{
    "info": {
        "nct_id": "NCT01477060",
        "official_title": "Modulation of Response to Hormonal Therapy With Lapatinib and/or Metformin in Patients With HER2-negative, ER and/or PgR Positive Metastatic Brest Cancer With Progressive Disease After First-line Therapy",
        "inclusion_criteria": "1. Female patients with a histologically or cytologically confirmed adenocarcinoma of the breast progressing from prior hormonal therapy\n2. Receptor positive disease (ER+ and/or PgR+)\n3. HER2 negative\n4. Pre- and post-menopausal status\n5. Documented disease progression after first-line hormone therapy\n6. Age ≥18 years.\n7. Measurable or evaluable metastatic disease\n8. Life expectancy > 3 months\n9. ECOG Performance Status < 1\n10. Adequate bone marrow, liver, and renal function as assessed by the following parameters:\n\n    * Hemoglobin > 9.0 g/dl\n    * Leucocytes count ≥ 3,000/mL\n    * Absolute neutrophil count (ANC) ≥ 1.500/mL\n    * Platelet count ≥ 100,000/mL\n    * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)\n    * Albumine and total bilirubin ≤ 1.5 x ULN\n    * Prothrombin Time (PT) < 70 %\n    * Serum creatinine < 1.4 mg/ml, creatinine clearance > 70 ml/min\n11. Normal Respiratory Function and Saturation level ≥ 90%\n12. New York Hearth Association (NYHA) Classification ≤ 2 and baseline left ventricular ejection fraction (LVEF)≥ 50%\n13. Patients must be willing and able to sign a written informed consent.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Previous or concomitant treatment with lapatinib and/or metformin\n2. More than one line of prior hormone therapy for metastatic breast cancer.\n3. More than two lines of prior chemotherapy for metastatic breast cancer\n4. Unique location of disease local-regionally treated (surgery, radiotherapy , other)\n5. Disease progression not documented or less than 30%\n6. Metastatic disease defined as aggressive at investigator's judgement (e.g. visceral disease more than >1/3 of involved parenchyma, symptomatic disease requiring intensive supportive measures or therapies not allowed by protocol)\n7. Patients with brain metastasis\n8. Osteosclerotic bone metastasis as unique disease site\n9. Pathological tumor markers as unique sign of progressive disease\n10. Concomitant treatment with any other anticancer drugs (biphosphonates are permitted)\n11. Serious, not solved or unstable toxicity from previous treatment\n12. Diabetes mellitus Type I and Type II\n13. Renal insufficiency (creatinine ≥ 1.4 mg/ml)\n14. Malabsorption syndrome or diseases that significantly may alter gastroenteric functions\n15. Other serious illness or medical conditions judged by the investigator to be clinically significant that may adversely affect patient's participation in the trial or interfere with safety profile\n16. Active clinically significant or uncontrolled infections (bacterial or viral)\n17. Known history of unstable angina (angina symptoms at rest), cardiac ventricular arrhythmias clinically significant, myocardial infarction, stroke or congestive heart failure within 12 months prior to randomization\n18. History of lactic acidosis\n19. Evidence or symptoms of hepatic insufficiency\n20. Chronic alcoholism\n21. Concomitant treatment with amiodarone or any other agent that could interfere with study drugs\n22. Known or suspected hypersensitivity or allergy to lapatinib, metformin or used excipients\n23. Women who are pregnant or lactating\n24. History of previous cancer, unless at low risk of relapse per investigator's judgement",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Female patients with a histologically or cytologically confirmed adenocarcinoma of the breast progressing from prior hormonal therapy",
                "criterions": [
                    {
                        "exact_snippets": "Female patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "histologically or cytologically confirmed adenocarcinoma of the breast",
                        "criterion": "adenocarcinoma of the breast",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically or cytologically"
                        }
                    },
                    {
                        "exact_snippets": "progressing from prior hormonal therapy",
                        "criterion": "progression from prior hormonal therapy",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Female patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "histologically or cytologically confirmed adenocarcinoma of the breast",
                        "criterion": "adenocarcinoma of the breast",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically or cytologically"
                        }
                    },
                    {
                        "exact_snippets": "progressing from prior hormonal therapy",
                        "criterion": "progression from prior hormonal therapy",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. HER2 negative",
                "criterions": [
                    {
                        "exact_snippets": "HER2 negative",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "HER2 negative",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Pre- and post-menopausal status",
                "criterions": [
                    {
                        "exact_snippets": "Pre- and post-menopausal status",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "pre-menopausal",
                                "post-menopausal"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Pre- and post-menopausal status",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "pre-menopausal",
                                "post-menopausal"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Documented disease progression after first-line hormone therapy",
                "criterions": [
                    {
                        "exact_snippets": "Documented disease progression after first-line hormone therapy",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Documented disease progression after first-line hormone therapy",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": "after first-line hormone therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Documented disease progression after first-line hormone therapy",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Documented disease progression after first-line hormone therapy",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": "after first-line hormone therapy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Age ≥18 years.",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age ≥18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Measurable or evaluable metastatic disease",
                "criterions": [
                    {
                        "exact_snippets": "Measurable or evaluable metastatic disease",
                        "criterion": "metastatic disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Measurable or evaluable metastatic disease",
                        "criterion": "metastatic disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Life expectancy > 3 months",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy > 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy > 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. ECOG Performance Status < 1",
                "criterions": [
                    {
                        "exact_snippets": "ECOG Performance Status < 1",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG Performance Status < 1",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Adequate bone marrow, liver, and renal function as assessed by the following parameters:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate bone marrow ... assessed by the following parameters:",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... liver ... assessed by the following parameters:",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... renal function ... assessed by the following parameters:",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate bone marrow ... assessed by the following parameters:",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... liver ... assessed by the following parameters:",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... renal function ... assessed by the following parameters:",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hemoglobin > 9.0 g/dl",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin > 9.0 g/dl",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9.0,
                                "unit": "g/dl"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hemoglobin > 9.0 g/dl",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9.0,
                                "unit": "g/dl"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Leucocytes count ≥ 3,000/mL",
                "criterions": [
                    {
                        "exact_snippets": "Leucocytes count ≥ 3,000/mL",
                        "criterion": "leucocytes count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Leucocytes count ≥ 3,000/mL",
                        "criterion": "leucocytes count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count (ANC) ≥ 1.500/mL",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.500/mL",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x10^3/mL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.500/mL",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x10^3/mL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count ≥ 100,000/mL",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count ≥ 100,000/mL",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelet count ≥ 100,000/mL",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)",
                "criterions": [
                    {
                        "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)",
                        "criterion": "Alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)",
                        "criterion": "Alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level with liver involvement",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level with liver involvement",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)",
                                        "criterion": "Alanine aminotransferase (ALT)",
                                        "requirement": {
                                            "requirement_type": "level",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 2.5,
                                                        "unit": "x ULN"
                                                    }
                                                ]
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)",
                                        "criterion": "aspartate aminotransferase (AST)",
                                        "requirement": {
                                            "requirement_type": "level",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 2.5,
                                                        "unit": "x ULN"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)",
                                        "criterion": "Alanine aminotransferase (ALT)",
                                        "requirement": {
                                            "requirement_type": "level with liver involvement",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 5,
                                                        "unit": "x ULN"
                                                    }
                                                ]
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)",
                                        "criterion": "aspartate aminotransferase (AST)",
                                        "requirement": {
                                            "requirement_type": "level with liver involvement",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 5,
                                                        "unit": "x ULN"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Normal Respiratory Function and Saturation level ≥ 90%",
                "criterions": [
                    {
                        "exact_snippets": "Normal Respiratory Function",
                        "criterion": "respiratory function",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "Saturation level ≥ 90%",
                        "criterion": "saturation level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Normal Respiratory Function",
                        "criterion": "respiratory function",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "Saturation level ≥ 90%",
                        "criterion": "saturation level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. Patients must be willing and able to sign a written informed consent.",
                "criterions": [
                    {
                        "exact_snippets": "willing and able to sign a written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing and able to sign a written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "willing and able to sign a written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing and able to sign a written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "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": [
        {
            "identified_line": {
                "line": "1. Previous or concomitant treatment with lapatinib and/or metformin",
                "criterions": [
                    {
                        "exact_snippets": "Previous or concomitant treatment with lapatinib",
                        "criterion": "treatment with lapatinib",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Previous or concomitant treatment with ... metformin",
                        "criterion": "treatment with metformin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
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                    {
                        "or_criteria": [
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                                "and_criteria": [
                                    {
                                        "exact_snippets": "Previous or concomitant treatment with lapatinib",
                                        "criterion": "treatment with lapatinib",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Previous or concomitant treatment with ... metformin",
                                        "criterion": "treatment with metformin",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Previous or concomitant treatment with lapatinib",
                                "criterion": "treatment with lapatinib",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Previous or concomitant treatment with ... metformin",
                        "criterion": "treatment with metformin",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. More than one line of prior hormone therapy for metastatic breast cancer.",
                "criterions": [
                    {
                        "exact_snippets": "More than one line of prior hormone therapy for metastatic breast cancer.",
                        "criterion": "prior hormone therapy",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "line"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "More than one line of prior hormone therapy for metastatic breast cancer.",
                        "criterion": "prior hormone therapy",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "line"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. More than two lines of prior chemotherapy for metastatic breast cancer",
                "criterions": [
                    {
                        "exact_snippets": "More than two lines of prior chemotherapy for metastatic breast cancer",
                        "criterion": "prior chemotherapy for metastatic breast cancer",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "More than two lines of prior chemotherapy for metastatic breast cancer",
                    "criterion": "prior chemotherapy for metastatic breast cancer",
                    "requirement": {
                        "requirement_type": "quantity",
                        "expected_value": {
                            "operator": ">",
                            "value": 2,
                            "unit": "lines"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Unique location of disease local-regionally treated (surgery, radiotherapy , other)",
                "criterions": [
                    {
                        "exact_snippets": "Unique location of disease",
                        "criterion": "location of disease",
                        "requirement": {
                            "requirement_type": "uniqueness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "local-regionally treated (surgery, radiotherapy , other)",
                        "criterion": "treatment type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "surgery",
                                "radiotherapy",
                                "other"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Unique location of disease",
                            "criterion": "location of disease",
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                                "requirement_type": "uniqueness",
                                "expected_value": true
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "local-regionally treated (surgery, radiotherapy , other)",
                            "criterion": "treatment type",
                            "requirement": {
                                "requirement_type": "type",
                                "expected_value": [
                                    "surgery",
                                    "radiotherapy",
                                    "other"
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Disease progression not documented or less than 30%",
                "criterions": [
                    {
                        "exact_snippets": "Disease progression not documented",
                        "criterion": "disease progression documentation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Disease progression ... less than 30%",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Disease progression not documented",
                        "criterion": "disease progression documentation",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Disease progression ... less than 30%",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Metastatic disease defined as aggressive at investigator's judgement (e.g. visceral disease more than >1/3 of involved parenchyma, symptomatic disease requiring intensive supportive measures or therapies not allowed by protocol)",
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                    {
                        "exact_snippets": "Metastatic disease defined as aggressive at investigator's judgement",
                        "criterion": "metastatic disease",
                        "requirement": {
                            "requirement_type": "aggressiveness",
                            "expected_value": "investigator's judgement"
                        }
                    },
                    {
                        "exact_snippets": "visceral disease more than >1/3 of involved parenchyma",
                        "criterion": "visceral disease",
                        "requirement": {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "3 of involved parenchyma"
                            }
                        }
                    },
                    {
                        "exact_snippets": "symptomatic disease requiring intensive supportive measures or therapies not allowed by protocol",
                        "criterion": "symptomatic disease",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": "intensive supportive measures or therapies not allowed by protocol"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "condition": {
                            "exact_snippets": "Metastatic disease defined as aggressive at investigator's judgement",
                            "criterion": "metastatic disease",
                            "requirement": {
                                "requirement_type": "aggressiveness",
                                "expected_value": "investigator's judgement"
                            }
                        },
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                                {
                                    "exact_snippets": "visceral disease more than >1/3 of involved parenchyma",
                                    "criterion": "visceral disease",
                                    "requirement": {
                                        "requirement_type": "extent",
                                        "expected_value": {
                                            "operator": ">",
                                            "value": 1,
                                            "unit": "3 of involved parenchyma"
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "symptomatic disease requiring intensive supportive measures or therapies not allowed by protocol",
                                    "criterion": "symptomatic disease",
                                    "requirement": {
                                        "requirement_type": "treatment requirement",
                                        "expected_value": "intensive supportive measures or therapies not allowed by protocol"
                                    }
                                }
                            ]
                        },
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Patients with brain metastasis",
                "criterions": [
                    {
                        "exact_snippets": "Patients with brain metastasis",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients with brain metastasis",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Osteosclerotic bone metastasis as unique disease site",
                "criterions": [
                    {
                        "exact_snippets": "Osteosclerotic bone metastasis as unique disease site",
                        "criterion": "osteosclerotic bone metastasis",
                        "requirement": {
                            "requirement_type": "uniqueness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Osteosclerotic bone metastasis as unique disease site",
                    "criterion": "osteosclerotic bone metastasis",
                    "requirement": {
                        "requirement_type": "uniqueness",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "9. Pathological tumor markers as unique sign of progressive disease",
                "criterions": [
                    {
                        "exact_snippets": "Pathological tumor markers",
                        "criterion": "tumor markers",
                        "requirement": {
                            "requirement_type": "pathological",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unique sign of progressive disease",
                        "criterion": "progressive disease",
                        "requirement": {
                            "requirement_type": "sign",
                            "expected_value": "unique"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Pathological tumor markers",
                                "criterion": "tumor markers",
                                "requirement": {
                                    "requirement_type": "pathological",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "unique sign of progressive disease",
                                "criterion": "progressive disease",
                                "requirement": {
                                    "requirement_type": "sign",
                                    "expected_value": "unique"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Serious, not solved or unstable toxicity from previous treatment",
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                    {
                        "exact_snippets": "Serious, not solved or unstable toxicity from previous treatment",
                        "criterion": "toxicity from previous treatment",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "Serious, not solved or unstable toxicity from previous treatment",
                        "criterion": "toxicity from previous treatment",
                        "requirement": {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Serious, not solved or unstable toxicity from previous treatment",
                        "criterion": "toxicity from previous treatment",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    }
                ]
            },
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                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Serious, not solved or unstable toxicity from previous treatment",
                                "criterion": "toxicity from previous treatment",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "serious"
                                }
                            },
                            {
                                "exact_snippets": "Serious, not solved or unstable toxicity from previous treatment",
                                "criterion": "toxicity from previous treatment",
                                "requirement": {
                                    "requirement_type": "resolution",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Serious, not solved or unstable toxicity from previous treatment",
                        "criterion": "toxicity from previous treatment",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Diabetes mellitus Type I and Type II",
                "criterions": [
                    {
                        "exact_snippets": "Diabetes mellitus Type I",
                        "criterion": "Diabetes mellitus Type I",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Diabetes mellitus ... Type II",
                        "criterion": "Diabetes mellitus Type II",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Diabetes mellitus Type I",
                        "criterion": "Diabetes mellitus Type I",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Diabetes mellitus ... Type II",
                        "criterion": "Diabetes mellitus Type II",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. Renal insufficiency (creatinine ≥ 1.4 mg/ml)",
                "criterions": [
                    {
                        "exact_snippets": "Renal insufficiency (creatinine ≥ 1.4 mg/ml)",
                        "criterion": "renal insufficiency",
                        "requirement": {
                            "requirement_type": "creatinine level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.4,
                                "unit": "mg/ml"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Renal insufficiency (creatinine ≥ 1.4 mg/ml)",
                        "criterion": "renal insufficiency",
                        "requirement": {
                            "requirement_type": "creatinine level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.4,
                                "unit": "mg/ml"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "14. Malabsorption syndrome or diseases that significantly may alter gastroenteric functions",
                "criterions": [
                    {
                        "exact_snippets": "Malabsorption syndrome",
                        "criterion": "malabsorption syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "diseases that significantly may alter gastroenteric functions",
                        "criterion": "diseases altering gastroenteric functions",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Malabsorption syndrome",
                        "criterion": "malabsorption syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "diseases that significantly may alter gastroenteric functions",
                        "criterion": "diseases altering gastroenteric functions",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "15. Other serious illness or medical conditions judged by the investigator to be clinically significant that may adversely affect patient's participation in the trial or interfere with safety profile",
                "criterions": [
                    {
                        "exact_snippets": "Other serious illness or medical conditions",
                        "criterion": "serious illness or medical conditions",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "judged by the investigator to be clinically significant",
                        "criterion": "clinical significance",
                        "requirement": {
                            "requirement_type": "judgment",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "may adversely affect patient's participation in the trial",
                        "criterion": "adverse effect on trial participation",
                        "requirement": {
                            "requirement_type": "potential",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "interfere with safety profile",
                        "criterion": "interference with safety profile",
                        "requirement": {
                            "requirement_type": "potential",
                            "expected_value": true
                        }
                    }
                ]
            },
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                        "and_criteria": [
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                                "and_criteria": [
                                    {
                                        "exact_snippets": "Other serious illness or medical conditions",
                                        "criterion": "serious illness or medical conditions",
                                        "requirement": {
                                            "requirement_type": "severity",
                                            "expected_value": "serious"
                                        }
                                    },
                                    {
                                        "exact_snippets": "judged by the investigator to be clinically significant",
                                        "criterion": "clinical significance",
                                        "requirement": {
                                            "requirement_type": "judgment",
                                            "expected_value": "clinically significant"
                                        }
                                    }
                                ]
                            },
                            {
                                "or_criteria": [
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                                        "exact_snippets": "may adversely affect patient's participation in the trial",
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                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "interfere with safety profile",
                                        "criterion": "interference with safety profile",
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                                            "requirement_type": "potential",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
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        },
        {
            "identified_line": {
                "line": "18. History of lactic acidosis",
                "criterions": [
                    {
                        "exact_snippets": "History of lactic acidosis",
                        "criterion": "lactic acidosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "History of lactic acidosis",
                    "criterion": "lactic acidosis",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "19. Evidence or symptoms of hepatic insufficiency",
                "criterions": [
                    {
                        "exact_snippets": "Evidence or symptoms of hepatic insufficiency",
                        "criterion": "hepatic insufficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Evidence or symptoms of hepatic insufficiency",
                        "criterion": "hepatic insufficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "20. Chronic alcoholism",
                "criterions": [
                    {
                        "exact_snippets": "Chronic alcoholism",
                        "criterion": "chronic alcoholism",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Chronic alcoholism",
                    "criterion": "chronic alcoholism",
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                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "21. Concomitant treatment with amiodarone or any other agent that could interfere with study drugs",
                "criterions": [
                    {
                        "exact_snippets": "Concomitant treatment with amiodarone",
                        "criterion": "concomitant treatment with amiodarone",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Concomitant treatment with ... any other agent that could interfere with study drugs",
                        "criterion": "concomitant treatment with interfering agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Concomitant treatment with amiodarone",
                        "criterion": "concomitant treatment with amiodarone",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Concomitant treatment with ... any other agent that could interfere with study drugs",
                        "criterion": "concomitant treatment with interfering agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "22. Known or suspected hypersensitivity or allergy to lapatinib, metformin or used excipients",
                "criterions": [
                    {
                        "exact_snippets": "Known or suspected hypersensitivity or allergy to lapatinib",
                        "criterion": "hypersensitivity or allergy to lapatinib",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Known or suspected hypersensitivity or allergy to ... metformin",
                        "criterion": "hypersensitivity or allergy to metformin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Known or suspected hypersensitivity or allergy to ... used excipients",
                        "criterion": "hypersensitivity or allergy to used excipients",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "and_criteria": [
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                                "exact_snippets": "Known or suspected hypersensitivity or allergy to lapatinib",
                                "criterion": "hypersensitivity or allergy to lapatinib",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Known or suspected hypersensitivity or allergy to ... metformin",
                                "criterion": "hypersensitivity or allergy to metformin",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Known or suspected hypersensitivity or allergy to ... used excipients",
                                "criterion": "hypersensitivity or allergy to used excipients",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "23. Women who are pregnant or lactating",
                "criterions": [
                    {
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}