{
    "info": {
        "nct_id": "NCT00146601",
        "official_title": "A Phase II Study of Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer",
        "inclusion_criteria": "* Histologically or cytologically confirmed invasive breast cancer, with stage IV disease.\n* Tumors must be positive for estrogen receptors, progesterone receptors, or both.\n* Patients must be premenopausal.\n* Prior anti-estrogen therapy (with or without ovarian suppression)\n* Platelet count > 100,000/mm3\n* Age older than 18 years\n* ECOG performance status 0-2\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Hormonal treatment for metastatic disease\n* Pregnant or breast-feeding women\n* Postmenopausal\n* Concurrent hormonal therapy or chemotherapy\n* Prior fulvestrant therapy\n* More than three prior chemotherapy regimens for metastatic disease\n* Concurrent, long-term anticoagulation therapy\n* Severe, uncontrolled intercurrent illness\n* History of hypersensitivity to castor oil",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed invasive breast cancer, with stage IV disease.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed invasive breast cancer",
                    "criterion": "invasive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "stage IV disease",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumors must be positive for estrogen receptors, progesterone receptors, or both.",
            "criterions": [
                {
                    "exact_snippets": "Tumors must be positive for estrogen receptors",
                    "criterion": "estrogen receptor status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumors must be positive for ... progesterone receptors",
                    "criterion": "progesterone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be premenopausal.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be premenopausal.",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "premenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior anti-estrogen therapy (with or without ovarian suppression)",
            "criterions": [
                {
                    "exact_snippets": "Prior anti-estrogen therapy",
                    "criterion": "anti-estrogen therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without ovarian suppression",
                    "criterion": "ovarian suppression",
                    "requirements": [
                        {
                            "requirement_type": "concurrent treatment",
                            "expected_value": [
                                "with",
                                "without"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count > 100,000/mm3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count > 100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age older than 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age older than 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "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": "* Hormonal treatment for metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Hormonal treatment for metastatic disease",
                    "criterion": "hormonal treatment",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "metastatic disease"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breast-feeding women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Postmenopausal",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent hormonal therapy or chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Concurrent hormonal therapy",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent ... chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior fulvestrant therapy",
            "criterions": [
                {
                    "exact_snippets": "Prior fulvestrant therapy",
                    "criterion": "fulvestrant therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than three prior chemotherapy regimens for metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "More than three prior chemotherapy regimens for metastatic disease",
                    "criterion": "prior chemotherapy regimens for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent, long-term anticoagulation therapy",
            "criterions": [
                {
                    "exact_snippets": "Concurrent, long-term anticoagulation therapy",
                    "criterion": "anticoagulation therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "long-term"
                        },
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe, uncontrolled intercurrent illness",
            "criterions": [
                {
                    "exact_snippets": "Severe, uncontrolled intercurrent illness",
                    "criterion": "intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of hypersensitivity to castor oil",
            "criterions": [
                {
                    "exact_snippets": "History of hypersensitivity to castor oil",
                    "criterion": "hypersensitivity to castor oil",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}