{
    "info": {
        "nct_id": "NCT00258960",
        "official_title": "Phase IV/II Trial With the Combination of Pegylated Liposomal Doxorubicin (Caelyx), Cyclophosphamide and Trastuzumab in Patients With Metastatic Breast Cancer With Overexpression of Human Epidermal Growth Factor Receptor 2 (HER2)/Neu",
        "inclusion_criteria": "* Patients must sign an informed consent before of specific procedures of clinical trial.\n* Patients with histologically confirmed breast cancer and overexpression of Her2neu.\n* Age> 18 years.\n* Eastern Cooperative Oncology Group (ECOG) equal or < 2.\n* Patients have not been treated previously with chemotherapy for metastatic disease.\n* Patients must have at least one measurable lesion according to RECIST criteria.\n* Patients should have an adequate organ function to tolerate chemotherapy.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Patients with hypersensitivity reactions to any of the medications of the clinical trial.\n* Patients who are pregnant or lactating are not eligible.\n* Hepatic disease.\n* Not controlled active infection\n* Symptomatic metastatic brain cancer\n* Previous adjuvant treatment with anthracyclines with a total accumulated dose > 300 mg/m2 (Doxorubicin) or > 600 mg/m2 (Epirubicin)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must sign an informed consent before of specific procedures of clinical trial.",
            "criterions": [
                {
                    "exact_snippets": "Patients must sign an informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with histologically confirmed breast cancer and overexpression of Her2neu.",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "overexpression of Her2neu",
                    "criterion": "Her2neu",
                    "requirements": [
                        {
                            "requirement_type": "expression level",
                            "expected_value": "overexpression"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age> 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age> 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) equal or < 2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) equal or < 2",
                    "criterion": "Eastern Cooperative Oncology Group (ECOG)",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients have not been treated previously with chemotherapy for metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "Patients have not been treated previously with chemotherapy for metastatic disease.",
                    "criterion": "previous chemotherapy treatment for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have at least one measurable lesion according to RECIST criteria.",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable lesion according to RECIST criteria",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients should have an adequate organ function to tolerate chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tolerate chemotherapy",
                    "criterion": "chemotherapy tolerance",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients with hypersensitivity reactions to any of the medications of the clinical trial.",
            "criterions": [
                {
                    "exact_snippets": "hypersensitivity reactions to any of the medications of the clinical trial",
                    "criterion": "hypersensitivity reactions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are pregnant or lactating are not eligible.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hepatic disease.",
            "criterions": [
                {
                    "exact_snippets": "Hepatic disease",
                    "criterion": "hepatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not controlled active infection",
            "criterions": [
                {
                    "exact_snippets": "Not controlled active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic metastatic brain cancer",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic metastatic brain cancer",
                    "criterion": "metastatic brain cancer",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Previous adjuvant treatment with anthracyclines with a total accumulated dose > 300 mg/m2 (Doxorubicin) or > 600 mg/m2 (Epirubicin)",
            "criterions": [
                {
                    "exact_snippets": "Previous adjuvant treatment with anthracyclines",
                    "criterion": "previous adjuvant treatment with anthracyclines",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "total accumulated dose > 300 mg/m2 (Doxorubicin)",
                    "criterion": "total accumulated dose of Doxorubicin",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 300,
                                "unit": "mg/m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total accumulated dose > 600 mg/m2 (Epirubicin)",
                    "criterion": "total accumulated dose of Epirubicin",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 600,
                                "unit": "mg/m2"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}