{
    "info": {
        "nct_id": "NCT00002920",
        "official_title": "A Randomized Comparison Of Medroxyprogesterone Acetate (MA) And Observation For Prevention Of Endometrial Pathology In Postmenopausal Breast Cancer Patients Treated With Tamoxifen, Phase III",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* One of the following histologically proven diagnoses:\n\n  * Primary invasive adenocarcinoma of the unilateral or bilateral breast\n\n    * Stage I, IIA, or IIB (T1-3, N0-1, M0)\n    * No recurrent invasive breast cancer\n  * Ductal carcinoma in situ (DCIS)\n  * Lobular carcinoma in situ (LCIS) with microinvasion\n  * Paget's disease of the nipple\n* No sarcoma, lymphoma, or apocrine, adenocystic, or squamous cell cancer of the breast\n* Currently free of breast cancer (no evidence of disease)\n\n  * No evidence of distant disease on chest x-ray or chest CT scan and mammogram of the opposite breast within the past year\n* Prior definitive local treatment of primary lesion (mastectomy or breast-sparing procedure with radiotherapy) and either axillary node or sentinel node biopsy\n\n  * Surgical margins clear of both infiltrating carcinoma (any type) and DCIS\n\n    * No gross or microscopically positive margins except:\n\n      * Invasive cancer or DCIS at the focal margin treated with definitive radiotherapy\n      * Gross or LCIS at the final margin\n  * Biopsy requirement waived for DCIS or LCIS with minimal microinvasion\n* Patients with breast-sparing procedure must have received or be planning to receive radiotherapy at start of tamoxifen treatment\n* No endometrial simple or cystic hyperplasia, proliferative changes, complex (adenomatous) or atypical hyperplasia, or carcinoma\n* Patients must be planning one of the following:\n\n  * Starting adjuvant tamoxifen for five years OR\n  * Started tamoxifen within 28 days prior to study and planning to receive adjuvant tamoxifen for five years\n* Hormone receptor status:\n\n  * Candidate for adjuvant tamoxifen therapy\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Adult\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Postmenopausal defined as:\n\n  * At least 1 year since last menstrual period\n  * At least 2 months since bilateral oophorectomy prior to breast cancer diagnosis\n  * 4-12 months since last menstrual period and FSH elevated to postmenopausal range\n  * Postmenopausal estrogen therapy and 55 years of age or older\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* Fertile patients must use effective contraception during and for at least 2 months after study\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer currently in complete remission\n* No concurrent nonmalignant-related illness that would preclude study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Adjuvant chemotherapy allowed\n* No concurrent chemotherapy\n\nEndocrine therapy:\n\n* See Disease Characteristics\n* No prior hormonal treatment for breast cancer (except tamoxifen)\n* No concurrent postmenopausal estrogen therapy\n\nRadiotherapy:\n\n* See Disease Characteristics\n\nSurgery:\n\n* See Disease Characteristics\n* No prior or concurrent hysterectomy\n\nOther:\n\n* No prior or current participation in an adjuvant intergroup trial"
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "* One of the following histologically proven diagnoses:",
            "criterions": [
                {
                    "exact_snippets": "One of the following histologically proven diagnoses",
                    "criterion": "histologically proven diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Primary invasive adenocarcinoma of the unilateral or bilateral breast",
            "criterions": [
                {
                    "exact_snippets": "Primary invasive adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "primary"
                        },
                        {
                            "requirement_type": "invasiveness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unilateral or bilateral breast",
                    "criterion": "breast involvement",
                    "requirements": [
                        {
                            "requirement_type": "laterality",
                            "expected_value": [
                                "unilateral",
                                "bilateral"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage I, IIA, or IIB (T1-3, N0-1, M0)",
            "criterions": [
                {
                    "exact_snippets": "Stage I, IIA, or IIB",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "IIA",
                                "IIB"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "T1-3",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "T category",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "N0-1",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "N category",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "M category",
                            "expected_value": "0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No recurrent invasive breast cancer",
            "criterions": [
                {
                    "exact_snippets": "No recurrent invasive breast cancer",
                    "criterion": "recurrent invasive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ductal carcinoma in situ (DCIS)",
            "criterions": [
                {
                    "exact_snippets": "Ductal carcinoma in situ (DCIS)",
                    "criterion": "ductal carcinoma in situ (DCIS)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lobular carcinoma in situ (LCIS) with microinvasion",
            "criterions": [
                {
                    "exact_snippets": "Lobular carcinoma in situ (LCIS)",
                    "criterion": "lobular carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "microinvasion",
                    "criterion": "microinvasion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Paget's disease of the nipple",
            "criterions": [
                {
                    "exact_snippets": "Paget's disease of the nipple",
                    "criterion": "Paget's disease of the nipple",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No sarcoma, lymphoma, or apocrine, adenocystic, or squamous cell cancer of the breast",
            "criterions": [
                {
                    "exact_snippets": "No sarcoma ... of the breast",
                    "criterion": "sarcoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... lymphoma ... of the breast",
                    "criterion": "lymphoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... apocrine ... cancer of the breast",
                    "criterion": "apocrine cancer of the breast",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... adenocystic ... cancer of the breast",
                    "criterion": "adenocystic cancer of the breast",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... squamous cell cancer of the breast",
                    "criterion": "squamous cell cancer of the breast",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently free of breast cancer (no evidence of disease)",
            "criterions": [
                {
                    "exact_snippets": "Currently free of breast cancer (no evidence of disease)",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of distant disease on chest x-ray or chest CT scan and mammogram of the opposite breast within the past year",
            "criterions": [
                {
                    "exact_snippets": "No evidence of distant disease on chest x-ray or chest CT scan",
                    "criterion": "distant disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "mammogram of the opposite breast within the past year",
                    "criterion": "mammogram of the opposite breast",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past year"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior definitive local treatment of primary lesion (mastectomy or breast-sparing procedure with radiotherapy) and either axillary node or sentinel node biopsy",
            "criterions": [
                {
                    "exact_snippets": "Prior definitive local treatment of primary lesion (mastectomy or breast-sparing procedure with radiotherapy)",
                    "criterion": "local treatment of primary lesion",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "mastectomy",
                                "breast-sparing procedure with radiotherapy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "axillary node or sentinel node biopsy",
                    "criterion": "node biopsy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "axillary",
                                "sentinel"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Surgical margins clear of both infiltrating carcinoma (any type) and DCIS",
            "criterions": [
                {
                    "exact_snippets": "Surgical margins clear of both infiltrating carcinoma",
                    "criterion": "surgical margins",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Surgical margins clear of ... DCIS",
                    "criterion": "surgical margins",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No gross or microscopically positive margins except:",
            "criterions": [
                {
                    "exact_snippets": "No gross or microscopically positive margins",
                    "criterion": "surgical margins",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Invasive cancer or DCIS at the focal margin treated with definitive radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Invasive cancer or DCIS at the focal margin",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "Invasive cancer",
                                "DCIS"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with definitive radiotherapy",
                    "criterion": "treatment",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "definitive radiotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gross or LCIS at the final margin",
            "criterions": [
                {
                    "exact_snippets": "Gross or LCIS at the final margin",
                    "criterion": "gross involvement at the final margin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Gross or LCIS at the final margin",
                    "criterion": "LCIS at the final margin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biopsy requirement waived for DCIS or LCIS with minimal microinvasion",
            "criterions": [
                {
                    "exact_snippets": "Biopsy requirement waived for DCIS or LCIS with minimal microinvasion",
                    "criterion": "biopsy requirement",
                    "requirements": [
                        {
                            "requirement_type": "waived",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": [
                                "DCIS",
                                "LCIS with minimal microinvasion"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with breast-sparing procedure must have received or be planning to receive radiotherapy at start of tamoxifen treatment",
            "criterions": [
                {
                    "exact_snippets": "Patients with breast-sparing procedure",
                    "criterion": "breast-sparing procedure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have received or be planning to receive radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "received",
                                "planning to receive"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at start of tamoxifen treatment",
                    "criterion": "tamoxifen treatment",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "start"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No endometrial simple or cystic hyperplasia, proliferative changes, complex (adenomatous) or atypical hyperplasia, or carcinoma",
            "criterions": [
                {
                    "exact_snippets": "No endometrial simple or cystic hyperplasia",
                    "criterion": "endometrial simple or cystic hyperplasia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... proliferative changes",
                    "criterion": "endometrial proliferative changes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... complex (adenomatous) or atypical hyperplasia",
                    "criterion": "endometrial complex (adenomatous) or atypical hyperplasia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... carcinoma",
                    "criterion": "endometrial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be planning one of the following:",
            "criterions": [
                {
                    "exact_snippets": "Patients must be planning one of the following",
                    "criterion": "treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "options",
                            "expected_value": [
                                "one of the following"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Starting adjuvant tamoxifen for five years OR",
            "criterions": [
                {
                    "exact_snippets": "Starting adjuvant tamoxifen for five years",
                    "criterion": "adjuvant tamoxifen treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Started tamoxifen within 28 days prior to study and planning to receive adjuvant tamoxifen for five years",
            "criterions": [
                {
                    "exact_snippets": "Started tamoxifen within 28 days prior to study",
                    "criterion": "tamoxifen start date",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "planning to receive adjuvant tamoxifen for five years",
                    "criterion": "adjuvant tamoxifen duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormone receptor status:",
            "criterions": [
                {
                    "exact_snippets": "Hormone receptor status",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Candidate for adjuvant tamoxifen therapy",
            "criterions": [
                {
                    "exact_snippets": "Candidate for adjuvant tamoxifen therapy",
                    "criterion": "adjuvant tamoxifen therapy candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age:",
            "criterions": [
                {
                    "exact_snippets": "Age:",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adult",
            "criterions": [
                {
                    "exact_snippets": "Adult",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Sex:",
            "criterions": [
                {
                    "exact_snippets": "Sex:",
                    "criterion": "sex",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Menopausal status:",
            "criterions": [
                {
                    "exact_snippets": "Menopausal status:",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Postmenopausal defined as:",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 1 year since last menstrual period",
            "criterions": [
                {
                    "exact_snippets": "At least 1 year since last menstrual period",
                    "criterion": "time since last menstrual period",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 2 months since bilateral oophorectomy prior to breast cancer diagnosis",
            "criterions": [
                {
                    "exact_snippets": "At least 2 months since bilateral oophorectomy",
                    "criterion": "time since bilateral oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 4-12 months since last menstrual period and FSH elevated to postmenopausal range",
            "criterions": [
                {
                    "exact_snippets": "4-12 months since last menstrual period",
                    "criterion": "time since last menstrual period",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "months"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "FSH elevated to postmenopausal range",
                    "criterion": "FSH level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "elevated to postmenopausal range"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Postmenopausal estrogen therapy and 55 years of age or older",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal estrogen therapy",
                    "criterion": "postmenopausal estrogen therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "55 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 55,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Performance status:",
            "criterions": [
                {
                    "exact_snippets": "Performance status:",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Life expectancy:",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hematopoietic:",
            "criterions": [
                {
                    "exact_snippets": "Hematopoietic:",
                    "criterion": "hematopoietic system",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic:",
            "criterions": [
                {
                    "exact_snippets": "Hepatic:",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal:",
            "criterions": [
                {
                    "exact_snippets": "Renal:",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception during and for at least 2 months after study",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during and for at least 2 months after study",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during and for at least 2 months after study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer currently in complete remission",
            "criterions": [
                {
                    "exact_snippets": "No other malignancy within the past 5 years",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except adequately treated basal cell or squamous cell skin cancer",
                    "criterion": "basal cell or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... stage I or II cancer currently in complete remission",
                    "criterion": "stage I or II cancer",
                    "requirements": [
                        {
                            "requirement_type": "remission status",
                            "expected_value": "complete remission"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent nonmalignant-related illness that would preclude study",
            "criterions": [
                {
                    "exact_snippets": "No concurrent nonmalignant-related illness",
                    "criterion": "nonmalignant-related illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Biologic therapy:",
            "criterions": [
                {
                    "exact_snippets": "Biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chemotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy:",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adjuvant chemotherapy allowed",
            "criterions": [
                {
                    "exact_snippets": "Adjuvant chemotherapy allowed",
                    "criterion": "adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "No concurrent chemotherapy",
                    "criterion": "concurrent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Endocrine therapy:",
            "criterions": [
                {
                    "exact_snippets": "Endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "see disease characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior hormonal treatment for breast cancer (except tamoxifen)",
            "criterions": [
                {
                    "exact_snippets": "No prior hormonal treatment for breast cancer",
                    "criterion": "prior hormonal treatment for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except tamoxifen",
                    "criterion": "prior tamoxifen treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent postmenopausal estrogen therapy",
            "criterions": [
                {
                    "exact_snippets": "No concurrent postmenopausal estrogen therapy",
                    "criterion": "postmenopausal estrogen therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Radiotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "see disease characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery:",
            "criterions": [
                {
                    "exact_snippets": "Surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "See Disease Characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior or concurrent hysterectomy",
            "criterions": [
                {
                    "exact_snippets": "No prior or concurrent hysterectomy",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior or current participation in an adjuvant intergroup trial",
            "criterions": [
                {
                    "exact_snippets": "No prior or current participation in an adjuvant intergroup trial",
                    "criterion": "participation in an adjuvant intergroup trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other:",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other:",
            "criterions": []
        }
    ]
}