "criterion": "hypersensitivity to Anastrozol",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. In-situ carcinoma of any size with or without Mb. Paget of the Mamilla respectively T4 tumor at the time of first diagnosis.",
            "criterions": [
                {
                    "exact_snippets": "In-situ carcinoma of any size",
                    "criterion": "in-situ carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without Mb. Paget of the Mamilla",
                    "criterion": "Mb. Paget of the Mamilla",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "with or without"
                        }
                    ]
                },
                {
                    "exact_snippets": "T4 tumor at the time of first diagnosis",
                    "criterion": "T4 tumor",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T4"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "at the time of first diagnosis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Receptor unknown or negative at time of diagnosis respectively at beginning of primary endocrine therapy",
            "criterions": [
                {
                    "exact_snippets": "Receptor unknown or negative at time of diagnosis",
                    "criterion": "receptor status at time of diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "unknown",
                                "negative"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Receptor unknown or negative ... at beginning of primary endocrine therapy",
                    "criterion": "receptor status at beginning of primary endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "unknown",
                                "negative"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Known liver- and/or kidneyinsufficiency",
            "criterions": [
                {
                    "exact_snippets": "Known liver-...insufficiency",
                    "criterion": "liver insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known...kidneyinsufficiency",
                    "criterion": "kidney insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Performance Index >2 according to WHO",
            "criterions": [
                {
                    "exact_snippets": "Performance Index >2 according to WHO",
                    "criterion": "Performance Index",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Regular intake of hormon supplement as well as Hormone Replacement Therapy (HRT) more than 6 months since primary surgery of the mamma carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Regular intake of hormon supplement",
                    "criterion": "hormone supplement intake",
                    "requirements": [
                        {
                            "requirement_type": "regularity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hormone Replacement Therapy (HRT) more than 6 months since primary surgery",
                    "criterion": "Hormone Replacement Therapy (HRT)",
                    "requirements": [
                        {
                            "requirement_type": "duration since primary surgery",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Serious accessory disease, that prevents the adjuvant therapy according to protocol and/or the regular follow-up care.",
            "criterions": [
                {
                    "exact_snippets": "Serious accessory disease, that prevents the adjuvant therapy according to protocol and/or the regular follow-up care.",
                    "criterion": "accessory disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "impact on treatment",
                            "expected_value": "prevents adjuvant therapy and/or regular follow-up care"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Lacking compliance of the patient",
            "criterions": [
                {
                    "exact_snippets": "Lacking compliance of the patient",
                    "criterion": "patient compliance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Legal incompetence and/or other circumstances, that prevent the patient from understanding the nature, meaning and consequences of the clinical trial",
            "criterions": [
                {
                    "exact_snippets": "Legal incompetence",
                    "criterion": "legal competence",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other circumstances, that prevent the patient from understanding the nature, meaning and consequences of the clinical trial",
                    "criterion": "understanding of the clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion criteria:",
            "criterions": []
        },
        {
            "line": "1. Postmenopausal patients with histologically confirmed, local radically treated invasive or minimal-invasiv Mammacarcinom with or without previous chemotherapie and/or radiotherapie.",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal patients",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed",
                    "criterion": "histological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "local radically treated invasive or minimal-invasive Mammacarcinom",
                    "criterion": "Mammacarcinom",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "local radically treated"
                        },
                        {
                            "requirement_type": "invasiveness",
                            "expected_value": [
                                "invasive",
                                "minimal-invasive"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without previous chemotherapie and/or radiotherapie",
                    "criterion": "previous treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "chemotherapy",
                                "radiotherapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Exclusion criteria:",
            "criterions": []
        },
        {
            "line": "2. Apparent secondary malignant tumor or status after secondary malignant tumor (Exceptions: simultaniously appearing bilateral breast carcinoma, estrogen- and or progesteronereceptor positive on both sides at the time of diagnosis; in situ carcinomaof the cervix and basal cell carcinoma of the skin)",
            "criterions": [
                {
                    "exact_snippets": "Apparent secondary malignant tumor",
                    "criterion": "secondary malignant tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "status after secondary malignant tumor",
                    "criterion": "status after secondary malignant tumor",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "after"
                        }
                    ]
                },
                {
                    "exact_snippets": "simultaniously appearing bilateral breast carcinoma",
                    "criterion": "bilateral breast carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "appearance",
                            "expected_value": "simultaneously"
                        }
                    ]
                },
                {
                    "exact_snippets": "estrogen- and or progesteronereceptor positive on both sides at the time of diagnosis",
                    "criterion": "estrogen- and or progesterone-receptor status",
                    "requirements": [
                        {
                            "requirement_type": "receptor status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ carcinoma of the cervix",
                    "criterion": "in situ carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Existing psychiatrical diseaseaccording to ICD (especially alcohol addiction) et the time of admission into the study",
            "criterions": [
                {
                    "exact_snippets": "Existing psychiatrical disease according to ICD",
                    "criterion": "psychiatrical disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "especially alcohol addiction",
                    "criterion": "alcohol addiction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ]
}