{
    "info": {
        "nct_id": "NCT00352872",
        "official_title": "A Pilot Study of Cytochrome P450 Pharmacogenetics as a Predictor of Toxicity in Pre-Menopausal Women Receiving Doxorubicin and Cyclophosphamide in Early Breast Cancer",
        "inclusion_criteria": "1. Histologically or cytologically confirmed adenocarcinoma of the breast and appropriate for treatment with Doxorubicin and Cyclophosphamide.\n2. Age > 18 years and <45 years.\n3. ECOG performance status of 0 to 2.\n4. Signed informed consent.\n5. Premenopausal: defined as regularly occurring menstrual cycles or serologic estradiol and FSH levels consistent with premenopausal status.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 45 Years",
        "exclusion_criteria": "1. Patients with distant metastatic disease will be excluded.\n2. Pregnancy or breast feeding (women of childbearing potential must have a negative pregnancy test). Women of childbearing potential must be willing to consent to using effective contraception (oral contraceptive pill or implant or barrier method) while on treatment and for a 30 days after taking the last dose of chemotherapy.\n3. Male sex will be excluded.\n4. Use of agent designed to suppress ovarian function (i.e. LHRH agonist).\n5. Use of exogenous estrogen (hormone replacement therapy) will be prohibited with the exception of topical vaginal preparations (as deemed necessary by the treating physician) and oral contraceptives.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histologically or cytologically confirmed adenocarcinoma of the breast and appropriate for treatment with Doxorubicin and Cyclophosphamide.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed adenocarcinoma of the breast",
                    "criterion": "adenocarcinoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "appropriate for treatment with Doxorubicin and Cyclophosphamide",
                    "criterion": "treatment appropriateness",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "Doxorubicin",
                                "Cyclophosphamide"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Age > 18 years and <45 years.",
            "criterions": [
                {
                    "exact_snippets": "Age > 18 years and <45 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 45,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. ECOG performance status of 0 to 2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0 to 2.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Signed informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Premenopausal: defined as regularly occurring menstrual cycles or serologic estradiol and FSH levels consistent with premenopausal status.",
            "criterions": [
                {
                    "exact_snippets": "regularly occurring menstrual cycles",
                    "criterion": "menstrual cycles",
                    "requirements": [
                        {
                            "requirement_type": "regularity",
                            "expected_value": "regularly occurring"
                        }
                    ]
                },
                {
                    "exact_snippets": "serologic estradiol and FSH levels consistent with premenopausal status",
                    "criterion": "serologic estradiol and FSH levels",
                    "requirements": [
                        {
                            "requirement_type": "consistency with premenopausal status",
                            "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 45 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 45 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 45,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients with distant metastatic disease will be excluded.",
            "criterions": [
                {
                    "exact_snippets": "distant metastatic disease",
                    "criterion": "distant metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Pregnancy or breast feeding (women of childbearing potential must have a negative pregnancy test). Women of childbearing potential must be willing to consent to using effective contraception (oral contraceptive pill or implant or barrier method) while on treatment and for a 30 days after taking the last dose of chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential must have a negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of childbearing potential must be willing to consent to using effective contraception (oral contraceptive pill or implant or barrier method)",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "oral contraceptive pill",
                                "implant",
                                "barrier method"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "while on treatment and for a 30 days after taking the last dose of chemotherapy",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "while on treatment and for 30 days after last dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Male sex will be excluded.",
            "criterions": [
                {
                    "exact_snippets": "Male sex will be excluded.",
                    "criterion": "sex",
                    "requirements": [
                        {
                            "requirement_type": "expected value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Use of agent designed to suppress ovarian function (i.e. LHRH agonist).",
            "criterions": [
                {
                    "exact_snippets": "Use of agent designed to suppress ovarian function (i.e. LHRH agonist)",
                    "criterion": "use of agent designed to suppress ovarian function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Use of exogenous estrogen (hormone replacement therapy) will be prohibited with the exception of topical vaginal preparations (as deemed necessary by the treating physician) and oral contraceptives.",
            "criterions": [
                {
                    "exact_snippets": "Use of exogenous estrogen (hormone replacement therapy) will be prohibited",
                    "criterion": "use of exogenous estrogen",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of topical vaginal preparations",
                    "criterion": "use of topical vaginal estrogen preparations",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of ... oral contraceptives",
                    "criterion": "use of oral contraceptives",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}