{
    "info": {
        "nct_id": "NCT02482376",
        "official_title": "A Phase II Preoperative Single-Fraction Partial Breast Radiotherapy in Early Stage Breast Cancer: Analysis of Pathologic Response",
        "inclusion_criteria": "1. Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast\n\n   a. Biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis.\n2. Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)\n3. Clinical T1N0M0 invasive carcinoma or Ductal carcinoma in situ (DCIS) < or equal to 2cm\n4. 60 years of age or older or 50-59 with a low Oncotype score (0-17) Oncotype is not required for women diagnosed with DCIS.\n5. Estrogen receptor positive (ER+), Human epidermal growth factor 2 negative (HER2-) HER-2 status is not required for women diagnosed with DCIS.\n6. Women of child-bearing potential must consent to use adequate contraception during the course of the study. Female subjects must agree to use a medically acceptable contraceptives including: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use.\n7. White blood cells (WBC) > 3000, Hemoglobin ( Hgb) > 9, platelets >100000 within 30 days of consent\n8. Eligible for contrasted magnetic resonance imaging (MRI) on initial evaluation with glomerular filtration rate (GFR) ≥ 60 ml/min. A diagnostic MRI ordered within one month will be considered an acceptable alternative and will not be repeated.\n9. Outside breast imaging will be reviewed at Duke to confirm findings are consistent with trial eligibility.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 50 Years",
        "exclusion_criteria": "1. Neoadjuvant chemotherapy\n2. Breast implant in the breast to be treated with SBRT\n3. Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)\n4. Subjects unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length\n5. HER2 positive\n6. Positive serum pregnancy test\n7. Insufficient breast imaging to judge clinical stage\n8. Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.\n9. Subjects in whom treatment planning constraints cannot be met",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast",
            "criterions": [
                {
                    "exact_snippets": "Women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "biopsy proven diagnosis of ductal carcinoma in situ",
                    "criterion": "ductal carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "biopsy proven diagnosis of ... invasive carcinoma of the breast",
                    "criterion": "invasive carcinoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "a. Biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis.",
            "criterions": [
                {
                    "exact_snippets": "Biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis.",
                    "criterion": "biopsy tissue",
                    "requirements": [
                        {
                            "requirement_type": "review",
                            "expected_value": "confirm diagnosis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)",
            "criterions": [
                {
                    "exact_snippets": "no prior breast or nodal radiotherapy",
                    "criterion": "prior breast or nodal radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no imaging evidence of multicentric or multifocal disease",
                    "criterion": "imaging evidence of multicentric or multifocal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no pregnant women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no comorbid conditions precluding surgery",
                    "criterion": "comorbid conditions precluding surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Clinical T1N0M0 invasive carcinoma or Ductal carcinoma in situ (DCIS) < or equal to 2cm",
            "criterions": [
                {
                    "exact_snippets": "Clinical T1N0M0 invasive carcinoma",
                    "criterion": "invasive carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T1N0M0"
                        }
                    ]
                },
                {
                    "exact_snippets": "Ductal carcinoma in situ (DCIS)",
                    "criterion": "Ductal carcinoma in situ (DCIS)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "< or equal to 2cm",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. 60 years of age or older or 50-59 with a low Oncotype score (0-17) Oncotype is not required for women diagnosed with DCIS.",
            "criterions": [
                {
                    "exact_snippets": "60 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "50-59 with a low Oncotype score (0-17)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 59,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "50-59 with a low Oncotype score (0-17)",
                    "criterion": "Oncotype score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 17,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Oncotype is not required for women diagnosed with DCIS",
                    "criterion": "Oncotype requirement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "diagnosed with DCIS"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Estrogen receptor positive (ER+), Human epidermal growth factor 2 negative (HER2-) HER-2 status is not required for women diagnosed with DCIS.",
            "criterions": [
                {
                    "exact_snippets": "Estrogen receptor positive (ER+)",
                    "criterion": "estrogen receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Human epidermal growth factor 2 negative (HER2-)",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER-2 status is not required for women diagnosed with DCIS",
                    "criterion": "HER2 status requirement for DCIS",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Women of child-bearing potential must consent to use adequate contraception during the course of the study. Female subjects must agree to use a medically acceptable contraceptives including: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use.",
            "criterions": [
                {
                    "exact_snippets": "Women of child-bearing potential must consent to use adequate contraception during the course of the study.",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Female subjects must agree to use a medically acceptable contraceptives including: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD).",
                    "criterion": "contraceptive methods",
                    "requirements": [
                        {
                            "requirement_type": "acceptable methods",
                            "expected_value": [
                                "surgical sterilization",
                                "approved hormonal contraceptives",
                                "barrier methods with spermicide",
                                "intrauterine device (IUD)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use.",
                    "criterion": "contraceptive methods",
                    "requirements": [
                        {
                            "requirement_type": "unacceptable methods",
                            "expected_value": [
                                "Plan B (TM)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. White blood cells (WBC) > 3000, Hemoglobin ( Hgb) > 9, platelets >100000 within 30 days of consent",
            "criterions": [
                {
                    "exact_snippets": "White blood cells (WBC) > 3000",
                    "criterion": "white blood cells",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 3000,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin ( Hgb) > 9",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets >100000",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Eligible for contrasted magnetic resonance imaging (MRI) on initial evaluation with glomerular filtration rate (GFR) ≥ 60 ml/min. A diagnostic MRI ordered within one month will be considered an acceptable alternative and will not be repeated.",
            "criterions": [
                {
                    "exact_snippets": "Eligible for contrasted magnetic resonance imaging (MRI)",
                    "criterion": "eligibility for contrasted MRI",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "glomerular filtration rate (GFR) ≥ 60 ml/min",
                    "criterion": "glomerular filtration rate (GFR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "A diagnostic MRI ordered within one month",
                    "criterion": "diagnostic MRI timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within one month"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Outside breast imaging will be reviewed at Duke to confirm findings are consistent with trial eligibility.",
            "criterions": [
                {
                    "exact_snippets": "Outside breast imaging will be reviewed ... to confirm findings are consistent with trial eligibility.",
                    "criterion": "breast imaging findings",
                    "requirements": [
                        {
                            "requirement_type": "consistency",
                            "expected_value": "consistent with trial eligibility"
                        }
                    ]
                }
            ]
        },
        {
            "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": "N/A",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 50 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 50 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Neoadjuvant chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Neoadjuvant chemotherapy",
                    "criterion": "neoadjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Breast implant in the breast to be treated with SBRT",
            "criterions": [
                {
                    "exact_snippets": "Breast implant in the breast to be treated with SBRT",
                    "criterion": "breast implant",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)",
            "criterions": [
                {
                    "exact_snippets": "Lupus",
                    "criterion": "Lupus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rheumatoid arthritis",
                    "criterion": "rheumatoid arthritis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "scleroderma",
                    "criterion": "scleroderma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Subjects unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length",
            "criterions": [
                {
                    "exact_snippets": "unable to receive study treatment planning secondary to body habitus",
                    "criterion": "body habitus",
                    "requirements": [
                        {
                            "requirement_type": "ability to receive treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to receive study treatment planning secondary to ... inability to lie flat on the stomach at length",
                    "criterion": "ability to lie flat on the stomach",
                    "requirements": [
                        {
                            "requirement_type": "ability to receive treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. HER2 positive",
            "criterions": [
                {
                    "exact_snippets": "HER2 positive",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Positive serum pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Positive serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Insufficient breast imaging to judge clinical stage",
            "criterions": [
                {
                    "exact_snippets": "Insufficient breast imaging",
                    "criterion": "breast imaging",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.",
            "criterions": [
                {
                    "exact_snippets": "placement of a biopsy clip at the diagnostic procedure",
                    "criterion": "biopsy clip placement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unwilling to undergo clip placement",
                    "criterion": "willingness to undergo clip placement",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Subjects in whom treatment planning constraints cannot be met",
            "criterions": [
                {
                    "exact_snippets": "Subjects in whom treatment planning constraints cannot be met",
                    "criterion": "treatment planning constraints",
                    "requirements": [
                        {
                            "requirement_type": "feasibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}