{
    "info": {
        "nct_id": "NCT01186991",
        "official_title": "A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Patients With Metastatic, Triple-Negative Breast Cancer",
        "inclusion_criteria": "* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR)-, and human epidermal growth factor 2 (HER2)-negative (triple-negative) adenocarcinoma of the breast\n* Confirmed availability of tumor tissue\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior therapy with two or more regimens for metastatic breast cancer\n* Any systemic anti-cancer therapy within 3 weeks prior to Day 1 of Cycle 1\n* Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1 of Cycle 1\n* Prior therapy with a taxane for metastatic breast cancer\n* Prior therapy with bevacizumab, sorafenib, sunitinib, or other putative vascular endothelial growth factor (VEGF) pathway-targeted therapy following diagnosis of breast cancer\n* Prior therapy with hormones and/or trastuzumab\n* Inadequate hematology, renal, or hepatic organ function\n\nBevacizumab Exclusion Criteria:\n\n* Uncontrolled hypertension (systolic pressure greater than [>] 150 millimeters of mercury [mmHg] and/or diastolic pressure > 100 mmHg), with or without anti-hypertensive medication\n* Evidence of bleeding diathesis or coagulopathy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR)-, and human epidermal growth factor 2 (HER2)-negative (triple-negative) adenocarcinoma of the breast",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed estrogen receptor (ER)- ... negative",
                    "criterion": "estrogen receptor (ER) status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed ... progesterone receptor (PR)- ... negative",
                    "criterion": "progesterone receptor (PR) status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed ... human epidermal growth factor 2 (HER2)-negative",
                    "criterion": "human epidermal growth factor 2 (HER2) status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed ... adenocarcinoma of the breast",
                    "criterion": "adenocarcinoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Confirmed availability of tumor tissue",
            "criterions": [
                {
                    "exact_snippets": "availability of tumor tissue",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Prior therapy with two or more regimens for metastatic breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy with two or more regimens for metastatic breast cancer",
                    "criterion": "prior therapy regimens for metastatic breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "regimens"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any systemic anti-cancer therapy within 3 weeks prior to Day 1 of Cycle 1",
            "criterions": [
                {
                    "exact_snippets": "systemic anti-cancer therapy within 3 weeks prior to Day 1 of Cycle 1",
                    "criterion": "systemic anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1 of Cycle 1",
            "criterions": [
                {
                    "exact_snippets": "Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1 of Cycle 1",
                    "criterion": "major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1 of Cycle 1",
                    "criterion": "open biopsy",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1 of Cycle 1",
                    "criterion": "significant traumatic injury",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior therapy with a taxane for metastatic breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy with a taxane",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "drug",
                            "expected_value": "taxane"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic breast cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior therapy with bevacizumab, sorafenib, sunitinib, or other putative vascular endothelial growth factor (VEGF) pathway-targeted therapy following diagnosis of breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy with bevacizumab, sorafenib, sunitinib, or other putative vascular endothelial growth factor (VEGF) pathway-targeted therapy",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "specific treatments",
                            "expected_value": [
                                "bevacizumab",
                                "sorafenib",
                                "sunitinib",
                                "other putative VEGF pathway-targeted therapy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "following diagnosis of breast cancer",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior therapy with hormones and/or trastuzumab",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy with hormones",
                    "criterion": "prior hormone therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior therapy with ... trastuzumab",
                    "criterion": "prior trastuzumab therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inadequate hematology, renal, or hepatic organ function",
            "criterions": [
                {
                    "exact_snippets": "Inadequate hematology ... function",
                    "criterion": "hematology function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Inadequate ... renal ... function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Inadequate ... hepatic organ function",
                    "criterion": "hepatic organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Bevacizumab Exclusion Criteria:",
            "criterions": [
                {
                    "exact_snippets": "Bevacizumab Exclusion Criteria",
                    "criterion": "Bevacizumab exclusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension (systolic pressure greater than [>] 150 millimeters of mercury [mmHg] and/or diastolic pressure > 100 mmHg), with or without anti-hypertensive medication",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension (systolic pressure greater than [>] 150 millimeters of mercury [mmHg]",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled hypertension ... diastolic pressure > 100 mmHg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of bleeding diathesis or coagulopathy",
            "criterions": [
                {
                    "exact_snippets": "Evidence of bleeding diathesis",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence of ... coagulopathy",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}