{
    "info": {
        "nct_id": "NCT04987931",
        "official_title": "Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Talazoparib-Treated Patients With HER2-Negative, Locally Advanced or Metastatic Breast Cancer and Germline BRCA1/2 Mutations: US Chart Review",
        "inclusion_criteria": "* Diagnosed with HER2-negative ABC\n* gBRCA1/2 mutation(s)\n* Treatment with talazoparib monotherapy initiated on or after October 16, 2018\n\n  -≥18 years of age at initiation of talazoparib\n* A minimum of 6 months follow-up time after initiation of talazoparib unless the patient died within this follow-up period\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Participation in any BC clinical trial after initiation of talazoparib\n* Treatment with a PARP inhibitor as neoadjuvant/adjuvant therapy\n* gBRCA1/2 or HER2 status unknown\n* Diagnosis of any other malignancy, except carcinoma in situ or nonmelanoma skin cancer, within the 5 years prior to data collection",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Diagnosed with HER2-negative ABC",
            "criterions": [
                {
                    "exact_snippets": "Diagnosed with HER2-negative ABC",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosed with HER2-negative ABC",
                    "criterion": "ABC (Advanced Breast Cancer)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* gBRCA1/2 mutation(s)",
            "criterions": [
                {
                    "exact_snippets": "gBRCA1/2 mutation(s)",
                    "criterion": "gBRCA1/2 mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment with talazoparib monotherapy initiated on or after October 16, 2018",
            "criterions": [
                {
                    "exact_snippets": "Treatment with talazoparib monotherapy initiated on or after October 16, 2018",
                    "criterion": "treatment with talazoparib monotherapy",
                    "requirements": [
                        {
                            "requirement_type": "initiation date",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2018,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "-≥18 years of age at initiation of talazoparib",
            "criterions": [
                {
                    "exact_snippets": "≥18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A minimum of 6 months follow-up time after initiation of talazoparib unless the patient died within this follow-up period",
            "criterions": [
                {
                    "exact_snippets": "A minimum of 6 months follow-up time after initiation of talazoparib",
                    "criterion": "follow-up time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the patient died within this follow-up period",
                    "criterion": "patient survival",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "alive"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Participation in any BC clinical trial after initiation of talazoparib",
            "criterions": [
                {
                    "exact_snippets": "Participation in any BC clinical trial after initiation of talazoparib",
                    "criterion": "participation in BC clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "after initiation of talazoparib"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment with a PARP inhibitor as neoadjuvant/adjuvant therapy",
            "criterions": [
                {
                    "exact_snippets": "Treatment with a PARP inhibitor",
                    "criterion": "PARP inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment phase",
                            "expected_value": [
                                "neoadjuvant",
                                "adjuvant"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* gBRCA1/2 or HER2 status unknown",
            "criterions": [
                {
                    "exact_snippets": "gBRCA1/2 ... status unknown",
                    "criterion": "gBRCA1/2 status",
                    "requirements": [
                        {
                            "requirement_type": "knowledge",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 status unknown",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "knowledge",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of any other malignancy, except carcinoma in situ or nonmelanoma skin cancer, within the 5 years prior to data collection",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of any other malignancy, except carcinoma in situ or nonmelanoma skin cancer",
                    "criterion": "other malignancy diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within the 5 years prior to data collection",
                    "criterion": "time since other malignancy diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}