{
    "info": {
        "nct_id": "NCT02413320",
        "official_title": "Randomized Open Label Phase II Trial of Neoadjuvant Carboplatin Plus Docetaxel or Carboplatin Plus Paclitaxel Followed by Doxorubicin Plus Cyclophosphamide in Stage I-III Triple-negative Breast Cancer",
        "inclusion_criteria": "* Patients with newly diagnosed stage I (T>1cm), II or III triple negative breast cancer who have not had definitive breast surgery or received systemic chemotherapy\n* The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor and progesterone receptor staining present in ≤ 10% of invasive cancer cells by Immunohistochemistry.\n* HER- 2 negativity will be based on the current ASCO-CAP guidelines for HER testing\n* No prior chemotherapy, endocrine therapy or radiation therapy with therapeutic intent for this cancer\n* Female subjects age 18 - 70 years\n* ECOG Performance Status of 0-1\n* Adequate organ and marrow function as defined below:\n\n  * Leukocytes ≥ 3,000/uL\n  * Absolute neutrophil count ≥ 1500/uL\n  * Platelets ≥ 100,000/uL\n  * Total bilirubin ≤ 1.5mg/dL\n  * AST(SGOT)/ALT(SPGT) ≤ 2 x institutional upper limit of normal\n  * Creatinine ≤ 1.5mg/dl and/or Creatinine Clearance ≥ 60mL/min\n  * Serum albumin ≥ 3.0 g/dL\n* Women of child-bearing potential must agree to use adequate contraception\n* Pretreatment lab values must be performed within 14 days of treatment initiation, and other baseline studies performed within 30 days prior to registration\n* Subjects should have LVEF ≥ 50% by echocardiogram or MUGA scan performed within 4 weeks prior to treatment initiation\n* Subjects should have breast and axillary imaging with breast MRI or breast and axillary ultrasound within 4 weeks prior to treatment initiation\n* Subjects with clinically/radiologically abnormal axillary lymph nodes should have pathological confirmation of disease with image guided biopsy/fine needle aspiration.\n* Subjects must be already enrolled in P.R.O.G.E.C.T observational registry\n* Staging to rule out metastatic disease is recommended for subjects with clinical stage III disease\n* Subjects with bilateral disease are eligible if they meet other eligibility criteria.\n* Neuropathy: No baseline neuropathy grade > 2\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* Current or anticipated use of other investigational agents\n* Subject has received chemotherapy, radiotherapy or surgery for the treatment of breast cancer\n* Subject with metastatic disease\n* History of allergic reactions to compounds of similar chemical or biologic composition to carboplatin, docetaxel, doxorubicin, cyclophosphamide, paclitaxel, or other agents used in the study\n* Subjects with inflammatory breast cancer\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements\n* Subject is pregnant or nursing\n* Subjects with concomitant or previous malignancies within the last 5 years. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).\n* Ejection Fraction <50% on ECHO or MUGA\n* Cardiac function: Subjects with congestive heart failure, myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia attack within the past 12 months, uncontrolled hypertension (Systolic BP>160 or Diastolic BP>90), uncontrolled or symptomatic arrhythmia, or grade ≥ 2 peripheral vascular disease",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* HER- 2 negativity will be based on the current ASCO-CAP guidelines for HER testing",
                "criterions": [
                    {
                        "exact_snippets": "HER- 2 negativity",
                        "criterion": "HER-2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "HER- 2 negativity",
                        "criterion": "HER-2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No prior chemotherapy, endocrine therapy or radiation therapy with therapeutic intent for this cancer",
                "criterions": [
                    {
                        "exact_snippets": "No prior chemotherapy",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior ... endocrine therapy",
                        "criterion": "prior endocrine therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior ... radiation therapy with therapeutic intent",
                        "criterion": "prior radiation therapy with therapeutic intent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No prior chemotherapy",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior ... endocrine therapy",
                        "criterion": "prior endocrine therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior ... radiation therapy with therapeutic intent",
                        "criterion": "prior radiation therapy with therapeutic intent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Female subjects age 18 - 70 years",
                "criterions": [
                    {
                        "exact_snippets": "Female subjects",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "age 18 - 70 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Female subjects",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "age 18 - 70 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ECOG Performance Status of 0-1",
                "criterions": [
                    {
                        "exact_snippets": "ECOG Performance Status of 0-1",
                        "criterion": "ECOG 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": "ECOG Performance Status of 0-1",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate organ and marrow function as defined below:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate organ and marrow function",
                        "criterion": "organ and marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate organ and marrow function",
                        "criterion": "organ and marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Leukocytes ≥ 3,000/uL",
                "criterions": [
                    {
                        "exact_snippets": "Leukocytes ≥ 3,000/uL",
                        "criterion": "leukocytes",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "uL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Leukocytes ≥ 3,000/uL",
                        "criterion": "leukocytes",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "uL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count ≥ 1500/uL",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count ≥ 1500/uL",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "uL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count ≥ 1500/uL",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "uL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelets ≥ 100,000/uL",
                "criterions": [
                    {
                        "exact_snippets": "Platelets ≥ 100,000/uL",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "uL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelets ≥ 100,000/uL",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "uL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Total bilirubin ≤ 1.5mg/dL",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin ≤ 1.5mg/dL",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Total bilirubin ≤ 1.5mg/dL",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* AST(SGOT)/ALT(SPGT) ≤ 2 x institutional upper limit of normal",
                "criterions": [
                    {
                        "exact_snippets": "AST(SGOT)/ALT(SPGT) ≤ 2 x institutional upper limit of normal",
                        "criterion": "AST(SGOT)/ALT(SPGT) levels",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "AST(SGOT)/ALT(SPGT) ≤ 2 x institutional upper limit of normal",
                        "criterion": "AST(SGOT)/ALT(SPGT) levels",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Serum albumin ≥ 3.0 g/dL",
                "criterions": [
                    {
                        "exact_snippets": "Serum albumin ≥ 3.0 g/dL",
                        "criterion": "serum albumin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.0,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Serum albumin ≥ 3.0 g/dL",
                        "criterion": "serum albumin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.0,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women of child-bearing potential must agree to use adequate contraception",
                "criterions": [
                    {
                        "exact_snippets": "Women of child-bearing potential",
                        "criterion": "child-bearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must agree to use adequate contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must agree to use adequate contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Women of child-bearing potential",
                    "criterion": "child-bearing potential",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "must agree to use adequate contraception",
                            "criterion": "contraception use",
                            "requirement": {
                                "requirement_type": "agreement",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "must agree to use adequate contraception",
                            "criterion": "contraception use",
                            "requirement": {
                                "requirement_type": "adequacy",
                                "expected_value": true
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Pretreatment lab values must be performed within 14 days of treatment initiation, and other baseline studies performed within 30 days prior to registration",
                "criterions": [
                    {
                        "exact_snippets": "Pretreatment lab values must be performed within 14 days of treatment initiation",
                        "criterion": "pretreatment lab values",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "other baseline studies performed within 30 days prior to registration",
                        "criterion": "baseline studies",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Pretreatment lab values must be performed within 14 days of treatment initiation",
                        "criterion": "pretreatment lab values",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "other baseline studies performed within 30 days prior to registration",
                        "criterion": "baseline studies",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects should have breast and axillary imaging with breast MRI or breast and axillary ultrasound within 4 weeks prior to treatment initiation",
                "criterions": [
                    {
                        "exact_snippets": "Subjects should have breast and axillary imaging with breast MRI or breast and axillary ultrasound",
                        "criterion": "breast and axillary imaging",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "within 4 weeks prior to treatment initiation",
                        "criterion": "timing of imaging",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Subjects should have breast and axillary imaging with breast MRI or breast and axillary ultrasound",
                                "criterion": "breast and axillary imaging",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Subjects should have breast and axillary imaging with breast MRI or breast and axillary ultrasound",
                                        "criterion": "breast MRI",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Subjects should have breast and axillary imaging with breast MRI or breast and axillary ultrasound",
                                        "criterion": "breast and axillary ultrasound",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "within 4 weeks prior to treatment initiation",
                        "criterion": "timing of imaging",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects with clinically/radiologically abnormal axillary lymph nodes should have pathological confirmation of disease with image guided biopsy/fine needle aspiration.",
                "criterions": [
                    {
                        "exact_snippets": "clinically/radiologically abnormal axillary lymph nodes",
                        "criterion": "axillary lymph nodes",
                        "requirement": {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pathological confirmation of disease",
                        "criterion": "disease confirmation",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "image guided biopsy",
                                "fine needle aspiration"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "clinically/radiologically abnormal axillary lymph nodes",
                    "criterion": "axillary lymph nodes",
                    "requirement": {
                        "requirement_type": "abnormality",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "exact_snippets": "pathological confirmation of disease",
                    "criterion": "disease confirmation",
                    "requirement": {
                        "requirement_type": "method",
                        "expected_value": [
                            "image guided biopsy",
                            "fine needle aspiration"
                        ]
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Subjects must be already enrolled in P.R.O.G.E.C.T observational registry",
                "criterions": [
                    {
                        "exact_snippets": "Subjects must be already enrolled in P.R.O.G.E.C.T observational registry",
                        "criterion": "enrollment in P.R.O.G.E.C.T observational registry",
                        "requirement": {
                            "requirement_type": "enrollment status",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Subjects must be already enrolled in P.R.O.G.E.C.T observational registry",
                        "criterion": "enrollment in P.R.O.G.E.C.T observational registry",
                        "requirement": {
                            "requirement_type": "enrollment status",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Staging to rule out metastatic disease is recommended for subjects with clinical stage III disease",
                "criterions": [
                    {
                        "exact_snippets": "clinical stage III disease",
                        "criterion": "clinical stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "III"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "clinical stage III disease",
                    "criterion": "clinical stage",
                    "requirement": {
                        "requirement_type": "stage",
                        "expected_value": "III"
                    }
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Subjects with bilateral disease are eligible if they meet other eligibility criteria.",
                "criterions": [
                    {
                        "exact_snippets": "bilateral disease",
                        "criterion": "bilateral disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "bilateral disease",
                        "criterion": "bilateral disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "if they meet other eligibility criteria",
                        "criterion": "other eligibility criteria",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Neuropathy: No baseline neuropathy grade > 2",
                "criterions": [
                    {
                        "exact_snippets": "Neuropathy: No baseline neuropathy grade > 2",
                        "criterion": "neuropathy",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Neuropathy: No baseline neuropathy grade > 2",
                        "criterion": "neuropathy",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "requirement_type": "status",
                            "expected_value": "healthy"
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                ]
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                        "exact_snippets": "Healthy volunteers allowed",
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        },
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            "identified_line": {
                "line": "Must be FEMALE",
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                    {
                        "exact_snippets": "Must be FEMALE",
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                            "requirement_type": "expected_value",
                            "expected_value": "female"
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                    }
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                        "exact_snippets": "Must be FEMALE",
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                    }
                ]
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        },
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            "identified_line": {
                "line": "Must have minimum age of 18 Years",
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                    {
                        "exact_snippets": "minimum age of 18 Years",
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                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
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                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "minimum age of 18 Years",
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                            "requirement_type": "minimum",
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        },
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            "identified_line": {
                "line": "Must have maximum age of 70 Years",
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                        "exact_snippets": "maximum age of 70 Years",
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                            "requirement_type": "maximum",
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                                "operator": "<=",
                                "value": 70,
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                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
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                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Current or anticipated use of other investigational agents",
                "criterions": [
                    {
                        "exact_snippets": "Current or anticipated use of other investigational agents",
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                            "requirement_type": "presence",
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            "identified_line": {
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                    {
                        "exact_snippets": "Subject has received chemotherapy ... for the treatment of breast cancer",
                        "criterion": "chemotherapy for breast cancer",
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                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Subject has received ... radiotherapy ... for the treatment of breast cancer",
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                            "expected_value": true
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                    },
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                        "exact_snippets": "Subject has received ... surgery for the treatment of breast cancer",
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                                "exact_snippets": "Subject has received chemotherapy ... for the treatment of breast cancer",
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                                }
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                                "exact_snippets": "Subject has received ... radiotherapy ... for the treatment of breast cancer",
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                                }
                            }
                        ]
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                                "exact_snippets": "Subject has received ... surgery for the treatment of breast cancer",
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                            }
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                        "exact_snippets": "metastatic disease",
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                    "exact_snippets": "metastatic disease",
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            "identified_line": {
                "line": "* History of allergic reactions to compounds of similar chemical or biologic composition to carboplatin, docetaxel, doxorubicin, cyclophosphamide, paclitaxel, or other agents used in the study",
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                    {
                        "exact_snippets": "History of allergic reactions to compounds of similar chemical or biologic composition to carboplatin, docetaxel, doxorubicin, cyclophosphamide, paclitaxel, or other agents used in the study",
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                            "requirement_type": "compounds",
                            "expected_value": [
                                "carboplatin",
                                "docetaxel",
                                "doxorubicin",
                                "cyclophosphamide",
                                "paclitaxel",
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                                "exact_snippets": "History of allergic reactions to compounds of similar chemical or biologic composition to carboplatin, docetaxel, doxorubicin, cyclophosphamide, paclitaxel, or other agents used in the study",
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                                "requirement": {
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                                }
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                                "exact_snippets": "History of allergic reactions to compounds of similar chemical or biologic composition to carboplatin, docetaxel, doxorubicin, cyclophosphamide, paclitaxel, or other agents used in the study",
                                "criterion": "allergic reactions",
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                                        "cyclophosphamide",
                                        "paclitaxel",
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                ]
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        },
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                        "exact_snippets": "inflammatory breast cancer",
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                ]
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                    "exact_snippets": "inflammatory breast cancer",
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                    }
                }
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        },
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            "identified_line": {
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                        }
                    },
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                        "exact_snippets": "social situations that would limit compliance with study requirements",
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                                        "exact_snippets": "social situations that would limit compliance with study requirements",
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        },
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                    {
                        "exact_snippets": "Ejection Fraction <50%",
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        },
        {
            "identified_line": {
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                    {
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                    {
                        "exact_snippets": "myocardial infarction",
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                    },
                    {
                        "exact_snippets": "uncontrolled or symptomatic arrhythmia",
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                    },
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                                "operator": ">=",
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                    {
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                    },
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    ],
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                    {
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                        }
                    },
                    {
                        "exact_snippets": "or received systemic chemotherapy",
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                                                    "expected_value": [
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                                                        "value": 1,
                                                        "unit": "cm"
                                                    }
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                                        ]
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                                        }
                                    }
                                ]
                            },
                            {
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                        ]
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                    {
                        "not_criteria": {
                            "exact_snippets": "or received systemic chemotherapy",
                            "criterion": "systemic chemotherapy",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor and progesterone receptor staining present in ≤ 10% of invasive cancer cells by Immunohistochemistry.",
                "criterions": [
                    {
                        "exact_snippets": "invasive tumor must be hormone receptor-poor",
                        "criterion": "hormone receptor status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "poor"
                        }
                    },
                    {
                        "exact_snippets": "estrogen receptor ... staining present in ≤ 10% of invasive cancer cells by Immunohistochemistry",
                        "criterion": "estrogen receptor staining",
                        "requirement": {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "% of invasive cancer cells"
                            }
                        }
                    },
                    {
                        "exact_snippets": "progesterone receptor staining present in ≤ 10% of invasive cancer cells by Immunohistochemistry",
                        "criterion": "progesterone receptor staining",
                        "requirement": {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "% of invasive cancer cells"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "estrogen receptor ... staining present in ≤ 10% of invasive cancer cells by Immunohistochemistry",
                                "criterion": "estrogen receptor staining",
                                "requirement": {
                                    "requirement_type": "percentage",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "% of invasive cancer cells"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "progesterone receptor staining present in ≤ 10% of invasive cancer cells by Immunohistochemistry",
                                "criterion": "progesterone receptor staining",
                                "requirement": {
                                    "requirement_type": "percentage",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "% of invasive cancer cells"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Creatinine ≤ 1.5mg/dl and/or Creatinine Clearance ≥ 60mL/min",
                "criterions": [
                    {
                        "exact_snippets": "Creatinine ≤ 1.5mg/dl",
                        "criterion": "creatinine level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dl"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Creatinine Clearance ≥ 60mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Creatinine \u0010 1.5mg/dl",
                                "criterion": "creatinine level",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "mg/dl"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Creatinine Clearance \u0010 60mL/min",
                                "criterion": "creatinine clearance",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 60,
                                        "unit": "mL/min"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects should have LVEF ≥ 50% by echocardiogram or MUGA scan performed within 4 weeks prior to treatment initiation",
                "criterions": [
                    {
                        "exact_snippets": "LVEF ≥ 50% by echocardiogram or MUGA scan",
                        "criterion": "LVEF",
                        "requirement": {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "echocardiogram or MUGA scan performed within 4 weeks prior to treatment initiation",
                        "criterion": "echocardiogram or MUGA scan timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks prior to treatment initiation"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "LVEF \u001e 50% by echocardiogram or MUGA scan",
                                "criterion": "LVEF",
                                "requirement": {
                                    "requirement_type": "measurement",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "%"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "echocardiogram or MUGA scan performed within 4 weeks prior to treatment initiation",
                                "criterion": "echocardiogram or MUGA scan timing",
                                "requirement": {
                                    "requirement_type": "timing",
                                    "expected_value": "within 4 weeks prior to treatment initiation"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "LVEF \u001e 50% by echocardiogram or MUGA scan",
                                "criterion": "LVEF",
                                "requirement": {
                                    "requirement_type": "measurement",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "%"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "echocardiogram or MUGA scan performed within 4 weeks prior to treatment initiation",
                                "criterion": "echocardiogram or MUGA scan timing",
                                "requirement": {
                                    "requirement_type": "timing",
                                    "expected_value": "within 4 weeks prior to treatment initiation"
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Subject is pregnant or nursing",
                "criterions": [
                    {
                        "exact_snippets": "Subject is pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "nursing",
                        "criterion": "nursing",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Subject is pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "nursing",
                        "criterion": "nursing",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}