{
    "info": {
        "nct_id": "NCT00897091",
        "official_title": "Molecular Predictors of Outcome on CAF Plus Tamoxifen Versus Tamoxifen Alone in Postmenopausal Women With Node Positive, Receptor Positive Breast Cancer [NCI Correlative Science Reference No. # 8814A-ICSC]",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed breast cancer\n\n  * Node-positive disease (pT1-3a, pN1-2 [clinical N0-1], M0)\n* Previously enrolled in SWOG-8814, a treatment clinical trial, and in SWOG-9445, a companion tissue banking study\n* Tumor block or unstained sections available from initial diagnosis in the SWOG archive\n\n  * Sufficient tumor in block or unstained sections\n  * Patients for whom only unstained slides are available must have acceptable reverse-transcriptase-polymerase chain reaction (RT-PCR) profiles\n* Sufficient RNA (≥ 300 ng) for RT-PCR analysis with the Oncotype DX 21 gene assay\n* Average normalized cycle threshold for the 5 reference genes ≤ 35\n* Follow-up data from the SWOG-8814 clinical trial obtained from the patient\n* Hormone receptor status:\n\n  * Estrogen and/or progesterone receptor positive tumor\n\nPATIENT CHARACTERISTICS:\n\n* Female\n* Postmenopausal\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics"
    },
    "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": "N/A",
                            "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": "* Histologically confirmed breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Node-positive disease (pT1-3a, pN1-2 [clinical N0-1], M0)",
            "criterions": [
                {
                    "exact_snippets": "Node-positive disease",
                    "criterion": "node-positive disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pT1-3a",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "pT"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "pT"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "pN1-2",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "pN"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "pN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical N0-1",
                    "criterion": "clinical lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "M"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previously enrolled in SWOG-8814, a treatment clinical trial, and in SWOG-9445, a companion tissue banking study",
            "criterions": [
                {
                    "exact_snippets": "Previously enrolled in SWOG-8814, a treatment clinical trial",
                    "criterion": "enrollment in SWOG-8814",
                    "requirements": [
                        {
                            "requirement_type": "enrollment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previously enrolled in ... SWOG-9445, a companion tissue banking study",
                    "criterion": "enrollment in SWOG-9445",
                    "requirements": [
                        {
                            "requirement_type": "enrollment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor block or unstained sections available from initial diagnosis in the SWOG archive",
            "criterions": [
                {
                    "exact_snippets": "Tumor block or unstained sections available",
                    "criterion": "tumor sample",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "initial diagnosis",
                    "criterion": "initial diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "SWOG archive",
                    "criterion": "SWOG archive",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "SWOG archive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sufficient tumor in block or unstained sections",
            "criterions": [
                {
                    "exact_snippets": "Sufficient tumor in block or unstained sections",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "sufficient"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients for whom only unstained slides are available must have acceptable reverse-transcriptase-polymerase chain reaction (RT-PCR) profiles",
            "criterions": [
                {
                    "exact_snippets": "only unstained slides are available",
                    "criterion": "unstained slides",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have acceptable reverse-transcriptase-polymerase chain reaction (RT-PCR) profiles",
                    "criterion": "RT-PCR profiles",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": "acceptable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sufficient RNA (≥ 300 ng) for RT-PCR analysis with the Oncotype DX 21 gene assay",
            "criterions": [
                {
                    "exact_snippets": "Sufficient RNA (≥ 300 ng)",
                    "criterion": "RNA quantity",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 300,
                                "unit": "ng"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Average normalized cycle threshold for the 5 reference genes ≤ 35",
            "criterions": [
                {
                    "exact_snippets": "Average normalized cycle threshold for the 5 reference genes ≤ 35",
                    "criterion": "average normalized cycle threshold for the 5 reference genes",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 35,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Follow-up data from the SWOG-8814 clinical trial obtained from the patient",
            "criterions": [
                {
                    "exact_snippets": "Follow-up data from the SWOG-8814 clinical trial obtained from the patient",
                    "criterion": "follow-up data",
                    "requirements": [
                        {
                            "requirement_type": "source",
                            "expected_value": "SWOG-8814 clinical trial"
                        },
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormone receptor status:",
            "criterions": [
                {
                    "exact_snippets": "Hormone receptor status",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Estrogen and/or progesterone receptor positive tumor",
            "criterions": [
                {
                    "exact_snippets": "Estrogen and/or progesterone receptor positive tumor",
                    "criterion": "estrogen receptor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Estrogen and/or progesterone receptor positive tumor",
                    "criterion": "progesterone receptor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Postmenopausal",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent 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": "refer to disease characteristics section"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        }
    ]
}