{
    "info": {
        "nct_id": "NCT00767520",
        "official_title": "A Randomized, Double-Blind, Multi-Center Phase II Trial of Exemestane (Aromasin®) Plus Dasatinib Versus Exemestane Plus Placebo in Advanced Estrogen Receptor-Positive Breast Cancer After Disease Progression on a Non-Steroidal Aromatase Inhibitor (NSAI)",
        "inclusion_criteria": "* Histologically-documented invasive estrogen receptor positive breast cancer , with tumor tissue from prior surgery available for analysis\n* Prior therapy with a non-steroidal aromatase inhibitor\n* Recurrent or progressive advanced breast cancer (locally-advanced or metastatic)\n* Documented breast cancer with tumor ≤ 28 days prior to study entry\n* Women who are NOT of childbearing potential\n* Must be able to take oral medication\n* Performance Status 0 or 1\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Pleural or pericardial effusion or ascites (of any etiology; Grade ≥ 1) within 6 months prior to study entry\n* Any chemotherapy, immunotherapy < 6 months before study entry. Any targeted therapy (eg. lapatinib) < 6 months before study entry, unless given in combination with an NSAI\n* Any antitumor therapy, including radiotherapy or hormonal therapy, within 15 days prior to study entry\n* Prior exposure to exemestane, any Src-family kinase inhibitor including dasatinib, to agents intended to control osteolytic disease other than bisphosphonates, or to any investigational agent for breast cancer\n* Concurrent or previous malignant disease requiring chemotherapy or radiation treatment within the prior 3 years\n* Significant bleeding disorder, or ongoing or recent clinically-significant gastrointestinal bleeding\n* Any serious cardiac condition, including congestive heart failure or myocardial infarction within 6 months, uncontrolled angina, or Class III or IV heart disease as defined by the New York Heart Association, baseline ejection fraction ≤ 40%, diagnosed congenital long QT syndrome, clinically-significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes), QTc interval > 450 msec at baseline (Fridericia correction)\n* Hematologic abnormality Grade ≥ 2\n* Hypocalcemia of Grade ≥ 1\n* Any Chemistry abnormality of Grade ≥ 2 [except Grade 2 indirect bilirubin permitted if diagnosed Gilbert's disease]\n* Pregnant Women and Women of Childbearing Potential (WOCBP)\n* Extremely lactose intolerant, in the judgment of treating physician (100 mg dasatinib contains 135 mg lactose, posing a problem only if intolerance is severe)\n* Receiving any of the following concomitant medications: Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Subjects must discontinue drug use at least 7 days prior to starting dasatinib)\n* Potent inhibitors of CYP3A4 isoenzyme\n* Prisoners or subjects who are involuntarily incarcerated; or subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically-documented invasive estrogen receptor positive breast cancer , with tumor tissue from prior surgery available for analysis",
            "criterions": [
                {
                    "exact_snippets": "Histologically-documented invasive estrogen receptor positive breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "histology",
                            "expected_value": "invasive"
                        },
                        {
                            "requirement_type": "receptor status",
                            "expected_value": "estrogen receptor positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor tissue from prior surgery available for analysis",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior therapy with a non-steroidal aromatase inhibitor",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy with a non-steroidal aromatase inhibitor",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-steroidal aromatase inhibitor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recurrent or progressive advanced breast cancer (locally-advanced or metastatic)",
            "criterions": [
                {
                    "exact_snippets": "Recurrent or progressive advanced breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "recurrent",
                                "progressive",
                                "advanced"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally-advanced or metastatic",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally-advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documented breast cancer with tumor ≤ 28 days prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "Documented breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor ≤ 28 days prior to study entry",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "time since documentation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women who are NOT of childbearing potential",
            "criterions": [
                {
                    "exact_snippets": "Women who are NOT of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "NOT of childbearing potential"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must be able to take oral medication",
            "criterions": [
                {
                    "exact_snippets": "Must be able to take oral medication",
                    "criterion": "ability to take oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance Status 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Performance Status 0 or 1",
                    "criterion": "Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Pleural or pericardial effusion or ascites (of any etiology; Grade ≥ 1) within 6 months prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "Pleural or pericardial effusion or ascites",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pleural or pericardial effusion or ascites",
                    "criterion": "pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pleural or pericardial effusion or ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Grade ≥ 1",
                    "criterion": "effusion or ascites grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 months prior to study entry",
                    "criterion": "effusion or ascites occurrence time",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months prior to study entry"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any chemotherapy, immunotherapy < 6 months before study entry. Any targeted therapy (eg. lapatinib) < 6 months before study entry, unless given in combination with an NSAI",
            "criterions": [
                {
                    "exact_snippets": "Any chemotherapy, immunotherapy < 6 months before study entry.",
                    "criterion": "chemotherapy, immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Any targeted therapy (eg. lapatinib) < 6 months before study entry, unless given in combination with an NSAI",
                    "criterion": "targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        },
                        {
                            "requirement_type": "combination with NSAI",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any antitumor therapy, including radiotherapy or hormonal therapy, within 15 days prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "Any antitumor therapy, including radiotherapy or hormonal therapy, within 15 days prior to study entry",
                    "criterion": "antitumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 15,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior exposure to exemestane, any Src-family kinase inhibitor including dasatinib, to agents intended to control osteolytic disease other than bisphosphonates, or to any investigational agent for breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Prior exposure to exemestane",
                    "criterion": "prior exposure to exemestane",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior exposure to ... any Src-family kinase inhibitor including dasatinib",
                    "criterion": "prior exposure to Src-family kinase inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior exposure to ... agents intended to control osteolytic disease other than bisphosphonates",
                    "criterion": "prior exposure to agents intended to control osteolytic disease other than bisphosphonates",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior exposure to ... any investigational agent for breast cancer",
                    "criterion": "prior exposure to investigational agent for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent or previous malignant disease requiring chemotherapy or radiation treatment within the prior 3 years",
            "criterions": [
                {
                    "exact_snippets": "Concurrent or previous malignant disease",
                    "criterion": "malignant disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring chemotherapy or radiation treatment",
                    "criterion": "chemotherapy or radiation treatment",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the prior 3 years",
                    "criterion": "time since treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant bleeding disorder, or ongoing or recent clinically-significant gastrointestinal bleeding",
            "criterions": [
                {
                    "exact_snippets": "Significant bleeding disorder",
                    "criterion": "bleeding disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "ongoing or recent clinically-significant gastrointestinal bleeding",
                    "criterion": "gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "ongoing",
                                "recent"
                            ]
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically-significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any serious cardiac condition, including congestive heart failure or myocardial infarction within 6 months, uncontrolled angina, or Class III or IV heart disease as defined by the New York Heart Association, baseline ejection fraction ≤ 40%, diagnosed congenital long QT syndrome, clinically-significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes), QTc interval > 450 msec at baseline (Fridericia correction)",
            "criterions": [
                {
                    "exact_snippets": "serious cardiac condition, including congestive heart failure",
                    "criterion": "serious cardiac condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled angina",
                    "criterion": "uncontrolled angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Class III or IV heart disease as defined by the New York Heart Association",
                    "criterion": "Class III or IV heart disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "baseline ejection fraction ≤ 40%",
                    "criterion": "baseline ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed congenital long QT syndrome",
                    "criterion": "congenital long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically-significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes)",
                    "criterion": "clinically-significant ventricular arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc interval > 450 msec at baseline (Fridericia correction)",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "msec"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hematologic abnormality Grade ≥ 2",
            "criterions": [
                {
                    "exact_snippets": "Hematologic abnormality Grade ≥ 2",
                    "criterion": "hematologic abnormality",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypocalcemia of Grade ≥ 1",
            "criterions": [
                {
                    "exact_snippets": "Hypocalcemia of Grade ≥ 1",
                    "criterion": "hypocalcemia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any Chemistry abnormality of Grade ≥ 2 [except Grade 2 indirect bilirubin permitted if diagnosed Gilbert's disease]",
            "criterions": [
                {
                    "exact_snippets": "Chemistry abnormality of Grade ≥ 2",
                    "criterion": "chemistry abnormality",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Grade 2 indirect bilirubin permitted if diagnosed Gilbert's disease",
                    "criterion": "indirect bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        },
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "Gilbert's disease"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant Women and Women of Childbearing Potential (WOCBP)",
            "criterions": [
                {
                    "exact_snippets": "Pregnant Women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of Childbearing Potential (WOCBP)",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "women of childbearing potential"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Extremely lactose intolerant, in the judgment of treating physician (100 mg dasatinib contains 135 mg lactose, posing a problem only if intolerance is severe)",
            "criterions": [
                {
                    "exact_snippets": "Extremely lactose intolerant",
                    "criterion": "lactose intolerance",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "extreme"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receiving any of the following concomitant medications: Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Subjects must discontinue drug use at least 7 days prior to starting dasatinib)",
            "criterions": [
                {
                    "exact_snippets": "Receiving any of the following concomitant medications: Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes",
                    "criterion": "concomitant medications",
                    "requirements": [
                        {
                            "requirement_type": "category",
                            "expected_value": "Category I drugs"
                        },
                        {
                            "requirement_type": "risk",
                            "expected_value": "causing Torsades de Pointes"
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects must discontinue drug use at least 7 days prior to starting dasatinib",
                    "criterion": "discontinuation of drug use",
                    "requirements": [
                        {
                            "requirement_type": "time before starting dasatinib",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Potent inhibitors of CYP3A4 isoenzyme",
            "criterions": [
                {
                    "exact_snippets": "Potent inhibitors of CYP3A4 isoenzyme",
                    "criterion": "CYP3A4 isoenzyme inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "potency",
                            "expected_value": "potent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prisoners or subjects who are involuntarily incarcerated; or subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness",
            "criterions": [
                {
                    "exact_snippets": "Prisoners or subjects who are involuntarily incarcerated",
                    "criterion": "incarceration status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "involuntarily incarcerated"
                        }
                    ]
                },
                {
                    "exact_snippets": "subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness",
                    "criterion": "detention status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "compulsorily detained"
                        }
                    ]
                },
                {
                    "exact_snippets": "subjects who are compulsorily detained for treatment of either a psychiatric ... illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "compulsorily detained"
                        }
                    ]
                },
                {
                    "exact_snippets": "subjects who are compulsorily detained for treatment of either a ... physical (eg, infectious disease) illness",
                    "criterion": "physical illness",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "compulsorily detained"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}