{
    "info": {
        "nct_id": "NCT05552001",
        "official_title": "ISIdE: Open Label, Multicentric, Single-arm Phase IIIB Trial to Evaluate the Safety and Efficacy of Sacituzumab Govitecan in Triple Negative Metastatic Breast Cancer Patients With a Biomarker Analysis",
        "inclusion_criteria": "1. Patient must have signed a written informed consent prior to any trial specific procedures;\n\n   Note: When the patient is unable to write to give his written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent\n2. Male or female ≥ 18 years of age;\n3. Patients with pathologically documented locally advanced inoperable or metastatic triple negative breast cancer (mTNBC) whose disease has progressed either on 1st line chemotherapy +/- immune checkpoint inhibitors (ICIs) or target therapy (e.g. AKT inhibitor, PI3K inhibitor, PARP inhibitor) for metastatic or inoperable locally advanced breast cancer (ABC) or on (neo)adjuvant chemotherapy+/-immunotherapy for early TNBC or within 6 months after the end of any systemic therapy, surgery or radiotherapy with curative intent, whatever comes last.\n\n   Note: TNBC is defined as the absence of HER2 overexpression by immunohistochemistry (IHC) defined as IHC 0, 1+, or 2+ and fluorescence in situ hybridization [FISH] non-amplified and estrogen receptor (ER) expression <10% and progesterone receptor (PR) expression <10% by local pathological assessment on the baseline biopsy or in a recent tissue sample collected within 3 months (if no anticancer therapy started between the biopsy and baseline)\n4. Prior exposure to a taxane\n\n   Note: If indicated, prior therapy with ICI for patients with PD1 positive tumor and prior treatment with PARP inhibitor for patients with gBRCAm is required\n5. Measurable disease, as defined by RECIST v1.1\n6. Patient must have accepted to perform pre-treatment, on-treatment and post-treatment biopsies. If the physician considers doing the biopsy on the primary tumor site because accessibility, it can be performed only if the primary tumor site has not been previously irradiated;\n7. Have metastatic site easily accessible to biopsy (with exception of bone metastasis)\n\n   Note 1: Patients with only bone metastasis will be eligible if the primary tumor is accessible for biopsy at inclusion\n\n   Note 2: If the patient has a single measurable lesion and it is the only one that can be biopsied, the patient cannot be included because the disease is no longer measurable according to RECIST v1.1\n8. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;\n9. Life expectancy ≥12 weeks;\n10. Adequate haematologic and organ function\n11. Negative hepatitis B surface antigen (HBsAg) test at screening (patients with a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening are eligible), negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening;\n12. Evidence of post-menopausal status or negative pregnancy urinary test within 72 hours or serum pregnancy test within 14 days before study treatment and confirmed prior to treatment on Cycle 1 Day 1 for female pre-menopausal patients;\n13. Woman of childbearing potential and male patient must agree to use adequate contraception for the duration of trial participation and up to 6 months after completing treatment for women and up to 3 months for men;\n14. Patient affiliated to a social security system (or equivalent);\n15. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up;\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Participation in another therapeutic trial within the 30 days prior to C1D1;\n2. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases or evidence of leptomeningeal disease or clinically active spinal cord compression. Patients with stable and asymptomatic brain metastases will be eligible, yet the number will be capped to 15% of the overall population;\n3. Previous history of cancer other than mTNBC within 5 years prior to C1D1, except of those with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%) and treated with curative intent (e.g. carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer);\n4. Met any of the following criteria for cardiac disease:\n\n   1. Myocardial infarction or unstable angina pectoris within 6 months of enrolment.\n   2. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.\n   3. New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of <40%.\n5. Severe uncontrolled infection requiring oral or IV antibiotics within 4 weeks prior to C1D1;\n6. Major surgical procedure within 4 weeks prior to C1D1;\n7. History of severe allergic, anaphylactic, or other hypersensitivity reactions to humanized antibodies;\n8. Known hypersensitivity to the study drug, its metabolites, or formulation excipient.\n9. Patients receiving concomitant anti-cancer treatments such as chemotherapy, immunotherapy, endocrine therapy and radiotherapy;\n10. Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved according to the common terminology criteria for adverse events of the National Cancer Institute (NCI-CTCAE) v5.0 grade >2\n11. Treatment with systemic corticosteroids dosed at >20 mg prednisone or equivalent or other systemic immunosuppressive medications within 2 weeks prior to C1D1;\n12. Known history of testing positive for HIV or known acquired immunodeficiency syndrome if not controlled;\n13. Covid-19 infection at screening;\n14. Evidence of significant uncontrolled concomitant disease;\n15. Individuals with physical or psychological conditions considered not to be compatible with the trial;\n16. Persons deprived of their liberty or under protective custody or guardianship;\n17. Pregnant or breastfeeding women;\n18. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patient must have signed a written informed consent prior to any trial specific procedures;",
            "criterions": [
                {
                    "exact_snippets": "Patient must have signed a written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: When the patient is unable to write to give his written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent",
            "criterions": [
                {
                    "exact_snippets": "patient is unable to write",
                    "criterion": "ability to write",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Male or female ≥ 18 years of age;",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with pathologically documented locally advanced inoperable or metastatic triple negative breast cancer (mTNBC) whose disease has progressed either on 1st line chemotherapy +/- immune checkpoint inhibitors (ICIs) or target therapy (e.g. AKT inhibitor, PI3K inhibitor, PARP inhibitor) for metastatic or inoperable locally advanced breast cancer (ABC) or on (neo)adjuvant chemotherapy+/-immunotherapy for early TNBC or within 6 months after the end of any systemic therapy, surgery or radiotherapy with curative intent, whatever comes last.",
            "criterions": [
                {
                    "exact_snippets": "pathologically documented locally advanced inoperable or metastatic triple negative breast cancer (mTNBC)",
                    "criterion": "triple negative breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "pathologically documented"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced inoperable",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "disease has progressed either on 1st line chemotherapy +/- immune checkpoint inhibitors (ICIs) or target therapy (e.g. AKT inhibitor, PI3K inhibitor, PARP inhibitor) for metastatic or inoperable locally advanced breast cancer (ABC)",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "1st line chemotherapy",
                                "immune checkpoint inhibitors",
                                "target therapy"
                            ]
                        },
                        {
                            "requirement_type": "context",
                            "expected_value": "metastatic or inoperable locally advanced breast cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "disease has progressed ... on (neo)adjuvant chemotherapy+/-immunotherapy for early TNBC",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "(neo)adjuvant chemotherapy",
                                "immunotherapy"
                            ]
                        },
                        {
                            "requirement_type": "context",
                            "expected_value": "early TNBC"
                        }
                    ]
                },
                {
                    "exact_snippets": "disease has progressed ... within 6 months after the end of any systemic therapy, surgery or radiotherapy with curative intent, whatever comes last",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        },
                        {
                            "requirement_type": "context",
                            "expected_value": "after the end of any systemic therapy, surgery or radiotherapy with curative intent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: TNBC is defined as the absence of HER2 overexpression by immunohistochemistry (IHC) defined as IHC 0, 1+, or 2+ and fluorescence in situ hybridization [FISH] non-amplified and estrogen receptor (ER) expression <10% and progesterone receptor (PR) expression <10% by local pathological assessment on the baseline biopsy or in a recent tissue sample collected within 3 months (if no anticancer therapy started between the biopsy and baseline)",
            "criterions": [
                {
                    "exact_snippets": "absence of HER2 overexpression by immunohistochemistry (IHC) defined as IHC 0, 1+, or 2+",
                    "criterion": "HER2 overexpression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "fluorescence in situ hybridization [FISH] non-amplified",
                    "criterion": "HER2 amplification by FISH",
                    "requirements": [
                        {
                            "requirement_type": "amplification",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "estrogen receptor (ER) expression <10%",
                    "criterion": "estrogen receptor (ER) expression",
                    "requirements": [
                        {
                            "requirement_type": "expression level",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "progesterone receptor (PR) expression <10%",
                    "criterion": "progesterone receptor (PR) expression",
                    "requirements": [
                        {
                            "requirement_type": "expression level",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "local pathological assessment on the baseline biopsy or in a recent tissue sample collected within 3 months",
                    "criterion": "tissue sample timing",
                    "requirements": [
                        {
                            "requirement_type": "collection timing",
                            "expected_value": "within 3 months"
                        }
                    ]
                },
                {
                    "exact_snippets": "if no anticancer therapy started between the biopsy and baseline",
                    "criterion": "anticancer therapy status",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "no therapy started between biopsy and baseline"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Prior exposure to a taxane",
            "criterions": [
                {
                    "exact_snippets": "Prior exposure to a taxane",
                    "criterion": "taxane exposure",
                    "requirements": [
                        {
                            "requirement_type": "prior exposure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: If indicated, prior therapy with ICI for patients with PD1 positive tumor and prior treatment with PARP inhibitor for patients with gBRCAm is required",
            "criterions": [
                {
                    "exact_snippets": "prior therapy with ICI for patients with PD1 positive tumor",
                    "criterion": "prior therapy with ICI",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "PD1 positive tumor"
                        }
                    ]
                },
                {
                    "exact_snippets": "prior treatment with PARP inhibitor for patients with gBRCAm",
                    "criterion": "prior treatment with PARP inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "gBRCAm"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Measurable disease, as defined by RECIST v1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease, as defined by RECIST v1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patient must have accepted to perform pre-treatment, on-treatment and post-treatment biopsies. If the physician considers doing the biopsy on the primary tumor site because accessibility, it can be performed only if the primary tumor site has not been previously irradiated;",
            "criterions": [
                {
                    "exact_snippets": "Patient must have accepted to perform pre-treatment, on-treatment and post-treatment biopsies.",
                    "criterion": "biopsy acceptance",
                    "requirements": [
                        {
                            "requirement_type": "acceptance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "If the physician considers doing the biopsy on the primary tumor site because accessibility, it can be performed only if the primary tumor site has not been previously irradiated;",
                    "criterion": "primary tumor site irradiation",
                    "requirements": [
                        {
                            "requirement_type": "previous irradiation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Have metastatic site easily accessible to biopsy (with exception of bone metastasis)",
            "criterions": [
                {
                    "exact_snippets": "metastatic site easily accessible to biopsy",
                    "criterion": "metastatic site accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": "easily accessible to biopsy"
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of bone metastasis",
                    "criterion": "bone metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note 1: Patients with only bone metastasis will be eligible if the primary tumor is accessible for biopsy at inclusion",
            "criterions": [
                {
                    "exact_snippets": "Patients with only bone metastasis",
                    "criterion": "bone metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "primary tumor is accessible for biopsy",
                    "criterion": "primary tumor accessibility for biopsy",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note 2: If the patient has a single measurable lesion and it is the only one that can be biopsied, the patient cannot be included because the disease is no longer measurable according to RECIST v1.1",
            "criterions": [
                {
                    "exact_snippets": "single measurable lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "only one that can be biopsied",
                    "criterion": "biopsiable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "disease is no longer measurable according to RECIST v1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "standard",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status ≤2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Life expectancy ≥12 weeks;",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥12 weeks;",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Adequate haematologic and organ function",
            "criterions": [
                {
                    "exact_snippets": "Adequate haematologic ... function",
                    "criterion": "haematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Negative hepatitis B surface antigen (HBsAg) test at screening (patients with a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening are eligible), negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening;",
            "criterions": [
                {
                    "exact_snippets": "Negative hepatitis B surface antigen (HBsAg) test at screening",
                    "criterion": "hepatitis B surface antigen (HBsAg)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening",
                    "criterion": "total hepatitis B core antibody (HBcAb)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative hepatitis C virus (HCV) antibody test at screening",
                    "criterion": "hepatitis C virus (HCV) antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "positive HCV antibody test followed by a negative HCV RNA test at screening",
                    "criterion": "HCV RNA",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Evidence of post-menopausal status or negative pregnancy urinary test within 72 hours or serum pregnancy test within 14 days before study treatment and confirmed prior to treatment on Cycle 1 Day 1 for female pre-menopausal patients;",
            "criterions": [
                {
                    "exact_snippets": "Evidence of post-menopausal status",
                    "criterion": "post-menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative pregnancy urinary test within 72 hours",
                    "criterion": "pregnancy urinary test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 72 hours"
                        }
                    ]
                },
                {
                    "exact_snippets": "serum pregnancy test within 14 days before study treatment",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days before study treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed prior to treatment on Cycle 1 Day 1 for female pre-menopausal patients",
                    "criterion": "confirmation of pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "prior to treatment on Cycle 1 Day 1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Woman of childbearing potential and male patient must agree to use adequate contraception for the duration of trial participation and up to 6 months after completing treatment for women and up to 3 months for men;",
            "criterions": [
                {
                    "exact_snippets": "Woman of childbearing potential",
                    "criterion": "woman of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "male patient",
                    "criterion": "male patient",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use adequate contraception for the duration of trial participation and up to 6 months after completing treatment for women",
                    "criterion": "contraception use for women",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "for the duration of trial participation and up to 6 months after completing treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use adequate contraception for the duration of trial participation ... up to 3 months for men",
                    "criterion": "contraception use for men",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "for the duration of trial participation and up to 3 months after completing treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Patient affiliated to a social security system (or equivalent);",
            "criterions": [
                {
                    "exact_snippets": "Patient affiliated to a social security system (or equivalent)",
                    "criterion": "social security affiliation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up;",
            "criterions": [
                {
                    "exact_snippets": "Patient is willing",
                    "criterion": "willingness to comply",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "able to comply with the protocol",
                    "criterion": "ability to comply",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undergoing treatment",
                    "criterion": "ability to undergo treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled visits",
                    "criterion": "ability to attend scheduled visits",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "examinations including follow-up",
                    "criterion": "ability to undergo examinations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 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. Participation in another therapeutic trial within the 30 days prior to C1D1;",
            "criterions": [
                {
                    "exact_snippets": "Participation in another therapeutic trial within the 30 days prior to C1D1",
                    "criterion": "participation in another therapeutic trial",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases or evidence of leptomeningeal disease or clinically active spinal cord compression. Patients with stable and asymptomatic brain metastases will be eligible, yet the number will be capped to 15% of the overall population;",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases",
                    "criterion": "central nervous system (CNS) metastases",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "symptomatic",
                                "untreated",
                                "actively progressing"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically active spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "clinically active"
                        }
                    ]
                },
                {
                    "exact_snippets": "stable and asymptomatic brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "stable",
                                "asymptomatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "number will be capped to 15% of the overall population",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "population cap",
                            "expected_value": {
                                "operator": "<=",
                                "value": 15,
                                "unit": "% of overall population"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Previous history of cancer other than mTNBC within 5 years prior to C1D1, except of those with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%) and treated with curative intent (e.g. carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer);",
            "criterions": [
                {
                    "exact_snippets": "Previous history of cancer other than mTNBC within 5 years prior to C1D1",
                    "criterion": "previous history of cancer",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "other than mTNBC"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 5 years prior to C1D1"
                        }
                    ]
                },
                {
                    "exact_snippets": "except of those with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%)",
                    "criterion": "risk of metastasis or death",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "negligible"
                        },
                        {
                            "requirement_type": "5-year OS rate",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with curative intent (e.g. carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer)",
                    "criterion": "treatment intent",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Met any of the following criteria for cardiac disease:",
            "criterions": [
                {
                    "exact_snippets": "Met any of the following criteria for cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Myocardial infarction or unstable angina pectoris within 6 months of enrolment.",
            "criterions": [
                {
                    "exact_snippets": "Myocardial infarction ... within 6 months of enrolment.",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris within 6 months of enrolment.",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.",
            "criterions": [
                {
                    "exact_snippets": "History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation)",
                    "criterion": "serious ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "high-grade atrioventricular block",
                    "criterion": "high-grade atrioventricular block",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication)",
                    "criterion": "cardiac arrhythmias requiring antiarrhythmic medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of QT interval prolongation",
                    "criterion": "QT interval prolongation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of <40%.",
            "criterions": [
                {
                    "exact_snippets": "New York Heart Association (NYHA) Class III or greater congestive heart failure",
                    "criterion": "NYHA class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "left ventricular ejection fraction of <40%",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Severe uncontrolled infection requiring oral or IV antibiotics within 4 weeks prior to C1D1;",
            "criterions": [
                {
                    "exact_snippets": "Severe uncontrolled infection requiring oral or IV antibiotics within 4 weeks prior to C1D1",
                    "criterion": "severe uncontrolled infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "oral antibiotics",
                                "IV antibiotics"
                            ]
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks prior to C1D1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Major surgical procedure within 4 weeks prior to C1D1;",
            "criterions": [
                {
                    "exact_snippets": "Major surgical procedure within 4 weeks prior to C1D1",
                    "criterion": "major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. History of severe allergic, anaphylactic, or other hypersensitivity reactions to humanized antibodies;",
            "criterions": [
                {
                    "exact_snippets": "History of severe allergic, anaphylactic, or other hypersensitivity reactions to humanized antibodies",
                    "criterion": "severe allergic, anaphylactic, or other hypersensitivity reactions to humanized antibodies",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Known hypersensitivity to the study drug, its metabolites, or formulation excipient.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to the study drug",
                    "criterion": "hypersensitivity to study drug",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... its metabolites",
                    "criterion": "hypersensitivity to metabolites of study drug",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... formulation excipient",
                    "criterion": "hypersensitivity to formulation excipient",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients receiving concomitant anti-cancer treatments such as chemotherapy, immunotherapy, endocrine therapy and radiotherapy;",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving concomitant anti-cancer treatments such as chemotherapy",
                    "criterion": "concomitant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients receiving concomitant anti-cancer treatments such as ... immunotherapy",
                    "criterion": "concomitant immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients receiving concomitant anti-cancer treatments such as ... endocrine therapy",
                    "criterion": "concomitant endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients receiving concomitant anti-cancer treatments such as ... radiotherapy",
                    "criterion": "concomitant radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved according to the common terminology criteria for adverse events of the National Cancer Institute (NCI-CTCAE) v5.0 grade >2",
            "criterions": [
                {
                    "exact_snippets": "unresolved toxicities from previous anticancer therapy",
                    "criterion": "unresolved toxicities from previous anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "toxicities (other than alopecia) not yet resolved according to the common terminology criteria for adverse events of the National Cancer Institute (NCI-CTCAE) v5.0 grade >2",
                    "criterion": "toxicities according to NCI-CTCAE v5.0",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Treatment with systemic corticosteroids dosed at >20 mg prednisone or equivalent or other systemic immunosuppressive medications within 2 weeks prior to C1D1;",
            "criterions": [
                {
                    "exact_snippets": "Treatment with systemic corticosteroids dosed at >20 mg prednisone or equivalent",
                    "criterion": "systemic corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "mg prednisone or equivalent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other systemic immunosuppressive medications within 2 weeks prior to C1D1",
                    "criterion": "systemic immunosuppressive medications",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 2 weeks prior to C1D1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Known history of testing positive for HIV or known acquired immunodeficiency syndrome if not controlled;",
            "criterions": [
                {
                    "exact_snippets": "Known history of testing positive for HIV",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known acquired immunodeficiency syndrome if not controlled",
                    "criterion": "acquired immunodeficiency syndrome (AIDS)",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "not controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Covid-19 infection at screening;",
            "criterions": [
                {
                    "exact_snippets": "Covid-19 infection at screening",
                    "criterion": "Covid-19 infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Evidence of significant uncontrolled concomitant disease;",
            "criterions": [
                {
                    "exact_snippets": "Evidence of significant uncontrolled concomitant disease",
                    "criterion": "uncontrolled concomitant disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Individuals with physical or psychological conditions considered not to be compatible with the trial;",
            "criterions": [
                {
                    "exact_snippets": "physical ... conditions considered not to be compatible with the trial",
                    "criterion": "physical conditions",
                    "requirements": [
                        {
                            "requirement_type": "compatibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "psychological conditions considered not to be compatible with the trial",
                    "criterion": "psychological conditions",
                    "requirements": [
                        {
                            "requirement_type": "compatibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Persons deprived of their liberty or under protective custody or guardianship;",
            "criterions": [
                {
                    "exact_snippets": "Persons deprived of their liberty",
                    "criterion": "deprivation of liberty",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "under protective custody",
                    "criterion": "protective custody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "under ... guardianship",
                    "criterion": "guardianship",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Pregnant or breastfeeding women;",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.",
            "criterions": [
                {
                    "exact_snippets": "unwilling or unable to comply with the medical follow-up",
                    "criterion": "compliance with medical follow-up",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "because of geographic, familial, social, or psychological reasons",
                    "criterion": "reasons for non-compliance",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "geographic",
                                "familial",
                                "social",
                                "psychological"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}