{
    "info": {
        "nct_id": "NCT00212082",
        "official_title": "Gene Expression Profiles of Breast Cancer Treated With Sequential Adriamycin and Docetaxel in Relation to Tumor Responses",
        "inclusion_criteria": "* Female, age > 18 years.\n* Histologic or cytologic diagnosis of breast carcinoma.\n* Stage II to IV breast cancer with measurable primary breast tumor, defined as palpable tumor with both diameters 2.0cm or greater as measured by caliper.\n* Patients must not have received prior chemotherapy or hormonal therapy for the treatment of breast cancer.\n* Karnofsky performance status of 70 or higher.\n* Estimated life expectancy of at least 12 weeks.\n* Adequate organ function including the following:\n\n  - Bone marrow: White blood cells (WBC) >= 3.5 x 109/L Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 x 109/L Platelets >= 100 x 109/L Haemoglobin >= 9g/dL\n\n  - Hepatic: Bilirubin <= 1.5 x upper limit of normal (ULN), ALT or AST <= 2.5x ULN, (or <=5 X with liver metastases) Alkaline phosphatase <= 2.5x ULN.\n\n  - Renal: creatinine <= 1.5x ULN\n  * Cardiac:\n  * Adequate cardiac function\n* Signed informed consent from patient or legal representative.\n* Patients with reproductive potential must use an approved contraceptive method if appropriate (eg, intrauterine device, birth control pills, or barrier device) during and for three months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior treatment for locally advanced or metastatic breast cancer.\n* Treatment within the last 30 days with any investigational drug.\n* Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.\n* Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.\n* Pregnancy.\n* Breast feeding.\n* Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.\n* Poorly controlled diabetes mellitus.\n* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.\n* Symptomatic brain metastasis.\n* History of significant neurological or mental disorder, including seizures or dementia.\n* Peripheral neuropathy of >= CTC grade 2.\n* History of hypersensitivity to drugs formulated in Tween 80, the vehicle used for commercial docetaxel formulations.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Female, age > 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "age > 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologic or cytologic diagnosis of breast carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Histologic or cytologic diagnosis of breast carcinoma",
                    "criterion": "breast carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis method",
                            "expected_value": [
                                "histologic",
                                "cytologic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage II to IV breast cancer with measurable primary breast tumor, defined as palpable tumor with both diameters 2.0cm or greater as measured by caliper.",
            "criterions": [
                {
                    "exact_snippets": "Stage II to IV breast cancer",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable primary breast tumor",
                    "criterion": "primary breast tumor measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "palpable tumor",
                    "criterion": "tumor palpability",
                    "requirements": [
                        {
                            "requirement_type": "palpability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "both diameters 2.0cm or greater as measured by caliper",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2.0,
                                        "unit": "cm"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must not have received prior chemotherapy or hormonal therapy for the treatment of breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "Patients must not have received prior chemotherapy ... for the treatment of breast cancer.",
                    "criterion": "prior chemotherapy for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must not have received prior ... hormonal therapy for the treatment of breast cancer.",
                    "criterion": "prior hormonal therapy for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky performance status of 70 or higher.",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky performance status of 70 or higher",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Estimated life expectancy of at least 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Estimated life expectancy of at least 12 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function including the following:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "- Bone marrow: White blood cells (WBC) >= 3.5 x 109/L Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 x 109/L Platelets >= 100 x 109/L Haemoglobin >= 9g/dL",
            "criterions": [
                {
                    "exact_snippets": "White blood cells (WBC) >= 3.5 x 109/L",
                    "criterion": "white blood cells (WBC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.5,
                                "unit": "x 109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 x 109/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets >= 100 x 109/L",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Haemoglobin >= 9g/dL",
                    "criterion": "haemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "- Hepatic: Bilirubin <= 1.5 x upper limit of normal (ULN), ALT or AST <= 2.5x ULN, (or <=5 X with liver metastases) Alkaline phosphatase <= 2.5x ULN.",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin <= 1.5 x upper limit of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT or AST <= 2.5x ULN",
                    "criterion": "ALT or AST level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT or AST ... (or <=5 X with liver metastases)",
                    "criterion": "ALT or AST level with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alkaline phosphatase <= 2.5x ULN",
                    "criterion": "alkaline phosphatase level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "- Renal: creatinine <= 1.5x ULN",
            "criterions": [
                {
                    "exact_snippets": "Renal: creatinine <= 1.5x ULN",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiac:",
            "criterions": [
                {
                    "exact_snippets": "Cardiac",
                    "criterion": "cardiac condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate cardiac function",
            "criterions": [
                {
                    "exact_snippets": "Adequate cardiac function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent from patient or legal representative.",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent from patient or legal representative.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with reproductive potential must use an approved contraceptive method if appropriate (eg, intrauterine device, birth control pills, or barrier device) during and for three months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Patients with reproductive potential must use an approved contraceptive method",
                    "criterion": "reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "contraceptive use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "pregnancy test",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior treatment for locally advanced or metastatic breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment for locally advanced or metastatic breast cancer.",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "locally advanced or metastatic breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment within the last 30 days with any investigational drug.",
            "criterions": [
                {
                    "exact_snippets": "Treatment within the last 30 days with any investigational drug.",
                    "criterion": "treatment with investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy",
                    "criterion": "concurrent cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent administration of any other tumor therapy, including ... hormonal therapy",
                    "criterion": "concurrent hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent administration of any other tumor therapy, including ... immunotherapy",
                    "criterion": "concurrent immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.",
            "criterions": [
                {
                    "exact_snippets": "Active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Breast feeding.",
            "criterions": [
                {
                    "exact_snippets": "Breast feeding.",
                    "criterion": "breast feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.",
            "criterions": [
                {
                    "exact_snippets": "Serious concomitant disorders",
                    "criterion": "serious concomitant disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Poorly controlled diabetes mellitus.",
            "criterions": [
                {
                    "exact_snippets": "Poorly controlled diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Second primary malignancy that is clinically detectable",
                    "criterion": "second primary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic brain metastasis.",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of significant neurological or mental disorder, including seizures or dementia.",
            "criterions": [
                {
                    "exact_snippets": "History of significant neurological or mental disorder",
                    "criterion": "neurological or mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "significance",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "seizures",
                    "criterion": "seizures",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "dementia",
                    "criterion": "dementia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Peripheral neuropathy of >= CTC grade 2.",
            "criterions": [
                {
                    "exact_snippets": "Peripheral neuropathy of >= CTC grade 2.",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTC grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of hypersensitivity to drugs formulated in Tween 80, the vehicle used for commercial docetaxel formulations.",
            "criterions": [
                {
                    "exact_snippets": "History of hypersensitivity to drugs formulated in Tween 80",
                    "criterion": "hypersensitivity to drugs formulated in Tween 80",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}