{
    "info": {
        "nct_id": "NCT05486182",
        "official_title": "Impact of 18F-fluoroestradiol (FES) Positron Emission Tomography (PET) on the Therapeutic Treatment of Metastatic Breast Cancer Patients, Initially ER Positive and HER2 Negative, in Relapse After First-line Therapy Combining Hormone Therapy",
        "inclusion_criteria": "1. Female aged at least 18 years old at the time of enrolment\n2. Oestrogen-receptor positive primary breast cancer in IHC (ER ≥10%)\n3. HER2-negative primary breast cancer (0, 1+, 2+ FISH negative)\n4. Metastatic stage with at least one lesion identifiable on the conventional work-up other than a liver lesion\n5. Patient relapsing under first-line treatment combining a CDK4/6inhibitor and hormone therapy\n6. Patient having undergone an FDG PET/CT during follow-up of first-line treatment for metastatic tumour revealing the relapse or undergoing a baseline FDG PET/CT seeking the relapse during 2nd line staging (according to the recommendations of the Guide to Correct Use (GBU) for medical imaging tests). A period of 2 to 28 days will be respected between the 2 PET/CT scans (FDG/FES).\n7. ECOG 0, 1 or 2\n8. Life expectancy of at least 12 months\n9. Patient registered with a Social Security scheme\n10. Patient having signed an informed consent form\n11. Patient able to follow the study procedures and fill in the quality of life questionnaires\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES)\n2. Patients as first-line treatment for metastatic cancer or aftersecond-line treatment for metastatic cancer\n3. Person presenting a known allergy to one of the components of EstroTep\n4. Patients having been treated with a CDK4/6 inhibitor in combination with an SERM or SERD as first-line metastatic therapy\n5. atients suffering from severe or known chronic liver or renal failure\n6. Patient following a low-sodium diet or having alcohol consumption levels incompatible with the administration of EstroTep, according to the investigator's opinion\n7. Woman of childbearing age with no effective means of contraception according to the investigator's opinion\n8. Severe intercurrent disease or comorbidity assessed at risk\n9. Persons referred to in articles L. 1121-5 to L. 1121-8 and L11222 of the French Public Health Code",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Female aged at least 18 years old at the time of enrolment",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged at least 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Oestrogen-receptor positive primary breast cancer in IHC (ER ≥10%)",
            "criterions": [
                {
                    "exact_snippets": "Oestrogen-receptor positive primary breast cancer",
                    "criterion": "oestrogen-receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "ER ≥10%",
                    "criterion": "ER percentage",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. HER2-negative primary breast cancer (0, 1+, 2+ FISH negative)",
            "criterions": [
                {
                    "exact_snippets": "HER2-negative primary breast cancer",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary breast cancer",
                    "criterion": "breast cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "primary"
                        }
                    ]
                },
                {
                    "exact_snippets": "0, 1+, 2+ FISH negative",
                    "criterion": "FISH score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": [
                                "0",
                                "1+",
                                "2+ FISH negative"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Metastatic stage with at least one lesion identifiable on the conventional work-up other than a liver lesion",
            "criterions": [
                {
                    "exact_snippets": "Metastatic stage",
                    "criterion": "metastatic stage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one lesion identifiable on the conventional work-up",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other than a liver lesion",
                    "criterion": "liver lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patient having undergone an FDG PET/CT during follow-up of first-line treatment for metastatic tumour revealing the relapse or undergoing a baseline FDG PET/CT seeking the relapse during 2nd line staging (according to the recommendations of the Guide to Correct Use (GBU) for medical imaging tests). A period of 2 to 28 days will be respected between the 2 PET/CT scans (FDG/FES).",
            "criterions": [
                {
                    "exact_snippets": "Patient having undergone an FDG PET/CT during follow-up of first-line treatment for metastatic tumour",
                    "criterion": "FDG PET/CT during follow-up of first-line treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "revealing the relapse",
                    "criterion": "relapse revealed by FDG PET/CT",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undergoing a baseline FDG PET/CT seeking the relapse during 2nd line staging",
                    "criterion": "baseline FDG PET/CT during 2nd line staging",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "seeking the relapse"
                        }
                    ]
                },
                {
                    "exact_snippets": "A period of 2 to 28 days will be respected between the 2 PET/CT scans (FDG/FES)",
                    "criterion": "period between 2 PET/CT scans",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. ECOG 0, 1 or 2",
            "criterions": [
                {
                    "exact_snippets": "ECOG 0, 1 or 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Life expectancy of at least 12 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 12 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patient registered with a Social Security scheme",
            "criterions": [
                {
                    "exact_snippets": "Patient registered with a Social Security scheme",
                    "criterion": "Social Security scheme registration",
                    "requirements": [
                        {
                            "requirement_type": "registration",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patient having signed an informed consent form",
            "criterions": [
                {
                    "exact_snippets": "Patient having signed an informed consent form",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patient able to follow the study procedures and fill in the quality of life questionnaires",
            "criterions": [
                {
                    "exact_snippets": "Patient able to follow the study procedures",
                    "criterion": "ability to follow study procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fill in the quality of life questionnaires",
                    "criterion": "ability to fill in quality of life questionnaires",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES)",
            "criterions": [
                {
                    "exact_snippets": "Isolated hepatic metastases",
                    "criterion": "hepatic metastases",
                    "requirements": [
                        {
                            "requirement_type": "isolation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Person presenting a known allergy to one of the components of EstroTep",
            "criterions": [
                {
                    "exact_snippets": "known allergy to one of the components of EstroTep",
                    "criterion": "allergy to EstroTep components",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients having been treated with a CDK4/6 inhibitor in combination with an SERM or SERD as first-line metastatic therapy",
            "criterions": [
                {
                    "exact_snippets": "Patients having been treated with a CDK4/6 inhibitor",
                    "criterion": "CDK4/6 inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in combination with an SERM or SERD",
                    "criterion": "SERM or SERD treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "as first-line metastatic therapy",
                    "criterion": "first-line metastatic therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment line",
                            "expected_value": "first-line"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. atients suffering from severe or known chronic liver or renal failure",
            "criterions": [
                {
                    "exact_snippets": "severe or known chronic liver ... failure",
                    "criterion": "liver failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "chronicity",
                            "expected_value": "known chronic"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe or known chronic ... renal failure",
                    "criterion": "renal failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "chronicity",
                            "expected_value": "known chronic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patient following a low-sodium diet or having alcohol consumption levels incompatible with the administration of EstroTep, according to the investigator's opinion",
            "criterions": [
                {
                    "exact_snippets": "Patient following a low-sodium diet",
                    "criterion": "low-sodium diet",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "alcohol consumption levels incompatible with the administration of EstroTep",
                    "criterion": "alcohol consumption levels",
                    "requirements": [
                        {
                            "requirement_type": "compatibility with EstroTep",
                            "expected_value": "incompatible"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Woman of childbearing age with no effective means of contraception according to the investigator's opinion",
            "criterions": [
                {
                    "exact_snippets": "Woman of childbearing age",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing age"
                        }
                    ]
                },
                {
                    "exact_snippets": "no effective means of contraception according to the investigator's opinion",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "assessment",
                            "expected_value": "investigator's opinion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Severe intercurrent disease or comorbidity assessed at risk",
            "criterions": [
                {
                    "exact_snippets": "Severe intercurrent disease",
                    "criterion": "intercurrent disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "comorbidity assessed at risk",
                    "criterion": "comorbidity",
                    "requirements": [
                        {
                            "requirement_type": "risk assessment",
                            "expected_value": "at risk"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Persons referred to in articles L. 1121-5 to L. 1121-8 and L11222 of the French Public Health Code",
            "criterions": [
                {
                    "exact_snippets": "Persons referred to in articles L. 1121-5 to L. 1121-8 and L11222 of the French Public Health Code",
                    "criterion": "legal status under French Public Health Code",
                    "requirements": [
                        {
                            "requirement_type": "reference",
                            "expected_value": [
                                "L. 1121-5",
                                "L. 1121-6",
                                "L. 1121-7",
                                "L. 1121-8",
                                "L11222"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "5. Patient relapsing under first-line treatment combining a CDK4/6inhibitor and hormone therapy",
            "criterions": [
                {
                    "exact_snippets": "Patient relapsing under first-line treatment combining a CDK4/6 inhibitor and hormone therapy",
                    "criterion": "relapse under first-line treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment components",
                            "expected_value": [
                                "CDK4/6 inhibitor",
                                "hormone therapy"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [
        {
            "line": "2. Patients as first-line treatment for metastatic cancer or aftersecond-line treatment for metastatic cancer",
            "criterions": [
                {
                    "exact_snippets": "first-line treatment for metastatic cancer",
                    "criterion": "treatment line for metastatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "line",
                            "expected_value": "first-line"
                        }
                    ]
                },
                {
                    "exact_snippets": "after second-line treatment for metastatic cancer",
                    "criterion": "treatment line for metastatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "line",
                            "expected_value": "after second-line"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}