{
    "info": {
        "nct_id": "NCT06076772",
        "official_title": "Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients",
        "inclusion_criteria": "* Histological pathological confirmation of primary breast cancer or metastatic disease.\n* Hormonal receptor-positive, HER2 negative.\n* Metastatic breast cancer at presentation (Den novo) or recurrent.\n* Patients did not receive any previous systemic therapy for metastatic disease.\n* Performance status (ECOG) 0-2.\nHealthy volunteers allowed",
        "exclusion_criteria": "* Patient with co-morbidity\n* Pregnant and breast lactating women",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histological pathological confirmation of primary breast cancer or metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "Histological pathological confirmation of primary breast cancer",
                    "criterion": "primary breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histological pathological"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histological pathological confirmation of ... metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histological pathological"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormonal receptor-positive, HER2 negative.",
            "criterions": [
                {
                    "exact_snippets": "Hormonal receptor-positive",
                    "criterion": "hormonal receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 negative",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic breast cancer at presentation (Den novo) or recurrent.",
            "criterions": [
                {
                    "exact_snippets": "Metastatic breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients did not receive any previous systemic therapy for metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "Patients did not receive any previous systemic therapy for metastatic disease.",
                    "criterion": "previous systemic therapy for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status (ECOG) 0-2.",
            "criterions": [
                {
                    "exact_snippets": "Performance status (ECOG) 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "ECOG"
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patient with co-morbidity",
            "criterions": [
                {
                    "exact_snippets": "co-morbidity",
                    "criterion": "co-morbidity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant and breast lactating women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}