{
    "info": {
        "nct_id": "NCT06830720",
        "official_title": "A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence to Evaluate Real-world Effectiveness, Safety Profile, Patient Compliance and Quality of Life",
        "inclusion_criteria": "* Histological diagnosis of HR+/HER2- early breast cancer with curative intent\n* Patients must have an indication for a treatment with ribociclib + NSAI ± LHRH as described in the current SmPC/\"Fachinformation\" of ribociclib (to be included into the cohorts of ribociclib + NSAI ± LHRH and ET mono ± LHRH) or abemaciclib + ET ± LHRH as described in the current SmPC/\"Fachinformation\" of abemaciclib (to be included into the abemaciclib + ET ± LHRH cohort) in the adjuvant setting\n* Before enrollment the treating physician has made the decision in accordance with the patient to treat the patient with either\n\n  * ribociclib + NSAI ± LHRH, or\n  * ET mono ± LHRH, or\n  * abemaciclib + ET ± LHRH and baseline is no longer than 2 weeks (14 days) prior to written informed consent for this study.\n\nBaseline = for ribociclib + NSAI ± LHRH cohort: date of therapy start; for abemaciclib + ET ± LHRH cohort: date of therapy start; for ET mono ± LHRH cohort: 4 weeks after therapy start or 4 weeks after last non-endocrine based therapy, whichever is last.\n\n* ≥18 years of age\n* Written informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 100 Years",
        "exclusion_criteria": "* Patient is currently under active treatment in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib\n* For ribociclib + NSAI ± LHRH cohort: ET pre-treatment is longer than 12 months, according to the current SmPC/\"Fachinformation\" of ribociclib; for abemaciclib + ET ± LHRH cohort: ET pre-treatment is longer than 12 weeks, according to the current SmPC/\"Fachinformation\" of abemaciclib",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histological diagnosis of HR+/HER2- early breast cancer with curative intent",
            "criterions": [
                {
                    "exact_snippets": "Histological diagnosis of HR+/HER2- early breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "histological diagnosis",
                            "expected_value": "HR+/HER2- early"
                        }
                    ]
                },
                {
                    "exact_snippets": "curative intent",
                    "criterion": "treatment intent",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have an indication for a treatment with ribociclib + NSAI ± LHRH as described in the current SmPC/\"Fachinformation\" of ribociclib (to be included into the cohorts of ribociclib + NSAI ± LHRH and ET mono ± LHRH) or abemaciclib + ET ± LHRH as described in the current SmPC/\"Fachinformation\" of abemaciclib (to be included into the abemaciclib + ET ± LHRH cohort) in the adjuvant setting",
            "criterions": [
                {
                    "exact_snippets": "indication for a treatment with ribociclib + NSAI ± LHRH as described in the current SmPC/\"Fachinformation\" of ribociclib",
                    "criterion": "indication for ribociclib + NSAI ± LHRH treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "indication for a treatment with ... abemaciclib + ET ± LHRH as described in the current SmPC/\"Fachinformation\" of abemaciclib",
                    "criterion": "indication for abemaciclib + ET ± LHRH treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Before enrollment the treating physician has made the decision in accordance with the patient to treat the patient with either",
            "criterions": [
                {
                    "exact_snippets": "Before enrollment the treating physician has made the decision in accordance with the patient to treat the patient with either",
                    "criterion": "treatment decision",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ribociclib + NSAI ± LHRH, or",
            "criterions": [
                {
                    "exact_snippets": "ribociclib",
                    "criterion": "ribociclib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "NSAI",
                    "criterion": "NSAI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "LHRH",
                    "criterion": "LHRH",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ET mono ± LHRH, or",
            "criterions": [
                {
                    "exact_snippets": "ET mono",
                    "criterion": "ET mono",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "LHRH",
                    "criterion": "LHRH",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* abemaciclib + ET ± LHRH and baseline is no longer than 2 weeks (14 days) prior to written informed consent for this study.",
            "criterions": [
                {
                    "exact_snippets": "baseline is no longer than 2 weeks (14 days) prior to written informed consent",
                    "criterion": "baseline timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Baseline = for ribociclib + NSAI ± LHRH cohort: date of therapy start; for abemaciclib + ET ± LHRH cohort: date of therapy start; for ET mono ± LHRH cohort: 4 weeks after therapy start or 4 weeks after last non-endocrine based therapy, whichever is last.",
            "criterions": [
                {
                    "exact_snippets": "ribociclib + NSAI ± LHRH cohort: date of therapy start",
                    "criterion": "ribociclib + NSAI ± LHRH cohort",
                    "requirements": [
                        {
                            "requirement_type": "date of therapy start",
                            "expected_value": "N/A"
                        }
                    ]
                },
                {
                    "exact_snippets": "abemaciclib + ET ± LHRH cohort: date of therapy start",
                    "criterion": "abemaciclib + ET ± LHRH cohort",
                    "requirements": [
                        {
                            "requirement_type": "date of therapy start",
                            "expected_value": "N/A"
                        }
                    ]
                },
                {
                    "exact_snippets": "ET mono ± LHRH cohort: 4 weeks after therapy start or 4 weeks after last non-endocrine based therapy, whichever is last",
                    "criterion": "ET mono ± LHRH cohort",
                    "requirements": [
                        {
                            "requirement_type": "time after therapy start",
                            "expected_value": {
                                "operator": "=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "time after last non-endocrine based therapy",
                            "expected_value": {
                                "operator": "=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≥18 years of age",
            "criterions": [
                {
                    "exact_snippets": "≥18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "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 100 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 100 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patient is currently under active treatment in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib",
            "criterions": [
                {
                    "exact_snippets": "Patient is currently under active treatment in any investigational trial",
                    "criterion": "active treatment in investigational trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib",
                    "criterion": "participation in Novartis-sponsored non-interventional study with ribociclib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For ribociclib + NSAI ± LHRH cohort: ET pre-treatment is longer than 12 months, according to the current SmPC/\"Fachinformation\" of ribociclib; for abemaciclib + ET ± LHRH cohort: ET pre-treatment is longer than 12 weeks, according to the current SmPC/\"Fachinformation\" of abemaciclib",
            "criterions": [
                {
                    "exact_snippets": "ribociclib + NSAI ± LHRH cohort: ET pre-treatment is longer than 12 months",
                    "criterion": "ET pre-treatment duration for ribociclib + NSAI ± LHRH cohort",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "abemaciclib + ET ± LHRH cohort: ET pre-treatment is longer than 12 weeks",
                    "criterion": "ET pre-treatment duration for abemaciclib + ET ± LHRH cohort",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}