{
    "info": {
        "nct_id": "NCT04240548",
        "official_title": "Role of Regional Nodal Irradiation in Node Positive Breast Cancer Patients With ypN0 After Preoperative Chemotherapy",
        "inclusion_criteria": "* WHO performance status 0-1\n* Invasive Breast Cancer with cT1-3 cN1-2 at time of diagnosis\n* Axillary nodal involvement can be detected using, clinical examination, ultrasound, CT scan or PET scan\n* Pathologic confirmation using, FNAC, core biopsy or excisional biopsy\n* ER, PR, Her2 neu and Ki67 status should be available for all patients\n* All patients should have received standard preoperative chemotherapy prior to surgery\n* At the time of surgery, all patients should have axillary clearance with at least 6 nodes harvested from the axilla\n* Patients who have undergone mastectomy or lumpectomy with negative margins with ypN0, ypN0(+i) or ypN0(+mol) are eligible for randomization\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* Poor performance status\n* Definitive clinical or radiologic evidence of metastatic disease\n* T4 tumors including inflammatory breast cancer\n* N3 disease detected clinically or by imaging\n* Patients with histologically positive axillary nodes after preoperative chemotherapy\n* Positive surgical margin after definitive surgery\n* Previous ipsilateral or contralateral breast cancer\n* Previous chest wall or breast irradiation\n* Second primary cancer\n* Active connective tissue disease",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* WHO performance status 0-1",
                "criterions": [
                    {
                        "exact_snippets": "WHO performance status 0-1",
                        "criterion": "WHO performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "WHO performance status 0-1",
                        "criterion": "WHO performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Invasive Breast Cancer with cT1-3 cN1-2 at time of diagnosis",
                "criterions": [
                    {
                        "exact_snippets": "Invasive Breast Cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "invasiveness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "cT1-3",
                        "criterion": "tumor size",
                        "requirement": {
                            "requirement_type": "clinical stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "cN1-2",
                        "criterion": "lymph node involvement",
                        "requirement": {
                            "requirement_type": "clinical stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Invasive Breast Cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "invasiveness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "cT1-3",
                        "criterion": "tumor size",
                        "requirement": {
                            "requirement_type": "clinical stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "cN1-2",
                        "criterion": "lymph node involvement",
                        "requirement": {
                            "requirement_type": "clinical stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Axillary nodal involvement can be detected using, clinical examination, ultrasound, CT scan or PET scan",
                "criterions": [
                    {
                        "exact_snippets": "Axillary nodal involvement can be detected",
                        "criterion": "axillary nodal involvement",
                        "requirement": {
                            "requirement_type": "detection",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Axillary nodal involvement can be detected",
                        "criterion": "axillary nodal involvement",
                        "requirement": {
                            "requirement_type": "detection",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ER, PR, Her2 neu and Ki67 status should be available for all patients",
                "criterions": [
                    {
                        "exact_snippets": "ER ... status should be available",
                        "criterion": "ER status",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "PR ... status should be available",
                        "criterion": "PR status",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Her2 neu ... status should be available",
                        "criterion": "Her2 neu status",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Ki67 status should be available",
                        "criterion": "Ki67 status",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ER ... status should be available",
                        "criterion": "ER status",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "PR ... status should be available",
                        "criterion": "PR status",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Her2 neu ... status should be available",
                        "criterion": "Her2 neu status",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Ki67 status should be available",
                        "criterion": "Ki67 status",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* All patients should have received standard preoperative chemotherapy prior to surgery",
                "criterions": [
                    {
                        "exact_snippets": "All patients should have received standard preoperative chemotherapy",
                        "criterion": "preoperative chemotherapy",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "All patients should have received standard preoperative chemotherapy",
                        "criterion": "preoperative chemotherapy",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* At the time of surgery, all patients should have axillary clearance with at least 6 nodes harvested from the axilla",
                "criterions": [
                    {
                        "exact_snippets": "axillary clearance",
                        "criterion": "axillary clearance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "at least 6 nodes harvested from the axilla",
                        "criterion": "nodes harvested from the axilla",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "nodes"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "axillary clearance",
                        "criterion": "axillary clearance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "at least 6 nodes harvested from the axilla",
                        "criterion": "nodes harvested from the axilla",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "nodes"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients who have undergone mastectomy or lumpectomy with negative margins with ypN0, ypN0(+i) or ypN0(+mol) are eligible for randomization",
                "criterions": [
                    {
                        "exact_snippets": "undergone mastectomy or lumpectomy",
                        "criterion": "surgical procedure",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "mastectomy",
                                "lumpectomy"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "negative margins",
                        "criterion": "surgical margins",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "ypN0, ypN0(+i) or ypN0(+mol)",
                        "criterion": "nodal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "ypN0",
                                "ypN0(+i)",
                                "ypN0(+mol)"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "undergone mastectomy or lumpectomy",
                                "criterion": "surgical procedure",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": [
                                        "mastectomy",
                                        "lumpectomy"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "negative margins",
                        "criterion": "surgical margins",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "ypN0, ypN0(+i) or ypN0(+mol)",
                                "criterion": "nodal status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": [
                                        "ypN0",
                                        "ypN0(+i)",
                                        "ypN0(+mol)"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 70 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Poor performance status",
                "criterions": [
                    {
                        "exact_snippets": "Poor performance status",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Poor performance status",
                    "criterion": "performance status",
                    "requirement": {
                        "requirement_type": "quality",
                        "expected_value": "poor"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Definitive clinical or radiologic evidence of metastatic disease",
                "criterions": [
                    {
                        "exact_snippets": "Definitive clinical or radiologic evidence of metastatic disease",
                        "criterion": "metastatic disease",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": [
                                "clinical",
                                "radiologic"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Definitive clinical or radiologic evidence of metastatic disease",
                    "criterion": "metastatic disease",
                    "requirement": {
                        "requirement_type": "evidence",
                        "expected_value": [
                            "clinical",
                            "radiologic"
                        ]
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* T4 tumors including inflammatory breast cancer",
                "criterions": [
                    {
                        "exact_snippets": "T4 tumors",
                        "criterion": "tumor stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "T4"
                        }
                    },
                    {
                        "exact_snippets": "inflammatory breast cancer",
                        "criterion": "breast cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "inflammatory"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "T4 tumors",
                        "criterion": "tumor stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "T4"
                        }
                    },
                    {
                        "exact_snippets": "inflammatory breast cancer",
                        "criterion": "breast cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "inflammatory"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* N3 disease detected clinically or by imaging",
                "criterions": [
                    {
                        "exact_snippets": "N3 disease detected clinically or by imaging",
                        "criterion": "N3 disease",
                        "requirement": {
                            "requirement_type": "detection method",
                            "expected_value": [
                                "clinically",
                                "imaging"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "N3 disease detected clinically or by imaging",
                        "criterion": "N3 disease",
                        "requirement": {
                            "requirement_type": "detection method",
                            "expected_value": [
                                "clinically",
                                "imaging"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with histologically positive axillary nodes after preoperative chemotherapy",
                "criterions": [
                    {
                        "exact_snippets": "histologically positive axillary nodes",
                        "criterion": "axillary nodes",
                        "requirement": {
                            "requirement_type": "histological status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "after preoperative chemotherapy",
                        "criterion": "preoperative chemotherapy",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "histologically positive axillary nodes",
                        "criterion": "axillary nodes",
                        "requirement": {
                            "requirement_type": "histological status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "after preoperative chemotherapy",
                        "criterion": "preoperative chemotherapy",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Positive surgical margin after definitive surgery",
                "criterions": [
                    {
                        "exact_snippets": "Positive surgical margin after definitive surgery",
                        "criterion": "surgical margin",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Positive surgical margin after definitive surgery",
                        "criterion": "surgical margin",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Previous chest wall or breast irradiation",
                "criterions": [
                    {
                        "exact_snippets": "Previous chest wall or breast irradiation",
                        "criterion": "chest wall irradiation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Previous chest wall or breast irradiation",
                        "criterion": "breast irradiation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Previous chest wall or breast irradiation",
                        "criterion": "chest wall irradiation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Previous chest wall or breast irradiation",
                        "criterion": "breast irradiation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Second primary cancer",
                "criterions": [
                    {
                        "exact_snippets": "Second primary cancer",
                        "criterion": "second primary cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Second primary cancer",
                    "criterion": "second primary cancer",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Active connective tissue disease",
                "criterions": [
                    {
                        "exact_snippets": "Active connective tissue disease",
                        "criterion": "connective tissue disease",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Active connective tissue disease",
                    "criterion": "connective tissue disease",
                    "requirement": {
                        "requirement_type": "activity",
                        "expected_value": "active"
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Pathologic confirmation using, FNAC, core biopsy or excisional biopsy",
                "criterions": [
                    {
                        "exact_snippets": "Pathologic confirmation using, FNAC, core biopsy or excisional biopsy",
                        "criterion": "pathologic confirmation",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "FNAC",
                                "core biopsy",
                                "excisional biopsy"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pathologic confirmation using, FNAC, core biopsy or excisional biopsy",
                        "criterion": "pathologic confirmation",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "FNAC"
                        }
                    },
                    {
                        "exact_snippets": "Pathologic confirmation using, FNAC, core biopsy or excisional biopsy",
                        "criterion": "pathologic confirmation",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "core biopsy"
                        }
                    },
                    {
                        "exact_snippets": "Pathologic confirmation using, FNAC, core biopsy or excisional biopsy",
                        "criterion": "pathologic confirmation",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "excisional biopsy"
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Previous ipsilateral or contralateral breast cancer",
                "criterions": [
                    {
                        "exact_snippets": "Previous ipsilateral or contralateral breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "laterality",
                            "expected_value": [
                                "ipsilateral",
                                "contralateral"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Previous ipsilateral or contralateral breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Previous ipsilateral or contralateral breast cancer",
                                "criterion": "breast cancer",
                                "requirement": {
                                    "requirement_type": "laterality",
                                    "expected_value": [
                                        "ipsilateral"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "Previous ipsilateral or contralateral breast cancer",
                                "criterion": "breast cancer",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Previous ipsilateral or contralateral breast cancer",
                                "criterion": "breast cancer",
                                "requirement": {
                                    "requirement_type": "laterality",
                                    "expected_value": [
                                        "contralateral"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "Previous ipsilateral or contralateral breast cancer",
                                "criterion": "breast cancer",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}