{
    "info": {
        "nct_id": "NCT02391194",
        "official_title": "A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery",
        "inclusion_criteria": "* Ductal carcinoma in situ (DCIS) or Stage I-III, primary invasive carcinoma of the breast\n* Primary surgical treatment is planned to be a mastectomy or lumpectomy. Sentinel lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the subject's therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Adequate renal function\n* Lab values (hematology and chemistry) within institution's normal laboratory limits\n* Willing to remain on-site for approximately 24 hours after administration of AVB-620 or, if required, stay overnight after the surgical procedure\n* If the subject received neoadjuvant therapy, residual tumor is present (to be determined by the primary surgeon)\n* If the subject received prior anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within institution's normal limits\n* Subject has the ability to understand and the willingness to sign a written informed consent document\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Recurrent ipsilateral breast cancer\n* Prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer within 4 weeks before the planned surgery.\n* Open surgery in the ipsilateral breast within 1 year of AVB-620 administration\n* History of radiation therapy to ipsilateral breast\n* Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of AVB-620 administration\n* Diagnosis of autoimmune disorders\n* History of drug-related anaphylactic reactions or allergic reactions; subjects with an active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids will be excluded\n* History of renal disease or current evidence of renal disease\n* Current diagnosis of any other active or clinically significant non-breast cancer\n* Systemic investigational drug of any kind within 6 weeks of AVB-620 administration\n* Pregnant or breast feeding",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Ductal carcinoma in situ (DCIS) or Stage I-III, primary invasive carcinoma of the breast",
            "criterions": [
                {
                    "exact_snippets": "Ductal carcinoma in situ (DCIS)",
                    "criterion": "ductal carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage I-III, primary invasive carcinoma of the breast",
                    "criterion": "primary invasive carcinoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "Stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "Stage"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Primary surgical treatment is planned to be a mastectomy or lumpectomy. Sentinel lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the subject's therapy.",
            "criterions": [
                {
                    "exact_snippets": "Primary surgical treatment is planned to be a mastectomy or lumpectomy.",
                    "criterion": "primary surgical treatment",
                    "requirements": [
                        {
                            "requirement_type": "planned procedure",
                            "expected_value": [
                                "mastectomy",
                                "lumpectomy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Sentinel lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the subject's therapy.",
                    "criterion": "lymph node procedure",
                    "requirements": [
                        {
                            "requirement_type": "planned procedure",
                            "expected_value": [
                                "Sentinel lymph node biopsy",
                                "axillary lymph node dissection"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lab values (hematology and chemistry) within institution's normal laboratory limits",
            "criterions": [
                {
                    "exact_snippets": "Lab values (hematology and chemistry) within institution's normal laboratory limits",
                    "criterion": "hematology lab values",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within institution's normal laboratory limits"
                        }
                    ]
                },
                {
                    "exact_snippets": "Lab values (hematology and chemistry) within institution's normal laboratory limits",
                    "criterion": "chemistry lab values",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within institution's normal laboratory limits"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to remain on-site for approximately 24 hours after administration of AVB-620 or, if required, stay overnight after the surgical procedure",
            "criterions": [
                {
                    "exact_snippets": "Willing to remain on-site for approximately 24 hours after administration of AVB-620",
                    "criterion": "willingness to remain on-site",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 24,
                                "unit": "hours"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "if required, stay overnight after the surgical procedure",
                    "criterion": "willingness to stay overnight",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "if required"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If the subject received neoadjuvant therapy, residual tumor is present (to be determined by the primary surgeon)",
            "criterions": [
                {
                    "exact_snippets": "If the subject received neoadjuvant therapy",
                    "criterion": "neoadjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "residual tumor is present",
                    "criterion": "residual tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If the subject received prior anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within institution's normal limits",
            "criterions": [
                {
                    "exact_snippets": "If the subject received prior anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within institution's normal limits",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within institution's normal limits"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has the ability to understand and the willingness to sign a written informed consent document",
            "criterions": [
                {
                    "exact_snippets": "Subject has the ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": "* Recurrent ipsilateral breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Recurrent ipsilateral breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "laterality",
                            "expected_value": "ipsilateral"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer within 4 weeks before the planned surgery.",
            "criterions": [
                {
                    "exact_snippets": "Prior neoadjuvant chemotherapy",
                    "criterion": "neoadjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks before the planned surgery"
                        }
                    ]
                },
                {
                    "exact_snippets": "biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks before the planned surgery"
                        }
                    ]
                },
                {
                    "exact_snippets": "current clinically or biopsy-proven node positive breast cancer",
                    "criterion": "node positive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "clinically proven",
                                "biopsy-proven"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Open surgery in the ipsilateral breast within 1 year of AVB-620 administration",
            "criterions": [
                {
                    "exact_snippets": "Open surgery in the ipsilateral breast",
                    "criterion": "open surgery in the ipsilateral breast",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of radiation therapy to ipsilateral breast",
            "criterions": [
                {
                    "exact_snippets": "History of radiation therapy to ipsilateral breast",
                    "criterion": "radiation therapy to ipsilateral breast",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of AVB-620 administration",
            "criterions": [
                {
                    "exact_snippets": "Abnormal cardiac rhythm not controlled with medication",
                    "criterion": "abnormal cardiac rhythm",
                    "requirements": [
                        {
                            "requirement_type": "control with medication",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of stroke",
                    "criterion": "history of stroke",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "coronary events",
                    "criterion": "coronary events",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "heart failure within 1 year of AVB-620 administration",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of autoimmune disorders",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of autoimmune disorders",
                    "criterion": "autoimmune disorders",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of drug-related anaphylactic reactions or allergic reactions; subjects with an active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids will be excluded",
            "criterions": [
                {
                    "exact_snippets": "History of drug-related anaphylactic reactions or allergic reactions",
                    "criterion": "drug-related anaphylactic reactions or allergic reactions",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active diagnosis of uncontrolled airway hyperactivity",
                    "criterion": "uncontrolled airway hyperactivity",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled asthma",
                    "criterion": "asthma",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "asthma requiring oral corticosteroids",
                    "criterion": "asthma",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "oral corticosteroids"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of renal disease or current evidence of renal disease",
            "criterions": [
                {
                    "exact_snippets": "History of renal disease",
                    "criterion": "renal disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "current evidence of renal disease",
                    "criterion": "renal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current diagnosis of any other active or clinically significant non-breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Current diagnosis of any other active or clinically significant non-breast cancer",
                    "criterion": "non-breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "active or clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Systemic investigational drug of any kind within 6 weeks of AVB-620 administration",
            "criterions": [
                {
                    "exact_snippets": "Systemic investigational drug of any kind within 6 weeks of AVB-620 administration",
                    "criterion": "systemic investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}