{
    "info": {
        "nct_id": "NCT01831076",
        "official_title": "Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors. A Phase II Study to Identify Molecular Predictors for Hormone Responsiveness and/or Resistance.",
        "inclusion_criteria": "* Histologically or cytologically confirmed breast cancer\n* ER positive (+)\n* Primary tumor 2-4 regional lymph nodes 0-2 (T2-4N0-2); patients may have metastatic disease, provided local-regional surgery is clinically indicated\n* Clinical stage II/III\n* Postmenopausal- defined as having had a previous bilateral oophorectomy or, for women with no prior hysterectomy, the absence of spontaneous menstrual cycles for more than 1 year\n* Newly diagnosed\n* Patients with prior non-breast malignancies are eligible if they have been disease free for >= 5 years before study entry; patients with squamous or basal cell carcinoma of the skin that has been effectively treated, carcinoma in situ of the cervix that has been treated by surgery only, or lobular carcinoma in situ (LCIS) of the ipsilateral or contralateral breast that has been treated by surgery only are eligible, even if the cancer was diagnosed within 5 years before randomization\n* Serum creatinine =< 1.5 x institutional upper limit of normal (ULN)\n* Hemoglobin within normal limits for institution\n* Absolute granulocyte count >= 1500\n* Platelet count >= 100,000\n* Serum glutamic oxaloacetic transaminase (SGOT), aspartate aminotransferase (AST) or serum glutamate pyruvate transaminase (SGPT), alanine aminotransferase (ALT) =< 2.5 x ULN\n* Total bilirubin < 2 x ULN for institution\n* Alkaline phosphatase < 2 x the ULN\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 50 Years",
        "exclusion_criteria": "* Completely resected\n* Prior hormone or chemotherapy\n* Unable to take oral medication\n* Patients who have nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude their being subjected to protocol therapy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Histologically or cytologically confirmed breast cancer",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ER positive (+)",
                "criterions": [
                    {
                        "exact_snippets": "ER positive (+)",
                        "criterion": "ER status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ER positive (+)",
                        "criterion": "ER status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Clinical stage II/III",
                "criterions": [
                    {
                        "exact_snippets": "Clinical stage II/III",
                        "criterion": "clinical stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "II",
                                "III"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Clinical stage II/III",
                        "criterion": "clinical stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "II",
                                "III"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Postmenopausal- defined as having had a previous bilateral oophorectomy or, for women with no prior hysterectomy, the absence of spontaneous menstrual cycles for more than 1 year",
                "criterions": [
                    {
                        "exact_snippets": "Postmenopausal- defined as having had a previous bilateral oophorectomy",
                        "criterion": "postmenopausal status",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "previous bilateral oophorectomy"
                        }
                    },
                    {
                        "exact_snippets": "Postmenopausal- defined as ... for women with no prior hysterectomy, the absence of spontaneous menstrual cycles for more than 1 year",
                        "criterion": "postmenopausal status",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "absence of spontaneous menstrual cycles for more than 1 year"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Postmenopausal- defined as having had a previous bilateral oophorectomy",
                                "criterion": "postmenopausal status",
                                "requirement": {
                                    "requirement_type": "definition",
                                    "expected_value": "previous bilateral oophorectomy"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Postmenopausal- defined as ... for women with no prior hysterectomy, the absence of spontaneous menstrual cycles for more than 1 year",
                                "criterion": "postmenopausal status",
                                "requirement": {
                                    "requirement_type": "definition",
                                    "expected_value": "absence of spontaneous menstrual cycles for more than 1 year"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Newly diagnosed",
                "criterions": [
                    {
                        "exact_snippets": "Newly diagnosed",
                        "criterion": "diagnosis status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "newly diagnosed"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Newly diagnosed",
                        "criterion": "diagnosis status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "newly diagnosed"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with prior non-breast malignancies are eligible if they have been disease free for >= 5 years before study entry; patients with squamous or basal cell carcinoma of the skin that has been effectively treated, carcinoma in situ of the cervix that has been treated by surgery only, or lobular carcinoma in situ (LCIS) of the ipsilateral or contralateral breast that has been treated by surgery only are eligible, even if the cancer was diagnosed within 5 years before randomization",
                "criterions": [
                    {
                        "exact_snippets": "prior non-breast malignancies",
                        "criterion": "prior non-breast malignancies",
                        "requirement": {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "squamous or basal cell carcinoma of the skin that has been effectively treated",
                        "criterion": "squamous or basal cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "treatment effectiveness",
                            "expected_value": "effectively treated"
                        }
                    },
                    {
                        "exact_snippets": "carcinoma in situ of the cervix that has been treated by surgery only",
                        "criterion": "carcinoma in situ of the cervix",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": "surgery only"
                        }
                    },
                    {
                        "exact_snippets": "lobular carcinoma in situ (LCIS) of the ipsilateral or contralateral breast that has been treated by surgery only",
                        "criterion": "lobular carcinoma in situ (LCIS) of the breast",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": "surgery only"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "prior non-breast malignancies",
                                "criterion": "prior non-breast malignancies",
                                "requirement": {
                                    "requirement_type": "disease-free duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "squamous or basal cell carcinoma of the skin that has been effectively treated",
                                "criterion": "squamous or basal cell carcinoma of the skin",
                                "requirement": {
                                    "requirement_type": "treatment effectiveness",
                                    "expected_value": "effectively treated"
                                }
                            },
                            {
                                "exact_snippets": "carcinoma in situ of the cervix that has been treated by surgery only",
                                "criterion": "carcinoma in situ of the cervix",
                                "requirement": {
                                    "requirement_type": "treatment type",
                                    "expected_value": "surgery only"
                                }
                            },
                            {
                                "exact_snippets": "lobular carcinoma in situ (LCIS) of the ipsilateral or contralateral breast that has been treated by surgery only",
                                "criterion": "lobular carcinoma in situ (LCIS) of the breast",
                                "requirement": {
                                    "requirement_type": "treatment type",
                                    "expected_value": "surgery only"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Serum creatinine =< 1.5 x institutional upper limit of normal (ULN)",
                "criterions": [
                    {
                        "exact_snippets": "Serum creatinine =< 1.5 x institutional upper limit of normal (ULN)",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper limit of normal (ULN)"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Serum creatinine =< 1.5 x institutional upper limit of normal (ULN)",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper limit of normal (ULN)"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hemoglobin within normal limits for institution",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin within normal limits for institution",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "within normal limits for institution"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hemoglobin within normal limits for institution",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "within normal limits for institution"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute granulocyte count >= 1500",
                "criterions": [
                    {
                        "exact_snippets": "Absolute granulocyte count >= 1500",
                        "criterion": "absolute granulocyte count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute granulocyte count >= 1500",
                        "criterion": "absolute granulocyte count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count >= 100,000",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count >= 100,000",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": ""
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelet count >= 100,000",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": ""
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Serum glutamic oxaloacetic transaminase (SGOT), aspartate aminotransferase (AST) or serum glutamate pyruvate transaminase (SGPT), alanine aminotransferase (ALT) =< 2.5 x ULN",
                "criterions": [
                    {
                        "exact_snippets": "Serum glutamic oxaloacetic transaminase (SGOT), aspartate aminotransferase (AST) ... =< 2.5 x ULN",
                        "criterion": "SGOT/AST level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "serum glutamate pyruvate transaminase (SGPT), alanine aminotransferase (ALT) =< 2.5 x ULN",
                        "criterion": "SGPT/ALT level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Serum glutamic oxaloacetic transaminase (SGOT), aspartate aminotransferase (AST) ... =< 2.5 x ULN",
                                "criterion": "SGOT/AST level",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "serum glutamate pyruvate transaminase (SGPT), alanine aminotransferase (ALT) =< 2.5 x ULN",
                                "criterion": "SGPT/ALT level",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Total bilirubin < 2 x ULN for institution",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin < 2 x ULN for institution",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "x ULN for institution"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Total bilirubin < 2 x ULN for institution",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "x ULN for institution"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Alkaline phosphatase < 2 x the ULN",
                "criterions": [
                    {
                        "exact_snippets": "Alkaline phosphatase < 2 x the ULN",
                        "criterion": "alkaline phosphatase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "x the ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Alkaline phosphatase < 2 x the ULN",
                        "criterion": "alkaline phosphatase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "x the ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 50 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 50 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 50 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Completely resected",
                "criterions": [
                    {
                        "exact_snippets": "Completely resected",
                        "criterion": "tumor",
                        "requirement": {
                            "requirement_type": "resection status",
                            "expected_value": "completely resected"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Completely resected",
                    "criterion": "tumor",
                    "requirement": {
                        "requirement_type": "resection status",
                        "expected_value": "completely resected"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Prior hormone or chemotherapy",
                "criterions": [
                    {
                        "exact_snippets": "Prior hormone or chemotherapy",
                        "criterion": "prior treatment",
                        "requirement": {
                            "requirement_type": "types",
                            "expected_value": [
                                "hormone",
                                "chemotherapy"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Prior hormone or chemotherapy",
                    "criterion": "prior treatment",
                    "requirement": {
                        "requirement_type": "types",
                        "expected_value": [
                            "hormone",
                            "chemotherapy"
                        ]
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Unable to take oral medication",
                "criterions": [
                    {
                        "exact_snippets": "Unable to take oral medication",
                        "criterion": "ability to take oral medication",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Unable to take oral medication",
                    "criterion": "ability to take oral medication",
                    "requirement": {
                        "requirement_type": "ability",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients who have nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude their being subjected to protocol therapy",
                "criterions": [
                    {
                        "exact_snippets": "nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.)",
                        "criterion": "nonmalignant systemic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "preclude their being subjected to protocol therapy",
                        "criterion": "ability to undergo protocol therapy",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.)",
                            "criterion": "nonmalignant systemic disease",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "preclude their being subjected to protocol therapy",
                            "criterion": "ability to undergo protocol therapy",
                            "requirement": {
                                "requirement_type": "ability",
                                "expected_value": true
                            }
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Primary tumor 2-4 regional lymph nodes 0-2 (T2-4N0-2); patients may have metastatic disease, provided local-regional surgery is clinically indicated",
                "criterions": [
                    {
                        "exact_snippets": "Primary tumor 2-4",
                        "criterion": "primary tumor",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "regional lymph nodes 0-2",
                        "criterion": "regional lymph nodes",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "patients may have metastatic disease",
                        "criterion": "metastatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "local-regional surgery is clinically indicated",
                        "criterion": "local-regional surgery",
                        "requirement": {
                            "requirement_type": "indication",
                            "expected_value": "clinically indicated"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}