{
    "info": {
        "nct_id": "NCT04998682",
        "official_title": "TAD: Prospective Evaluation of Targeted Axillary Dissection After Neoadjuvant Systemic Therapy in Patients with Breast Cancer with Advanced Nodal Disease At Diagnosis",
        "inclusion_criteria": "* Women or men greater than or equal to 18 years.\n* Histologically confirmed invasive adenocarcinoma of the breast.\n* Clinical T0-4 N2-3 M0 at diagnosis (American Joint Committee on Cancer, 7th Edition)\n\n  * Assessment for cN2 disease will be performed by clinical exam and imaging. Patients should have pathologic level 1 and/or 2 axillary lymph nodes which are fixed/matted on physical exam.\n  * Cross-sectional imaging will be used to identify advanced nodal disease involving the axilla, infraclavicular, supraclavicular, and internal mammary regions, cN3 disease.\n* Patients must have biopsy proven involvement of the axillary lymph nodes.\n* Receipt of standard multiagent chemotherapy +/- targeted therapy based on tumor subtype.\n* Candidate for surgical management of breast cancer.\n* Ability to understand and willingness to sign a written informed consent document.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* History of allergic reactions or hypersensitivity to radioactive lymph node mapping agents or blue dye.\n* Pregnancy.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Women or men greater than or equal to 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Women or men",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "women",
                                "men"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "greater than or equal to 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed invasive adenocarcinoma of the breast.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed invasive adenocarcinoma of the breast",
                    "criterion": "adenocarcinoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically"
                        },
                        {
                            "requirement_type": "invasiveness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical T0-4 N2-3 M0 at diagnosis (American Joint Committee on Cancer, 7th Edition)",
            "criterions": [
                {
                    "exact_snippets": "T0-4",
                    "criterion": "tumor size (T)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "N2-3",
                    "criterion": "regional lymph nodes (N)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "distant metastasis (M)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Assessment for cN2 disease will be performed by clinical exam and imaging. Patients should have pathologic level 1 and/or 2 axillary lymph nodes which are fixed/matted on physical exam.",
            "criterions": [
                {
                    "exact_snippets": "cN2 disease",
                    "criterion": "cN2 disease",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": [
                                "clinical exam",
                                "imaging"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "pathologic level 1 and/or 2 axillary lymph nodes",
                    "criterion": "axillary lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "pathologic level",
                            "expected_value": [
                                "1",
                                "2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "axillary lymph nodes which are fixed/matted on physical exam",
                    "criterion": "axillary lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "fixed/matted"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cross-sectional imaging will be used to identify advanced nodal disease involving the axilla, infraclavicular, supraclavicular, and internal mammary regions, cN3 disease.",
            "criterions": [
                {
                    "exact_snippets": "advanced nodal disease involving the axilla",
                    "criterion": "advanced nodal disease",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "axilla"
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced nodal disease involving the ... infraclavicular",
                    "criterion": "advanced nodal disease",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "infraclavicular"
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced nodal disease involving the ... supraclavicular",
                    "criterion": "advanced nodal disease",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "supraclavicular"
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced nodal disease involving the ... internal mammary regions",
                    "criterion": "advanced nodal disease",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "internal mammary regions"
                        }
                    ]
                },
                {
                    "exact_snippets": "cN3 disease",
                    "criterion": "cN3 disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have biopsy proven involvement of the axillary lymph nodes.",
            "criterions": [
                {
                    "exact_snippets": "biopsy proven involvement of the axillary lymph nodes",
                    "criterion": "axillary lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receipt of standard multiagent chemotherapy +/- targeted therapy based on tumor subtype.",
            "criterions": [
                {
                    "exact_snippets": "Receipt of standard multiagent chemotherapy",
                    "criterion": "receipt of standard multiagent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "targeted therapy based on tumor subtype",
                    "criterion": "targeted therapy based on tumor subtype",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Candidate for surgical management of breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "Candidate for surgical management of breast cancer.",
                    "criterion": "surgical management of breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and willingness to sign a written informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "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 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": "* History of allergic reactions or hypersensitivity to radioactive lymph node mapping agents or blue dye.",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reactions or hypersensitivity to radioactive lymph node mapping agents",
                    "criterion": "allergic reactions or hypersensitivity to radioactive lymph node mapping agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "History of allergic reactions or hypersensitivity to ... blue dye",
                    "criterion": "allergic reactions or hypersensitivity to blue dye",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}