{
    "info": {
        "nct_id": "NCT02614794",
        "official_title": "Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Double-blind Phase Inclusion Criteria\n\n* Histologically confirmed HER2+ breast carcinoma, with HER2+ defined by in situ hybridization (ISH), immunohistochemistry (IHC), or fluorescence in situ hybridization (FISH) methodology\n* Received previous treatment with trastuzumab, pertuzumab, and T-DM1\n* Progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by investigator), or be intolerant of last systemic therapy\n* Have measurable or non-measurable disease assessable by RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Adequate hepatic and renal function and hematologic parameters\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n* CNS Inclusion - Based on screening brain magnetic resonance imaging (MRI), patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\n     1. Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy\n     2. Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI performed during screening for this study may be eligible to enroll if the following criteria are met:\n\n     i. Time since whole brain radiation therapy (WBRT) is ≥ 21 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to first dose of study treatment, or time since surgical resection is ≥ 28 days.\n\n     ii. Other sites of disease assessable by RECIST 1.1 are present\n  4. Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions\n\nDouble-blind Phase Exclusion Criteria\n\n* Previously been treated with:\n\n  1. lapatinib within 12 months of starting study treatment (except in cases where lapatinib was given for ≤ 21 days and was discontinued for reasons other than disease progression or toxicity)\n  2. neratinib, afatinib, or other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) at any time previously\n  3. capecitabine (or other fluoropyrimidine) for metastatic disease except in cases where capecitabine was given for < 21 days and was discontinued for reasons other than disease progression or toxicity. Patients who have received capecitabine for adjuvant or neoadjuvant treatment at least 12 months prior to starting study treatment are eligible.\n* Clinically significant cardiopulmonary disease\n* Carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease\n* Positive for human immunodeficiency virus (HIV)\n* Unable for any reason to undergo MRI of the brain\n* Have used a strong CYP3A4 or CYP2C8 inhibitor within 5 half-lives of the inhibitor, or a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment\n* Have known dihydropyrimidine dehydrogenase deficiency (DPD)\n* CNS Exclusion - Based on screening brain MRI, patients must not have any of the following:\n\n  1. Any untreated brain lesions > 2.0 cm in size, unless approved by medical monitor\n  2. Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg of dexamethasone (or equivalent)\n  3. Any brain lesion thought to require immediate local therapy. Patients who undergo local treatment for such lesions identified by screening contrast brain MRI may still be eligible for the study based on criteria described under CNS inclusion criteria\n  4. Known or suspected leptomeningeal disease (LMD)\n  5. Poorly controlled seizures Unblinded Phase Crossover Inclusion Criteria - Participants who were randomized to the control arm (placebo + trastuzumab + capecitabine) must meet the following criteria to be eligible to crossover to the experimental arm.\n* Have measurable or non-measurable disease assessable by RECIST 1.1\n* For patients who were randomized to the control arm and on the long-term follow-up period at the time of crossover screening: have progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by investigator), or be intolerant of last systemic therapy.\n* Have an ECOG Performance Status of 0 or 1\n* Have a life expectancy of at least 6 months\n* Have adequate hepatic and renal function and hematologic parameters\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n* CNS Inclusion - Based on screening brain magnetic resonance imaging (MRI), patients must have one of the following:\n\n  i. No evidence of brain metastases ii. Untreated brain metastases not needing immediate local therapy iii. Previously treated brain metastases not needing immediate local therapy\n* Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy\n* Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI performed during screening for this study may be eligible to enroll if the following criteria are met:\n\n  1. Time since whole brain radiation therapy (WBRT) is ≥ 21 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to first dose of study treatment, or time since surgical resection is ≥ 28 days.\n  2. Other sites of disease assessable by RECIST 1.1 are present Unblinded Phase Crossover Exclusion Criteria - Participants who were randomized to the control arm (placebo + trastuzumab + capecitabine) will be excluded from the crossover to the experimental arm for any of the following reasons.\n* Discontinuation of study treatment due to an adverse event while on the double-blind phase of the study. If the adverse event leading to discontinuation of study treatment has resolved, the patient may be allowed to crossover with approval from the medical monitor.\n* History of exposure to the following cumulative doses of anthracyclines:\n\n  * Doxorubicin > 360 mg/m^2\n  * Epirubicin > 720 mg/m^2\n  * Mitoxantrone > 120 mg/m^2\n  * Idarubicin > 90 mg/m^2\n  * Liposomal doxorubicin > 550 mg/m^2\n* History of allergic reactions to trastuzumab, capecitabine, or compounds chemically or biologically similar to tucatinib\n\n  o Exceptions for Grade 1 or 2 infusion related reactions to trastuzumab that were successfully managed, or known allergy to one of the excipients in the study drugs\n* Have received treatment with any systemic anti-cancer therapy, non-CNS radiation, or experimental agent within 3 weeks prior to start of crossover therapy\n* Any toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the following exceptions:\n\n  * Alopecia and neuropathy (must have resolved to ≤ Grade 2)\n  * CHF (must have been ≤ Grade 1 in severity at the time of occurrence and must have resolved completely)\n  * Anemia (must have resolved to ≤ Grade 2)\n* Have clinically significant cardiopulmonary disease\n* Have known myocardial infarction or unstable angina within 6 months prior to start of crossover therapy\n* Require therapy with warfarin or other coumarin derivatives\n* Inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications\n* Have used a strong CYP2C8 inhibitor within 5 half-lives of the inhibitor or have used a strong CYP2C8 or CYP34A inducer within 5 days prior to start of the crossover (tucatinib) treatment.\n* Known dihydropyrimidine dehydrogenase deficiency\n* Unable to undergo contract MRI of the brain\n* Have evidence within 2 years prior to start of crossover therapy of another malignancy that required systemic treatment\n* CNS Exclusion:\n* CNS Exclusion - Based on screening brain MRI, patients must not have any of the following:\n\n  * Any untreated brain lesions > 2.0 cm in size, unless approved by medical monitor\n  * Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg of dexamethasone (or equivalent)\n  * Any brain lesion thought to require immediate local therapy. Patients who undergo local treatment for such lesions identified by screening contrast brain MRI may still be eligible for the study based on criteria described under CNS inclusion criteria\n  * Known or suspected leptomeningeal disease (LMD)\n  * Poorly controlled seizures"
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                        }
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                ]
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        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "Double-blind Phase Inclusion Criteria",
                "criterions": [
                    {
                        "exact_snippets": "Double-blind Phase",
                        "criterion": "study phase",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "double-blind"
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Double-blind Phase",
                        "criterion": "study phase",
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                            "requirement_type": "type",
                            "expected_value": "double-blind"
                        }
                    }
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        },
        {
            "identified_line": {
                "line": "* Histologically confirmed HER2+ breast carcinoma, with HER2+ defined by in situ hybridization (ISH), immunohistochemistry (IHC), or fluorescence in situ hybridization (FISH) methodology",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed HER2+ breast carcinoma",
                        "criterion": "HER2+ breast carcinoma",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "HER2+ defined by in situ hybridization (ISH), immunohistochemistry (IHC), or fluorescence in situ hybridization (FISH) methodology",
                        "criterion": "HER2+ definition",
                        "requirement": {
                            "requirement_type": "methodology",
                            "expected_value": [
                                "in situ hybridization (ISH)",
                                "immunohistochemistry (IHC)",
                                "fluorescence in situ hybridization (FISH)"
                            ]
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Histologically confirmed HER2+ breast carcinoma",
                                "criterion": "HER2+ breast carcinoma",
                                "requirement": {
                                    "requirement_type": "confirmation method",
                                    "expected_value": "histologically confirmed"
                                }
                            },
                            {
                                "exact_snippets": "HER2+ defined by in situ hybridization (ISH), immunohistochemistry (IHC), or fluorescence in situ hybridization (FISH) methodology",
                                "criterion": "HER2+ definition",
                                "requirement": {
                                    "requirement_type": "methodology",
                                    "expected_value": [
                                        "in situ hybridization (ISH)",
                                        "immunohistochemistry (IHC)",
                                        "fluorescence in situ hybridization (FISH)"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Received previous treatment with trastuzumab, pertuzumab, and T-DM1",
                "criterions": [
                    {
                        "exact_snippets": "Received previous treatment with trastuzumab",
                        "criterion": "previous treatment with trastuzumab",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Received previous treatment with ... pertuzumab",
                        "criterion": "previous treatment with pertuzumab",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Received previous treatment with ... T-DM1",
                        "criterion": "previous treatment with T-DM1",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Received previous treatment with trastuzumab",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Received previous treatment with ... pertuzumab",
                        "criterion": "previous treatment with pertuzumab",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Received previous treatment with ... T-DM1",
                        "criterion": "previous treatment with T-DM1",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by investigator), or be intolerant of last systemic therapy",
                "criterions": [
                    {
                        "exact_snippets": "Progression of unresectable locally advanced or metastatic breast cancer",
                        "criterion": "breast cancer progression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "intolerant of last systemic therapy",
                        "criterion": "intolerance to last systemic therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Progression of unresectable locally advanced or metastatic breast cancer",
                                "criterion": "breast cancer progression",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "as confirmed by investigator",
                                "criterion": "confirmation by investigator",
                                "requirement": {
                                    "requirement_type": "confirmation",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "intolerant of last systemic therapy",
                        "criterion": "intolerance to last systemic therapy",
                        "requirement": {
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                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Have measurable or non-measurable disease assessable by RECIST 1.1",
                "criterions": [
                    {
                        "exact_snippets": "measurable or non-measurable disease assessable by RECIST 1.1",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "assessability",
                            "expected_value": "RECIST 1.1"
                        }
                    }
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            "logical_structure": {
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                    {
                        "exact_snippets": "measurable or non-measurable disease assessable by RECIST 1.1",
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                            "requirement_type": "assessability",
                            "expected_value": "RECIST 1.1"
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate hepatic and renal function and hematologic parameters",
                "criterions": [
                    {
                        "exact_snippets": "Adequate hepatic ... function",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... renal function",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... hematologic parameters",
                        "criterion": "hematologic parameters",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
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                        "exact_snippets": "Adequate hepatic ... function",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... renal function",
                        "criterion": "renal function",
                        "requirement": {
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                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... hematologic parameters",
                        "criterion": "hematologic parameters",
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                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Left ventricular ejection fraction (LVEF) ≥ 50%",
                "criterions": [
                    {
                        "exact_snippets": "Left ventricular ejection fraction (LVEF) ≥ 50%",
                        "criterion": "left ventricular ejection fraction (LVEF)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
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                                "unit": "%"
                            }
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                        "exact_snippets": "Left ventricular ejection fraction (LVEF) ≥ 50%",
                        "criterion": "left ventricular ejection fraction (LVEF)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
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                ]
            }
        },
        {
            "identified_line": {
                "line": "* CNS Inclusion - Based on screening brain magnetic resonance imaging (MRI), patients must have one of the following:",
                "criterions": [
                    {
                        "exact_snippets": "screening brain magnetic resonance imaging (MRI)",
                        "criterion": "brain MRI",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
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                    "exact_snippets": "screening brain magnetic resonance imaging (MRI)",
                    "criterion": "brain MRI",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "1. No evidence of brain metastases",
                "criterions": [
                    {
                        "exact_snippets": "No evidence of brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "No evidence of brain metastases",
                        "criterion": "brain metastases",
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                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Untreated brain metastases not needing immediate local therapy",
                "criterions": [
                    {
                        "exact_snippets": "Untreated brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    },
                    {
                        "exact_snippets": "not needing immediate local therapy",
                        "criterion": "immediate local therapy",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    }
                ]
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            "logical_structure": {
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                        "exact_snippets": "Untreated brain metastases",
                        "criterion": "brain metastases",
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                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    },
                    {
                        "exact_snippets": "not needing immediate local therapy",
                        "criterion": "immediate local therapy",
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        },
        {
            "identified_line": {
                "line": "3. Previously treated brain metastases not needing immediate local therapy",
                "criterions": [
                    {
                        "exact_snippets": "Previously treated brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": "previously treated"
                        }
                    },
                    {
                        "exact_snippets": "not needing immediate local therapy",
                        "criterion": "immediate local therapy",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": false
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            "logical_structure": {
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                        "exact_snippets": "Previously treated brain metastases",
                        "criterion": "brain metastases",
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                            "expected_value": "previously treated"
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                    },
                    {
                        "exact_snippets": "not needing immediate local therapy",
                        "criterion": "immediate local therapy",
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        },
        {
            "identified_line": {
                "line": "1. Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy",
                "criterions": [
                    {
                        "exact_snippets": "Brain metastases previously treated with local therapy",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "local therapy"
                        }
                    },
                    {
                        "exact_snippets": "Brain metastases ... may either be stable since treatment",
                        "criterion": "brain metastases stability",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "stable since treatment"
                        }
                    },
                    {
                        "exact_snippets": "Brain metastases ... may have progressed since prior local CNS therapy",
                        "criterion": "brain metastases progression",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": "progressed since prior local CNS therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Brain metastases previously treated with local therapy",
                        "criterion": "brain metastases",
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                            "requirement_type": "treatment",
                            "expected_value": "local therapy"
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Brain metastases ... may either be stable since treatment",
                                "criterion": "brain metastases stability",
                                "requirement": {
                                    "requirement_type": "stability",
                                    "expected_value": "stable since treatment"
                                }
                            },
                            {
                                "exact_snippets": "Brain metastases ... may have progressed since prior local CNS therapy",
                                "criterion": "brain metastases progression",
                                "requirement": {
                                    "requirement_type": "progression",
                                    "expected_value": "progressed since prior local CNS therapy"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI performed during screening for this study may be eligible to enroll if the following criteria are met:",
                "criterions": [
                    {
                        "exact_snippets": "CNS local therapy",
                        "criterion": "CNS local therapy",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "newly identified lesions",
                        "criterion": "newly identified lesions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "contrast brain MRI",
                        "criterion": "contrast brain MRI",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "screening for this study",
                        "criterion": "screening for this study",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    }
                ]
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                    {
                        "and_criteria": [
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                                "exact_snippets": "CNS local therapy",
                                "criterion": "CNS local therapy",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": true
                                }
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                            {
                                "exact_snippets": "newly identified lesions",
                                "criterion": "newly identified lesions",
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                                    "requirement_type": "presence",
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                                }
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                    {
                        "and_criteria": [
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                                "exact_snippets": "contrast brain MRI",
                                "criterion": "contrast brain MRI",
                                "requirement": {
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                                }
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                                "exact_snippets": "screening for this study",
                                "criterion": "screening for this study",
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                                    "requirement_type": "procedure",
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        {
            "identified_line": {
                "line": "i. Time since whole brain radiation therapy (WBRT) is ≥ 21 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to first dose of study treatment, or time since surgical resection is ≥ 28 days.",
                "criterions": [
                    {
                        "exact_snippets": "Time since whole brain radiation therapy (WBRT) is ≥ 21 days prior to first dose of study treatment",
                        "criterion": "time since whole brain radiation therapy (WBRT)",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to first dose of study treatment",
                        "criterion": "time since stereotactic radiosurgery (SRS)",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "time since surgical resection is ≥ 28 days",
                        "criterion": "time since surgical resection",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Time since whole brain radiation therapy (WBRT) is ≥ 21 days prior to first dose of study treatment",
                        "criterion": "time since whole brain radiation therapy (WBRT)",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to first dose of study treatment",
                        "criterion": "time since stereotactic radiosurgery (SRS)",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "time since surgical resection is ≥ 28 days",
                        "criterion": "time since surgical resection",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "ii. Other sites of disease assessable by RECIST 1.1 are present",
                "criterions": [
                    {
                        "exact_snippets": "Other sites of disease assessable by RECIST 1.1 are present",
                        "criterion": "other sites of disease",
                        "requirement": {
                            "requirement_type": "assessability",
                            "expected_value": "RECIST 1.1"
                        }
                    },
                    {
                        "exact_snippets": "Other sites of disease assessable by RECIST 1.1 are present",
                        "criterion": "other sites of disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Other sites of disease assessable by RECIST 1.1 are present",
                        "criterion": "other sites of disease",
                        "requirement": {
                            "requirement_type": "assessability",
                            "expected_value": "RECIST 1.1"
                        }
                    },
                    {
                        "exact_snippets": "Other sites of disease assessable by RECIST 1.1 are present",
                        "criterion": "other sites of disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions",
                "criterions": [
                    {
                        "exact_snippets": "Relevant records of any CNS treatment must be available",
                        "criterion": "CNS treatment records",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "classification of target and non-target lesions",
                        "criterion": "lesion classification",
                        "requirement": {
                            "requirement_type": "purpose",
                            "expected_value": "classification of target and non-target lesions"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Relevant records of any CNS treatment must be available",
                        "criterion": "CNS treatment records",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "classification of target and non-target lesions",
                        "criterion": "lesion classification",
                        "requirement": {
                            "requirement_type": "purpose",
                            "expected_value": "classification of target and non-target lesions"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Double-blind Phase Exclusion Criteria",
                "criterions": [
                    {
                        "exact_snippets": "Double-blind Phase",
                        "criterion": "trial phase",
                        "requirement": {
                            "requirement_type": "phase",
                            "expected_value": "double-blind"
                        }
                    },
                    {
                        "exact_snippets": "Exclusion Criteria",
                        "criterion": "eligibility criteria type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "exclusion"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Double-blind Phase",
                        "criterion": "trial phase",
                        "requirement": {
                            "requirement_type": "phase",
                            "expected_value": "double-blind"
                        }
                    },
                    {
                        "exact_snippets": "Exclusion Criteria",
                        "criterion": "eligibility criteria type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "exclusion"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Previously been treated with:",
                "criterions": [
                    {
                        "exact_snippets": "Previously been treated with",
                        "criterion": "previous treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Previously been treated with",
                        "criterion": "previous treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. lapatinib within 12 months of starting study treatment (except in cases where lapatinib was given for ≤ 21 days and was discontinued for reasons other than disease progression or toxicity)",
                "criterions": [
                    {
                        "exact_snippets": "lapatinib within 12 months of starting study treatment",
                        "criterion": "lapatinib treatment",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "lapatinib was given for ≤ 21 days",
                        "criterion": "lapatinib treatment duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "discontinued for reasons other than disease progression or toxicity",
                        "criterion": "reason for lapatinib discontinuation",
                        "requirement": {
                            "requirement_type": "reason",
                            "expected_value": [
                                "not disease progression",
                                "not toxicity"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "lapatinib within 12 months of starting study treatment",
                            "criterion": "lapatinib treatment",
                            "requirement": {
                                "requirement_type": "time since last treatment",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 12,
                                    "unit": "months"
                                }
                            }
                        },
                        {
                            "not_criteria": {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "lapatinib was given for ≤ 21 days",
                                        "criterion": "lapatinib treatment duration",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 21,
                                                "unit": "days"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "discontinued for reasons other than disease progression or toxicity",
                                        "criterion": "reason for lapatinib discontinuation",
                                        "requirement": {
                                            "requirement_type": "reason",
                                            "expected_value": [
                                                "not disease progression",
                                                "not toxicity"
                                            ]
                                        }
                                    }
                                ]
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "lapatinib within 12 months of starting study treatment",
                    "criterion": "lapatinib treatment",
                    "requirement": {
                        "requirement_type": "time since last treatment",
                        "expected_value": {
                            "operator": "<=",
                            "value": 12,
                            "unit": "months"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "3. capecitabine (or other fluoropyrimidine) for metastatic disease except in cases where capecitabine was given for < 21 days and was discontinued for reasons other than disease progression or toxicity. Patients who have received capecitabine for adjuvant or neoadjuvant treatment at least 12 months prior to starting study treatment are eligible.",
                "criterions": [
                    {
                        "exact_snippets": "capecitabine (or other fluoropyrimidine) for metastatic disease",
                        "criterion": "capecitabine or other fluoropyrimidine for metastatic disease",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "capecitabine was given for < 21 days",
                        "criterion": "capecitabine treatment duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "discontinued for reasons other than disease progression or toxicity",
                        "criterion": "discontinuation reason",
                        "requirement": {
                            "requirement_type": "reason",
                            "expected_value": [
                                "not disease progression",
                                "not toxicity"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "capecitabine for adjuvant or neoadjuvant treatment at least 12 months prior to starting study treatment",
                        "criterion": "capecitabine for adjuvant or neoadjuvant treatment",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "capecitabine (or other fluoropyrimidine) for metastatic disease",
                                    "criterion": "capecitabine or other fluoropyrimidine for metastatic disease",
                                    "requirement": {
                                        "requirement_type": "treatment",
                                        "expected_value": false
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "capecitabine was given for < 21 days",
                                                "criterion": "capecitabine treatment duration",
                                                "requirement": {
                                                    "requirement_type": "duration",
                                                    "expected_value": {
                                                        "operator": "<",
                                                        "value": 21,
                                                        "unit": "days"
                                                    }
                                                }
                                            },
                                            {
                                                "exact_snippets": "discontinued for reasons other than disease progression or toxicity",
                                                "criterion": "discontinuation reason",
                                                "requirement": {
                                                    "requirement_type": "reason",
                                                    "expected_value": [
                                                        "not disease progression",
                                                        "not toxicity"
                                                    ]
                                                }
                                            }
                                        ]
                                    }
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": "capecitabine for adjuvant or neoadjuvant treatment at least 12 months prior to starting study treatment",
                        "criterion": "capecitabine for adjuvant or neoadjuvant treatment",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Clinically significant cardiopulmonary disease",
                "criterions": [
                    {
                        "exact_snippets": "Clinically significant cardiopulmonary disease",
                        "criterion": "cardiopulmonary disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Clinically significant cardiopulmonary disease",
                        "criterion": "cardiopulmonary disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease",
                "criterions": [
                    {
                        "exact_snippets": "Carriers of Hepatitis B",
                        "criterion": "Hepatitis B",
                        "requirement": {
                            "requirement_type": "carrier status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Carriers of ... Hepatitis C",
                        "criterion": "Hepatitis C",
                        "requirement": {
                            "requirement_type": "carrier status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other known chronic liver disease",
                        "criterion": "chronic liver disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Carriers of Hepatitis B",
                        "criterion": "Hepatitis B",
                        "requirement": {
                            "requirement_type": "carrier status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Carriers of ... Hepatitis C",
                        "criterion": "Hepatitis C",
                        "requirement": {
                            "requirement_type": "carrier status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other known chronic liver disease",
                        "criterion": "chronic liver disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Positive for human immunodeficiency virus (HIV)",
                "criterions": [
                    {
                        "exact_snippets": "Positive for human immunodeficiency virus (HIV)",
                        "criterion": "human immunodeficiency virus (HIV)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Positive for human immunodeficiency virus (HIV)",
                        "criterion": "human immunodeficiency virus (HIV)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Unable for any reason to undergo MRI of the brain",
                "criterions": [
                    {
                        "exact_snippets": "Unable for any reason to undergo MRI of the brain",
                        "criterion": "ability to undergo MRI of the brain",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Unable for any reason to undergo MRI of the brain",
                    "criterion": "ability to undergo MRI of the brain",
                    "requirement": {
                        "requirement_type": "ability",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Have used a strong CYP3A4 or CYP2C8 inhibitor within 5 half-lives of the inhibitor, or a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment",
                "criterions": [
                    {
                        "exact_snippets": "Have used a strong CYP3A4 or CYP2C8 inhibitor within 5 half-lives of the inhibitor",
                        "criterion": "use of strong CYP3A4 or CYP2C8 inhibitor",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    },
                    {
                        "exact_snippets": "a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment",
                        "criterion": "use of strong CYP3A4 or CYP2C8 inducer",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Have used a strong CYP3A4 or CYP2C8 inhibitor within 5 half-lives of the inhibitor",
                                "criterion": "use of strong CYP3A4 or CYP2C8 inhibitor",
                                "requirement": {
                                    "requirement_type": "time since last use",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment",
                                "criterion": "use of strong CYP3A4 or CYP2C8 inducer",
                                "requirement": {
                                    "requirement_type": "time since last use",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Have known dihydropyrimidine dehydrogenase deficiency (DPD)",
                "criterions": [
                    {
                        "exact_snippets": "known dihydropyrimidine dehydrogenase deficiency (DPD)",
                        "criterion": "dihydropyrimidine dehydrogenase deficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "known dihydropyrimidine dehydrogenase deficiency (DPD)",
                        "criterion": "dihydropyrimidine dehydrogenase deficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* CNS Exclusion - Based on screening brain MRI, patients must not have any of the following:",
                "criterions": [
                    {
                        "exact_snippets": "screening brain MRI",
                        "criterion": "brain MRI",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "patients must not have any of the following",
                        "criterion": "CNS condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "screening brain MRI",
                        "criterion": "brain MRI",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "patients must not have any of the following",
                        "criterion": "CNS condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Any untreated brain lesions > 2.0 cm in size, unless approved by medical monitor",
                "criterions": [
                    {
                        "exact_snippets": "untreated brain lesions > 2.0 cm in size",
                        "criterion": "brain lesions",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    },
                    {
                        "exact_snippets": "untreated brain lesions > 2.0 cm in size",
                        "criterion": "brain lesions",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.0,
                                "unit": "cm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "untreated brain lesions > 2.0 cm in size",
                            "criterion": "brain lesions",
                            "requirement": {
                                "requirement_type": "treatment status",
                                "expected_value": "untreated"
                            }
                        },
                        {
                            "exact_snippets": "untreated brain lesions > 2.0 cm in size",
                            "criterion": "brain lesions",
                            "requirement": {
                                "requirement_type": "size",
                                "expected_value": {
                                    "operator": ">",
                                    "value": 2.0,
                                    "unit": "cm"
                                }
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "unless approved by medical monitor",
                    "criterion": "medical monitor approval",
                    "requirement": {
                        "requirement_type": "approval",
                        "expected_value": true
                    }
                },
                "else_criteria": {
                    "exact_snippets": "untreated brain lesions > 2.0 cm in size",
                    "criterion": "brain lesions",
                    "requirement": {
                        "requirement_type": "eligibility",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg of dexamethasone (or equivalent)",
                "criterions": [
                    {
                        "exact_snippets": "Ongoing use of systemic corticosteroids",
                        "criterion": "systemic corticosteroids use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "control of symptoms of brain metastases",
                        "criterion": "brain metastases symptoms control",
                        "requirement": {
                            "requirement_type": "purpose",
                            "expected_value": "control"
                        }
                    },
                    {
                        "exact_snippets": "total daily dose of > 2 mg of dexamethasone (or equivalent)",
                        "criterion": "dexamethasone dose",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "mg"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Ongoing use of systemic corticosteroids",
                                "criterion": "systemic corticosteroids use",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "control of symptoms of brain metastases",
                                "criterion": "brain metastases symptoms control",
                                "requirement": {
                                    "requirement_type": "purpose",
                                    "expected_value": "control"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "total daily dose of > 2 mg of dexamethasone (or equivalent)",
                        "criterion": "dexamethasone dose",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "mg"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Any brain lesion thought to require immediate local therapy. Patients who undergo local treatment for such lesions identified by screening contrast brain MRI may still be eligible for the study based on criteria described under CNS inclusion criteria",
                "criterions": [
                    {
                        "exact_snippets": "brain lesion thought to require immediate local therapy",
                        "criterion": "brain lesion",
                        "requirement": {
                            "requirement_type": "immediate local therapy requirement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "brain lesion thought to require immediate local therapy",
                    "criterion": "brain lesion",
                    "requirement": {
                        "requirement_type": "immediate local therapy requirement",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "not_criteria": {
                        "exact_snippets": "brain lesion thought to require immediate local therapy",
                        "criterion": "brain lesion",
                        "requirement": {
                            "requirement_type": "immediate local therapy requirement",
                            "expected_value": true
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "4. Known or suspected leptomeningeal disease (LMD)",
                "criterions": [
                    {
                        "exact_snippets": "Known or suspected leptomeningeal disease (LMD)",
                        "criterion": "leptomeningeal disease (LMD)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Known or suspected leptomeningeal disease (LMD)",
                    "criterion": "leptomeningeal disease (LMD)",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Poorly controlled seizures Unblinded Phase Crossover Inclusion Criteria - Participants who were randomized to the control arm (placebo + trastuzumab + capecitabine) must meet the following criteria to be eligible to crossover to the experimental arm.",
                "criterions": [
                    {
                        "exact_snippets": "Poorly controlled seizures",
                        "criterion": "seizures",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Poorly controlled seizures",
                        "criterion": "seizures",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Have measurable or non-measurable disease assessable by RECIST 1.1",
                "criterions": [
                    {
                        "exact_snippets": "measurable or non-measurable disease",
                        "criterion": "disease measurability",
                        "requirement": {
                            "requirement_type": "assessability",
                            "expected_value": "assessable by RECIST 1.1"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "measurable or non-measurable disease",
                        "criterion": "disease measurability",
                        "requirement": {
                            "requirement_type": "assessability",
                            "expected_value": "assessable by RECIST 1.1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* For patients who were randomized to the control arm and on the long-term follow-up period at the time of crossover screening: have progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by investigator), or be intolerant of last systemic therapy.",
                "criterions": [
                    {
                        "exact_snippets": "progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy",
                        "criterion": "progression of unresectable locally advanced or metastatic breast cancer",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "confirmed by investigator"
                        }
                    },
                    {
                        "exact_snippets": "intolerant of last systemic therapy",
                        "criterion": "intolerance to last systemic therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "randomized to the control arm and on the long-term follow-up period at the time of crossover screening",
                    "criterion": "randomization and follow-up status",
                    "requirement": {
                        "requirement_type": "status",
                        "expected_value": "control arm and long-term follow-up"
                    }
                },
                "then_criteria": {
                    "or_criteria": [
                        {
                            "exact_snippets": "progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy",
                            "criterion": "progression of unresectable locally advanced or metastatic breast cancer",
                            "requirement": {
                                "requirement_type": "confirmation",
                                "expected_value": "confirmed by investigator"
                            }
                        },
                        {
                            "exact_snippets": "intolerant of last systemic therapy",
                            "criterion": "intolerance to last systemic therapy",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Have an ECOG Performance Status of 0 or 1",
                "criterions": [
                    {
                        "exact_snippets": "ECOG Performance Status of 0 or 1",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG Performance Status of 0 or 1",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Have a life expectancy of at least 6 months",
                "criterions": [
                    {
                        "exact_snippets": "life expectancy of at least 6 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "life expectancy of at least 6 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Have adequate hepatic and renal function and hematologic parameters",
                "criterions": [
                    {
                        "exact_snippets": "adequate hepatic ... function",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate ... renal function",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate ... hematologic parameters",
                        "criterion": "hematologic parameters",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "adequate hepatic ... function",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate ... renal function",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate ... hematologic parameters",
                        "criterion": "hematologic parameters",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Left ventricular ejection fraction (LVEF) ≥ 50%",
                "criterions": [
                    {
                        "exact_snippets": "Left ventricular ejection fraction (LVEF) ≥ 50%",
                        "criterion": "left ventricular ejection fraction (LVEF)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Left ventricular ejection fraction (LVEF) ≥ 50%",
                        "criterion": "left ventricular ejection fraction (LVEF)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* CNS Inclusion - Based on screening brain magnetic resonance imaging (MRI), patients must have one of the following:",
                "criterions": [
                    {
                        "exact_snippets": "screening brain magnetic resonance imaging (MRI)",
                        "criterion": "brain MRI",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "screening brain magnetic resonance imaging (MRI)",
                    "criterion": "brain MRI",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "i. No evidence of brain metastases ii. Untreated brain metastases not needing immediate local therapy iii. Previously treated brain metastases not needing immediate local therapy",
                "criterions": [
                    {
                        "exact_snippets": "No evidence of brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Untreated brain metastases not needing immediate local therapy",
                        "criterion": "untreated brain metastases",
                        "requirement": {
                            "requirement_type": "immediate local therapy",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Previously treated brain metastases not needing immediate local therapy",
                        "criterion": "previously treated brain metastases",
                        "requirement": {
                            "requirement_type": "immediate local therapy",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "No evidence of brain metastases",
                                "criterion": "brain metastases",
                                "requirement": {
                                    "requirement_type": "evidence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Untreated brain metastases not needing immediate local therapy",
                                "criterion": "untreated brain metastases",
                                "requirement": {
                                    "requirement_type": "immediate local therapy",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Previously treated brain metastases not needing immediate local therapy",
                                "criterion": "previously treated brain metastases",
                                "requirement": {
                                    "requirement_type": "immediate local therapy",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy",
                "criterions": [
                    {
                        "exact_snippets": "Brain metastases previously treated with local therapy",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "local therapy"
                        }
                    },
                    {
                        "exact_snippets": "Brain metastases ... may either be stable since treatment",
                        "criterion": "brain metastases stability",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "stable since treatment"
                        }
                    },
                    {
                        "exact_snippets": "Brain metastases ... may have progressed since prior local CNS therapy",
                        "criterion": "brain metastases progression",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": "progressed since prior local CNS therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Brain metastases previously treated with local therapy",
                    "criterion": "brain metastases",
                    "requirement": {
                        "requirement_type": "treatment",
                        "expected_value": "local therapy"
                    }
                },
                "then_criteria": {
                    "or_criteria": [
                        {
                            "exact_snippets": "Brain metastases ... may either be stable since treatment",
                            "criterion": "brain metastases stability",
                            "requirement": {
                                "requirement_type": "stability",
                                "expected_value": "stable since treatment"
                            }
                        },
                        {
                            "exact_snippets": "Brain metastases ... may have progressed since prior local CNS therapy",
                            "criterion": "brain metastases progression",
                            "requirement": {
                                "requirement_type": "progression",
                                "expected_value": "progressed since prior local CNS therapy"
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI performed during screening for this study may be eligible to enroll if the following criteria are met:",
                "criterions": [
                    {
                        "exact_snippets": "CNS local therapy",
                        "criterion": "CNS local therapy",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "newly identified lesions",
                        "criterion": "newly identified lesions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "contrast brain MRI performed during screening",
                        "criterion": "contrast brain MRI",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": "performed during screening"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "CNS local therapy",
                                "criterion": "CNS local therapy",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "newly identified lesions",
                                "criterion": "newly identified lesions",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "contrast brain MRI performed during screening",
                        "criterion": "contrast brain MRI",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": "performed during screening"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Time since whole brain radiation therapy (WBRT) is ≥ 21 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to first dose of study treatment, or time since surgical resection is ≥ 28 days.",
                "criterions": [
                    {
                        "exact_snippets": "Time since whole brain radiation therapy (WBRT) is ≥ 21 days",
                        "criterion": "time since whole brain radiation therapy (WBRT)",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "time since stereotactic radiosurgery (SRS) is ≥ 7 days",
                        "criterion": "time since stereotactic radiosurgery (SRS)",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "time since surgical resection is ≥ 28 days",
                        "criterion": "time since surgical resection",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Time since whole brain radiation therapy (WBRT) is ≥ 21 days",
                        "criterion": "time since whole brain radiation therapy (WBRT)",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "time since stereotactic radiosurgery (SRS) is ≥ 7 days",
                        "criterion": "time since stereotactic radiosurgery (SRS)",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "time since surgical resection is ≥ 28 days",
                        "criterion": "time since surgical resection",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Idarubicin > 90 mg/m^2",
                "criterions": [
                    {
                        "exact_snippets": "Idarubicin > 90 mg/m^2",
                        "criterion": "Idarubicin dosage",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mg/m^2"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Idarubicin > 90 mg/m^2",
                        "criterion": "Idarubicin dosage",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mg/m^2"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Liposomal doxorubicin > 550 mg/m^2",
                "criterions": [
                    {
                        "exact_snippets": "Liposomal doxorubicin > 550 mg/m^2",
                        "criterion": "liposomal doxorubicin dosage",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 550,
                                "unit": "mg/m^2"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Liposomal doxorubicin > 550 mg/m^2",
                        "criterion": "liposomal doxorubicin dosage",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 550,
                                "unit": "mg/m^2"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of allergic reactions to trastuzumab, capecitabine, or compounds chemically or biologically similar to tucatinib",
                "criterions": [
                    {
                        "exact_snippets": "History of allergic reactions to trastuzumab",
                        "criterion": "allergic reactions to trastuzumab",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of allergic reactions to ... capecitabine",
                        "criterion": "allergic reactions to capecitabine",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of allergic reactions to ... compounds chemically or biologically similar to tucatinib",
                        "criterion": "allergic reactions to compounds chemically or biologically similar to tucatinib",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of allergic reactions to trastuzumab",
                                "criterion": "allergic reactions to trastuzumab",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of allergic reactions to ... capecitabine",
                                "criterion": "allergic reactions to capecitabine",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of allergic reactions to ... compounds chemically or biologically similar to tucatinib",
                                "criterion": "allergic reactions to compounds chemically or biologically similar to tucatinib",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "o Exceptions for Grade 1 or 2 infusion related reactions to trastuzumab that were successfully managed, or known allergy to one of the excipients in the study drugs",
                "criterions": [
                    {
                        "exact_snippets": "Grade 1 or 2 infusion related reactions to trastuzumab",
                        "criterion": "infusion related reactions to trastuzumab",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 1,
                                        "unit": "Grade"
                                    },
                                    {
                                        "operator": "=",
                                        "value": 2,
                                        "unit": "Grade"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "known allergy to one of the excipients in the study drugs",
                        "criterion": "allergy to excipients in study drugs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Grade 1 or 2 infusion related reactions to trastuzumab",
                                "criterion": "infusion related reactions to trastuzumab",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "=",
                                                "value": 1,
                                                "unit": "Grade"
                                            },
                                            {
                                                "operator": "=",
                                                "value": 2,
                                                "unit": "Grade"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Grade 1 or 2 infusion related reactions to trastuzumab",
                                "criterion": "infusion related reactions to trastuzumab",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "=",
                                                "value": 1,
                                                "unit": "Grade"
                                            },
                                            {
                                                "operator": "=",
                                                "value": 2,
                                                "unit": "Grade"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "known allergy to one of the excipients in the study drugs",
                        "criterion": "allergy to excipients in study drugs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Have received treatment with any systemic anti-cancer therapy, non-CNS radiation, or experimental agent within 3 weeks prior to start of crossover therapy",
                "criterions": [
                    {
                        "exact_snippets": "Have received treatment with any systemic anti-cancer therapy",
                        "criterion": "systemic anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Have received treatment with any ... non-CNS radiation",
                        "criterion": "non-CNS radiation",
                        "requirement": {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Have received treatment with any ... experimental agent",
                        "criterion": "experimental agent",
                        "requirement": {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Have received treatment with any systemic anti-cancer therapy",
                                "criterion": "systemic anti-cancer therapy",
                                "requirement": {
                                    "requirement_type": "recency",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Have received treatment with any ... non-CNS radiation",
                                "criterion": "non-CNS radiation",
                                "requirement": {
                                    "requirement_type": "recency",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Have received treatment with any ... experimental agent",
                                "criterion": "experimental agent",
                                "requirement": {
                                    "requirement_type": "recency",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Alopecia and neuropathy (must have resolved to ≤ Grade 2)",
                "criterions": [
                    {
                        "exact_snippets": "Alopecia",
                        "criterion": "alopecia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "neuropathy (must have resolved to ≤ Grade 2)",
                        "criterion": "neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Alopecia",
                        "criterion": "alopecia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "neuropathy (must have resolved to ≤ Grade 2)",
                        "criterion": "neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Anemia (must have resolved to ≤ Grade 2)",
                "criterions": [
                    {
                        "exact_snippets": "Anemia (must have resolved to ≤ Grade 2)",
                        "criterion": "anemia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Anemia (must have resolved to ≤ Grade 2)",
                        "criterion": "anemia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Have clinically significant cardiopulmonary disease",
                "criterions": [
                    {
                        "exact_snippets": "clinically significant cardiopulmonary disease",
                        "criterion": "cardiopulmonary disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "clinically significant cardiopulmonary disease",
                    "criterion": "cardiopulmonary disease",
                    "requirement": {
                        "requirement_type": "severity",
                        "expected_value": "clinically significant"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Have known myocardial infarction or unstable angina within 6 months prior to start of crossover therapy",
                "criterions": [
                    {
                        "exact_snippets": "known myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "unstable angina within 6 months",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unstable angina within 6 months",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "known myocardial infarction",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "known myocardial infarction",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 6,
                                                "unit": "months"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "unstable angina within 6 months",
                                "criterion": "unstable angina",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "unstable angina within 6 months",
                                "criterion": "unstable angina",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 6,
                                                "unit": "months"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Require therapy with warfarin or other coumarin derivatives",
                "criterions": [
                    {
                        "exact_snippets": "Require therapy with warfarin or other coumarin derivatives",
                        "criterion": "therapy with warfarin or other coumarin derivatives",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Require therapy with warfarin or other coumarin derivatives",
                        "criterion": "therapy with warfarin or other coumarin derivatives",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications",
                "criterions": [
                    {
                        "exact_snippets": "Inability to swallow pills",
                        "criterion": "ability to swallow pills",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "significant gastrointestinal disease which would preclude the adequate oral absorption of medications",
                        "criterion": "gastrointestinal disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Inability to swallow pills",
                            "criterion": "ability to swallow pills",
                            "requirement": {
                                "requirement_type": "ability",
                                "expected_value": true
                            }
                        }
                    },
                    {
                        "exact_snippets": "significant gastrointestinal disease which would preclude the adequate oral absorption of medications",
                        "criterion": "gastrointestinal disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Have used a strong CYP2C8 inhibitor within 5 half-lives of the inhibitor or have used a strong CYP2C8 or CYP34A inducer within 5 days prior to start of the crossover (tucatinib) treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Have used a strong CYP2C8 inhibitor within 5 half-lives of the inhibitor",
                        "criterion": "use of strong CYP2C8 inhibitor",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    },
                    {
                        "exact_snippets": "have used a strong CYP2C8 or CYP34A inducer within 5 days prior to start of the crossover (tucatinib) treatment",
                        "criterion": "use of strong CYP2C8 or CYP34A inducer",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Have used a strong CYP2C8 inhibitor within 5 half-lives of the inhibitor",
                                "criterion": "use of strong CYP2C8 inhibitor",
                                "requirement": {
                                    "requirement_type": "time since last use",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "have used a strong CYP2C8 or CYP34A inducer within 5 days prior to start of the crossover (tucatinib) treatment",
                                "criterion": "use of strong CYP2C8 or CYP34A inducer",
                                "requirement": {
                                    "requirement_type": "time since last use",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known dihydropyrimidine dehydrogenase deficiency",
                "criterions": [
                    {
                        "exact_snippets": "Known dihydropyrimidine dehydrogenase deficiency",
                        "criterion": "dihydropyrimidine dehydrogenase deficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Known dihydropyrimidine dehydrogenase deficiency",
                        "criterion": "dihydropyrimidine dehydrogenase deficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Unable to undergo contract MRI of the brain",
                "criterions": [
                    {
                        "exact_snippets": "Unable to undergo contract MRI of the brain",
                        "criterion": "ability to undergo contrast MRI of the brain",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Unable to undergo contract MRI of the brain",
                    "criterion": "ability to undergo contrast MRI of the brain",
                    "requirement": {
                        "requirement_type": "ability",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Have evidence within 2 years prior to start of crossover therapy of another malignancy that required systemic treatment",
                "criterions": [
                    {
                        "exact_snippets": "evidence within 2 years prior to start of crossover therapy of another malignancy",
                        "criterion": "evidence of another malignancy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "evidence within 2 years prior to start of crossover therapy of another malignancy",
                        "criterion": "evidence of another malignancy",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": "systemic treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "evidence within 2 years prior to start of crossover therapy of another malignancy",
                        "criterion": "evidence of another malignancy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "evidence within 2 years prior to start of crossover therapy of another malignancy",
                        "criterion": "evidence of another malignancy",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": "systemic treatment"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* CNS Exclusion:",
                "criterions": [
                    {
                        "exact_snippets": "CNS Exclusion",
                        "criterion": "CNS involvement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "CNS Exclusion",
                    "criterion": "CNS involvement",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* CNS Exclusion - Based on screening brain MRI, patients must not have any of the following:",
                "criterions": [
                    {
                        "exact_snippets": "screening brain MRI",
                        "criterion": "brain MRI",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "patients must not have any of the following",
                        "criterion": "CNS condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "screening brain MRI",
                        "criterion": "brain MRI",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "patients must not have any of the following",
                        "criterion": "CNS condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any untreated brain lesions > 2.0 cm in size, unless approved by medical monitor",
                "criterions": [
                    {
                        "exact_snippets": "untreated brain lesions > 2.0 cm in size",
                        "criterion": "brain lesions",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    },
                    {
                        "exact_snippets": "untreated brain lesions > 2.0 cm in size",
                        "criterion": "brain lesions",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.0,
                                "unit": "cm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "untreated brain lesions > 2.0 cm in size",
                            "criterion": "brain lesions",
                            "requirement": {
                                "requirement_type": "treatment status",
                                "expected_value": "untreated"
                            }
                        },
                        {
                            "exact_snippets": "untreated brain lesions > 2.0 cm in size",
                            "criterion": "brain lesions",
                            "requirement": {
                                "requirement_type": "size",
                                "expected_value": {
                                    "operator": ">",
                                    "value": 2.0,
                                    "unit": "cm"
                                }
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "untreated brain lesions > 2.0 cm in size",
                    "criterion": "brain lesions",
                    "requirement": {
                        "requirement_type": "approval",
                        "expected_value": "approved by medical monitor"
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg of dexamethasone (or equivalent)",
                "criterions": [
                    {
                        "exact_snippets": "Ongoing use of systemic corticosteroids for control of symptoms of brain metastases",
                        "criterion": "systemic corticosteroids use",
                        "requirement": {
                            "requirement_type": "purpose",
                            "expected_value": "control of symptoms of brain metastases"
                        }
                    },
                    {
                        "exact_snippets": "Ongoing use of systemic corticosteroids for control of symptoms of brain metastases",
                        "criterion": "systemic corticosteroids use",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    },
                    {
                        "exact_snippets": "a total daily dose of > 2 mg of dexamethasone (or equivalent)",
                        "criterion": "dexamethasone dose",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "mg"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Ongoing use of systemic corticosteroids for control of symptoms of brain metastases",
                                "criterion": "systemic corticosteroids use",
                                "requirement": {
                                    "requirement_type": "purpose",
                                    "expected_value": "control of symptoms of brain metastases"
                                }
                            },
                            {
                                "exact_snippets": "Ongoing use of systemic corticosteroids for control of symptoms of brain metastases",
                                "criterion": "systemic corticosteroids use",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "ongoing"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "a total daily dose of > 2 mg of dexamethasone (or equivalent)",
                        "criterion": "dexamethasone dose",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "mg"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any brain lesion thought to require immediate local therapy. Patients who undergo local treatment for such lesions identified by screening contrast brain MRI may still be eligible for the study based on criteria described under CNS inclusion criteria",
                "criterions": [
                    {
                        "exact_snippets": "Any brain lesion thought to require immediate local therapy",
                        "criterion": "brain lesion",
                        "requirement": {
                            "requirement_type": "immediate local therapy requirement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Any brain lesion thought to require immediate local therapy",
                    "criterion": "brain lesion",
                    "requirement": {
                        "requirement_type": "immediate local therapy requirement",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "not_criteria": {
                        "exact_snippets": "Any brain lesion thought to require immediate local therapy",
                        "criterion": "brain lesion",
                        "requirement": {
                            "requirement_type": "immediate local therapy requirement",
                            "expected_value": true
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Known or suspected leptomeningeal disease (LMD)",
                "criterions": [
                    {
                        "exact_snippets": "Known or suspected leptomeningeal disease (LMD)",
                        "criterion": "leptomeningeal disease (LMD)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Known or suspected leptomeningeal disease (LMD)",
                        "criterion": "leptomeningeal disease (LMD)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Poorly controlled seizures",
                "criterions": [
                    {
                        "exact_snippets": "Poorly controlled seizures",
                        "criterion": "seizures",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Poorly controlled seizures",
                    "criterion": "seizures",
                    "requirement": {
                        "requirement_type": "control",
                        "expected_value": "poorly controlled"
                    }
                }
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "0"
                        }
                    },
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. neratinib, afatinib, or other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) at any time previously",
                "criterions": [
                    {
                        "exact_snippets": "neratinib, afatinib, or other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) at any time previously",
                        "criterion": "prior treatment with specific drugs",
                        "requirement": {
                            "requirement_type": "drugs",
                            "expected_value": [
                                "neratinib",
                                "afatinib",
                                "other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI)"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "neratinib, afatinib, or other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) at any time previously",
                        "criterion": "prior treatment with specific drugs",
                        "requirement": {
                            "requirement_type": "time",
                            "expected_value": "at any time previously"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "neratinib, afatinib, or other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) at any time previously",
                                        "criterion": "prior treatment with specific drugs",
                                        "requirement": {
                                            "requirement_type": "drugs",
                                            "expected_value": [
                                                "neratinib"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "neratinib, afatinib, or other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) at any time previously",
                                        "criterion": "prior treatment with specific drugs",
                                        "requirement": {
                                            "requirement_type": "drugs",
                                            "expected_value": [
                                                "afatinib"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "neratinib, afatinib, or other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) at any time previously",
                                        "criterion": "prior treatment with specific drugs",
                                        "requirement": {
                                            "requirement_type": "drugs",
                                            "expected_value": [
                                                "other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI)"
                                            ]
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "neratinib, afatinib, or other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) at any time previously",
                        "criterion": "prior treatment with specific drugs",
                        "requirement": {
                            "requirement_type": "time",
                            "expected_value": "at any time previously"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Other sites of disease assessable by RECIST 1.1 are present Unblinded Phase Crossover Exclusion Criteria - Participants who were randomized to the control arm (placebo + trastuzumab + capecitabine) will be excluded from the crossover to the experimental arm for any of the following reasons.",
                "criterions": [
                    {
                        "exact_snippets": "Other sites of disease assessable by RECIST 1.1 are present",
                        "criterion": "other sites of disease",
                        "requirement": {
                            "requirement_type": "assessability",
                            "expected_value": "RECIST 1.1"
                        }
                    },
                    {
                        "exact_snippets": "Other sites of disease assessable by RECIST 1.1 are present",
                        "criterion": "other sites of disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Participants who were randomized to the control arm (placebo + trastuzumab + capecitabine)",
                        "criterion": "randomization to control arm",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Discontinuation of study treatment due to an adverse event while on the double-blind phase of the study. If the adverse event leading to discontinuation of study treatment has resolved, the patient may be allowed to crossover with approval from the medical monitor.",
                "criterions": [
                    {
                        "exact_snippets": "Discontinuation of study treatment due to an adverse event",
                        "criterion": "discontinuation of study treatment",
                        "requirement": {
                            "requirement_type": "cause",
                            "expected_value": "adverse event"
                        }
                    },
                    {
                        "exact_snippets": "adverse event leading to discontinuation of study treatment has resolved",
                        "criterion": "adverse event resolution",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "resolved"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* History of exposure to the following cumulative doses of anthracyclines:",
                "criterions": [
                    {
                        "exact_snippets": "History of exposure to the following cumulative doses of anthracyclines",
                        "criterion": "exposure to anthracyclines",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Doxorubicin > 360 mg/m^2",
                "criterions": [
                    {
                        "exact_snippets": "Doxorubicin > 360 mg/m^2",
                        "criterion": "Doxorubicin dosage",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 360,
                                "unit": "mg/m^2"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Epirubicin > 720 mg/m^2",
                "criterions": [
                    {
                        "exact_snippets": "Epirubicin > 720 mg/m^2",
                        "criterion": "Epirubicin dosage",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 720,
                                "unit": "mg/m^2"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Mitoxantrone > 120 mg/m^2",
                "criterions": [
                    {
                        "exact_snippets": "Mitoxantrone > 120 mg/m^2",
                        "criterion": "Mitoxantrone dosage",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 120,
                                "unit": "mg/m^2"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Any toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the following exceptions:",
                "criterions": [
                    {
                        "exact_snippets": "Any toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1",
                        "criterion": "toxicity related to prior cancer therapies",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Any toxicity related to prior cancer therapies that has not resolved to \u0010 Grade 1",
                    "criterion": "toxicity related to prior cancer therapies",
                    "requirement": {
                        "requirement_type": "severity",
                        "expected_value": {
                            "operator": "<=",
                            "value": 1,
                            "unit": "Grade"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* CHF (must have been ≤ Grade 1 in severity at the time of occurrence and must have resolved completely)",
                "criterions": [
                    {
                        "exact_snippets": "CHF (must have been ≤ Grade 1 in severity at the time of occurrence",
                        "criterion": "CHF",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "CHF ... must have resolved completely",
                        "criterion": "CHF",
                        "requirement": {
                            "requirement_type": "resolution",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "CHF (must have been \u0010 Grade 1 in severity at the time of occurrence",
                        "criterion": "CHF",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "CHF ... must have resolved completely",
                        "criterion": "CHF",
                        "requirement": {
                            "requirement_type": "resolution",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ]
}