{
    "info": {
        "nct_id": "NCT01934894",
        "official_title": "Phase II Study With Lead-in Safety Cohort of Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases",
        "inclusion_criteria": "1. Patients with HER2-positive MBC and unequivocal evidence of brain metastases.\n2. Documented HER2-positive tumor status at study entry defined as:\n\n   * Immunohistochemical (IHC) score 3+ or\n   * IHC score 1-2+ and confirmed as FISH (Fluorescence in situ hybridization) positive (based on ASCO-CAP guidelines 2013) or\n   * FISH or ISH (in situ hybridization) positive (based on ASCO-CAP guidelines 2013)\n3. Patient must have at least one measurable brain lesion (defined as any lesion ≥ 5mm cm in the longest dimension), on T1 weighted, gadolinium enhanced MRI. Patients may have had surgical excisions of brain metastases provided at least one lesions meets the following criteria:\n\n   * Patients with brain metastases previously untreated with any intra-cranial radiation (i.e. no whole brain radiation therapy [WBRT]/partial brain radiation or stereotactic radiosurgery [SRS]) must have at least one intra-cranial tumor lesion that is ≥ 5mm.\n   * Patients with brain metastases previously untreated with any intracranial radiation (i.e., no whole brain radiation therapy [WBRT]/partial brain radiation or stereotactic radiosurgery [SRS]) must have at least one intracranial tumor lesion that is ≥ 5mm.\n   * Patients with brain metastases previously treated with WBRT/partial brain radiation only must have at least one intracranial tumor lesion ≥ 5mm and must have evidence of intracranial progressive disease\n   * Patients previously treated with WBRT/partial brain radiation and SRS must have at least one intracranial tumor lesion ≥ 5mm that was not treated with SRS and must have intracranial disease.\n   * Patients previously treated with SRS must either demonstrate disease progression ≥ 12 weeks after completing SRS with a lesion measuring ≥ 5mm or must have at least one intracranial tumor lesion ≥ 5mm that was not treated with SRS.\n4. Patients who have received WBRT/partial brain radiation for intra-cranial metastases are eligible if treatment was completed ≥28 days prior to the first dose of study drug.\n5. Estrogen receptor (ER) and progesterone receptor (PR) status in the primary or most recent tumor assessment must be known or pending at the time of study registration. Patient's ER/PR status (i.e., positive or negative) does not influence enrollment but is a requirement.\n6. Patient must have received prior treatment with HER2-directed therapy such as trastuzumab, either in the adjuvant or metastatic setting.\n7. Prior treatment with lapatinib in the (neo)adjuvant and metastatic setting.\n8. Patients without prior chemotherapy for MBC are eligible provided the patients relapsed during adjuvant therapy with trastuzumab or ≤6 months following completion of adjuvant therapy. Otherwise, there is no specific minimum or maximum number of previous chemotherapy regimens for MBC.\n9. Patients must have completed cytotoxic chemotherapy ≥21 days (for an every 3-week regimen) or ≥14 days (for an every 2-week or weekly regimen) and have recovered from or come to a new chronic or stable baseline from all treatment-related toxicities in order to be eligible for study treatment.\n\n   * Patient must have completed biologic therapy ≥3 weeks or 5-half lives whichever is shorter.\n   * Patient must be discontinued from hormonal therapy a minimum of 1 day prior to the first dose of study treatment.\n   * Patients receiving palliative radiation to bone, soft tissue or any other disease sites must have completed this ≥1 week prior to the first dose of study treatment.\n10. Patients must have recovered (>2 week recovery is mandated) from any acute neurosurgical intervention for metastatic CNS disease (e.g., resection, shunt placement) and must be clinically stable. These patients must have residual measurable CNS lesion(s) following the surgical procedure if this site is to serve as the target lesion.\n11. Patients must be neurologically stable, and if receiving steroids, must be on stable or decreasing doses of corticosteroids and/or anticonvulsants for defined as being on stable low doses of corticosteroids ≥ 5 days prior to the first dose of study treatment.\n12. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2.\n13. Adequate hematologic, renal, and hepatic function.\n14. Adequate coagulation parameters.\n15. Other laboratory testing:\n\n    * Serum magnesium ≥ the institutional lower limit of normal (LLN)\n    * Serum potassium ≥ the institutional LLN\n16. Left-ventricular-ejection fraction (LVEF) of ≥50% by an echocardiogram (ECHO) or by a multiple-gated acquisition (MUGA)\n17. Male patients willing to use adequate contraceptive measures.\n18. Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start of treatment.\n19. Life expectancy ≥12 weeks.\n20. Ability to swallow oral medications.\n21. Willingness and ability to comply with trial and follow-up procedures.\n22. Ability to understand the nature of this trial and give written informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Previous treatment with cabazitaxel.\n2. CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.).\n3. Leptomeningeal metastases as the only site of CNS metastases. Patients with parenchymal brain metastases and leptomeningeal metastases are eligible provided they meet all other eligibility criteria.\n4. Peripheral neuropathy ≥Grade 2 (CTCAE v4.0).\n5. Concurrent treatment with radiation therapy, hormonal therapy, biologic therapy or chemotherapy is not allowed. Low dose corticosteroids (≤30 mg/day prednisone or its equivalent) are allowed.\n6. Concurrent treatment with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A that cannot be discontinued or switched to different medication prior to starting study drug.\n7. Concurrent use of St. John's wort and grapefruit/grapefruit juice ≤7 days prior to starting study drug is not allowed.\n8. Presence of active gastrointestinal (GI) disease or other condition that in the opinion of the investigator will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (e.g. ulcerative disease, uncontrolled nausea, or vomiting).\n9. Known diagnosis of human immunodeficiency virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV).\n10. Presence of other active cancers, or history of treatment for invasive cancer ≥3 years. Patients with stage I cancer who have received definitive local treatment with curative intent at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e. non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.\n11. Any severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study such as:\n\n    * Symptomatic congestive heart failure (CHF) of New York Heart Association Class III or IV.\n    * QTc > 480 ms on screening ECG (using the Fredericia formula)\n    * Poorly controlled or clinically significant atherosclerotic vascular disease including cerebrovascular accident (CVA), transient ischemic attack (TIA), angioplasty, cardiac or vascular stenting in the past 6 months\n    * Active (acute or chronic) or uncontrolled severe infections.\n    * Active hepatic or biliary disease (except for patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment).\n12. Known hypersensitivity to cabazitaxel or other drugs formulated with polysorbate 80.\n13. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.\n14. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients with HER2-positive MBC and unequivocal evidence of brain metastases.",
            "criterions": [
                {
                    "exact_snippets": "HER2-positive MBC",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2-positive MBC",
                    "criterion": "metastatic breast cancer (MBC)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unequivocal evidence of brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "unequivocal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Documented HER2-positive tumor status at study entry defined as:",
            "criterions": [
                {
                    "exact_snippets": "Documented HER2-positive tumor status",
                    "criterion": "HER2-positive tumor status",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Immunohistochemical (IHC) score 3+ or",
            "criterions": [
                {
                    "exact_snippets": "Immunohistochemical (IHC) score 3+",
                    "criterion": "Immunohistochemical (IHC) score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "+"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* IHC score 1-2+ and confirmed as FISH (Fluorescence in situ hybridization) positive (based on ASCO-CAP guidelines 2013) or",
            "criterions": [
                {
                    "exact_snippets": "IHC score 1-2+",
                    "criterion": "IHC score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed as FISH (Fluorescence in situ hybridization) positive",
                    "criterion": "FISH (Fluorescence in situ hybridization)",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "based on ASCO-CAP guidelines 2013",
                    "criterion": "ASCO-CAP guidelines",
                    "requirements": [
                        {
                            "requirement_type": "year",
                            "expected_value": "2013"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* FISH or ISH (in situ hybridization) positive (based on ASCO-CAP guidelines 2013)",
            "criterions": [
                {
                    "exact_snippets": "FISH or ISH (in situ hybridization) positive",
                    "criterion": "FISH or ISH (in situ hybridization)",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient must have at least one measurable brain lesion (defined as any lesion ≥ 5mm cm in the longest dimension), on T1 weighted, gadolinium enhanced MRI. Patients may have had surgical excisions of brain metastases provided at least one lesions meets the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable brain lesion",
                    "criterion": "measurable brain lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lesion ≥ 5mm cm in the longest dimension",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "T1 weighted, gadolinium enhanced MRI",
                    "criterion": "MRI type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "T1 weighted, gadolinium enhanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "surgical excisions of brain metastases",
                    "criterion": "surgical excisions of brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with brain metastases previously untreated with any intra-cranial radiation (i.e. no whole brain radiation therapy [WBRT]/partial brain radiation or stereotactic radiosurgery [SRS]) must have at least one intra-cranial tumor lesion that is ≥ 5mm.",
            "criterions": [
                {
                    "exact_snippets": "brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": "previously untreated with any intra-cranial radiation"
                        }
                    ]
                },
                {
                    "exact_snippets": "intra-cranial tumor lesion that is ≥ 5mm",
                    "criterion": "intra-cranial tumor lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with brain metastases previously untreated with any intracranial radiation (i.e., no whole brain radiation therapy [WBRT]/partial brain radiation or stereotactic radiosurgery [SRS]) must have at least one intracranial tumor lesion that is ≥ 5mm.",
            "criterions": [
                {
                    "exact_snippets": "brain metastases previously untreated with any intracranial radiation (i.e., no whole brain radiation therapy [WBRT]/partial brain radiation or stereotactic radiosurgery [SRS])",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": "previously untreated with any intracranial radiation"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one intracranial tumor lesion that is ≥ 5mm",
                    "criterion": "intracranial tumor lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with brain metastases previously treated with WBRT/partial brain radiation only must have at least one intracranial tumor lesion ≥ 5mm and must have evidence of intracranial progressive disease",
            "criterions": [
                {
                    "exact_snippets": "brain metastases previously treated with WBRT/partial brain radiation",
                    "criterion": "brain metastases treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "WBRT",
                                "partial brain radiation"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one intracranial tumor lesion ≥ 5mm",
                    "criterion": "intracranial tumor lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of intracranial progressive disease",
                    "criterion": "intracranial progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients previously treated with WBRT/partial brain radiation and SRS must have at least one intracranial tumor lesion ≥ 5mm that was not treated with SRS and must have intracranial disease.",
            "criterions": [
                {
                    "exact_snippets": "Patients previously treated with WBRT/partial brain radiation and SRS",
                    "criterion": "previous treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "WBRT",
                                "partial brain radiation",
                                "SRS"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "must have at least one intracranial tumor lesion ≥ 5mm",
                    "criterion": "intracranial tumor lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "that was not treated with SRS",
                    "criterion": "SRS treatment status",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "not treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "must have intracranial disease",
                    "criterion": "intracranial disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients previously treated with SRS must either demonstrate disease progression ≥ 12 weeks after completing SRS with a lesion measuring ≥ 5mm or must have at least one intracranial tumor lesion ≥ 5mm that was not treated with SRS.",
            "criterions": [
                {
                    "exact_snippets": "Patients previously treated with SRS",
                    "criterion": "previous SRS treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "disease progression ≥ 12 weeks after completing SRS",
                    "criterion": "disease progression after SRS",
                    "requirements": [
                        {
                            "requirement_type": "time since SRS",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lesion measuring ≥ 5mm",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "intracranial tumor lesion ≥ 5mm",
                    "criterion": "intracranial tumor lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "not treated with SRS",
                    "criterion": "SRS treatment status of lesion",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "not treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients who have received WBRT/partial brain radiation for intra-cranial metastases are eligible if treatment was completed ≥28 days prior to the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received WBRT/partial brain radiation for intra-cranial metastases",
                    "criterion": "WBRT/partial brain radiation for intra-cranial metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Estrogen receptor (ER) and progesterone receptor (PR) status in the primary or most recent tumor assessment must be known or pending at the time of study registration. Patient's ER/PR status (i.e., positive or negative) does not influence enrollment but is a requirement.",
            "criterions": [
                {
                    "exact_snippets": "Estrogen receptor (ER) and progesterone receptor (PR) status ... must be known or pending",
                    "criterion": "ER and PR status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "known",
                                "pending"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient's ER/PR status (i.e., positive or negative) does not influence enrollment but is a requirement",
                    "criterion": "ER/PR status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patient must have received prior treatment with HER2-directed therapy such as trastuzumab, either in the adjuvant or metastatic setting.",
            "criterions": [
                {
                    "exact_snippets": "Patient must have received prior treatment with HER2-directed therapy such as trastuzumab",
                    "criterion": "prior HER2-directed therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Prior treatment with lapatinib in the (neo)adjuvant and metastatic setting.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with lapatinib",
                    "criterion": "prior treatment with lapatinib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients without prior chemotherapy for MBC are eligible provided the patients relapsed during adjuvant therapy with trastuzumab or ≤6 months following completion of adjuvant therapy. Otherwise, there is no specific minimum or maximum number of previous chemotherapy regimens for MBC.",
            "criterions": [
                {
                    "exact_snippets": "Patients without prior chemotherapy for MBC",
                    "criterion": "prior chemotherapy for MBC",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients relapsed during adjuvant therapy with trastuzumab",
                    "criterion": "relapse during adjuvant therapy with trastuzumab",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "relapsed ... ≤6 months following completion of adjuvant therapy",
                    "criterion": "relapse following completion of adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients must have completed cytotoxic chemotherapy ≥21 days (for an every 3-week regimen) or ≥14 days (for an every 2-week or weekly regimen) and have recovered from or come to a new chronic or stable baseline from all treatment-related toxicities in order to be eligible for study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Patients must have completed cytotoxic chemotherapy ≥21 days (for an every 3-week regimen) or ≥14 days (for an every 2-week or weekly regimen)",
                    "criterion": "completion of cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 21,
                                        "unit": "days"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "have recovered from or come to a new chronic or stable baseline from all treatment-related toxicities",
                    "criterion": "recovery from treatment-related toxicities",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": [
                                "recovered",
                                "new chronic or stable baseline"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have completed biologic therapy ≥3 weeks or 5-half lives whichever is shorter.",
            "criterions": [
                {
                    "exact_snippets": "Patient must have completed biologic therapy ≥3 weeks or 5-half lives",
                    "criterion": "completion of biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must be discontinued from hormonal therapy a minimum of 1 day prior to the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Patient must be discontinued from hormonal therapy",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a minimum of 1 day prior to the first dose of study treatment",
                    "criterion": "time since discontinuation of hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving palliative radiation to bone, soft tissue or any other disease sites must have completed this ≥1 week prior to the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving palliative radiation to bone, soft tissue or any other disease sites",
                    "criterion": "palliative radiation",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients must have recovered (>2 week recovery is mandated) from any acute neurosurgical intervention for metastatic CNS disease (e.g., resection, shunt placement) and must be clinically stable. These patients must have residual measurable CNS lesion(s) following the surgical procedure if this site is to serve as the target lesion.",
            "criterions": [
                {
                    "exact_snippets": "recovered (>2 week recovery is mandated) from any acute neurosurgical intervention for metastatic CNS disease",
                    "criterion": "recovery from neurosurgical intervention",
                    "requirements": [
                        {
                            "requirement_type": "time since intervention",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "week"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "must be clinically stable",
                    "criterion": "clinical stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have residual measurable CNS lesion(s) following the surgical procedure",
                    "criterion": "residual measurable CNS lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patients must be neurologically stable, and if receiving steroids, must be on stable or decreasing doses of corticosteroids and/or anticonvulsants for defined as being on stable low doses of corticosteroids ≥ 5 days prior to the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be neurologically stable",
                    "criterion": "neurological stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if receiving steroids, must be on stable or decreasing doses of corticosteroids",
                    "criterion": "corticosteroid dosage",
                    "requirements": [
                        {
                            "requirement_type": "stability or decrease",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if receiving steroids, must be on stable or decreasing doses of ... anticonvulsants",
                    "criterion": "anticonvulsant dosage",
                    "requirements": [
                        {
                            "requirement_type": "stability or decrease",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "defined as being on stable low doses of corticosteroids ≥ 5 days prior to the first dose of study treatment",
                    "criterion": "corticosteroid dosage duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2.",
                    "criterion": "ECOG Performance Status score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Adequate hematologic, renal, and hepatic function.",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic ... function.",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal ... function.",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... hepatic function.",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Adequate coagulation parameters.",
            "criterions": [
                {
                    "exact_snippets": "Adequate coagulation parameters.",
                    "criterion": "coagulation parameters",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Other laboratory testing:",
            "criterions": [
                {
                    "exact_snippets": "Other laboratory testing",
                    "criterion": "laboratory testing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum magnesium ≥ the institutional lower limit of normal (LLN)",
            "criterions": [
                {
                    "exact_snippets": "Serum magnesium ≥ the institutional lower limit of normal (LLN)",
                    "criterion": "serum magnesium",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0,
                                "unit": "institutional lower limit of normal (LLN)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum potassium ≥ the institutional LLN",
            "criterions": [
                {
                    "exact_snippets": "Serum potassium ≥ the institutional LLN",
                    "criterion": "serum potassium",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0,
                                "unit": "institutional LLN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Left-ventricular-ejection fraction (LVEF) of ≥50% by an echocardiogram (ECHO) or by a multiple-gated acquisition (MUGA)",
            "criterions": [
                {
                    "exact_snippets": "Left-ventricular-ejection fraction (LVEF) of ≥50%",
                    "criterion": "left-ventricular-ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "by an echocardiogram (ECHO)",
                    "criterion": "echocardiogram (ECHO)",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "by a multiple-gated acquisition (MUGA)",
                    "criterion": "multiple-gated acquisition (MUGA)",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Male patients willing to use adequate contraceptive measures.",
            "criterions": [
                {
                    "exact_snippets": "Male patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to use adequate contraceptive measures",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Female patients who are not of child-bearing potential",
                    "criterion": "child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "female patients of child-bearing potential who agree to use adequate contraceptive measures",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "who are not breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "who have a negative serum or urine pregnancy test within 72 hours prior to start of treatment",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 72 hours prior to start of treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Life expectancy ≥12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥12 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Ability to swallow oral medications.",
            "criterions": [
                {
                    "exact_snippets": "Ability to swallow oral medications",
                    "criterion": "ability to swallow oral medications",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. Willingness and ability to comply with trial and follow-up procedures.",
            "criterions": [
                {
                    "exact_snippets": "Willingness ... to comply with trial and follow-up procedures.",
                    "criterion": "willingness to comply with trial and follow-up procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ability to comply with trial and follow-up procedures.",
                    "criterion": "ability to comply with trial and follow-up procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "22. Ability to understand the nature of this trial and give written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand the nature of this trial",
                    "criterion": "understanding of trial",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "give written informed consent",
                    "criterion": "informed consent",
                    "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 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. Previous treatment with cabazitaxel.",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment with cabazitaxel",
                    "criterion": "cabazitaxel treatment",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.).",
            "criterions": [
                {
                    "exact_snippets": "CNS disease requiring immediate neurosurgical intervention",
                    "criterion": "CNS disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "requiring immediate neurosurgical intervention"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Leptomeningeal metastases as the only site of CNS metastases. Patients with parenchymal brain metastases and leptomeningeal metastases are eligible provided they meet all other eligibility criteria.",
            "criterions": [
                {
                    "exact_snippets": "Leptomeningeal metastases as the only site of CNS metastases.",
                    "criterion": "leptomeningeal metastases",
                    "requirements": [
                        {
                            "requirement_type": "site",
                            "expected_value": "only site of CNS metastases"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with parenchymal brain metastases and leptomeningeal metastases are eligible",
                    "criterion": "parenchymal brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with parenchymal brain metastases and leptomeningeal metastases are eligible",
                    "criterion": "leptomeningeal metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Peripheral neuropathy ≥Grade 2 (CTCAE v4.0).",
            "criterions": [
                {
                    "exact_snippets": "Peripheral neuropathy ≥Grade 2 (CTCAE v4.0)",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade (CTCAE v4.0)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Concurrent treatment with radiation therapy, hormonal therapy, biologic therapy or chemotherapy is not allowed. Low dose corticosteroids (≤30 mg/day prednisone or its equivalent) are allowed.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent treatment with radiation therapy ... is not allowed.",
                    "criterion": "concurrent radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent treatment with ... hormonal therapy ... is not allowed.",
                    "criterion": "concurrent hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent treatment with ... biologic therapy ... is not allowed.",
                    "criterion": "concurrent biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent treatment with ... chemotherapy is not allowed.",
                    "criterion": "concurrent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Low dose corticosteroids (≤30 mg/day prednisone or its equivalent) are allowed.",
                    "criterion": "low dose corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "mg/day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Concurrent treatment with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A that cannot be discontinued or switched to different medication prior to starting study drug.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent treatment with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A",
                    "criterion": "concurrent treatment with CYP3A inhibitors or inducers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Concurrent use of St. John's wort and grapefruit/grapefruit juice ≤7 days prior to starting study drug is not allowed.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent use of St. John's wort ... ≤7 days prior to starting study drug is not allowed.",
                    "criterion": "St. John's wort use",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent use of ... grapefruit/grapefruit juice ≤7 days prior to starting study drug is not allowed.",
                    "criterion": "grapefruit/grapefruit juice use",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Presence of active gastrointestinal (GI) disease or other condition that in the opinion of the investigator will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (e.g. ulcerative disease, uncontrolled nausea, or vomiting).",
            "criterions": [
                {
                    "exact_snippets": "Presence of active gastrointestinal (GI) disease",
                    "criterion": "active gastrointestinal (GI) disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other condition that in the opinion of the investigator will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy",
                    "criterion": "condition interfering with oral therapy",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Known diagnosis of human immunodeficiency virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV).",
            "criterions": [
                {
                    "exact_snippets": "Known diagnosis of human immunodeficiency virus (HIV)",
                    "criterion": "human immunodeficiency virus (HIV)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known diagnosis of ... Hepatitis B (HBV)",
                    "criterion": "Hepatitis B (HBV)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known diagnosis of ... Hepatitis C (HCV)",
                    "criterion": "Hepatitis C (HCV)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Presence of other active cancers, or history of treatment for invasive cancer ≥3 years. Patients with stage I cancer who have received definitive local treatment with curative intent at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e. non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.",
            "criterions": [
                {
                    "exact_snippets": "Presence of other active cancers",
                    "criterion": "other active cancers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of treatment for invasive cancer ≥3 years",
                    "criterion": "treatment for invasive cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with stage I cancer who have received definitive local treatment with curative intent at least 3 years previously, and are considered unlikely to recur are eligible",
                    "criterion": "stage I cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "definitive local treatment with curative intent"
                        },
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "recurrence likelihood",
                            "expected_value": "unlikely"
                        }
                    ]
                },
                {
                    "exact_snippets": "All patients with previously treated in situ carcinoma (i.e. non-invasive) are eligible",
                    "criterion": "previously treated in situ carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with history of non-melanoma skin cancer",
                    "criterion": "history of non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Any severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study such as:",
            "criterions": [
                {
                    "exact_snippets": "severe and/or uncontrolled medical conditions",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other conditions that could affect participation in the study",
                    "criterion": "conditions affecting study participation",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "could affect participation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic congestive heart failure (CHF) of New York Heart Association Class III or IV.",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic congestive heart failure (CHF)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "New York Heart Association Class III or IV",
                    "criterion": "New York Heart Association Class",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* QTc > 480 ms on screening ECG (using the Fredericia formula)",
            "criterions": [
                {
                    "exact_snippets": "QTc > 480 ms on screening ECG",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 480,
                                "unit": "ms"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Poorly controlled or clinically significant atherosclerotic vascular disease including cerebrovascular accident (CVA), transient ischemic attack (TIA), angioplasty, cardiac or vascular stenting in the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "Poorly controlled or clinically significant atherosclerotic vascular disease",
                    "criterion": "atherosclerotic vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        },
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrovascular accident (CVA)",
                    "criterion": "cerebrovascular accident (CVA)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "transient ischemic attack (TIA)",
                    "criterion": "transient ischemic attack (TIA)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "angioplasty",
                    "criterion": "angioplasty",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": "in the past 6 months"
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac or vascular stenting",
                    "criterion": "cardiac or vascular stenting",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": "in the past 6 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active (acute or chronic) or uncontrolled severe infections.",
            "criterions": [
                {
                    "exact_snippets": "Active (acute or chronic) or uncontrolled severe infections.",
                    "criterion": "infections",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": [
                                "active",
                                "uncontrolled"
                            ]
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active hepatic or biliary disease (except for patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment).",
            "criterions": [
                {
                    "exact_snippets": "Active hepatic or biliary disease",
                    "criterion": "hepatic or biliary disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Gilbert's syndrome",
                    "criterion": "Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic gallstones",
                    "criterion": "asymptomatic gallstones",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "liver metastases",
                    "criterion": "liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stable chronic liver disease per investigator assessment",
                    "criterion": "stable chronic liver disease",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Known hypersensitivity to cabazitaxel or other drugs formulated with polysorbate 80.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to cabazitaxel",
                    "criterion": "hypersensitivity to cabazitaxel",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... other drugs formulated with polysorbate 80",
                    "criterion": "hypersensitivity to drugs formulated with polysorbate 80",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Psychological ... conditions that do not permit compliance with the protocol.",
                    "criterion": "psychological conditions",
                    "requirements": [
                        {
                            "requirement_type": "compliance with protocol",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "familial ... conditions that do not permit compliance with the protocol.",
                    "criterion": "familial conditions",
                    "requirements": [
                        {
                            "requirement_type": "compliance with protocol",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "sociological ... conditions that do not permit compliance with the protocol.",
                    "criterion": "sociological conditions",
                    "requirements": [
                        {
                            "requirement_type": "compliance with protocol",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "geographical conditions that do not permit compliance with the protocol.",
                    "criterion": "geographical conditions",
                    "requirements": [
                        {
                            "requirement_type": "compliance with protocol",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Inability or unwillingness to comply with study and/or follow-up procedures",
                    "criterion": "compliance with study and follow-up procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability and willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}