{
    "info": {
        "nct_id": "NCT00696072",
        "official_title": "Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic",
        "inclusion_criteria": "* Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease\n* Has measurable or evaluable-only disease\n* Is female, ≥18 yrs of age, post menopausal or surgically sterile\n* HER2 negative, HR+, ER+ and/or PgR+ breast cancer\n* 0-1 prior chemotherapy regimen for metastatic disease.\n* Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior\n* Prior tamoxifen therapy is allowed\n* No AI therapy for >1 year without recurrence\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Pregnant or breast feeding\n* Prior hormonal therapy for metastatic or locally recurrent disease\n* >1 chemotherapy regimen for metastatic disease\n* Pleural or pericardial effusion\n* Serious cardiac condition",
        "miscellaneous_criteria": "For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com."
    },
    "inclusion_lines": [
        {
            "line": "* Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Has histologic or cytologic diagnosis of breast cancer",
                    "criterion": "breast cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologic",
                                "cytologic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of unresectable locally recurrent or metastatic disease",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "unresectable locally recurrent or metastatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has measurable or evaluable-only disease",
            "criterions": [
                {
                    "exact_snippets": "measurable or evaluable-only disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "measurable",
                                "evaluable-only"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Is female, ≥18 yrs of age, post menopausal or surgically sterile",
            "criterions": [
                {
                    "exact_snippets": "Is female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "≥18 yrs of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "yrs"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "post menopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post menopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "surgically sterile",
                    "criterion": "reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "surgically sterile"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HER2 negative, HR+, ER+ and/or PgR+ breast cancer",
            "criterions": [
                {
                    "exact_snippets": "HER2 negative",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "HR+",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "ER+",
                    "criterion": "estrogen receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "PgR+",
                    "criterion": "progesterone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 0-1 prior chemotherapy regimen for metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "0-1 prior chemotherapy regimen for metastatic disease",
                    "criterion": "prior chemotherapy regimen for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior",
            "criterions": [
                {
                    "exact_snippets": "Prior adjuvant or neoadjuvant chemotherapy",
                    "criterion": "adjuvant or neoadjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "completed at least 1 month prior",
                    "criterion": "time since chemotherapy completion",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior tamoxifen therapy is allowed",
            "criterions": [
                {
                    "exact_snippets": "Prior tamoxifen therapy is allowed",
                    "criterion": "tamoxifen therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No AI therapy for >1 year without recurrence",
            "criterions": [
                {
                    "exact_snippets": "AI therapy for >1 year without recurrence",
                    "criterion": "AI therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        },
                        {
                            "requirement_type": "recurrence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Pregnant or breast feeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior hormonal therapy for metastatic or locally recurrent disease",
            "criterions": [
                {
                    "exact_snippets": "Prior hormonal therapy for metastatic or locally recurrent disease",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic or locally recurrent disease",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "metastatic",
                                "locally recurrent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* >1 chemotherapy regimen for metastatic disease",
            "criterions": [
                {
                    "exact_snippets": ">1 chemotherapy regimen for metastatic disease",
                    "criterion": "chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pleural or pericardial effusion",
            "criterions": [
                {
                    "exact_snippets": "Pleural or pericardial effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pleural or pericardial effusion",
                    "criterion": "pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious cardiac condition",
            "criterions": [
                {
                    "exact_snippets": "Serious cardiac condition",
                    "criterion": "cardiac condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.",
            "criterions": []
        }
    ]
}